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Prescription: LUOFUCON® Silver Wound Gel is under the medical supervision of a healthcare professional for the management of 1st and 2nd degree burns, wounds such as stasis ulcers, pressure ulcers, lacerations, abrasions, skin tears, surgical incision sites, device insertion site wounds, graft sites, and donor sites.

OTC: LUOFUCON® Silver Antimicrobial Wound Gel is indicated for the topical management of minor cuts, minor lacerations and minor burns.

LUOFUCON® Silver Wound Gel /LUOFUCON® Silver Antimicrobial Wound Gel is a sterile, water-based amorphous gel composed of hydrophilic polymer and silver compound. The gel helps to maintain a moist wound environment. The silver compound acts as a preservative to inhibit the growth of microorganisms in the gel during shelf storage.

LUOFUCON® Silver Wound Gel /LUOFUCON® Silver Antimicrobial Wound Gel is supplied in a tube (collapsible, polypropylene tube, sealed on one end and fitted with a screw cap on the other end).

The provided document is a 510(k) summary for the LUOFUCON® Silver Wound Gel / LUOFUCON® Silver Antimicrobial Wound Gel. It describes the device, its intended use, and compares it to predicate devices to demonstrate substantial equivalence.

Based on the content, here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a "table of acceptance criteria" with numerical targets for clinical performance metrics (like sensitivity, specificity, accuracy) that would be common for AI/diagnostic devices. Instead, it focuses on demonstrating substantial equivalence to a predicate device by comparing various physical, chemical, and biological properties, as well as general performance attributes relevant to wound care gels.

The table below summarizes the comparative data presented, which implicitly serves as "acceptance criteria" by showing the subject device is comparable to the predicate/reference devices for key properties and performance aspects.

The document states: "Performance tests were conducted to demonstrate that the subject device is as effective as its predicate device." The "acceptance criteria" for these performance tests are implicitly met if the test results demonstrate comparable performance attributes to the predicate/reference devices, supporting the claim of substantial equivalence.

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

The document does not detail specific sample sizes for the performance tests listed (Appearance, Fluid Affinity, Loss on Drying, pH Value, Preservative Effectiveness). These are typically bench tests or in vitro studies, not requiring human patient test sets.

For the Animal Study (Porcine Wound Healing Study):

• Sample Size: Not explicitly stated.
• Data Provenance: Not explicitly stated (e.g., country or retrospective/prospective). This was an animal study, not human clinical data.

For Clinical Studies:

• Sample Size: "No clinical study was conducted."
• Data Provenance: Not applicable, as no human clinical data was used for direct performance evaluation of this device.

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 applicable to this submission. The device is a wound care gel, not an AI or diagnostic medical device that requires expert adjudication for a test set. The efficacy (or non-inhibition of wound healing) was assessed in an animal model and through comparative performance testing.

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

This information is not applicable. As mentioned above, this is not an AI/diagnostic device that relies on expert adjudication for ground truth.

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. An MRMC study is relevant for AI/diagnostic imaging devices. This submission concerns a wound care gel.

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

This information is not applicable. This question refers to AI algorithm performance.

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

For the various performance tests (Appearance, Fluid Affinity, Loss on Drying, pH Value, Preservative Effectiveness):

• Ground Truth: These properties are determined through standardized laboratory testing methods (e.g., EN 13726-1, USP , USP , USP ). The "ground truth" is the quantitative or qualitative result obtained from these validated methods.

For the Biocompatibility Testing:

• Ground Truth: Compliance with ISO 10993 standards. The "ground truth" is the biological response (or lack thereof) observed in standardized in vitro and in vivo biocompatibility tests, interpreted by toxicologists or biologists.

For the Animal Study (Porcine Wound Healing Study):

• Ground Truth: Histological and macroscopic assessment of wound healing, and observation for adverse biological reactions. This ground truth is established by veterinary pathologists or researchers.

8. The sample size for the training set

This information is not applicable. This device is not an AI algorithm and therefore does not have a "training set."

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

This information is not applicable. As there is no training set for an AI algorithm, there is no ground truth established for it.

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