(185 days)
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
| Parameter | Test Method | Specification (Acceptance Criteria) | Reported Performance (Results from Shelf-Life Testing) |
|---|---|---|---|
| Appearance | Visual inspection | White to off-white | Maintained specifications over 24 months |
| Density (g/cm³) | Ph. Eur 2.2.5; USP | 0.9970 - 0.9995 | Maintained specifications over 24 months |
| pH | USP | 2.5-3.5 | Maintained specifications over 24 months |
| Consistency (1/10mm) | Ph. Eur 2.9.9 | 145 - 200 | Maintained specifications over 24 months |
| Viscosity (Pa.s) | USP | 120 - 220 | Maintained specifications over 24 months |
| Osmolality (mOsm/kg) | USP | 15-35 | Maintained specifications over 24 months |
| Total Aerobic Microbial Count (TAMC) | USP | ≤ 10² CFU/g | Maintained specifications over 24 months |
| Total combined yeasts/molds count (TYMC) | USP | ≤ 10¹ CFU/g | Maintained specifications over 24 months |
| Absence of pathogenic organisms: Staphylococcus Aureus, Pseudomonas Aeruginosa, and Candida Albicans | USP | Absent | Maintained specifications over 24 months |
| Antimicrobial Effectiveness Test | USP | Bacteria: No less than 2.0 log reduction at 14 days and no increase from 14-day count at the 28-day count | |
| Yeast/Mold: No increase from the initial calculated count at 14 and 28 day | Maintained specifications over 24 months |
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:
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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.
- Tests Conducted:
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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.
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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.
§ 884.5300 Condom.
(a)
Identification. A condom is a sheath which completely covers the penis with a closely fitting membrane. The condom is used for contraceptive and for prophylactic purposes (preventing transmission of sexually transmitted infections). The device may also be used to collect semen to aid in the diagnosis of infertility.(b)
Classification. (1) Class II (special controls) for condoms made of materials other than natural rubber latex, including natural membrane (skin) or synthetic.(2) Class II (special controls) for natural rubber latex condoms. The guidance document entitled “Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300” will serve as the special control. See § 884.1(e) for the availability of this guidance document.