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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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L-Mesitran Hydro and Border dressings are indicated for acute and chronic superficial wounds such as: bruises, cuts, bedsores, first and second-degree burns and other traumatic wounds, venous and arterial ulcera, diabetes ulcers, donor sites, and post-operative wounds. L-Mesitran Hydro and Border should not be used as a covering for deep narrow cavities, dirty wounds (these should first be cleansed), third-degree burns and fistulae. Maintains a moist wound healing environment. This moist environment supports optimal wound healing.

L-Mesitran Active dressings are indicated for treating minor burns, superficial cuts, lacerations and abrasions, and other small wounds. Maintains a moist wound healing environment. This moist environment supports optimal wound healing.

L-Mesitran dressings are indicated for acute and chronic superficial wounds such as: bruises, tears, pressure ulcers, venous and arterial ulcera, diabetes ulcers, donor sites, cuts, first and second degree burns, postoperative wounds and other external wounds caused by trauma. L-Mesitran Net is to be used in conjunction with other secondary dressings. It should not be used on its own as a covering for dirty infected and heavily exudating wounds (should first be cleansed), third degree burns, or deep narrow cavities. Maintains a moist wound healing environment. This moist environment supports optimal wound healing.

L-Mesitran Hydro, L-Mesitran Border, and L-Mesitran Active are hydro-active hydrogel wound dressings containing honey. L-Mesitran Net is a hydro-active hydrogel coated wound dressing containing honey on an open weave polyester net.

Here's an analysis of the provided text regarding the acceptance criteria and study for the L-Mesitran® Dressing Family:

Based on the provided 510(k) Summary, it's important to note that this submission is for a wound care dressing, which typically relies on biocompatibility and performance testing rather than the kind of AI/machine learning performance assessment described in the prompt's questions (e.g., sensitivity, specificity, reader studies, etc.). The 510(k) pathway focuses on demonstrating substantial equivalence to a legally marketed predicate device.

Therefore, many of the questions related to AI/ML performance metrics, ground truth, expert opinions for image interpretation, and reader studies are not applicable to this type of device and submission.

Here's the information that can be extracted from the provided text, addressed within the context of hardware/material device submission:

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)

• Sample Size: Not specified for the biocompatibility or performance tests.
• Data Provenance: Not specified. Standard biocompatibility tests are generally conducted by certified laboratories.

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 device is a wound dressing, not an AI/imaging device requiring expert interpretation for ground truth establishment. Biocompatibility and performance tests follow established laboratory protocols and standards, not expert consensus on images.

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

• Not applicable. Adjudication methods like 2+1 or 3+1 are used for discrepancies in expert interpretations (e.g., radiology reads). This does not apply to biocompatibility or physical performance testing of a wound dressing.

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

• No, this was not done. MRMC studies are specific to AI/imaging devices involving human reader performance. This device is a passive wound dressing.

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

• Not applicable. This device does not involve an algorithm or AI.

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

• Not applicable in the typical AI sense. For biocompatibility, "ground truth" would equate to established biological safety standards (e.g., ISO 10993 series) and laboratory results conforming to these standards. For performance, it would be the physical and chemical characteristics of the dressing that ensure it functions as intended (e.g., ability to maintain moisture, adhesion properties, non-shedding, etc.) as demonstrated through validated test methods. The text mentions "Biocompatibility study and performance test results," implying these standard tests were performed.

8. The sample size for the training set

• Not applicable. This device is not an AI/ML system and does not have a training set.

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

• Not applicable. This device is not an AI/ML system and does not have a training set.

Summary of Relevant Information:

The core of this 510(k) submission for the L-Mesitran® Dressing Family relies on:

• Biocompatibility Studies: Demonstrating the device is non-irritating, non-sensitizing, and non-toxic. The specific tests (e.g., cytotoxicity, sensitization, irritation) are implied but not detailed.
• Performance Tests: Demonstrating the dressing's ability to maintain a moist wound healing environment and physical integrity.
• Substantial Equivalence: Comparing the device's materials, design, intended use, and performance to a legally marketed predicate device (Southwest Technologies' Elasto-Gel Dressings, #K872165) to show that it is as safe and effective. The conclusion explicitly states substantial equivalence.

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