Search Results

Nonlubricated rubber male condom for use as a contraceptive and prophylactic.

Condom, smooth surface, reservoir end, approximately 180 mm in length and 52 mm in width (Type 1, Style 2, Class A) colored rubber contraceptive device, nonlubricated or lubricated with silicone.

This 510(k) summary is for a condom, a mechanical contraceptive device. The provided text is a 510(k) notification letter, and as such, it focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study report with specific acceptance criteria and performance data for the device itself.

Therefore, many of the requested elements for a scientific study of an AI/algorithm-based device are not directly applicable or available in this document. The information primarily pertains to regulatory approval based on demonstrating equivalence to already approved condoms.

Here's a breakdown of the available information and why other points are not applicable:

1. Table of Acceptance Criteria and Reported Device Performance: This information is not provided in a format typical for an AI/algorithm study. The acceptance criteria for condoms relate to physical properties and manufacturing standards, not algorithmic performance. The document states the device is "substantially equivalent" to predicate devices, implying it meets the same established performance criteria for condoms.

2. Sample sized used for the test set and the data provenance: Not applicable. There isn't a "test set" in the context of an AI/algorithm. The regulatory approval is based on manufacturing standards and performance tests for condoms, which are not detailed here beyond the general statement of substantial equivalence.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. "Ground truth" in the context of expert consensus isn't relevant for a physical condom. The "ground truth" for a condom is its physical properties and effectiveness as a contraceptive, established through well-defined laboratory tests (e.g., burst strength, leakage) and clinical trials (for effectiveness), which are not detailed in this 510(k) summary.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for a physical device like a condom.

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 device is a physical product, not an AI or imaging diagnostic tool that would involve human readers or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable, as this is not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): The "ground truth" for a condom's efficacy and safety is established through a combination of:

   • Laboratory Testing: Physical properties like burst strength, volume, and absence of holes, as per international and national standards (e.g., ISO, ASTM). These tests are typically conducted by manufacturers according to their quality control processes.
   • Clinical Studies (for initial condom approval): Efficacy and safety are established through large-scale clinical trials comparing use of condoms to other or no contraceptive methods. The 510(k) process for this specific device relies on the fact that the predicate devices have already demonstrated this.

8. The sample size for the training set: Not applicable for this type of device.

9. How the ground truth for the training set was established: Not applicable for this type of device.

Summary of relevant information from the provided document:

• Device Name: Condom, smooth surface, reservoir end, approximately 180 mm in length and 52 mm in width (Type 1, Style 2, Class A) colored rubber contraceptive device, nonlubricated or lubricated with silicone.
• Intended Use: Nonlubricated rubber male condom for use as a contraceptive and prophylactic.
• Regulatory Class: Class II, Condom (rubber) Contraceptive - 85HIS.
• Predicate Devices: K963319 (nonlubricated), K963321 (lubricated), and Ansell Inc. Condom (K901112) listed under the trade name Lifestyle®.
• Demonstration of Acceptance Criteria: The filing states the device is "substantially equivalent" to the predicate devices. This implies that the device meets the same established performance standards (e.g., physical integrity, burst volume, hole detection) that allowed the predicate devices to be marketed. The specific numerical acceptance criteria and performance data are not detailed in this 510(k) summary but would be part of the underlying design control and testing documentation held by the manufacturer. The "study" proving this is implicitly the battery of tests conducted by the manufacturer to demonstrate compliance with relevant standards and equivalence to the predicate devices, though these specific tests are not reported in this summary. The primary "proof" is the FDA's concurrence that it is substantially equivalent.

Ask a specific question about this device