(158 days)
The FAMA Male Latex Condoms are used for contraception and prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).
The FAMA Male Latex Condoms are single-use, non-sterile condoms made of a natural rubber latex sheath, which covers the penis with a closely fitted membrane. The condoms have a smooth, dotted or ribbed surface and have a straight-walled nipple-end (SWNE) style within specifications listed in ASTM D3492-16, Standard Specification for Rubber Contraceptives (Male Condoms are lubricated with no colorants and fragrances added. The product is made of natural rubber latex, additives are sulfur, zinc oxide, promoter PX, promoter ZDC, antioxidant 264, stabilizer casein, and silicone oil as lubricant. These condoms conform with FDA-recognized standards ASTM D3492-16 and ISO 4074:2015.
The provided text is a 510(k) summary for the FAMA Male Latex Condoms, a medical device. This document details the device's technical specifications, intended use, and its comparison to a predicate device to establish substantial equivalence for FDA clearance.
Crucially, the request asks for "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of AI/ML medical devices, specifying aspects like sample size for test/training sets, expert ground truth establishment, MRMC studies, and standalone performance.
However, the FAMA Male Latex Condoms are not an AI/ML medical device. They are a physical product (condoms) whose performance is evaluated based on physical and biological properties (e.g., length, width, thickness, burst pressure/volume, biocompatibility, shelf-life), not on an algorithm's diagnostic or predictive capabilities.
Therefore, the specific information requested regarding AI/ML device testing (like sample sizes for test/training sets, expert ground truth, MRMC studies, standalone algorithm performance, and adjudication methods) is not applicable to this document. The "studies" mentioned in the document are physical and biological performance tests, not AI model evaluations.
Summary of Device Performance and Acceptance Criteria (as applicable to a physical device):
The document provides acceptance criteria and performance data for the FAMA Male Latex Condoms based on physical and biological testing to meet established standards.
1. Table of Acceptance Criteria and Reported Device Performance:
| Parameter | Acceptance Criteria (from referenced standards ISO 4074:2015 & ASTM D3492-16) | Reported Device Performance (from K220576 510(k) Summary) |
|---|---|---|
| Nominal Length | 180 ± 10 mm (ASTM D3492-16) | 180 ± 10 mm |
| Nominal Width | 53 ± 2 mm (ASTM D3492-16) | 53 ± 2 mm |
| Nominal Thickness (Plain) | (Specific range within standards) | 0.046 - 0.047 mm |
| Nominal Thickness (Dotted) | (Specific range within standards) | 0.068 - 0.069 mm |
| Nominal Thickness (Ribbed) | (Specific range within standards) | 0.074 - 0.075 mm |
| Burst Pressure | ≥ 1.0 kPa (ISO 4074:2015 & ASTM D3492-16) | ≥ 1.0 kPa |
| Burst Volume | ≥ 18 dm³ (ISO 4074:2015 & ASTM D3492-16) | ≥ 18 dm³ |
| Biocompatibility | Non-cytotoxic, non-irritating, non-sensitizing, not systemically toxic | Met all requirements (non-cytotoxic, non-irritating, non-sensitizing, not systemically toxic) |
| Shelf Life | Predefined acceptance criteria for stability (21 CFR 801.435) | 5 years (samples met predefined acceptance criteria) |
2. Sample size used for the test set and the data provenance:
- The document states that "The FAMA Male Latex Condoms were tested at baseline and met all the requirements of ISO 4074:2015 -Natural rubber latex male condoms – Requirements and test methods and ASTM D3492-16 - Standard Specification for Rubber Contraceptives (Male Condoms)."
- For Biocompatibility, "Biocompatibility studies... were performed in accordance with... ISO 10993-1, -5, -10, -11."
- For Shelf-Life, "accelerated stability evaluations conducted as required in 21 CFR 801.435."
- Specific sample sizes for each test are not detailed in this 510(k) summary. These details would typically be found in the full test reports referenced by the standards (e.g., how many condoms were burst-tested).
- Data Provenance: The manufacturing entity is "Shanghai Personage Hygiene Products Co.,Ltd." located in Shanghai, China. The testing was conducted by or on behalf of this company, presumably according to international standards. The nature of the physical and stability testing is inherently prospective in the sense that the manufactured devices are subjected to these tests to evaluate their properties.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This is a physical device. "Ground truth" for physical and biological properties is established by adherence to validated test methods and measurement protocols defined in international standards (ISO, ASTM, FDA regulations), not by expert consensus on interpretations of complex data like medical images.
4. Adjudication method for the test set:
- Not Applicable. As a physical device, testing involves quantitative measurements (e.g., length, burst pressure) and standardized biological assays, not 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 is not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is not an AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For physical properties (length, width, thickness, burst pressure/volume): The "ground truth" is defined by the objective, measurable parameters specified in the ASTM and ISO standards, measured using calibrated equipment and standardized test methods.
- For biocompatibility: The "ground truth" is established by the results of validated biological assays (e.g., cytotoxicity, sensitization, irritation, systemic toxicity tests) as per ISO 10993 series. These tests have defined endpoints and criteria for determining toxicity.
- For shelf-life: The "ground truth" is established through stability testing that demonstrates the device maintains its performance and safety characteristics over time under specified conditions, according to 21 CFR 801.435.
8. The sample size for the training set:
- Not Applicable. This is not an AI/ML device, so there is no "training set."
9. How the ground truth for the training set was established:
- Not Applicable. This is not an AI/ML device, so there is no "training set."
In conclusion, the document successfully demonstrates that the FAMA Male Latex Condoms meet the required physical and biological acceptance criteria by adhering to recognized international standards and FDA regulations for medical devices, thereby establishing substantial equivalence to the predicate device. The detailed questions regarding AI/ML device performance are not relevant to this product.
§ 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.