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a) Over-The-Counter (OTC) use
The L-Mesitran Dressing Family II - Soft and Tulle provide a moist environment conducive to wound healing and are indicated for light to moderately exuding wounds. For over the counter use, L-Mesitran Dressing Family II may be used for:

• minor abrasions
• lacerations
• minor cuts
• minor scalds and burns

b) Prescription (Rx) use

Under the supervision of a healthcare professional, The L-Mesitran Dressing Family II - Soft and Tulle provide a moist environment conducive to wound healing and are indicated for light to moderately exuding wounds. The L-Mesitran Dressing Family II is intended for the management of the following:

• Diabetic foot ulcers

• Leg ulcers (venous stasis ulcers, arterial ulcers and leg ulcers of mixed etiology)

• Pressure ulcers / sores (partial and full thickness)

• 1st and 2nd degree partial thickness burns

• Donor sites, and traumatic and surgical wounds

L-Mesitran Soft and Tulle are to be used in conjunction with other secondary dressings.

L-Mesitran® Soft and Tulle are wound dressings for the use on wounds

• L-Mesitran® Soft is a gel that contains: 40% medical grade honey, medical grade hypoallergenic lanolin, propylene glycol, PEG 4000, and vitamins C and E.

• L-Mesitran® Tulle is a non-adherent polyethylene dressing impregnated with the patented L-Mesitran® Soft gel.

This document is a 510(k) Pre-market Notification for the L-Mesitran® Dressing Family II, which includes L-Mesitran® Soft and L-Mesitran® Tulle. The FDA determined that the device is substantially equivalent to legally marketed predicate devices.

Here's an analysis based on the provided text, focusing on acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not provide specific quantitative acceptance criteria or a table detailing the device's performance against such criteria. The submission focuses on demonstrating substantial equivalence to predicate devices through biocompatibility and other non-clinical tests, rather than meeting specific performance metrics for wound healing efficacy.

The "performance" demonstrated is that the device is biocompatible and suitable and safe for its intended use. This is concluded based on meeting the specifications of various ISO and pharmacopoeial tests.

2. Sample Size Used for the Test Set and Data Provenance

The document does not describe a "test set" in the context of clinical performance data or a specific dataset of wound images/patient data for evaluating an AI (which is not applicable here).

For the non-clinical performance testing:

• Sample size: Not explicitly stated for each test (e.g., number of test articles for cytotoxicity, sensitization). However, the tests referenced (ISO, Ph.Eur., USP) typically specify sample size requirements.
• Data provenance: Not specified by country. These are laboratory-based tests of the device material itself. They are retrospective in the sense that the testing was performed on the manufactured device components.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable. This submission concerns a medical device (wound dressing), not an AI/imaging diagnostic device requiring expert interpretation for ground truth. The ground truth for the non-clinical tests is based on objective, standardized laboratory measurements and compliance with international standards.

4. Adjudication Method for the Test Set

Not applicable for a medical device (wound dressing) regulatory submission. Adjudication methods are typically employed in clinical trials or studies involving human interpretation, especially for AI or diagnostic devices.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC study is not relevant for this type of medical device (wound dressing). MRMC studies are typically performed for diagnostic imaging devices to assess the performance of readers with and without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. There is no algorithm or AI component to this medical device.

7. The Type of Ground Truth Used

The "ground truth" for this device's safety and performance is based on:

• Scientific and regulatory standards: Compliance with ISO 10993 for biocompatibility, European Pharmacopoeia (Ph.Eur.), and United States Pharmacopeia (USP) for preservative efficacy and bioburden.
• Objective laboratory measurements: The tests performed generate quantifiable data that are compared against predefined acceptance criteria outlined in these standards.

8. The Sample Size for the Training Set

Not applicable. There is no AI or algorithm involved that would require a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no AI, there is no training set or ground truth in that context.

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