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510(k) Data Aggregation
(46 days)
The Sheer Thin condom is used for contraception and for prophylactic purposes to help prevent pregnancy and the transmission of sexually transmitted diseases.
The condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. This condom is straight shafted, nipple end condom having a nominal width of 52 mm, nominal length of 180 mm and nominal thickness of 0.060 mm.
This document is a 510(k) summary for a natural rubber latex condom, not an AI/ML device. Therefore, the requested information about acceptance criteria, study details, and AI/ML specific metrics (like MRMC studies, training set, and ground truth establishment) is not applicable to this submission.
The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (Trojan Ultra Thin Condom, K912901) based on material, design, and intended use, and conformance to ASTM Latex Condom Standard D-3492.
To directly answer the prompt components, given the context of this traditional medical device submission:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (ASTM Standard D-3492) | Reported Device Performance |
|---|---|
| Specific criteria for latex condoms (e.g., burst pressure, freedom from holes, dimensions, etc.) would be detailed in the full ASTM D-3492 standard. This summary document does not provide specific performance values for each criterion. | The device is stated to be "in conformance with the ASTM Latex Condom Standard D-3492," implying that it met all applicable criteria within that standard. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the 510(k) summary. Testing for conformance to ASTM standards would typically involve a prospective sample of manufactured condoms.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. The ground truth for condom performance is established through physical and mechanical testing as per the ASTM standard, not expert review of subjective data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is a traditional device where performance is measured objectively against a standard, not through expert 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/ML device, so no MRMC study or AI assistance evaluation was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance would be the objective measurements and test results obtained from physical and mechanical testing of the condoms, demonstrating adherence to the specifications outlined in ASTM D-3492.
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.
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