109 Evaluation of a FDA and Health Canada Compliant Novel Medical Device for Improving Erectile Function Across Erectile Dysfunction Etiologies
Bibliographic record
Abstract
We sought to evaluate a new FDA and Health Canada compliant medical device consisting of a soft silicone occlusion loop (SSOL) with geodesigned anchoring in a cross-section of men. The SSOL design is novel, offering a unique means of loop fixing compared to traditional penile occlusion bands (POB) or c*ck rings (CR). We identified complimentary force vectors to circular constriction applied by the anchoring mechanism and theorized that this may optimize venous trapping in CVOD ED. Finally, the design of the SSOL is less obtrusive to the man and his partner, and does not impact external genitalia of the partner, which may make acceptance as a sexual function (SF) enhancement device for intimacy easier. SSOLs were obtained in January 2016. Groups using POB/CR, PDE5i use for ED contributed to most likely by CVOD, Peyronie's disease (PyD) less than 45 degrees responsive to PDE-5i or ICI (buckling segment or maximum EHS score 3 with PDE5i.), and men considered to have “normal” erectile function but seeking improved function, were offered SSOLs. Standard operating procedures in the clinic include IIEF-15, IPSS, and if applicable, PDQ/Pyd questionnaires. In-office teaching of ICI as well as the SSOL is strictly adhered to.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.006 | 0.012 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.002 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.002 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.002 | 0.001 |
| Insufficient payload (model declined to judge) | 0.030 | 0.002 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".