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Restrata™ Wound Matrix is intended for use in the management of wounds, including: Partial and full thickness wounds, pressure sores/ ulcers, diabetic ulcers, chronic vascular ulcers, tunneled / undermined wounds, surgical wound (e.g., donor site/ grafts, post-Mohs surgery, podiatric wounds, wound dehiscence), trauma wounds (e.g., abrasions, partial thickness burns, skin tears), and draining wounds.

The Restrata™ Wound Matrix is a sterile, single use device intended for use in local management of wounds. The Restrata™ Wound Matrix is a soft, white, conformable, non-friable, absorbable matrix that acts as a protective covering for wound defects, providing a moist environment for the body's natural healing process to occur. Restrata™ is made from synthetic biocompatible materials and was designed to include a fibrous structure with high porosity, similar to native extracellular matrix. Restrata™ is a porous matrix with a defined rate of resorption that provides a scaffold for cellular infiltration and vascularization before completely degrading via hydrolysis. The device permits the ingress of cells and soft tissue formation in the defect space / wound bed. The device does not contain any human or animal materials or tissues. Restrata™ Wound Matrix is supplied terminally sterile, in a single use double peel package in a variety of sizes. Contents of the package are guaranteed sterile and non-pyrogenic unless the package has been opened or damaged.

The provided text is a 510(k) Summary for the Acera Surgical Restrata™ Wound Matrix. This document describes the device, its intended use, and its technological characteristics as part of a premarket notification to the FDA to demonstrate substantial equivalence to an already legally marketed predicate device.

Key takeaway: This document is not a study proving a device meets acceptance criteria, but rather a submission to the FDA demonstrating substantial equivalence. Therefore, much of the requested information about acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment will not be found in this type of regulatory submission. The 510(k) process focuses on demonstrating similarity to an existing device, rather than proving a device meets specific, predefined performance metrics through a clinical study with acceptance criteria.

However, I can extract the information that is present and explain why other information is not available:

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

The document does not present a table of specific, numeric acceptance criteria with corresponding device performance metrics. Instead, it demonstrates equivalence through comparative tables of characteristics and references to performance data.

From the "Technological Characteristics" section, a comparative table is provided:

Performance Data Summary:

• "The subject device has mechanical properties (tensile strength and suture pull-out strength) equivalent or superior to the reference device." (No specific numerical values or acceptance criteria are stated).
• "The subject device was also tested against a commercially available wound dressing with the same intended use in a clinically relevant full thickness porcine wound model. Analysis included an assessment of biocompatibility, along with macroscopic assessment of wound healing, planimetric measurement of wound closure, and histopathology. Test results showed that the subject device had an equivalent wound healing response compared to the control article, and exhibited no adverse tissue responses." (Again, no specific numerical outcomes or acceptance criteria are provided; the finding is "equivalent").

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

• Sample size: Not explicitly stated. The "Performance Data" section mentions a "clinically relevant full thickness porcine wound model," implying animal testing, but the number of animals or wounds tested is not specified.
• Data provenance: The performance data comes from non-clinical testing (mechanical properties and a porcine wound model). The country of origin for the data is not specified, nor is whether the study was retrospective or prospective (though animal model studies are inherently prospective).

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

• This information is not provided. Since the described tests are primarily non-clinical (mechanical and animal model), the concept of "experts establishing ground truth for a test set" in the context of human data (e.g., radiologists for imaging) does not directly apply. For the animal study, the assessment of "equivalent wound healing response" and "no adverse tissue responses" would have been made by researchers/veterinarians/pathologists, but their number and specific qualifications are not detailed in this summary.

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

• This information is not provided and is generally not applicable to the non-clinical tests described in this 510(k) summary. Adjudication methods are typically used in clinical studies involving interpretation of human 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

• No MRMC study was performed or described. This document is for a physical medical device (wound matrix), not an AI/software device that assists human readers.

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

• Not applicable, as this is a physical medical device, not an algorithm.

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

• For the mechanical properties, the "ground truth" would be established by standardized mechanical testing methods.
• For the porcine wound model, the "ground truth" was established through "macroscopic assessment of wound healing, planimetric measurement of wound closure, and histopathology." This is effectively a combination of direct observation, quantitative measurement, and microscopic pathology, as assessed by the researchers of that study.

8. The sample size for the training set

• Not applicable. This is a physical device being submitted via 510(k), not an AI/machine learning algorithm that requires a training set. The "testing" referred to is for device performance, not algorithm training.

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

• Not applicable, as there is no training set for a physical device.

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