(318 days)
The Durex synthetic polyisoprene male condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted disease).
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Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Device: Durex Synthetic Polyisoprene Male Condom
1. Table of Acceptance Criteria and Reported Device Performance
The FDA 510(k) summary does not explicitly list numerical acceptance criteria in a dedicated table format. Instead, it relies on demonstrating equivalence to predicate devices and conformance to established standards. The acceptance criteria are implicitly those set by the referenced standards and the performance of the predicate device.
| Acceptance Criteria (Implicit from Standards/Predicate) | Reported Device Performance |
|---|---|
| Physical Properties: | |
| Conformance to ASTM D3942-03 (Male Latex Condoms) | Conforms to relevant sections |
| Conformance to ISO 4074:2002 (Natural Rubber Latex Condoms) | Conforms to relevant sections |
| Conformance to ASTM D6324-05 (Synthetic Condoms) | Conforms to relevant sections |
| Similar performance properties as natural rubber latex condoms | Similar performance properties |
| Biocompatibility: | |
| Conformance to ISO 10993 standard | Meets or exceeds requirements |
| Conformance to FDA Guidance Memorandum G95-1 (1995) | Meets or exceeds requirements |
| Conformance to FDA guidance for testing of male condoms made from new material | Meets or exceeds requirements |
| Viral Penetration: | |
| Acceptable results in viral penetration studies | Acceptable results |
| Clinical Performance (Comparison to Predicate): | |
| No significant difference in clinical breakage | No significant difference |
| No significant difference in clinical slippage | No significant difference |
| Consumer User Evaluation: | |
| Favorable results in comparison to natural rubber and polyurethane condoms | Favorable results |
| Low incidence of consumer complaints in launched markets | Low incidence of complaints |
2. Sample Size Used for the Test Set and Data Provenance
- Clinical Investigation: "A clinical investigation was conducted in 2007... using the predicate device... as the control condom." The specific sample size for this clinical study is not explicitly stated in the provided text.
- Consumer User Evaluation: Conducted "in the UK and Italy during 2004". The specific sample size is not explicitly stated.
- Data Provenance:
- Clinical Investigation: Prospective (conducted in 2007) and global (implicitly, as it refers to US FDA guidelines but typical for such studies to have international sites, though specific country not mentioned for this study itself, only for predicate use).
- Consumer User Evaluation: Prospective (conducted in 2004) in the UK and Italy.
- Physical Testing: Performed as part of manufacturing and submission process; provenance is the manufacturer and testing labs.
- Biocompatibility/Viral Penetration: Lab-based studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable in the context of condom testing. Ground truth for condom performance is established through objective physical measurements, viral penetration assays, and clinical outcomes (breakage, slippage) observed by study participants and collected by trained clinical staff. There isn't a need for expert consensus on individual "cases" in the way it applies to image interpretation or diagnosis.
4. Adjudication Method for the Test Set
This is not applicable in the traditional sense of medical device studies involving expert interpretation or diagnostic outcomes. For clinical breakage and slippage, the events are typically recorded by the users and confirmed by study staff. Discrepancies would be resolved through standard clinical trial monitoring and data validation procedures rather than an adjudication panel of experts.
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
This is not applicable. This is a device for contraception and disease prevention, not an interpretative medical device or AI-assisted diagnostic tool. Therefore, there are no "human readers" or "AI assistance" in the context of its primary function.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable. This device is a physical product (a condom), not an algorithm or AI system.
7. The Type of Ground Truth Used
- Physical Properties: Objective measurements against international and domestic standards (e.g., tensile strength, burst volume, length, width).
- Biocompatibility: Laboratory test results demonstrating non-toxicity, non-irritation, etc., as per ISO 10993 and FDA guidelines.
- Viral Penetration: Laboratory test results using viral challenge models.
- Clinical Performance: User-reported clinical outcomes (breakage and slippage) during actual use in a controlled clinical setting, compared to the predicate device.
- Consumer User Evaluation: User satisfaction, preference, and comfort reported by study participants.
- Post-Market Surveillance: Real-world consumer complaint data.
8. The Sample Size for the Training Set
This is not applicable in the context of device approval for a physical product like a condom. There isn't a "training set" in the machine learning sense. The device is manufactured based on established specifications and tested against those specifications and performance benchmarks derived from predicate devices and standards.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the reasons stated in point 8. The "ground truth" for manufacturing a condom to a certain standard is the set of specifications and physical properties required by the relevant ASTM/ISO standards and the performance profile of the predicate device, which itself was established through a historical process of testing and clinical use.
§ 884.5300 Condom.
(a)
Identification. A condom is a sheath which completely covers the penis with a closely fitting membrane. The condom is used for contraceptive and for prophylactic purposes (preventing transmission of sexually transmitted infections). The device may also be used to collect semen to aid in the diagnosis of infertility.(b)
Classification. (1) Class II (special controls) for condoms made of materials other than natural rubber latex, including natural membrane (skin) or synthetic.(2) Class II (special controls) for natural rubber latex condoms. The guidance document entitled “Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300” will serve as the special control. See § 884.1(e) for the availability of this guidance document.