(43 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 walled, contoured or flared with a reservoir tip; nominal length 180mm, nominal width 53mm, and nominal thickness 0.06mm. It is lubricated with silicone and cornstarch is used as a dressing material. The condom is colored and 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) summary for a male latex condom. It does not present a study with acceptance criteria and device performance results in the way a typical AI/software device would.
Instead, it focuses on demonstrating substantial equivalence to a predicate device by comparing technological characteristics and adherence to established standards for safety and performance of condoms.
Therefore, many of the requested categories for AI/software devices (like sample size for test/training sets, experts for ground truth, adjudication methods, MRMC studies, standalone performance) are not applicable to this type of medical device submission.
However, I can extract the relevant information regarding acceptance criteria and the methods used to show compliance for this specific device.
Acceptance Criteria and Reported Device Performance
For this male latex condom, the "acceptance criteria" are compliance with established national and international voluntary standards, and the reported "device performance" is its demonstration of conforming to these standards. The device is also evaluated for biocompatibility and oral toxicity of its components.
| Acceptance Criteria / Standard | Reported Device Performance / Compliance |
|---|---|
| ASTM D3492 (Latex Condom Standard) | The device is "designed to conform to established national and international voluntary standards including ASTM D3492." The technological characteristics section explicitly states, "The design of this condom is in conformance with ASTM Latex Condom Standard D3492." |
| ISO 4074 (Natural latex condoms) | The device is "designed to conform to established national and international voluntary standards including... ISO 4074." |
| ISO 10993 Biocompatibility (cytotoxicity, sensitization) | The "base formula was evaluated and confirmed to be in conformance with ISO 10993 biocompatibility requirements for cytotoxicity, and sensitization." The color pigments and flavorings "have also been evaluated as part of the Predicate Device formulations and have been confirmed to be compliant with ISO 10993." |
| Acceptable limits for oral toxicity | The color pigments and flavorings "have also been evaluated as part of the Predicate Device formulations... and compliant with acceptable limits for oral toxicity." |
| Substantial Equivalence to Predicate Device (K041837) | The FDA reviewed the 510(k) and "determined the device is substantially equivalent... to legally marketed predicate devices." This implies that the device performs similarly to the predicate device in terms of safety and effectiveness for its intended use. |
As this is a physical medical device (condom) and not an AI/software device, the following points are largely not applicable or cannot be extracted from the provided text.
2. Sample size used for the test set and the data provenance:
- Not applicable in the context of AI/software testing. For physical devices like condoms, testing involves batch sampling and physical/chemical tests. The specific sample sizes for material conformance or performance tests (e.g., burst tests) are not detailed in this summary but would be part of the underlying design control documentation. The data provenance would be from manufacturing and testing facilities.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth for a physical product's performance against industry standards is established through standardized testing methodologies, not expert consensus on interpretations.
4. Adjudication method for the test set:
- Not applicable. Standardized tests yield objective results (e.g., a burst pressure, a chemical concentration), 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 type of study is specific to AI-assisted human interpretation in diagnostic or screening tasks.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. There is no algorithm or software component described that would operate in a standalone manner.
7. The type of ground truth used:
- The "ground truth" here is compliance with established national and international voluntary standards (ASTM D3492, ISO 4074) for condom performance and biocompatibility and toxicity requirements (ISO 10993) for materials. This is based on objective measurements and established thresholds derived from scientific understanding and extensive testing in the field.
8. The sample size for the training set:
- Not applicable. There is no AI/machine learning component requiring a training set.
9. How the ground truth for the training set was established:
- Not applicable. There is no AI/machine learning component.
§ 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.