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Hydrolyzed Collagen with 10% Chondroitin Sulfate Wound gel is indicated for topical use in the management of chronic and acute wounds and dermal ulcers including the local management of:

• Pressure Ulcers (Stage I-IV)
• Venous Stasis Ulcers
• Diabetic Ulcers
• First and Second Degrec Burns
• Surgical wounds
• Traumatic wounds
• Superficial wounds
• Ulcers resulting from arterial insufficiency
• Grafted wounds and donor sites

For over the counter use, Hydrolyzed Collagen with 10% Chondroiiin Sulfate Wound Gel may be used for:

• minor abrasions
• laccrations
• minor cuts
• minor scalds and burns

Hydrolyzed Collagen with 10% Chondroitin Sulfate (PSGAG, Polysulfated glycosaminoglycan) Wound Gel is a line extension of the previously approved HyCure® Hydrolyzed Collagen (K955506). Hydrolyzed Collagen with 10% Chondroitin Sulfate (PSGAG, Polysulfated glycosaminoglycan) contains Chondroitin Sulfate as Chondroprotec® previously approved for market via 510(k) (K961930). Hydrolyzed Collagcn with 10% Chondroitin Sulfate Wound Gel contains a high concentration of water bound to the hydrolyzed collagen which maintains a moist wound environment as it manages wound healing. Hydrolyzed Collagen with 10% Chondroitin Sulfate (PSGAG, Polysulfated glycosaminoglycan) Wound gel is provided in a patient ready, one (1) ounce, collapsible tube.

This document is a 510(k) summary for a medical device called "Hydrolyzed Collagen with 10% Chondroitin Sulfate Wound Gel".

Based on a review of the provided text, the device did not undergo a study to prove it meets acceptance criteria in the way this request describes. Instead, the submission focuses on demonstrating substantial equivalence to predicate devices through:

• Formulation comparison: The device is described as a "line extension" of a previously approved hydrolyzed collagen product and incorporates an already approved chondroitin sulfate component.
• Non-clinical performance data: This data pertains to safety tests (cytotoxicity, irritation, sensitization) rather than efficacy or performance in a clinical setting for wound healing.
• Claim of identical intended use: The indications for use are aligned with those of the predicate components.

Therefore, many of the requested fields regarding acceptance criteria and studies are not applicable or cannot be extracted from this specific 510(k) summary. I will fill in what can be gathered and explicitly state when information is not available.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria: The document primarily focuses on demonstrating that the device is safe and performs comparably to its predicate devices, rather than meeting specific performance metrics for wound healing in this submission. The "acceptance criteria" here are implicitly related to the safety standards defined by ISO and the characteristics of the predicate devices.

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

• Sample Size for Test Set: Not explicitly stated as a clinical "test set" for efficacy. The non-clinical tests (cytotoxicity, irritation, sensitization) are typically performed on in vitro models or animal models without a specified "sample size" in this context. The document does not provide details on the number of samples or subjects used for these specific non-clinical tests.
• Data Provenance: Not specified. Standardized in vitro or animal tests are typically conducted in a laboratory setting. No country of origin for the data is mentioned.
• Retrospective or Prospective: Not applicable, as this refers to clinical studies, and the document explicitly states: "Hydrolyzed Collagen with 10% Chondroitin Sulfate Wound Gel has not been studied in a clinical setting."

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

Not applicable. There was no clinical test set for which ground truth would be established by experts. The non-clinical safety tests have objective endpoints measured by laboratory protocols.

4. Adjudication method for the test set

Not applicable. There was no clinical test set requiring expert adjudication.

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

Not applicable. This device is a wound gel, not an AI-powered diagnostic or assistive tool, and no MRMC study was performed.

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

Not applicable. This device is a wound gel, not an algorithm.

7. The type of ground truth used

For the non-clinical tests (cytotoxicity, irritation, sensitization), the "ground truth" is determined by objective laboratory measurements and standardized grading against predefined criteria (e.g., cytotoxicity grade 0, non-irritant, non-sensitizer). There is no "expert consensus," "pathology," or "outcomes data" in a clinical sense for these specific tests as presented.

8. The sample size for the training set

Not applicable. As a medical device (wound gel), there is no 'training set' in the context of machine learning or algorithm development.

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

Not applicable. There is no 'training set' for this device.

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