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N-TERFACE Interpositional Surfacing Material is indicated for use as a wound contact layer for partial thickness burns and and confection worselves of laser skin resurfacing. indicated for use as a wound concace in ......................................................................................................................................

N-TERFACE® Interpositional Surfacing Material is an extruded, non-woven, high density polyethylene sheeting material with the following physical properties: Weight, oz/yd2: 0.36 to 0.8, Thickness, Mils: 4.0 to 5.0, Tensile, Ibs/in .: roll direction 14 to 77, cross direction 1.5 to 4.5, Air Permeability ft3/min/ft2: 545 to 1144.

The provided text is a 510(k) Summary for the N-TERFACE® Interpositional Surfacing Material, which is a medical device. This document is a regulatory submission to the FDA for market clearance, not a study report detailing clinical acceptance criteria and performance data in the way requested by the prompt.

Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert qualifications, and specific performance metrics of a device-proving study cannot be found or inferred from this document.

The document primarily focuses on establishing "substantial equivalence" to a predicate device for regulatory approval.

Here's a breakdown of what can be extracted and why other parts cannot:

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

• Cannot be provided. This document does not present acceptance criteria for performance in a clinical study format, nor does it report specific device performance metrics against such criteria. The "performance" described is limited to physical properties of the material (weight, thickness, tensile strength, air permeability) for which acceptance criteria are not explicitly stated. The core "performance" for regulatory purposes is its substantial equivalence to the predicate device.

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

• Cannot be provided. No test set or clinical study data is presented in this 510(k) summary. The submission relies on the device being "physically identical" to a previously cleared device.

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)

• Cannot be provided. No test set or ground truth establishment process for a performance study is described.

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

• Cannot be provided. No adjudication method is described as there is no test set or clinical outcome data presented.

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

• Cannot be provided. This device is an interventional material, not an AI diagnostic tool. No MRMC study or AI-related information is present.

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

• Cannot be provided. This device is an interventional material, not an algorithm.

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

• Cannot be provided. The document does not describe the use of ground truth for a performance study. Its "ground truth" for regulatory equivalence is the functional properties and intended use of the predicate device.

8. The sample size for the training set

• Cannot be provided. This device is a physical material, not an AI algorithm. There is no concept of a "training set" in this context.

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

• Cannot be provided. As above, no training set or ground truth for it exists in this context.

Summary of available information related to "acceptance" (regulatory, not clinical performance):

The "acceptance criteria" in this context are interpreted as the requirements for Substantial Equivalence for FDA 510(k) clearance.

• Predicate Device: N-TERFACE® Interpositional Surfacing Material (K820198) manufactured by Winfield Laboratories, Inc.
• Basis for Equivalence: The new device (for laser skin resurfacing) is "physically identical" to the predicate device (for partial thickness burns). The argument is that wounds from laser skin resurfacing are partial thickness burns, making the new indication a subset of the previously cleared use.

No clinical study data is presented to "prove" the device meets acceptance criteria in the traditional sense of a performance study with outcome measures. Regulatory acceptance is based on demonstrating equivalence to a device already on the market without a new safety or effectiveness question.

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