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AWBAT-S Plus: is intended for clean Superficial burn wounds.

AWBAT-D Plus: are intended for Donor sites after hemostasis has been established.

AWBAT-M Plus: are intended to be used as a protective covering for Meshed autografts.

A Temporary Wound Dressing for coverage of Superficial burns, Donor sites and Meshed autografts until healing occurs. AWBAT Plus is composed of a single or multiple filesned knitted nylon fabric, bonded to a thin porous silicone membrane (enproximately 0.01 inch). The nylon side of these components is coated with a non-toxic mixture of porcine collagen. peptides, chondroitin-4-sulfate, chondroitin-6-sulfate, Immuno-10 (Aloe polysiaconarides), vitamin C, vitamin E, and polysorbate 20.

AWBAT Plus is manufactured in 12"x12" sheets that are cut to sizes of 6"x6", 6"x12" and 12"x12" and ink stamped AWBAT-S Plus, AWBAT-D Plus, AWBAT-M Plus accordingly.

AWBAT-S Plus has pores in the silicone membrane at 1/4" centers and the approximate area of an AWBAT-S Plus pore is 0.0036 square inch each.

AWBAT-D Plus has pores in the silicone membrane at 1/4" centers and the approximate area of an AWBAT-D Plus pore is 0.0073 square inch each.

AWBAT-M Plus has pores in the silicone membrane at 1/4" centers and the approximate area of an AWBAT-M Plus pore is 0.0070 square inch each.

The provided text is a 510(k) summary for the AWBAT Plus Wound Dressings. It describes the device, its intended use, and its substantial equivalence to a predicate device (AWBAT).

However, this document does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically found in submissions for AI/ML-driven medical devices. This is a traditional wound dressing, and the assessment here focuses on biocompatibility and comparison to a predicate device, rather than performance metrics like sensitivity, specificity, or AUC which would be relevant for an AI system.

Therefore, many of the requested fields cannot be filled from the provided text.

Here is an attempt to answer based on the available information, noting where information is absent:

1. Table of Acceptance Criteria and Reported Device Performance

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

This information is not available in the provided 510(k) summary. The submission focuses on biocompatibility testing (which is not typically "test set" based in the AI/ML sense) and demonstrating substantial equivalence to a predicate device, rather than a clinical performance study with a test set of cases.

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

This information is not available. The device is a wound dressing, not an AI/ML diagnostic tool, so the concept of "ground truth" and expert adjudication in this context does not apply. The assessment is based on material properties, biocompatibility, and intended use comparison.

4. Adjudication Method for the Test Set

This information is not available. Not applicable for this type of device and submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is specifically relevant for AI-assisted image analysis or diagnostic tools and is not applicable to a wound dressing. The device does not use software (as stated in Table 1, "Does the device use software? No").

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

No, a standalone performance study was not done. This device is a physical wound dressing and does not involve an algorithm or AI.

7. The Type of Ground Truth Used

The concept of "ground truth" as typically applied to AI/ML devices (e.g., pathology, outcomes data) is not applicable here. The assessment for this device relies on:

• Biocompatibility testing against a recognized standard (ISO 10993-1:2003). The 'truth' here is compliance with the assays defined by the standard (cytotoxicity, sensitization, irritation).
• Comparison of device characteristics to a legally marketed predicate device. The 'truth' of substantial equivalence is established by comparing features like intended use, materials, design, function, and operating characteristics.

8. The Sample Size for the Training Set

This information is not available. Not applicable as this is not an AI/ML device requiring a training set.

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

This information is not available. Not applicable as this is not an AI/ML device requiring a training set.

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AWBAT-S is intended for clean Superfical burn wounds.

AWBAT-D is intended for Donor sites after hemostasis has been established.

AWBAT-M is to be used as protective covering for Meshed autografts.

A Temporary Wound Dressing for coverage of Superficial burns, Donor sites and Meshed autografts until healing occurs. AWBAT is composed of a single or multiple filament knitted nylon fabric, bonded to a thin porous silicone membrane (approx 0.001 inch). The nylon side of these components is coated with a non-toxic mixture of porcine collagen peptides.

AWBAT is manufactured in 12"x12" sheets that are cut to sizes of 3"x3", 6"x12" and 12"x12" and ink stamped "AWBAT-S," "AWBAT-D" or "AWBAT-M" accordingly.

AWBAT-S has pores in the silicone membrane at 1/4" centers and the approximate area of an AWBAT-S pore is 0.0036 square inch each.

AWBAT-D has pores in the silicone membrane at 1/4" centers and the approximate area of an AWBAT-D pore is 0.0073 square inch each.

AWBAT-M has pores in the silicone membrane at 1/4" centers and the approximate area of an AWBAT-M pore is 0.0070 square inch each.

AWBAT-S is composed of a 15/2 denier multiple filament nylon knitted fabric, bonded to a thin porous silicone membrane. The nylon side of these components is coated with a non-toxic mixture of porcine collagen peptides (xenogenic component).

AWBAT-D has the same composition as AWBAT-S, except it is more porous to enable the clinician to evacuate a clot through the membrane into an outer sterile wrap.

AWBAT-M has the same composition as AWBAT-D, except the 12/1 denier nylon fabric is monofilament (thinner & less adherent).

This document is a 510(k) Summary for a medical device called AWBAT (AWBAT-S, AWBAT-D, AWBAT-M), which is a temporary wound dressing. It is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device (Biobrane®).

The document does not contain information about acceptance criteria or a study that proves the device meets those criteria. This type of submission (510(k)) primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting new clinical study data with specific acceptance criteria.

Therefore, I cannot provide the requested information from the given text. The text explicitly states "Does the submission include clinical information? No". This confirms that no clinical studies, and thus no stated acceptance criteria or performance data, are present in this 510(k) summary.

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