(219 days)
The Karex condom is used for contraceptive and for Prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).
This condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. This condom is straight sided or contoured , textured or non textured ,with a reservoir tip; nominal length 180mm, nominal width 53mm, and nominal thickness 0.07mm. It is nonlubricated or lubricated with silicone and cornstarch is used as a dressing material. The condom is either colored or non colored, flavored or non flavored, and designed to conform to established national and international voluntary standards including ASTM D3492 and ISO 4074.
The provided text describes a 510(k) premarket notification for a Male Natural Rubber Latex Condom, not a device that utilizes AI or requires complex studies with ground truth or expert adjudication to establish performance. The document focuses on demonstrating substantial equivalence to pre-existing predicate devices.
Therefore, many of the requested categories (such as sample size for test/training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth types) are not applicable to this type of regulatory submission. The performance criteria for a condom are physical and biological, verified through laboratory testing and material analysis, rather than clinical or AI-based assessments.
Here's how the information that is applicable can be extracted and presented, with explanations for the non-applicable sections:
Acceptance Criteria and Device Performance for Male Latex Condom
The acceptance criteria for this male latex condom are based on conformance to established national and international voluntary standards, specifically ASTM D3492 and ISO 4074, for its physical properties and biocompatibility. The performance is demonstrated by stating compliance with these standards and by establishing substantial equivalence to predicate devices that have already met these standards.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria / Standards Achieved | Reported Device Performance |
|---|---|---|
| Physical Characteristics & Design | Conformance to ASTM D3492 and ISO 4074 for nominal length (180mm), nominal width (53mm), nominal thickness (0.07mm), shape (straight-sided or contoured), texture (textured or non-textured), and reservoir tip. | The device's design (length, width, thickness, shape, texture) is stated to be in conformance with ASTM D3492 and ISO 4074. It is described as having a reservoir tip. |
| Material Composition | Made of natural rubber latex. | Made of a natural rubber latex sheath. |
| Lubrication/Dressing Material | Non-lubricated or lubricated with silicone; cornstarch used as dressing material. | Non-lubricated or lubricated with silicone and cornstarch is used as a dressing material. |
| Biocompatibility | Conformance with ISO 10993 for cytotoxicity and sensitization. Color pigments and flavorings compliant with ISO 10993 and acceptable limits for oral toxicity. | The base formula was evaluated and confirmed to be in conformance with ISO 10993 biocompatibility requirements for cytotoxicity and sensitization. Color pigments and flavorings have also been evaluated and confirmed to be compliant with ISO 10993 and acceptable limits for oral toxicity. |
| Colors and Flavorings (Safety) | Use of specific color pigments (Colanyl Yellow FGL 130, Colanyl Red FGRG 100, Colanyl Green GG 131, Colanyl Brown BM 100-ID) and flavorings (Banana Flavor Concentrate #8500, Strawberry Flavor Concentrate # 4837, Peppermint Flavor Oil #4608, Chocolate Flavor Oil # 2141) with confirmed compliance to ISO 10993 and oral toxicity limits. | The specific color pigments and flavorings listed are confirmed to be compliant with ISO 10993 and oral toxicity limits, as part of predicate device formulations. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated in the provided text. For physical and biocompatibility testing of condoms, various sample sizes would be used for each specific test (e.g., burst tests, tensile strength, cytotoxicity). These are typically defined by the standards (ASTM D3492, ISO 4074) themselves.
- Data Provenance: The device manufacturer, Karex Industries Sdn. Bhd., is based in Johor, Malaysia. The testing would have been conducted by or for this company, likely in Malaysia or accredited labs adhering to international standards. The evaluation of color pigments and flavorings is noted to have occurred "as part of the Predicate Device formulations," implying reliance on prior data or testing reports for those components.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. For a male latex condom, "ground truth" is established through standardized laboratory testing against international specifications (ASTM, ISO), rather than expert consensus on clinical or imaging data. The experts involved would be engineers, chemists, and quality assurance specialists performing the tests according to the established protocols.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods like 2+1 or 3+1 typically apply to interpretation of complex data (e.g., medical images) by multiple human readers. For condom testing, results are objective measurements (e.g., burst pressure, elongation, presence/absence of cytotoxic effects) that either meet or fail the specified criteria.
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 a medical device (condom) and not an AI-powered diagnostic or assistive tool. MRMC studies are irrelevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. There is no algorithm involved in the performance of a latex condom.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device is based on objective measurements from physical, chemical, and biological laboratory tests against the specific requirements and thresholds defined by international and national standards (ASTM D3492, ISO 4074, ISO 10993). This is analogous to a standard for a material property, rather than an interpretation of complex data.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device; therefore, there is no "training set."
9. How the ground truth for the training set was established
Not applicable. As there is no training set for an AI model, this question is not relevant.
§ 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.