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510(k) Data Aggregation
(244 days)
TROJAN SIS Synthetic Latex Condom with Silicone Lubricant
The TROJAN SIS Synthetic Latex Condom with Silicone Lubricant is used for contraception and for prophylactic purposes (to prevent pregnancy and the transmission of sexually transmitted infections).
The TROJAN SIS Synthetic Latex Condom with Silicone Lubricant is made of a styrene-isoprene-styrene copolymer sheath, which covers the penis with a fitted membrane, and a silicone lubricant applied directly to the exterior of the condom. The condom is straight-walled, smooth, and has a nipple end. The condom has a nominal length of 185 mm, a nominal flat width of 55 mm, a nominal thickness of 0.065 mm, and conforms to the requirements of ISO 23409:2011(E).
The provided text is related to the FDA 510(k) summary for a condom device (TROJAN SIS Synthetic Latex Condom). It details the device's characteristics, comparison to a predicate device, and summaries of non-clinical and clinical performance testing. However, the request asks for information pertaining to an AI/Software as a Medical Device (SaMD), specifically regarding its acceptance criteria and the study proving it meets these criteria.
The document discusses physical testing and a clinical trial for a physical medical device (condom), not an AI/SaMD. Therefore, many of the requested elements (e.g., number of experts for ground truth, MRMC study, standalone algorithm performance) are not applicable to the content provided.
Based on the provided text, I can extract the acceptance criteria and study results for the condom's clinical performance, but it will not align with the implied AI/SaMD context of the questions.
If we interpret the request strictly for the provided information (condom device), here's the breakdown:
The document describes a clinical study (NCT05370196) to evaluate the performance of the TROJAN SIS Synthetic Latex Condom with Silicone Lubricant.
Acceptance Criteria and Device Performance (for the Condom)
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Non-Inferiority Limit) | Reported Device Performance (Upper Bound of one-sided 95% CI of difference, SIS - NRL) | Met Criteria? |
|---|---|---|---|
| Total Clinical Failure | Upper limit of 1-sided 95% CI of (SIS rate - NRL rate) ≤ 2.5% | 1.70% | Yes |
| Clinical Breakage | Upper limit of 1-sided 95% CI of (SIS rate - NRL rate) ≤ 2.0% | 1.67% | Yes |
| Clinical Complete Slippage | Upper limit of 1-sided 95% CI of (SIS rate - NRL rate) ≤ 2.0% | 0.44% | Yes |
Note: The reported performance values in the table are the upper bounds of the one-sided 95% confidence intervals for the difference in failure rates between the subject device (SIS) and the control (NRL). The primary objective was non-inferiority, meaning the SIS condom rate should not be significantly worse than the NRL control by more than the specified margin.
2. Sample size used for the test set and the data provenance:
- Test Set (Clinical Study Population):
- Couples enrolled: 300
- Couples completed study: 289
- Total condom uses contributing to analysis: 1,129 SIS condom uses and 1,130 NRL control condom uses.
- Data Provenance: Clinical trial conducted in California, USA. The study is described as a "randomized crossover clinical trial". This indicates a prospective data collection design.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This concept is not applicable to this study. The "ground truth" for condom failure (breakage, slippage) was established by self-reports from the study participants (couples) during actual use, not by expert review of data/images.
4. Adjudication method for the test set:
Not applicable in the context of this condom study, as outcomes were self-reported failures rather than subjective interpretations requiring adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This was a study comparing two physical condom types, not an AI-assisted interpretation study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This refers to an AI algorithm's performance, which is not relevant to this device.
7. The type of ground truth used:
- Based on: Clinical self-reports of condom breakage and complete slippage during actual use by couples. This is a form of outcomes data from a user perspective.
8. The sample size for the training set:
- Not applicable. This device is a physical product (condom), not an AI algorithm that requires a training set. The study was a clinical performance evaluation.
9. How the ground truth for the training set was established:
- Not applicable, as there is no training set for a physical device.
In summary, the provided document details the performance testing and clinical study for a physical condom device, not an AI/Software as a Medical Device. Therefore, many of the questions related to AI/SaMD specific methodologies (like expert adjudication, MRMC, training sets, etc.) are not addressed in the text.
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