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The condom is used for contraception and for Prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted disease).

This condom is made of a natural rubber sheath, which completely covers the penis with a closely fitted membrane. This condom has smooth or textured surface, parallel-sided ,reservoir ended condoms with an integral bead at the open end. The nominal length is minimum 180 mm, the width is 52 or 53 +/- 2 mm and 0.03 mm minimum for the thickness.

The provided text is related to a 510(k) submission for male condoms and does not contain information about an AI-powered medical device or a study proving its performance. Therefore, I cannot generate the requested table and study details.

The document is a submission for a new line of flavored latex condoms, seeking substantial equivalence to a previously approved predicate device. It focuses on the physical characteristics, intended use, and technological characteristics of the condom, as well as regulatory compliance.

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The intended use of these latex coloured condoms with spermicidal lubricant is for contraception and prophylactics purposes (preventing transmission of venereal diseases.)

Colored Latex Condom with Spermicidal Lubricant (Maxima, Trustex, Ria, Premium and, EL LES Condoms)

The provided text is a 510(k) clearance letter from the FDA for a medical device: "Colored Latex Condom with Spermicidal Lubricant (Maxima, Trustex, Ria, Premium and, EL LES Condoms)".

This document is a regulatory approval letter and does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically found in clinical trial reports or performance studies.

The letter explicitly states:

• "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."
• It also mentions requirements for "Use Labeling for Latex Condoms: Expiration Dating, 21 CFR 801.435," and the need for "test data developed under the conditions specified in 801.435(d)" to support expiration dates. However, it clarifies that "Although supporting data is not to be provided in your 510(k) submission, 801.435(j) requires that you maintain this data and that it be available for inspection by FDA."

Therefore, based solely on the provided text, I cannot extract the requested information:

1. A table of acceptance criteria and the reported device performance: Not present. The letter does not describe specific performance metrics for the condom, only that it is substantially equivalent to predicates.
2. Sample size used for the test set and the data provenance: Not present.
3. Number of experts used to establish the ground truth for the test set and the qualifications: Not applicable, as no test set data is provided.
4. Adjudication method: Not applicable.
5. MRMC comparative effectiveness study: Not present or applicable to this type of device clearance document.
6. Standalone performance study: The letter refers to "test data developed under the conditions specified in 801.435(d)" for expiration dating, but the details of this study (if it can be considered a standalone performance study in the context of device function beyond shelf-life) are not included.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: Not applicable (this is not an AI/ML device).
9. How the ground truth for the training set was established: Not applicable (this is not an AI/ML device).

The letter merely grants clearance based on substantial equivalence to predicate devices and outlines ongoing regulatory compliance requirements for labeling and manufacturing. It does not disclose the technical performance data that would typically be used to demonstrate meeting acceptance criteria for a novel device.

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The intended use of these latex coloured condoms with flavour lubricant is for contraception and prophylactics purposes (preventing transmission of venereal diseases.)

Natural and Colored Lubricated Latex Condoms with Flavors (Maxima, Trustex, Ria, Premium and EL LES)

This document is a 510(k) clearance letter from the FDA for several brands of colored latex condoms with flavored lubricant. As such, it does not contain the kind of detailed information about acceptance criteria and a study proving a device meets them that one would find for a more complex medical device, especially software or AI-driven diagnostic tools.

This letter is primarily concerned with establishing "substantial equivalence" to a predicate device already on the market. The key "test" mentioned is compliance with existing regulations for latex condoms, particularly regarding labeling and expiration dating.

Therefore, many of your requested points cannot be answered from the provided text.

Here's an attempt to answer based on the information available, and highlighting what is not present:

Description of Acceptance Criteria and the Study:

The primary "acceptance criteria" discussed are regulatory compliance and substantial equivalence to legally marketed predicate devices. The "study" referenced implicitly is the manufacturer's internal testing to support shelf-life claims for expiration dating, which is not detailed in this document but is required to be maintained by the manufacturer for FDA inspection.

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

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

• Not provided in the document. The document refers to "test data developed under the conditions specified in 801.435(d)" for expiration dating, but no specifics on sample size, data provenance, or study design are given. This data is to be maintained by the manufacturer, not necessarily submitted with the 510(k). The device manufacturer is LS Rubber SDN.BHD., located in Malaysia.

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 provided. This type of information would be relevant for devices involving expert assessment or diagnostic accuracy, which is not the primary focus of this condom clearance letter.

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

• Not applicable/Not provided.

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 document is for a physical medical device (condoms), not an AI-assisted diagnostic tool.

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

• Not applicable.

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

• The "ground truth" implicitly referred to would be established through laboratory testing to confirm properties like burst pressure, tensile strength, freedom from holes, and shelf-life stability, as required by standards for condoms (e.g., ISO, ASTM, and FDA regulations like 21 CFR 801.435). This involves objective measurements rather than expert consensus on diagnostic images or pathology.

8. The sample size for the training set

• Not applicable/Not provided. This document does not describe a machine learning algorithm or a training set.

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

• Not applicable/Not provided.

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