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JALOSKIN is indicated for the management of superficial moderately exuding wounds including pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, skin tears) and first and second degree burns.

JALOSKIN is a semi-permeable, transparent film dressing, composed of HYAFF® 11, a benzyl ester of hyaluronic acid. The hyaluronic acid is derived from bacterial fermentation.

The provided text does not contain detailed acceptance criteria and a study demonstrating the device meets those criteria. Instead, it is a 510(k) summary for the JALOSKIN wound dressing, focusing on its substantial equivalence to predicate devices and biocompatibility data.

Here's a breakdown of what is and is not in the provided document, in relation to your request:

1. Table of Acceptance Criteria and Reported Device Performance:

• Not provided. The document does not specify quantitative or qualitative acceptance criteria that JALOSKIN needs to meet for performance (e.g., healing rates, time to wound closure, infection rates).
• Reported Device Performance: The document states that the device is "substantially equivalent to the predicate devices with regard to the intended use and/or technological characteristics." This statement implies that its performance is expected to be similar to the predicate devices, but no specific performance metrics for JALOSKIN are reported.

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

• Not provided. There is no mention of a clinical "test set" or a study designed to evaluate JALOSKIN's performance against specific endpoints in a clinical setting. The document focuses on demonstrating substantial equivalence through technological characteristics and biocompatibility.
• Data Provenance: The biocompatibility studies cited (in vitro cytotoxicity, hemolysis, acute toxicity, irritation, sensitization, genotoxicity, implantation) appear to be laboratory-based and animal studies, not human clinical data. No country of origin is specified for these studies, nor whether they are retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• Not applicable. Since no clinical study or test set with human data is described for JALOSKIN's performance, the concept of "ground truth" derived from expert consensus is not relevant to the information provided. The document relies on laboratory and animal study results for biocompatibility and comparison to predicate devices.

4. Adjudication Method:

• Not applicable. As no clinical study is described that requires expert review or evaluation of outcomes, there is no adjudication method mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No. The document does not describe a MRMC study, nor does it involve AI or human-in-the-loop performance evaluation. The device is a wound dressing, not a diagnostic or AI-driven system.

6. Standalone (Algorithm Only) Performance Study:

• No. The device is a wound dressing, not an algorithm.

7. Type of Ground Truth Used:

• Not applicable for clinical performance. For the biocompatibility aspects, the "ground truth" is derived from standard laboratory and animal testing protocols (e.g., observing cell viability, hemolysis rates, toxicity symptoms, inflammatory responses).

8. Sample Size for the Training Set:

• Not applicable. As the device is not an AI algorithm, there is no concept of a "training set."

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

• Not applicable.

Summary of what the document does provide regarding evidence:

The FDA 510(k) process primarily focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving efficacy through new clinical trials with acceptance criteria for the new device's performance.

• Substantial Equivalence: JALOSKIN is claimed to be substantially equivalent to HYALOMATRIX™ KC and HYALOMATRIX PA® based on intended use and technological characteristics (both use HYAFF 11).
• Biocompatibility Data: The document presents details of various biocompatibility tests:
  • In vitro cytotoxicity: HYAFF films are "neither cytogenic."
  • Hemolysis study (in rabbits): HYAFF films are "not hemolytic."
  • Acute oral and dermal toxicity studies (in rats): Lethal dose of HYAFF 11 is >5,000 mg/kg (oral) and >2,000 mg/kg (dermal).
  • Irritation studies (in rabbits): HYAFF 11 powder is "not an ocular or dermal irritant."
  • Sensitization study (in guinea pigs): Provides "evidence for the lack of a sensitizing effect."
  • Genotoxicity: No evidence observed in three in vitro and one in vivo (mice) study.
  • Implantation study (in rats, up to 1 year): No treatment-related toxicity; HYAFF film degraded within 4 months.

In conclusion, this document primarily addresses the regulatory requirement for substantial equivalence and provides biocompatibility data for the material (HYAFF 11) used in the device. It does not contain the kind of performance study, acceptance criteria, or ground truth details you would expect for evaluating a diagnostic algorithm or a device requiring specific clinical efficacy endpoints for approval beyond substantial equivalence.

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