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Gynomunal is a personal lubricant, for penile and/or 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 natural rubber latex and with polyisoprene condoms, but not with polyurethane condoms.

Gynomunal is a non-sterile, water-based, ivory to slightly yellow personal lubricant with a shelflife of 36 months. Gynomunal device specifications include color, odor, pH, viscosity, osmolality, antimicrobial effectiveness (Compliance with USP ), and microbiological quality (Compliance with USP , , and ).

The provided document is a 510(k) summary for the Gynomunal Vaginal Gel, a personal lubricant. It details the device's characteristics, intended use, and performance data to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria, based on the provided text:

1. Table of acceptance criteria and the reported device performance

The document lists several device specifications and performance criteria that Gynomunal must meet.

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Me Again® Long Lasting Vaginal Moisturizer is a personal lubricant, for penile and/or 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 not compatible with natural rubber latex, polyisoprene, and polyurethane condoms.

vH Essentials® Long Lasting Vaginal Moisturizer is a personal lubricant, for penile and/or 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 not compatible with natural rubber latex, polyisoprene, and polyurethane condoms.

Long Lasting Vaginal Moisturizer is a non-sterile, non-greasy, water-based personal lubricant delivered in single-use, pre-filled vaginal applicators. Long Lasting Vaginal Moisturizer can be used daily to supplement the body's natural lubrication. Long Lasting Vaginal Moisturizer contains ingredients commonly found in cleared personal lubricants.

This document is a 510(k) Summary for a medical device called "Long Lasting Vaginal Moisturizer" (marketed as Me Again® and vH Essentials®). It describes the device, its intended use, and provides evidence of its substantial equivalence to predicate devices.

However, the provided text does not contain any information about acceptance criteria or a study designed to demonstrate that the device meets specific performance acceptance criteria, as one would typically find for a complex diagnostic or therapeutic device.

Instead, the summary focuses on demonstrating substantial equivalence to previously cleared predicate devices for personal lubricants/vaginal moisturizers. This is a common pathway for Class II devices. The "performance data" presented is primarily related to safety (biocompatibility) and product integrity (stability) rather than a comparative effectiveness or diagnostic accuracy study.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not applicable to the information provided.

I will address the questions to the extent possible given the content:

Acceptance Criteria and Device Performance for Polichem SA Long Lasting Vaginal Moisturizer

The primary objective of the studies described in the 510(k) summary is to demonstrate substantial equivalence to predicate devices by ensuring the new device meets safety and basic functional requirements consistent with its classification as a personal lubricant/vaginal moisturizer. There are no explicit "acceptance criteria" for accuracy, sensitivity, specificity, or similar metrics that would be present for a diagnostic or therapeutic device.

The performance data listed addresses biocompatibility, stability, and compatibility.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of the device and the 510(k) submission, "acceptance criteria" are implied by compliance with recognized standards and successful completion of tests. There are no quantitative "performance metrics" in the traditional sense for this type of device submission's "performance data."

• Delayed hypersensitivity test (GPMT) according to ISO 10993-10:2010: Performed (implies acceptable results).
• Acute Vaginal Irritation hybrid test: Performed (implies acceptable results).
• Acute Systemic Toxicity hybrid test: Performed (implies acceptable results). |
  | Stability | Device maintains its properties for the claimed shelf life. | - Stability data confirms: A shelf life of 24 months. |
  | Compatibility | Condom compatibility is tested and clearly labeled. | - Recent condom compatibility testing per ASTM D7661-10 demonstrates: Not compatible with natural rubber latex, polyisoprene, and polyurethane condoms (This results in a clear labeling instruction rather than a "failure" of the device itself). |

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

The document does not specify the sample sizes used for the biocompatibility, stability, or compatibility tests. These types of tests typically follow recognized standards (e.g., ISO, ASTM), which specify sample sizes. The data provenance is not explicitly stated beyond indicating the performing entity ("Polichem SA") and the submission to the FDA. It is prospective testing for the specific device.

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

This question is not applicable. The studies performed are laboratory-based tests (biocompatibility, stability, ASTM compatibility), not clinical studies involving expert interpretation of patient data or images to establish a "ground truth." The "ground truth" for these tests is the objective outcome of the test itself (e.g., cytotoxicity present/absent, irritation present/absent, shelf life determined, material compatibility).

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

This question is not applicable, as these were laboratory tests, not studies requiring expert adjudication of clinical or imaging data.

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 question is not applicable. This device is a personal lubricant/vaginal moisturizer, not an AI-powered diagnostic or decision-support tool. Therefore, no MRMC study or AI-related effectiveness study was performed or is relevant to this submission.

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

This question is not applicable. The device is a physical product, not an algorithm or software. No standalone algorithm performance study was done.

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

As mentioned in #3, the "ground truth" for the tests described is the objective result of standardized laboratory testing according to established protocols (e.g., ISO, ASTM standards for biocompatibility and material testing). There is no "expert consensus," "pathology," or "outcomes data" in the context of device performance demonstration here, beyond the demonstration of safety and stability.

8. The sample size for the training set

This question is not applicable. This is a physical medical device, not an AI/machine learning algorithm that requires a "training set."

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

This question is not applicable, as there is no "training set" for this device.

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Ecocel® is a hydrosoluble lacquer indicated to protect intact or damaged nails from the effects of moisture, friction (rubbing) or shear (tearing), relieving symptoms and signs of nail dystrophy (i.e. nail splitting and fragility).

Ecocel® is a water-soluble lacquer contained in a glass bottle (1.5 or 3.3 mL) with a nylon brush fitted on the polypropylene screw cap.

The provided documentation for the Ecocel® device (K083087) does not contain sufficient information to describe specific acceptance criteria or a detailed study proving the device meets acceptance criteria in the format requested.

The document is a 510(k) summary for a Class I liquid bandage, Ecocel®, seeking substantial equivalence to existing predicate devices. It primarily focuses on the regulatory submission process and the determination of substantial equivalence by the FDA.

Here's an analysis based on the available information:

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

   • Not provided. The document states that Polichem submitted "summaries of preclinical studies, including biocompatibility and laboratory studies, and the reports from clinical studies as well as the post market experience in Europe that substantiate Ecocel's performance both in vitro as well as its in vivo use." However, no specific acceptance criteria (e.g., minimum efficacy rates, safety thresholds, or performance metrics) or corresponding reported performance data are detailed.

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

   • Not provided. The summary mentions "clinical studies" and "post market experience in Europe" but does not specify sample sizes, design (retrospective or prospective), or the exact country of origin for the data.

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 is typically relevant for medical imaging or diagnostic devices where expert consensus is used to establish ground truth for classification tasks. For a liquid bandage, ground truth would likely be established through objective measures of efficacy (e.g., reduction in nail splitting) or patient-reported outcomes, rather than expert interpretation of images. The document does not detail how outcomes were assessed or by whom.

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

   • Not applicable/Not provided. Similar to point 3, adjudication methods are usually applied to expert reviews in diagnostic studies. For a liquid bandage, if patient-reported outcomes or clinical assessments were used, the method of resolving discrepancies would be detailed, but this is not present in the summary.

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. MRMC studies are specific to diagnostic devices where human readers interpret cases, often with or without AI assistance. This device is a liquid bandage, not an AI-powered diagnostic tool. Therefore, an MRMC study would not be relevant.

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

   • Not applicable. This device is a topical medical product, not an algorithm, so a standalone algorithm performance study is not relevant.

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

   • Inferred to be outcomes data and possibly subjective assessments. The indications for use state "relieving symptoms and signs of nail dystrophy (i.e. nail splitting and fragility)." "Relief of symptoms and signs" would likely be measured through patient diaries, clinical assessments (e.g., visual scores of nail integrity), or other objective measures of nail health. The document does not explicitly state the methodology.

8. The sample size for the training set

   • Not applicable/Not provided. As this is not an AI/machine learning device, there is no "training set" in the conventional sense. If clinical studies were performed, the number of subjects in those studies would be the relevant "sample size," but this is not specified.

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

   • Not applicable/Not provided. As there is no training set for an algorithm, this question is not relevant. For the clinical studies mentioned, the "ground truth" (i.e., whether the treatment was effective) would be based on the pre-defined endpoints and measurement methodologies of those studies, which are not detailed.

In summary, the provided 510(k) summary for Ecocel® confirms its regulatory clearance based on substantial equivalence. However, it does not offer the granular detail on acceptance criteria, study methodologies, sample sizes, or ground truth establishment that would be present in a comprehensive study report, especially one for an AI or diagnostic device. The document states that the device's performance was substantiated by "preclinical studies" and "clinical studies," but the specifics of these studies are not disclosed in this summary.

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