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Elegant™ Advanced CompHort is a personal lubricant for vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with polyurethane condoms. This product is not compatible with natural rubber latex and polyisoprene condoms.

Elegant™ Advanced CompHort is a line extension to the "Elegant™" range to extend claims. It is a non-sterile, water-based, pearly white, non-irritating, non-greasy, hormone-free, paraben-free, fragrance-free, moisturizing creams for vaginal dryness. It is a personal lubricant that provides lubrication, and it is intended for ongoing use and is not exclusively for use during intimate sexual activity. The formulation of Elegant™ Advanced CompHort contains purified water, polycarbophil, carbomer homopolymer type B, labrafac, emulfree P, sorbic acid and sodium hydroxide. Elegant™ Advanced CompHort is packaged in an aluminium tube and applied using a reusable plastic applicator marked to deliver 3ml of product. Elegant™ Advanced CompHort is to be sold as an over-the-counter (OTC) product.

The provided document is a 510(k) Premarket Notification from the U.S. FDA for a personal lubricant called "Elegant™ Advanced CompHort." It aims to demonstrate substantial equivalence to a legally marketed predicate device. The document focuses on physical, chemical, and biological testing rather than an AI/ML-based diagnostic device.

Therefore, the requested information regarding acceptance criteria and a study proving an AI/ML device meets these criteria, including elements like data provenance, experts for ground truth, MRMC studies, and training set information, cannot be extracted from this document.

The document details the following for the personal lubricant:

1. Table of acceptance criteria and reported device performance:

This document provides device specifications (acceptance criteria) and the results from performance testing (reported device performance) in Table 1 and in the "Summary of Performance Data" section.

Table 1. Device Specifications for Elegant™ Advanced CompHort

Study Proving Device Meets Acceptance Criteria:

The document describes the following performance testing to demonstrate the device meets its specifications and is safe and effective:

• Biocompatibility Testing: Performed in accordance with the 2020 FDA guidance document "Use of International Standard ISO 10993-1."

  • Tests Conducted:
    • Cytotoxicity per ISO 10993-5
    • Vaginal Irritation per ISO 10993-10
    • Sensitization per ISO 10993-10
    • Acute Systemic Toxicity per ISO 10993-11:2017
  • Results: The device was found to be non-cytotoxic, non-irritating, non-sensitizing, and non-systemically toxic. A clinical test in women also reported no adverse events.

• Shelf-Life Testing:

  • Conditions: Conducted at 25°C/60% RH.
  • Duration: Data generated up to 24 months.
  • Results: Demonstrated that the device can maintain its specifications (as shown in Table 1) over the duration of a 24-month shelf-life.

• Condom Compatibility Testing:

  • Method: Evaluated in accordance with ASTM D7661-10 "Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms."
  • Results: The device is compatible with polyurethane condoms. It is not compatible with natural rubber latex and polyisoprene condoms.

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

• Sample size: Not explicitly stated in numerical terms (e.g., "N=XX samples"). The testing appears to be laboratory-based and possibly involved animal testing for biocompatibility before the clinical test mentioned for women.
• Data Provenance: Not specified regarding country of origin. The testing methods refer to internationally recognized standards (ISO, USP, ASTM), suggesting standard laboratory practices. The clinical test result ("clinically tested in women") implies prospective data collection, but no further details are given.

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

• This information is not applicable to this type of device and study. The testing relies on established physical, chemical, and biological test methods and standard specifications, rather than expert consensus on diagnostic image interpretation or similar.

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

• Not applicable. This is not a study requiring adjudication of interpretations.

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/ML 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/ML device.

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

• The "ground truth" here is defined by the established physical, chemical, and microbiological specifications (e.g., pH range, viscosity range, absence of specific pathogens) and biological compatibility outcomes (non-irritating, non-cytotoxic, etc.) as determined by standardized laboratory test methods (e.g., USP, ISO, ASTM).

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device requiring a training set.

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

• Not applicable. This is not an AI/ML device.

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Elegant™ 2 in 1 Vaginal Moisturizer/ Elegant™ Advanced 5 is a personal lubricant for vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with polyurethane condoms. This product is not compatible with natural rubber latex and polyisoprene condoms.

The subject device is a non-sterile, water-based, personal lubricant that provides lubrication during intimate sexual activity. The formulation contains purified water, polycarbophil, carbomer homopolymer type B, labrafac, emulfree P, sorbic acid and sodium hydroxide. Elegant™ 2 in 1 Vaginal Moisturizer is packaged in an aluminium tube and applied using a reusable plastic applicator marked to deliver 2ml of product. Elegant™ Advanced 5, is packaged in an aluminium tube and applied using a reusable plastic applicator marked to deliver 3ml of product. Elegant™ 2 in 1 Vaginal Moisturizer and Elegant™ Advanced 5 are personal lubricants for over-the-counter (OTC) use.

The provided document is a 510(k) summary for the Elegant™ 2 in 1 Vaginal Moisturizer and Elegant™ Advanced 5. This document assesses the substantial equivalence of a new medical device to a legally marketed predicate device. The information required primarily applies to AI/ML medical devices, which this product (a personal lubricant) is not. Therefore, specific details like sample sizes for training/test sets, number of experts for ground truth, adjudication methods, or MRMC studies are not applicable or provided for this type of device.

However, I can extract the acceptance criteria and a summary of the studies conducted to demonstrate the device meets those criteria, as much as possible from the provided text.

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

The document provides "Device Specifications" in Table 1, which serve as the acceptance criteria for the physical and biological properties of the lubricant. It also summarizes the performance studies conducted to demonstrate compliance with these specifications and other safety/effectiveness aspects.

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 sample sizes for the biological or chemical tests, which is typical for this type of submission focusing on standard test methodology and results. The studies appear to be laboratory-based and likely prospective, following recognized international and national standards (e.g., ISO, USP, ICH, ASTM). No country of origin for the data is explicitly mentioned, but the submitter is Viramal Limited, located in the United Kingdom.

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 is not applicable to a personal lubricant. The "ground truth" for this device type is established by standardized laboratory testing methods (e.g., pH meters for pH, specific assays for microbial counts, etc.), not expert consensus on interpretations.

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

This is not applicable to a personal lubricant. Standard laboratory tests do not use adjudication methods in the way clinical studies for diagnostic algorithms do.

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 is not applicable to a personal lubricant. MRMC studies are relevant for medical imaging or similar diagnostic AI/ML devices.

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

This is not applicable to a personal lubricant, as it is not an AI/ML algorithm.

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

The "ground truth" for the performance criteria (specifications) of this device is based on objective measurements obtained through standardized laboratory testing methods (e.g., USP monographs for pH, density, viscosity, osmolality, microbial counts; ISO standards for biocompatibility; ASTM standards for condom compatibility).

8. The sample size for the training set

This is not applicable to a personal lubricant, as it is not an AI/ML device and does not involve training data.

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

This is not applicable to a personal lubricant.

Ask a specific question about this device