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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.

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A Nitrile powder free examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. (21 CFR 880.6250)

ELEGANT Nitrile Powder Free Examination Gloves

This document is a 510(k) premarket notification decision letter from the FDA for medical examination gloves and does not contain information about acceptance criteria or a study proving that a device meets such criteria in the context of an AI/ML medical device.

The provided text pertains to the substantial equivalence determination for "Elegant Blue Violet Nitrile Examination Gloves Ambidextrous Powder-Free" (K120110). It states that the device is a "disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner." (21 CFR 880.6250).

Therefore, none of the requested information (1-9) can be extracted from this document, as it is not relevant to the performance evaluation of an AI-powered device.

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A Nitrile powder free examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. (21 CFR 880.6250)

Model 1: White Nitrile, Powder Free Examination Gloves
Model 2: Blue Nitrile, Powder Free Examination Gloves
Model 3: Pink Nitrile, Powder Free Examination Gloves

The input document is a letter from the FDA regarding a 510(k) premarket notification for "Elegant Powder Free Nitrile Examination Gloves". It primarily addresses the substantial equivalence determination for the device. The document does not contain any information about acceptance criteria for a device's performance, nor does it describe any study related to device performance, sample sizes, ground truth establishment, or expert adjudication that would be relevant to the questions posed.

Therefore, I cannot provide the requested information based on the provided text. The questions are designed for a document describing a clinical study or performance evaluation of a medical device, which this document is not.

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CAD/CAM veneering for anterior and posterior single crowns made of Lava Frame Zirconia, manufactured with Lava Design Software and the accordingly released Lava milling machine.

Elegant is classified as Porcelain powder for clinical use (21 C.F.R. § 872.6660). Elegant is used for production of glass ceramic veneers for 3M ESPE Lava™ Frame Zirconia frameworks.

Elegant consists of 4 glass ceramic blocks (E1 - E4), from which the veneer is milled. Each ceramic block is available in the two sizes S and M. The veneer is then fused to the Zirconia framework via color-coordinated fusion porcelain (D1 - D10). For smaller adjustments to the restoration, corrective porcelains (CR1 - CR4) can be used. For the tooth colors A4, B4, C3, C4, and D4, the basic shades ("Shade" A - D) must be used. The individual stains S1 (White), S2 (Lemon Yellow), S3 (Orange), S4 (Violet), S5 (Blue), S6 (Dark Brown), and glaze are used for individualization. For the mixing of the fusion porcelain powder and the corrective porcelain, modelling liquid is available; also, for stains and glaze, stain/glaze liquid is available.

For the production of an Elegant restoration, the Lava™ Frame Zirconia framework and the corresponding Elegant veneer are virtually designed on the screen with the Lava™ Design Software. The milling for both parts takes place in the accordingly released Lava™ milling machine with special milling cutters. Subsequently the Lava™ Frame Zirconia framework is shaped and then sintered in the Lava™ sintering furnace. All of the above-mentioned Lava products are manufactured by or for 3M ESPE.

This document is a 510(k) Summary for the device "Elegant," a porcelain powder for clinical use in dental restorations. It focuses on establishing substantial equivalence to predicate devices, rather than a traditional clinical study with acceptance criteria for device performance in terms of diagnostic accuracy or similar metrics.

Therefore, many of the requested elements pertaining to acceptance criteria and performance studies are not directly applicable or available in this type of submission, as it's not a clinical performance study evaluating outcomes like sensitivity or specificity. Instead, the "study" is a comparison to predicate devices, and the "acceptance criteria" are the demonstration of substantial equivalence.

Here's an interpretation based on the provided text:

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 applicable in the context of this 510(k) summary. This document does not describe a clinical performance study with a test set of patient data. The "test" for a 510(k) is typically a comparison of device characteristics (chemistry, performance, indications) to existing devices. If any physical or mechanical properties were tested, the sample sizes would refer to experimental batches of materials, not a "test set" of patient data. The manufacturer is based in Germany.

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. This submission does not involve a diagnostic decision-making process requiring expert ground truth for a test set. The "ground truth" here is regulatory acceptance of equivalence based on the provided technical data and comparisons to predicate devices, reviewed by FDA officials.

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

• Not applicable. There is no "test set" or adjudication of diagnostic findings described. The FDA's review process internally involves multiple reviewers, but this is a regulatory review, not a clinical adjudication.

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 device is a material for dental restorations, not an AI software or diagnostic tool that assists human readers.

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

• Not applicable. This device is a material, not an algorithm.

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

• The "ground truth" for this 510(k) submission is the established characteristics and regulatory acceptance of the predicate devices. The new device's data (chemistry, performance, indications) is compared against these known, legally marketed predicates to demonstrate substantial equivalence.

8. The sample size for the training set

• Not applicable. This device is a material, not a machine learning model, so there is no training set.

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

• Not applicable. As there is no training set, this question is not relevant.

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