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The Simplex brand condom is a male contraceptive device, fabricated of natural latex, which is designed to completely cover the penis during sexual intercourse. This condom is intended to be used for contraception and for prophylactics purposes. If used properly, this condom will help reduce the risk of transmission of HIV infection (AIDS) and many other sexually transmitted diseases including chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B and syphilis. In addition, this condom will help reduce the risk of pregnancy without the serious side effects sometimes associated with other methods. However, no contraceptive can guarantee 100 % effectiveness. Failure to use as directed, may further result in loss of protection. Furthermore. sexually transmitted diseases can be transmitted through lesions and various body fluids, during intimate contact. Therefore, the condom should be applied before any such contact.

This condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. This condom is made of first grade latex material, teatended, single wall and contoured. Its dimensions are: length 170mm minimum, width: 51mm, thickness: 0.04-0.06 mm (single wall), weight: 1.0-1.3 gm/piece

The provided document does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) summary for a condom, detailing its description, intended use, technological characteristics, and regulatory correspondence from the FDA. It primarily focuses on demonstrating substantial equivalence to a predicate device for market clearance, rather than presenting a performance study with acceptance criteria.

Therefore, I cannot extract the requested information from this document.

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The Simplex brand condom is a male contraceptive device, fabricated of natural latex. which is designed to completely cover the penis during sexual intercourse. This condom is intended to be used for contraception and for prophylactics purposes. If used properly, this condom will help reduce the risk of transmission of HIV infection (AIDS) and many other sexually transmitted diseases including chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B and syphilis. In addition, this condom will help reduce the risk of pregnancy without the serious side effects sometimes associated with other methods. However, no contraceptive can guarantee 100 % effectiveness. Failure to use as directed, may further result in loss of protection. Furthermore. sexually transmitted diseases can be transmitted through lesions and various body fluids, during intimate contact. Therefore, the condom should be applied before any such contact.

This condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. This condom is made of first grade latex material, teatended, single wall and contoured. Its dimensions are: length 170mm minimum, width: 51mm, thickness: 0.04-0.06 mm (single wall), weight: 1.0-1.3 gm/piece.

This is a 510(k) premarket notification for a medical device, specifically Simplex Condoms. It is not a study about an AI/ML device, therefore, the requested information about acceptance criteria and device performance in the context of AI/ML is not applicable.

The document describes the device, its intended use, and technological characteristics, and then states that it is substantially equivalent to a predicate device (Trustex aromatic, 510(K) # K991892). The FDA concurred with this assessment in their letter.

The submission focuses on meeting regulatory requirements for substantial equivalence to a legally marketed predicate device, rather than providing a study comparing the performance of the Simplex condom against specific, quantifiable acceptance criteria through controlled testing, as would be expected for an AI/ML device.

However, based on the provided text, I can infer some "acceptance criteria" through the lens of regulatory compliance, even though they are not explicitly presented as a table or study results in the traditional sense for AI/ML.

Here's an analysis based on the provided text, addressing the points where information is available or inferable, and explicitly stating where information is not applicable or available given the nature of the document:

1. A table of acceptance criteria and the reported device performance

Since this is a submission for a physical medical device (condoms) and not an AI/ML device, the concept of "acceptance criteria" and "reported device performance" is framed in terms of substantial equivalence to a predicate device and compliance with established standards, rather than performance metrics of an algorithm.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

This information is not applicable as this is a 510(k) for a physical medical device, not an AI/ML study. There is no "test set" in the context of an algorithm's performance. The documentation instead relies on demonstrating conformity to standards and substantial equivalence to a predicate device.

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)

This information is not applicable. "Ground truth" in the context of expert consensus for AI/ML is not relevant here. The "truth" in this submission relies on established standards for condom manufacturing and performance, as well as the design and material comparison to a predicate device.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This information is not applicable. There is no "test set" or adjudication method relevant to an algorithm's performance being described.

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 information is not applicable. This is not an AI/ML device.

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

This information is not applicable. This is not an AI/ML device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For this device, the "ground truth" for regulatory approval is based on:

• Compliance with recognized standards: WHO, ISO, EN 600, DIN, and ASTM D3492-96. These standards specify physical properties, test methods, and performance criteria for condoms.
• Established performance of the predicate device: The Simplex Condoms are stated to have "the same intended use" and "same technological characteristics" as the predicate device (Trustex aromatic, K991892), which is already legally marketed.
• Physical and material specifications: The stated dimensions, material (natural rubber latex), and manufacturing process (German-made automatic dipping line) are expected to meet the requirements for safe and effective condoms.

8. The sample size for the training set

This information is not applicable. There is no "training set" for an AI/ML algorithm.

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

This information is not applicable. There is no "training set" for an AI/ML algorithm.

Ask a specific question about this device

The Simplex brand condom is a male contraceptive device, fabricated of natural latex, which is designed to completely cover the penis during sexual intercourse. This condom is intended to be used for contraception and for prophylactics purposes. If used properly, this condom will help reduce the risk of transmission of HIV infection (AIDS) and many other sexually transmitted diseases including chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B and syphilis. In addition, this condom will help reduce the risk of pregnancy without the serious side effects sometimes associated with other methods. However, no contraceptive can guarantee 100 % effectiveness. Failure to use as directed, may further result in loss of protection. Furthermore. sexually transmitted diseases can be transmitted through lesions and various body fluids, during intimate contact. Therefore, the condom should be applied before any such contact.

This condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. This condom is made of first grade latex material, teatended, single wall and contoured. Its dimensions are: length 170mm minimum, width: 51mm, thickness: 0.04-0.06 mm (single wall), weight: 1.0-1.3 gm/piece

The provided document is a 510(k) summary for a medical device (Simplex Condoms). It details the device's description, intended use, and technological characteristics, and declares substantial equivalence to a predicate device. However, it does not contain any information about acceptance criteria or specific studies proving the device meets those criteria.

510(k) summaries, by nature, focus on demonstrating "substantial equivalence" to a predicate device rather than presenting detailed performance studies against specific acceptance criteria. This process often relies on existing standards, historical performance of similar devices, and general controls.

Therefore, I cannot provide the requested information based on the input text. The document does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for test sets.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study or effect size.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

The document indicates that the device's design is in conformance with WHO, ISO, EN 600, DIN, and ASTM D3492-96, which are likely the standards against which the device's physical properties (like dimensions, burst strength, etc.) would be tested. However, the specific results of these tests are not provided in this 510(k) summary.

Ask a specific question about this device