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The (no particular brand name) condom, is intended to reduce the risk of transmission of HIV infection (AIDS) and many other sexually transmitted diseases. In addition, if properly used, it can reduce the risk of pregnancy.

Non-spermicidal Lubricated male Latex Condom

The provided text is a scanned letter from the FDA regarding the 510(k) clearance for a "Non-spermicidal Lubricated male Latex Condom". It outlines the regulatory status and requirements for such devices.

However, the provided document does not contain any information about acceptance criteria for a device, nor does it describe any study (clinical or otherwise) that proves the device meets specific acceptance criteria.

The document primarily focuses on:

• The FDA's decision of "substantial equivalence" for the device based on a 510(k) submission.
• Regulatory requirements for marketing the device, including general controls, specific regulations like 21 CFR 801.435 for condom labeling and expiration dating, and Good Manufacturing Practice (GMP).
• The "Indications for Use" statement for the condom.

Therefore, I cannot extract the information requested in your prompt regarding acceptance criteria and a study from this document. The prompt asks for details about a study, sample sizes, ground truth establishment, expert qualifications, and MRMC studies, none of which are present in these pages.

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The Thai Nippon condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and 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-walled with a reservoir tip; nominal length 180-mm, nominal width 52-mm, and nominal thickness 0.06mm. The condom is offered in natural latex color, red, blue, green, and yellow.

The provided text is a 510(k) Summary for a Male Latex Condom and a subsequent FDA clearance letter. It is not a study report for a device using AI, statistical analysis, or comparison metrics like sensitivity, specificity, or AUC, which are typically found in studies with acceptance criteria, sample sizes, and expert ground truth.

Therefore, most of the requested information regarding acceptance criteria, device performance, sample sizes, ground truth, experts, and adjudication methods is not available in the provided document.

Here's what can be extracted based on the nature of the document:

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

The document states that the device's design is in conformance with ASTM Latex Condom Standard D3492. This standard sets the acceptance criteria for these types of devices. The reported device performance is presented as a direct comparison of technological characteristics to a predicate device, implying that the new device meets or is equivalent to the predicate's performance, which is presumably compliant with the ASTM standard.

Note: The specific numerical acceptance criteria (e.g., minimum burst pressure, maximum pinhole rate) detailed in ASTM D3492 are not explicitly listed in this document but are the underlying performance requirements the device is claiming to meet.

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

• Sample size: Not specified in the provided documents. The document describes the device and its intended use, along with a comparison to a predicate device, but does not include details of testing methodologies or sample sizes for performance evaluation.
• Data provenance: Not applicable in the context of this 510(k) summary, as it's not a clinical study report with patient data. The device itself is manufactured by Thai Nippon Rubber Industry, Ltd. in Thailand.

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

• Not applicable. This is a submission for a medical device (condom) and does not involve expert interpretation or ground truth establishment in the way an AI diagnostic device would. Compliance with standards and physical properties are the primary evaluation methods.

4. Adjudication method for the test set

• Not applicable. No expert adjudication method is 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

• Not applicable. This is not an AI-assisted diagnostic device.

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

• Not applicable. This is not an AI algorithm.

7. The type of ground truth used

• The "ground truth" for this device's performance is its physical properties (length, width, thickness, presence of lubricant, reservoir tip) and its ability to conform to established industry standards like ASTM D3492, which includes performance requirements such as burst volume/pressure and freedom from holes. These are typically verified through laboratory testing and quality control processes.

8. The sample size for the training set

• Not applicable. This device does not involve a "training set" like an AI model.

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

• Not applicable.

Ask a specific question about this device

If used properly, condoms will help to 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. Condoms, when properly used, are highly effective against pregnancy although no contraceptive can guarantee 100% effectiveness. Any use of this condom for other than vaginal intercourse can increase the potential damage to the condom. For maximum pleasure and protection, it is important to follow the instructions for use included inside this package. Failure to do so may result in the loss of the benefits of the condom.

Latex Condoms, Natural Color with Silicone Oil Lubricant

I am sorry, but the provided text from the FDA 510(k) notifications (K974323) for "Latex Condoms, Natural Color with Silicone Oil Lubricant" does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or multi-reader multi-case studies.

This document is a letter from the FDA confirming the substantial equivalence of the device to previously marketed devices and an "Indications for Use" statement. It does not include the detailed technical and clinical study information that your request is asking for.

Therefore, I cannot provide the requested table and information based on the given input.

Ask a specific question about this device

If used properly, condoms will help to 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. Condoms, when properly used, are highly effective against pregnancy although no contraceptive can guarantee 100% effectiveness. Any use of this condom for other than vaginal intercourse can increase the potential damage to the condom. For maximum pleasure and protection, it is important to follow the instructions for use included inside this package. Failure to do so may result in the loss of the benefits of the condom.

Not Found

The provided documents are a 510(k) clearance letter and an "Indications For Use" statement for a Latex Condom with Spermicidal Lubricant. These documents confirm the device has been cleared by the FDA as substantially equivalent to previously marketed devices. However, they do not contain any information regarding specific acceptance criteria, performance studies, or technical data that would describe how the device meets such criteria.

Therefore, for each of your requested points, I must state that the information is not available in the provided text.

Here's a breakdown based on your request:

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

   • Not Available: The provided documents do not specify any acceptance criteria (e.g., burst pressure, freedom from holes, shelf life, or spermicide effectiveness) or report specific performance metrics against such criteria.

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

   • Not Available: The documents do not describe any specific test sets, sample sizes, or data provenance for performance evaluation.

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 / Not Available: This type of information is typically related to diagnostic devices where expert interpretation establishes ground truth (e.g., pathology, radiology). For a condom, "ground truth" would relate to its physical properties and effectiveness, which are measured through standardized tests, not expert consensus in the same way. The documents do not describe any expert involvement in establishing ground truth.

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

   • Not Applicable / Not Available: Similar to point 3, adjudication methods are relevant for subjective interpretations, often in diagnostic studies. For a physical barrier device like a condom, performance is assessed objectively via standardized tests, not through adjudication of expert opinions. The documents do not mention any adjudication method.

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: MRMC studies are used for evaluating diagnostic imaging devices, often involving AI assistance for human readers. This device is a condom, not an AI-assisted diagnostic imaging tool. Therefore, an MRMC study is not relevant or described.

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

   • Not Applicable: This question pertains to AI algorithms. The device is a latex condom with spermicidal lubricant, not an algorithm, so a standalone algorithm performance study is not relevant.

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

   • Not Available / Not Applicable in the way typically asked for diagnostic devices: For a condom, ground truth would fundamentally be established through standardized physical and chemical testing (e.g., burst strength, freedom from holes, spermicide efficacy testing). The documents do not detail the specific types of ground truth used for performance assessment.

8. The sample size for the training set

   • Not Applicable / Not Available: This question is relevant to machine learning/AI models, which do not apply to this device. Also, the documents do not describe any "training set" for physical product testing.

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

   • Not Applicable / Not Available: Similar to point 8, this question is for AI/machine learning models and does not apply to this device.

In summary, the provided FDA 510(k) clearance documentation for this condom confirms its regulatory status but does not delve into the detailed performance study data, acceptance criteria, or methodology that would be expected for a comprehensive technical report. Such information would typically be found in the manufacturer's internal test reports or the complete 510(k) submission, which is not provided here.

Ask a specific question about this device

If used properly, condoms will help to 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. Condoms, when properly used, are highly effective against pregnancy although no contraceptive can guarantee 100% effectiveness. Any use of this condom for other than vaginal intercourse can increase the potential damage to the condom. For maximum pleasure and protection, it is important to follow the instructions for use included inside this package. Failure to do so may result in the loss of the benefits of the condom.

Latex Condom, Colored, with Spermicidal Lubricant

This document is a FDA 510(k) clearance letter for a "Latex Condom, Colored, with Spermicidal Lubricant" (K974326). It does not contain information about acceptance criteria, study designs, sample sizes, or expert qualifications for a medical device's performance study.

The letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976,".

This means the device was cleared based on substantial equivalence to a predicate device, not on a new study demonstrating its performance against specific acceptance criteria.

Therefore, I cannot provide the requested information from the provided text.

Ask a specific question about this device