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The Sentrex BioSponge Wound Dressing is indicated in the dressing and management of:

• Full thickness and partial thickness wounds
• Pressure ulcers
• Venous ulcers
• Ulcers caused by mixed vascular etiologies
• Diabetic ulcers
• First and second degree burns
• Donor sites and other bleeding surface wounds
• Abrasions .
• Trauma wounds healing by secondary intention
• Dehisced wounds
• Surgical wounds
• Dehisced surgical wounds

The Sentrex BioSponge Wound Dressing is a sterile, porous, soft chitosan sponge dressing that provides a moist healing environment to support wound healing. The Sentrex Wound Dressing is provided dry, in 10 cm x 10 cm and 5 cm x 5 cm squares. The dressing is made of chitosan, a naturally occurring, biocompatible polysaccharide derived from shellfish. The shells are processed and chemically treated. Once in bandage form, they are sterilized by gamma irradiation and packed in a heat-sealed foil laminate pouch. The Sentrex Wound Dressing may be moistened with saline in accordance with physician recommendation.

The provided text describes the Sentrex BioSponge Wound Dressing and its 510(k) premarket application. However, it does not include detailed information regarding specific acceptance criteria, a scientific study proving the device meets those criteria, sample sizes for test/training sets, expert qualifications, or adjudication methods in the manner typically found in a clinical study report for an AI/device performance evaluation.

The submission focuses on demonstrating substantial equivalence to predicate devices based on intended use, technical/material characteristics, and performance. The performance information provided is primarily related to non-clinical testing.

Therefore, many of the requested details cannot be extracted from the given document as they are not present.

Here's an analysis of the information that can be extracted or inferred:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria for device performance in the context of a clinical study or a table showcasing performance against such criteria. The "performance" mentioned is primarily in relation to biocompatibility, local tissue response, and bacterial inhibition, which are non-clinical evaluations for safety and basic function, not efficacy in wound healing against specific quantitative targets.

The statement: "Numerous studies including, biocompatibility testing, local tissue response testing, and bacterial inhibition (AATCC Test Method 100, Microbial Strike-Through Test, and Kirby-Bauer Antimicrobial Susceptibility Test performed with the naïve Sentrex BioSponge and the Sentrex BioSponge with antibiotics) testing demonstrate the performance of the Sentrex BioSponge Wound Dressing" refers to passing specific non-clinical tests.

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

Not specified for any clinical performance evaluation. The "numerous studies" mentioned are non-clinical, so "test set" in the context of patient data (which would imply provenance) is not applicable or provided.

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

Not applicable/Not specified. The document does not describe a clinical study involving human assessment of device performance against a ground truth.

4. Adjudication method for the test set

Not applicable/Not specified.

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 dressing, not an AI-powered diagnostic or assistive tool for human readers/clinicians, so an MRMC study comparing human performance with and without AI assistance is irrelevant to this submission.

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

Not applicable. This is a physical wound dressing, not an algorithm.

7. The type of ground truth used

The ground truth for the non-clinical performance tests would be defined by the specific test methods used (e.g., AATCC 100 for bacterial inhibition, ISO standards for biocompatibility). For example, "ground truth" for bacterial inhibition would be the quantitative reduction in bacterial count as measured by laboratory methods. There is no mention of clinical ground truth (e.g., pathology, outcomes data) in the context of device efficacy demonstration for this 510(k).

8. The sample size for the training set

Not applicable/Not specified. No algorithms or AI are described.

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

Not applicable/Not specified. No algorithms or AI are described.

Summary of what the document does indicate about how the device meets requirements:

The Sentrex BioSponge Wound Dressing secured 510(k) clearance by demonstrating substantial equivalence to previously cleared predicate devices (K071552, K080010, K092552). This means the FDA determined it is as safe and effective as the predicates, not that it met novel, pre-defined quantitative performance criteria in a clinical trial.

The "performance" demonstration relies on:

• Non-clinical testing: Biocompatibility, local tissue response, and bacterial inhibition (using AATCC 100, Microbial Strike-Through, and Kirby-Bauer methods) studies were conducted. These studies "demonstrate the performance" of the device, implying they met the relevant standards for these specific tests.
• Material characteristics: The dressing is made from chitosan, a well-established biocompatible and biodegradable biopolymer with extensive safety data in biomedical applications.
• Functional comparison: It's noted that chitosan "retains more moisture than standard gauze," supporting a moist wound healing environment.
• Intended Use consistency: The indications for use match those of the predicate devices.

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