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ReyaGel is intended for the management of wounds that include:

• · Partial and full thickness wounds
• · Pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers
• · Second degree burns
• · Surgical wounds donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence
• · Trauma wounds abrasions, lacerations, and skin tears
• · Tunneled/undermined wounds
• · Draining wounds

ReyaGel Wound Gel is an extracellular matrix wound product composed of porcine spleen and lung extracellular matrix in a saline gel, for the management of wounds. It is an off-white gel supplied in a syringe for topical application. The product is provided sterile for single use.

Here's an analysis of the provided FDA document regarding the ReyaGel (RG03 - MTP gel 3mL) device, addressing your specific questions.

Based on the provided document, the device in question (ReyaGel) is a wound dressing that is seeking substantial equivalence to a predicate device (XCelliStem Wound Powder). The document primarily focuses on demonstrating this substantial equivalence, rather than detailing the acceptance criteria and a study to prove meeting those criteria in the traditional sense of a performance study for a novel device.

The premise for substantial equivalence is that the subject device is composed of "identical animal source material" and processed using "identical methods" to the predicate, with the key difference being that ReyaGel is solubilized into a gel form with saline.

Therefore, the information presented is largely about why the device is considered substantially equivalent to a predicate device, which implies that the predicate device already met certain performance standards.

Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or corresponding reported device performance metrics in a typical table format that would be found for a de novo or new diagnostic device. Instead, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to the predicate device, K172593, which itself would have met certain performance requirements for wound dressings.

The "performance" described is about meeting the requirements to establish substantial equivalence:

• Comparison: "The subject device and predicate device (K172593) have the same indications for use." |
  | Technological Characteristics (Similar to Predicate): | - Material Composition: Identical animal source material (porcine spleen and lung extracellular matrix).
• Processing: Sourced and processed using identical methods as the predicate.
• Difference & Mitigation: The predicate material is "then made into a gel form to facilitate application" for ReyaGel.
• Supportive Testing: To address the technology difference (gel form), additional testing was conducted: "protein characterization, biocompatibility including cytotoxicity, sensitization, intracutaneous irritation, acute systemic toxicity, materials mediated pyrogenicity, a swine full-thickness wound healing study, and clinical testing including Human Repeat Insult Patch Testing." |
  | Conclusion of Substantial Equivalence: | - Based on the results of the bench, animal, and clinical testing completed on the subject device, it "demonstrates substantial equivalence to the predicate." |

Study Details:

1. Sample sizes used for the test set and the data provenance:

   • The document states that "bench, animal, and clinical testing" were conducted on the subject device.
   • Specific sample sizes for these tests are not provided in the excerpt.
   • The provenance of data for the additional testing (protein characterization, biocompatibility, swine wound healing, HRIPT) is not explicitly stated as retrospective or prospective, nor does it mention country of origin, but it is implied to be new testing conducted for this submission.
   • For the leveraged predicate device data (K172593), no details are given.

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

   • The document does not mention the use of experts to establish "ground truth" for a specific test set. The studies mentioned (e.g., biocompatibility, swine wound healing, HRIPT) would typically have standard outcome measures assessed by qualified personnel, but this isn't detailed in terms of "expert consensus."

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

   • No adjudication method is described.

4. 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 is not applicable. The device (ReyaGel) is a wound dressing, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study or AI-related effect size data would not be relevant or present.

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

   • This is not applicable as the device is a wound dressing, not a software algorithm.

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

   • For the additional testing mentioned (biocompatibility, swine wound healing, HRIPT), the "ground truth" would be the direct results of these specific scientific tests (e.g., cytotoxicity levels, wound closure rates in swine, skin irritation scores in HRIPT). This is based on objective measurements and established scientific protocols rather than expert consensus on images or pathology.

7. The sample size for the training set:

   • This is not applicable. There is no mention of a "training set" as this is not an AI/machine learning device.

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

   • This is not applicable as there is no training set for this type of device.

In summary, the document details the substantial equivalence of ReyaGel to an existing predicate device by highlighting shared materials and processing, and by presenting additional non-clinical and clinical testing to address the specific technological differences (gel form). It does not provide the kind of performance data (acceptance criteria vs. reported performance) or study details that would be typical for a new diagnostic device performance study using AI or image analysis.

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