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Condomi brand latex condoms are intended to be used as a contraceptive (for the prevention of pregnancy) and/or for the prevention of the transmission of sexually transmitted diseases.

Like other natural latex condoms on the market, the Condomi brand condoms are latex sheaths, which completely cover the penis with a closely fitting membrane. The following condom styles, colors, and flavors will be offered:
a) Standard transparent lubricated with silicon oil
b) Colored pink, studded, lubricated with silicon oil
c) Colored gold, lubricated with silicon oil, and vanilla flavor.
d) Transparent, form-fitting condom, lubricated with spermicidal lubricant N-9
e) Extra large condom transparent, lubricated with silicon oil
f) Extra strong condom, transparent, lubricated with silicon oil

The provided document is a 510(k) summary and FDA clearance letter for Condomi brand male latex condoms. It details the device's characteristics, intended use, and comparison to predicate devices, focusing on non-clinical testing. It explicitly states "No clinical testings were completed" and therefore does not contain information about a study proving the device meets acceptance criteria derived from clinical trials, nor human reader studies with AI.

However, based on the information provided regarding non-clinical tests, here's a description of the acceptance criteria and how the device meets them:

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

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

The document does not specify the sample sizes used for testing against these standards, nor does it detail the provenance of the test data (e.g., country of origin, retrospective or prospective nature). It only states that "Methods and results were provided" for meeting the standards.

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 and not provided. The "ground truth" for condom performance in this context is defined by the established international and national standards (ASTM, ISO). Compliance with these standards is typically assessed through laboratory testing, not expert consensus in the same way clinical images might be.

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

This information is not applicable and not provided. Adjudication methods like 2+1 or 3+1 are used for expert review of human-interpreted data, often in clinical studies. The testing described here involves laboratory methods to meet pre-defined performance standards.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is a physical product (condom), and the submission explicitly states "No clinical testings were completed." Therefore, there is no AI component or human reader improvement associated with this device.

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

No, a standalone algorithm-only performance study was not done. This device is a physical medical device (condom), not an AI algorithm.

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

The "ground truth" for the device's performance is established by the specified international and national consensus standards (ASTM D3492-97, ISO Standard 4074, and ISO 10993). Meeting the technical specifications and performance requirements outlined in these standards serves as the ground truth for demonstrating safety and effectiveness for non-clinical testing.

8. The sample size for the training set

This information is not applicable and not provided. The development and testing of condoms against established standards do not typically involve "training sets" in the context of machine learning or AI. The tests are designed to verify product specifications.

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

This information is not applicable and not provided. There is no "training set" in the context of this device's submission. The "ground truth" for product performance is defined by the aforementioned industry standards.

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Extra Strength lubricated rubber male condom for use as a contraceptive and prophylactic. Additional Statement: "Laboratory tests of physical properties show the ExtraWear condom is stronger than the InnerWear condom. However, the breakage rate during sex has not been tested."

Not Found

Here's an analysis of the provided text regarding the acceptance criteria and study for the ExtraWear™, Gentlemen's Choice™, Extra Strength… Lubricated Latex Condom:

The provided document is a 510(k) clearance letter from the FDA, not a detailed study report. As such, it does not contain the specific acceptance criteria or the study data that proves the device meets those criteria in the format requested.

The letter confirms that the device is "substantially equivalent" to legally marketed predicate devices, meaning it has similar indications for use, technological characteristics, and performs as safely and effectively. The letter also mentions general controls and relevant regulations for medical devices.

However, based on the limited information, we can extract some points about the indications for use and a very high-level statement about testing:

Indications for Use:
"Extra Strength lubricated rubber male condom for use as a contraceptive and prophylactic."

Statement about testing (from the "Indications for Use" section):
"Laboratory tests of physical properties show the ExtraWear condom is stronger than the InnerWear condom. However, the breakage rate during sex has not been tested."

Addressing your specific questions based on the available text (and noting where information is absent):

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

   This information is not present in the provided document. The document is an FDA clearance letter, not a detailed technical report of the device's performance against specific criteria. It only states that laboratory tests show the ExtraWear condom is "stronger than the InnerWear condom." No numerical values for strength or specific acceptance criteria are given.

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

   This information is not present in the provided document. The document refers generally to "Laboratory tests of physical properties" but provides no details on sample size, data provenance, or study design (retrospective/prospective).

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 present in the provided document. The concept of "ground truth" established by experts, as typically applied in AI/diagnostic device studies, is not applicable or discussed in this 510(k) clearance letter for a condom. The testing mentioned appears to be physical property tests, which would be measured objectively rather than through expert consensus.

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

   This information is not present in the provided document. Adjudication methods are typically relevant for subjective assessments or when discrepancies arise in expert reviews, which is not indicated for the type of testing broadly mentioned here.

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 present in the provided document. An MRMC study or AI-assisted improvement for human readers is entirely irrelevant to a physical device like a latex condom.

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

   This information is not present in the provided document. This concept applies to AI algorithms, not a physical device like a condom.

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

   Based on the statement "Laboratory tests of physical properties," the "ground truth" would likely be objective physical measurements rather than expert consensus, pathology, or outcomes data. However, the exact methods are not detailed.

8. The sample size for the training set

   This information is not present in the provided document. The concept of a "training set" applies to machine learning models, which is not applicable to this device.

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

   This information is not present in the provided document. As above, "training set" and its "ground truth" establishment are not relevant to this device.

Summary of what can be gleaned about the study:

The only study mentioned is "Laboratory tests of physical properties" which determined "the ExtraWear condom is stronger than the InnerWear condom." No further details on the methodology, sample sizes, or specific results are provided in this regulatory letter. A critical limitation is explicitly stated: "However, the breakage rate during sex has not been tested." This implies that while laboratory strength tests were conducted, real-world performance data regarding breakage was not part of this submission for substantial equivalence.

Ask a specific question about this device

Ask a specific question about this device