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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.

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.

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THE [No particular brand name] condom is used for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).

Male Natural Rubber Latex Condom

This document discusses the FDA's acceptance of a 510(k) premarket notification for a male natural rubber latex condom. It does not contain information about the acceptance criteria or a study proving the device meets those criteria. Such information would typically be detailed in the 510(k) submission itself, which this letter is a response to, rather than the approval letter.

Therefore, I cannot provide the requested table or answer the specific questions about the study design, sample sizes, expert qualifications, or ground truth, as none of that information is present in the provided text.

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The NRS Global Partners male latex 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 latex sheath, which completely covers the erect penis with a closely fitted membrane. This condom is straight sided, contoured or flared in shape, either textured or non-textured, with a reservoir tip; nominal length 180-mm, nominal width 53-mm, and nominal thickness 0.07mm. It is lubricated with silicone or Astroglide™, and USP grade cornstarch is used as a dressing material. This condom is designed to conform to established national and international voluntary standards including ASTM D3492 and ISO 4074. This condom is identical to the predicate device with respect to design, physical properties, and formulation.

The provided document is a 510(k) premarket notification for a male latex condom. It is a regulatory submission for a medical device and, therefore, does not contain information about a clinical study with acceptance criteria, device performance, sample sizes, expert ground truth, or MRMC studies in the context of AI/algorithm performance.

Instead, the submission aims to demonstrate "substantial equivalence" to a legally marketed predicate device (Innolatex Male Latex Condom; K002393). This typically involves showing that the new device has the same intended use and technological characteristics as the predicate device, and that any differences do not raise new questions of safety or effectiveness.

The "acceptance criteria" in this context would generally refer to the standards that the condom must meet (e.g., burst strength, freedom from holes) to be considered safe and effective, as outlined in recognized national and international voluntary standards like ASTM D3492 and ISO 4074. The "device performance" would be the results of testing conducted against these standards.

Here's how to interpret the request in the context of this document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states: "This condom is designed to conform to established national and international voluntary standards including ASTM D3492 and ISO 4074." and "The design is in conformance with ASTM Latex Condom Standard D3492 and that the condom is made of natural rubber latex."

This indicates that the acceptance criteria are defined by these standards. However, the specific quantitative pass/fail criteria (e.g., minimum burst volume, maximum number of holes per batch) and the actual test results (reported device performance) are not provided in this summary document. Such data would typically be found in the full 510(k) submission, not in the summary or the FDA's decision letter.

2. Sample Sizes Used for the Test Set and Data Provenance:
Not applicable in the context of an AI/algorithm study. The document only references conformance to standards, which would involve testing batches of condoms. No details are given about the number of condoms tested or their origin.

3. Number of Experts Used to Establish Ground Truth and Qualifications:
Not applicable. This is not a study involving expert annotation or ground truth generation in the way an AI study would.

4. Adjudication Method:
Not applicable.

5. MRMC Comparative Effectiveness Study:
Not applicable. This is not an AI-assisted diagnostic device.

6. Standalone (Algorithm Only) Performance:
Not applicable. This is a physical medical device, not an algorithm.

7. Type of Ground Truth Used:
For a latex condom, "ground truth" would be established through physical and mechanical testing against predefined standards (e.g., burst tests, leak tests, dimensional measurements, shelf-life studies). The document implies that such testing was done ("conformance with ASTM Latex Condom Standard D3492"), but does not detail the specific results or the methodology for establishing the "truth" beyond adherence to these standards.

8. Sample Size for the Training Set:
Not applicable. Condoms are not "trained" in the AI sense. The manufacturing process is validated and controlled, and batches are tested for quality.

9. How the Ground Truth for the Training Set Was Established:
Not applicable.

Summary based on the provided text:

The document states that the male latex condom is designed to conform to and is in conformance with ASTM D3492 and ISO 4074 voluntary standards. These standards define the acceptance criteria for various physical and mechanical properties of latex condoms (e.g., burst volume and pressure, dimensions, freedom from holes). However, the specific quantitative "acceptance criteria" from these standards and the "reported device performance" (i.e., the actual test results demonstrating conformance) are not detailed in this 510(k) summary. The submission's core assertion is that the device is "identical to the predicate device with respect to design, physical properties, and formulation," implying that its performance would be substantially equivalent and therefore also conform to these established standards.

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These multiple-brand condoms are used for contraception and for prophylactic purposes to help prevent pregnancy and the transmission of sexually transmitted diseases and HIV (AIDS).

Not Found

I am sorry, but the provided text does not contain the information requested in your prompt regarding acceptance criteria and a study proving a device meets them. The document is a 510(k) clearance letter from the FDA for "HardCover Condoms™ Male Latex Condoms," dated June 17, 1999.

It primarily discusses:

• The FDA's determination of substantial equivalence for the device.
• Regulatory classifications and general controls.
• Labeling requirements for latex condoms, specifically regarding expiration dating (21 CFR 801.435).
• Contact information for FDA offices.
• The product's indications for use: contraception and prevention of sexually transmitted diseases and HIV.

There is no mention of:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for test sets or data provenance.
3. Number or qualifications of experts for ground truth.
4. Adjudication methods.
5. MRMC comparative effectiveness studies.
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 letter pertains to regulatory clearance based on substantial equivalence to predicate devices, not on a detailed performance study as you've outlined for AI/ML device evaluations. The only "test data" mentioned is for supporting the expiration date as per 21 CFR 801.435, and it explicitly states that this data is not to be provided in the 510(k) submission itself but must be maintained by the manufacturer.

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