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The Phoenix Wound Matrix is intended for use in the management of wounds. Wound types include: Partial and fullthickness wounds, pressure ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites/grafts, post-Moh's surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second degree burns, skin tears) and draining wounds.

Device Description

The Phoenix Wound Matrix is a sterile, single use device intended for the management of wounds. The Phoenix Wound Matrix is a conformable, non-woven, fibrous, three-dimensional matrix. The Phoenix Wound Matrix is made from two types of polymer fibers: Poly(lactide-co-caprolactone) and Polyglycolic acid, which are bioabsorbed after degrading via hydrolysis.

AI/ML Overview

This response is based on the provided text, which is a 510(k) submission summary for the Phoenix Wound Matrix. It's important to note that a 510(k) submission primarily focuses on demonstrating substantial equivalence to a predicate device, rather than proving the safety and effectiveness of new technology through a comprehensive clinical study with acceptance criteria and a detailed study design. Therefore, much of the requested information regarding detailed acceptance criteria, specific study designs (like MRMC), and ground truth establishment for AI/algorithm performance cannot be extracted from this document, as it pertains to a different type of regulatory submission (most often for novel AI/ML medical devices).

The document is a declaration of substantial equivalence for a wound matrix, not an AI/ML device. Therefore, the questions about acceptance criteria for AI algorithms, sample sizes for test and training sets, expert consensus, MRMC studies, and ground truth establishment are not applicable in this context.

However, I can extract information related to the device's performance testing from the "Performance Data" section.

Device: Phoenix Wound Matrix
Regulatory Pathway: 510(k) (seeking substantial equivalence to predicate devices)

1. Acceptance Criteria and Reported Device Performance

Since this is a traditional medical device (wound matrix) and not an AI/ML device, the "acceptance criteria" are not defined as statistical metrics for an algorithm's performance (e.g., sensitivity, specificity, AUC). Instead, they relate to biocompatibility, mechanical properties, and non-inferiority in wound healing.

Acceptance Criteria Category	Specific Tests/Assessments	Reported Device Performance
Biocompatibility	ISO 10993, Biological Evaluation of Medical Devices testing:	"ISO 10993, Biological Evaluation of Medical Devices testing has demonstrated that the device is safe."
Specific tests conducted:
	- Cytotoxicity	Passed
	- Dermal irritation	Passed
	- Sensitization	Passed
	- Acute systemic toxicity	Passed
	- Genotoxicity	Passed
	- 6-week muscle implantation	Passed (device found to be safe through this evaluation)
	- 6-week sub-acute/sub-chronic toxicity	Passed (device found to be safe through this evaluation)
Mechanical Properties	Functional testing for sufficient mechanical properties	"Functional testing demonstrates that the device has sufficient mechanical properties (strength and flexibility) for unaged and aged devices."
Wound Healing Response	Animal wound healing study in a porcine model (demonstrating no delay in wound healing response)	"An animal wound healing study in a porcine model has demonstrated that there was no delay in the wound healing response due to the subject device." (This implies a comparison to a control or standard treatment, showing non-inferiority in healing time/pattern, though specific metrics are not detailed in this summary). This is a demonstration that the device does not negatively impact the healing process, supporting its safety and effectiveness for its intended use.

2. Sample Size and Data Provenance for the Test Set

Sample Size for Test Set: Not explicitly stated in terms of number of wounds or animals. The text only mentions "an animal wound healing study in a porcine model."
Data Provenance: The study was an "animal wound healing study in a porcine model." This implies a controlled laboratory setting, likely in the US given the FDA submission. It is by nature a prospective experiment in an animal model, not retrospective human data.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. This device is a wound dressing, not an AI/ML diagnostic device requiring expert interpretation for ground truth establishment. The performance data is based on direct biological and mechanical testing.

4. Adjudication Method for the Test Set

Not applicable. As above, no human expert adjudication is described for the performance testing of this physical device.

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

No. This is not an AI/ML diagnostic or image-based device. An MRMC study is not relevant for evaluating the performance of a wound matrix.

6. Standalone (Algorithm Only) Performance

Not applicable. There is no algorithm associated with this physical wound matrix device for standalone performance evaluation.

7. Type of Ground Truth Used

Biological and Physical Measurements: For biocompatibility, the ground truth is established by standard ISO 10993 biological assays (e.g., cell viability for cytotoxicity, skin reaction for irritation/sensitization, histological examination for implantation studies). For mechanical properties, it's defined by laboratory stress/strain measurements. For wound healing, it's based on observed healing progression in the animal model.

8. Sample Size for the Training Set

Not applicable. This device does not use machine learning or AI models, so there is no concept of a "training set."

9. How Ground Truth for Training Set was Established

Not applicable. As there is no training set, this question is irrelevant.

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