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PanoGauze™ Non-Woven Hydrogel Dressing, like the CarraGauze™ Carrasyn™ Gel Wound Dressing Saturated Pad, is intended to provide a moist packing/healing environment which helps to prevent wound desiccation.

absorbent pads saturated with water based hydrogels packaged in sterile single-use poly/Mylar-laminate pouches.

Here's an analysis of the provided text based on your request:

Based on the provided document (K964620 Summary Basis of Substantial Equivalence for PanoGauze™ Non-Woven Hydrogel Dressing), it's important to clarify that this document describes a medical device (a hydrogel wound dressing), not a diagnostic AI/ML algorithm. Therefore, many of the questions regarding "AI," "ground truth," "experts," and "training sets" are not applicable.

The "acceptance criteria" in this context refer to the demonstrations of substantial equivalence to a predicate device and the safety characteristics of the device.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not specify a numerical sample size for the safety studies. It states "several studies were conducted by an independent testing laboratory." For toxicology and irritation tests, it typically involves a small number of animal subjects or cell cultures, but no specific numbers are given here.
• Data Provenance: The studies were conducted by an "independent testing laboratory." The country of origin is not specified but implicitly assumed to be within regulatory standards relevant to the US FDA (given the 510(k) submission). The studies are inherently "prospective" in the sense that they were conducted specifically to evaluate the PanoGauze™ device.

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

• Not Applicable. This is a physical device, not an AI/ML diagnostic system requiring expert interpretation of outputs. "Ground truth" for safety studies is established by standardized laboratory assays and observation, not expert consensus.

4. Adjudication Method for the Test Set

• Not Applicable. As this is not an AI/ML diagnostic system, there is no need for adjudication of interpretations. The results of the laboratory tests are typically objective and quantitative (e.g., cell viability percentages, irritation scores).

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 is not a diagnostic AI device.

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

• Not Applicable. This is not an AI algorithm.

7. The Type of Ground Truth Used

• For the safety studies, the "ground truth" was established based on standardized laboratory assay results against established biochemical, cellular, and physiological endpoints (e.g., USP requirements for toxicity, FHSA guidelines for irritation).

8. The Sample Size for the Training Set

• Not Applicable. This is not an AI/ML algorithm that requires a "training set."

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

• Not Applicable. As above, no training set for an AI algorithm.

Summary of Device and Acceptance:

The PanoGauze™ Non-Woven Hydrogel Dressing gained acceptance (substantial equivalence) by demonstrating that it shares the same intended use, fundamental technological characteristics (hydrogel-saturated pad for moist wound healing), and safety profile (meeting USP and FHSA standards for toxicity, cytotoxicity, irritation, and sensitization) as its predicate device, the CarraGauze™ Carrasyn™ Gel Wound Dressing Saturated Pad. The "study" proving this involved a series of independent laboratory safety tests that yielded negative results for adverse effects, thereby establishing the device's safety and supporting its substantial equivalence claim.

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