(120 days)
The 45 Micron Polyisoprene Condom is used for contraception and for prophylactic purposes (to help reduce the risk of pregnancy and the transmission of sexually transmitted infections STIs).
The 45 Micron Polyisoprene Condom is a male contraceptive prophylactic device made from synthetic rubber (Polyisoprene latex) with a lubricant coating containing silicone gel with fragrance oil (Sensual Masking). The fragrance oil acts as a masking agent to minimize odor originated from the condom substrate. The condom is a fitted sheath with an integral ring at the open end and a reservoir (nipple end) at the closed end to contain semen. The condom dimensions are length 190 ± 10mm, width 53 ± 2mm, and thickness 0.045 ± 0.005mm. The condom is designed to conform to the requirements of ISO 23409:2011. This product has a 3-year shelf-life.
The provided document (K231908 510(k) Summary for 45 Micron Polyisoprene Condom) describes the acceptance criteria and the study that proves the device meets those criteria for a condom. This is not a medical imaging device or an AI/ML-enabled device, therefore, many of the requested elements of your prompt are not applicable (e.g., number of experts for ground truth, MRMC study, sample size for training set, etc.).
However, I can extract and present the available information most relevant to your request format, making it clear what information is and isn't provided in the context of this specific regulatory submission for a condom.
Acceptance Criteria and Device Performance for 45 Micron Polyisoprene Condom
1. Table of Acceptance Criteria and Reported Device Performance
For a condom, "performance" is primarily assessed through physical integrity, barrier properties, and clinical failure rates (breakage/slippage). The document refers to meeting various ISO standards and FDA guidance rather than listing specific numerical acceptance criteria (e.g., a "pass/fail" for an imaging diagnostic would have specific sensitivity/specificity targets).
| Test Category | Acceptance Criteria (Conceptual, based on standards adherence) | Reported Device Performance |
|---|---|---|
| Material/Biocompatibility | Non-irritating, non-sensitizing, not acutely/systemically toxic (per ISO 10993 series and FDA guidance) | The device demonstrated non-irritating, non-sensitizing, and non-acutely systemically toxic properties, leveraging data from the predicate device submission and performing specific tests (Cytotoxicity, Sensitization, Vaginal Irritation, Acute Systemic Toxicity). |
| Physical Performance | Compliance with ISO 23409:2011, ISO 4074:2015, and ASTM D624-00 (2020) for dimensions, tensile strength, force at break, lubricant quantity, visible defects, elongation, air burst volume, and air burst pressure. Also, tear resistance. | The subject condom met the predefined acceptance criteria for all tested physical performance parameters (dimensions, tensile strength, force at break, lubricant quantity, visible defects, elongation, air burst volume, air burst pressure, and tear resistance). It demonstrated comparable physical performance to the predicate device regarding tensile strength, force at break, tensile elongation, airburst pressure, airburst volume, and tear resistance. |
| Package Integrity | Satisfactory seal integrity per ASTM D6324-11. | Seal integrity evaluation on three lots yielded satisfactory results. |
| Barrier Properties/Permeability | Effective barrier against viral penetration, comparable to predicate and natural rubber latex condoms (per ISO 23409:2011). | Viral penetration study on three test lots demonstrated the device's barrier effectiveness comparable to the predicate device and natural rubber latex control condom. |
| Shelf Life | Stability over time (e.g., 5 years) with all physical and biological properties maintained per 21 CFR 801.435 and ASTM D6324-11. | Accelerated stability evaluations supported a five-year shelf life, with all samples meeting predefined acceptance criteria. |
| Clinical In-Use Slip/Break | Non-inferiority to a control natural rubber latex condom for clinical breakage, slippage, and total clinical failure rates, following FDA guidance. | Clinical Breakage Rate: 1.3% (Polyisoprene) vs. 0.7% (Natural Rubber Latex Control) |
| Clinical Slippage Rate: 0.6% (Polyisoprene) vs. 0.6% (Natural Rubber Latex Control) | ||
| Total Clinical Failure Rate: 1.9% (Polyisoprene) vs. 1.3% (Natural Rubber Latex Control) | ||
| Conclusion: The polyisoprene condom was statistically non-inferior to the natural rubber latex control for clinical breakage, slippage, and total clinical failure rate. |
2. Sample Sizes Used for the Test Set and Data Provenance
- Biocompatibility: Leveraged from predicate device submission, with additional specific tests on the subject device. Sample sizes not explicitly stated for each test, but standard for biocompatibility studies.
- Physical Performance: Not explicitly stated for each test, but testing was "for compliance" with standards.
- Package Integrity: 3 lots of the subject device.
- Barrier Properties/Permeability: 3 test lots of the subject polyisoprene condom, one lot of the commercially available predicate device, and a natural rubber latex condom comparator.
- Shelf Life: "All samples" met criteria, specific number not stated.
- Clinical In-Use Slip/Break: Over 267 couples were included in the study.
- Data Provenance: The submission is from Suretex Limited, located in Thailand. The study details (where it was conducted, retrospective/prospective) are not explicitly stated, but clinical performance studies for regulatory submissions are typically prospective and conducted under Good Clinical Practice (GCP) guidelines. The document states it "followed a protocol prepared to meet the FDA guidance".
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This question is not applicable as this is a physical medical device (condom) and not a medical imaging or AI diagnostic device. "Ground truth" for condom performance is established through objective physical and chemical testing, and clinical observation of real-world use rather than expert interpretation of images.
4. Adjudication Method for the Test Set
- This question is not applicable. Adjudication methods (e.g., 2+1, 3+1) are typically used in imaging studies where interpretations from multiple readers need to be reconciled. For a condom, performance is measured objectively (e.g., breakage, slippage, physical properties).
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 question is not applicable as this is not an AI/ML-enabled medical device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- This question is not applicable as this is not an AI/ML-enabled medical device.
7. The Type of Ground Truth Used
- For physical properties (tensile strength, air burst, etc.): Objective measurements against predefined ISO and ASTM standards.
- For biocompatibility: Laboratory testing results against established limits for toxicity, irritation, and sensitization.
- For barrier properties: Laboratory viral penetration testing.
- For clinical in-use performance (breakage/slippage): Direct observation of events (breakage or slippage) during actual use by participating couples. Non-inferiority was established by statistical comparison to a control latex condom.
8. The Sample Size for the Training Set
- This question is not applicable as this is a physical medical device and not an AI/ML-enabled device. There is no concept of a "training set" in this context.
9. How the Ground Truth for the Training Set Was Established
- This question is not applicable as this is a physical medical device and not an AI/ML-enabled device.
§ 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.