Search Results

The Medical Latex (DUA) condom is used for contraceptive and prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).

Not Found

Here's an analysis of the provided text, focusing on the acceptance criteria and study information for the CARE Condom (K120555):

Based on the provided FDA 510(k) approval letter and indications for use, this document does not contain the detailed acceptance criteria or a study description in the format requested for a medical device that uses algorithms or AI for diagnostic/prognostic purposes.

The document is a traditional 510(k) approval letter for a condom, which is a physical medical device. The "acceptance criteria" and "study" described in your prompt (e.g., sample size for test set, experts for ground truth, MRMC study, AI effectiveness) are relevant for devices like AI-powered diagnostic software, imaging analysis tools, or similar computational devices.

For a physical device like a condom, the "acceptance criteria" generally refer to quality control standards (e.g., burst pressure, freedom from holes, dimensions, lubricity), and the "study" would be performance testing against international standards (e.g., ISO 4074 for natural rubber latex condoms) and clinical studies for characteristics like breakage rate, slippage rate, and pregnancy prevention rate. This information is typically found in the 510(k) submission summary/report, not in the FDA's approval letter or the indications for use statement.

Therefore, many of the requested fields cannot be populated from the given text. I will fill in what can be inferred and explicitly state where information is missing due to the nature of the device and the provided document.

Acceptance Criteria and Device Performance for CARE Condom (K120555)

The provided document is an FDA 510(k) clearance letter for a condom. Such letters confirm substantial equivalence to a predicate device but typically do not detail the specific performance acceptance criteria or the full study reports. These details are usually found within the 510(k) summary submitted by the manufacturer. The "acceptance criteria" for condoms generally relate to physical performance tests rather than algorithmic performance.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The actual specifications for these criteria would be based on international standards for condoms (e.g., ISO 4074 for natural rubber latex condoms) which are used for 510(k) substantial equivalence. The provided document does not contain these specific values.

2. Sample size used for the test set and the data provenance

• Sample Size (Test Set): Not specified in the provided document. Condom testing involves batches of product for physical tests and potentially cohorts for clinical studies.
• Data Provenance: Not specified, but generally, testing for condoms would be performed by the manufacturer, often at their facilities or certified labs. Clinical studies, if performed, could be multi-site or single-site.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Number of Experts: Not applicable in the context of this device. For physical performance testing (burst, pinholes), the "ground truth" is determined by standardized test methods and calibrated equipment, not by expert consensus. For clinical outcomes (pregnancy, STI), the ground truth is statistical incidence within a study population.
• Qualifications of Experts: Not applicable.

4. Adjudication method for the test set

• Adjudication Method: Not applicable. Performance criteria for condoms are typically objective measurements against a standard, not subjective interpretations requiring adjudication. Clinical study outcomes are statistically analyzed.

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 to the CARE Condom as it is not an AI-powered diagnostic or interpretive device. MRMC studies are used to evaluate diagnostic accuracy of human readers, sometimes with AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• This question is not applicable to the CARE Condom as it is not an algorithm or AI device.

7. The type of ground truth used

• For physical performance: Objective measurements against established international standards (e.g., ISO 4074).
• For clinical efficacy (e.g., pregnancy prevention, STI prevention): Clinical outcomes data from well-designed studies (e.g., incidence of pregnancy or STIs in study participants using the device).
• The provided document does not explicitly state which specific type was used or the results.

8. The sample size for the training set

• Sample Size (Training Set): Not applicable in the context of a physical medical device. "Training set" refers to data used to develop and refine algorithms, which is not relevant for a condom. The manufacturing process does involve quality control and process validation, which might involve data, but it's not a "training set" in the AI sense.

9. How the ground truth for the training set was established

• Ground Truth Establishment (Training Set): Not applicable.

Ask a specific question about this device