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OTC: May be used for superficial wounds and abrasions and minor burns.

Rx: Under the supervision of health care professionals for the local management of partial- and full-thickness wounds including pressure, and diabetic ulcers; lower extremity ulcers including those of venous, arterial and mixed etiology; surgical wounds; first-degree and partial-thickness burns including management of abrasions and burns associated with dermabrasions and laser resurfacing.

G4Derm / G4Derm Plus Synthetic Wound Matrix is a sterile, biodegradable hydrogel matrix supplied in a prefilled syringe ready for topical use as primary wound dressing, with or without the use of an optional nozzle. The hydrogel in G4Derm / G4Derm Plus is composed of an aqueous solution of synthetic peptide (≥ 98% sterile water). The device is completely non-animal tissue and non-cellular derived.

G4Derm / G4Derm Plus forms a three-dimensional hydrogel scaffold, which, at a basic structural level, is composed of a matrix of interwoven fibrils formed from individual peptide monomers. This woven network structure, or matrix barrier, is similar to the microarchitecture of endogenous extracellular matrix ("ECM"). This structure also functions as a matrix that holds and donates water to underlying tissue, while providing an effective barrier to cover and protect the wound against the external environment, namely against bacterial penetration.

G4Derm / G4Derm Plus Synthetic Wound Matrix forms a clear, biodegradable hydrogel without expansion in volume. During dressing changes, the unincorporated or unintegrated material may be removed without causing trauma to the underlying tissue by gently flushing / wiping the wound.

The provided text describes the G4Derm / G4Derm Plus Synthetic Wound Matrix and its substantial equivalence to a predicate device, Woun'Dres® Collagen Hydrogel (K991202), and two reference devices, PuraDERM (K193085/K143058) and Excellagen (K110318). However, the document does not include a specific table of acceptance criteria or detailed reported device performance in a quantitative manner that would allow for a direct comparison with specific numerical targets.

Based on the information provided, here's a breakdown of the available data:

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

The document does not provide a formal table with specific numerical acceptance criteria and corresponding reported device performance values. Instead, it states that "Gel4Med / G4Derm Plus Synthetic Wound Matrix is substantially equivalent in intended use, indications for use, device design, function, physical properties, principles of operation, instructions for use, biocompatibility, safety, and performance to the predicate device." It also mentions that "Any differences in the technological characteristics of the subject device when compared to the predicate have been successfully evaluated using appropriate scientific methods."

The general performance attributes assessed are:

• Safety: Demonstrated through biocompatibility testing (ISO 10993-1) and human skin irritation testing.
• Effectiveness: Demonstrated through in vivo performance testing in a wound healing animal model.
• Sterility: Achieved a minimum sterility assurance level of 10^-6 in accordance with ISO 17665.
• Antibacterial barrier effectiveness: Tested in vitro.

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

• Test Set Sample Size: The document mentions "a large animal wound healing model" for performance testing. However, it does not specify the exact number of animals or wounds used in this in vivo study. It also mentions "Human Skin Irritation Test" and "antibacterial barrier effectiveness testing (in vitro)" but does not provide sample sizes for these tests.
• Data Provenance: The animal model is described as a "GLP pre-clinical performance testing in wound healing animal model". The location or country of origin of this study is not specified. The human skin irritation test is described as "clinical (human skin irritation) testing," but no further details on the population or location are provided. The in-vitro antibacterial barrier effectiveness testing, by its nature, is laboratory-based and not tied to patient cohorts.

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):

This information is not provided in the document. The studies mentioned (animal wound healing, human skin irritation, in vitro antibacterial testing) do not typically involve experts establishing "ground truth" in the same way, for example, diagnostic imaging studies do. Instead, their endpoints are measured objectively (e.g., wound closure rates, irritation scores, bacterial counts).

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

This information is not applicable and therefore not provided, as the studies described are not subjective assessments requiring adjudication like in diagnostic image interpretation.

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:

This information is not applicable and therefore not provided. The device described is a synthetic wound matrix, not an AI-powered diagnostic or assistive tool for human readers.

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

This information is not applicable and therefore not provided, as the device is a physical wound dressing and not an algorithm.

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

The "ground truth" for the performance evaluation of the wound matrix would be based on objective biological and physical measurements from the studies conducted:

• Animal performance testing: Likely measured outcomes related to wound healing, such as wound closure rates, reduction in wound size, tissue regeneration, and histological assessments. These are direct biological outcomes.
• Biocompatibility testing: Assesses the device's interaction with biological systems using standardized tests, leading to objective safety profiles.
• Human skin irritation testing: Measures physiological responses of the skin to the device.
• Antibacterial barrier effectiveness: Measures the device's ability to prevent bacterial penetration in an in vitro setup.

8. The sample size for the training set:

This information is not applicable and therefore not provided. As this is not an AI/ML device, there is no "training set" in the context of machine learning.

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

This information is not applicable and therefore not provided, as there is no training set for this device.

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