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The SiOxD 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, first degree and partial thickness burns, skin tears) and draining wounds.

The SiOxD Wound Matrix is a non-pyrogenic, sterile, single use device intended for use in local management of wounds. The SiOxD Wound Matrix is a soft, white, conformable, non-woven, absorbent, biocompatible fiber matrix made from synthetic biomaterials. The SiOxD Wound Matrix conforms in the defect space / wound bed and includes a fibrous, porous structure that allows for fluid absorption. The SiOxD Wound Matrix is structurally similar to collagen, a key component of the native extracellular matrix, and serves as a scaffold for cellular infiltration and vascularization. SiOxD Wound Matrix promotes a moist environment for the body's natural healing process.

The SiOxD Wound Matrix is not designed to be held in place with compression bandages or tapes. Only light pressure without mechanical compression or secondary bandaging is required for proper device function. The matrix applied to the wound bed naturally sloughs off during wound healing and does not require manual removal.

The provided document K232847, a 510(k) summary for the SiOxD Wound Matrix, does not contain information on an AI/ML-based medical device. Therefore, it does not include details on acceptance criteria, study methodologies for AI performance, sample sizes for training/test sets, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance.

The document describes a medical device, the SiOxD Wound Matrix, which is a non-pyrogenic, sterile, single-use wound dressing made from hydrated amorphous silica in fibrous form. The submission is for a line extension of an already cleared device (K222189). The new submission adds new intermediate size offerings and single barrier packaging configurations.

Since this is a submission for a physical medical device (wound dressing) and not a software/AI device, the information requested in your prompt regarding AI/ML performance, acceptance criteria, and specific study details (like sample size for test/training sets, expert ground truth) is not applicable to this document. The "study that proves the device meets the acceptance criteria" in this context refers to standard medical device testing (e.g., sterilization, packaging integrity, biocompatibility), not AI model validation.

If you have a document pertaining to an AI/ML medical device, please provide it, and I will be happy to extract the relevant information.

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The SiOxD 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, first degree and partial thickness burns, skin tears) and draining wounds.

The SiOxD Wound Matrix is a non-pyrogenic, sterile, single use device intended for use in local management of wounds. The SiOxD Wound Matrix is a soft, white, conformable, non-woven, absorbent, biocompatible fiber matrix made from synthetic biomaterials. The SiOxD Wound Matrix conforms in the defect space / wound bed and includes a fibrous, porous structure that allows for fluid absorption. The SiOxD Wound Matrix is structurally similar to collagen, a key component of the native extracellular matrix, and serves as a scaffold for cellular infiltration and vascularization. SiOxD Wound Matrix promotes a moist environment for the body's natural healing process.

The SiOxD Wound Matrix is not designed to be held in place with compression bandages or tapes. Only light pressure without mechanical compression or secondary bandaging is required for proper device function. The matrix applied to the wound bed naturally sloughs off during wound healing and does not require manual removal.

The provided document is a 510(k) summary for the SiOxD Wound Matrix, which is a medical device. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving that the device meets specific acceptance criteria for performance as an AI/ML powered device. Therefore, much of the requested information regarding AI/ML specific studies (MRMC study, standalone performance, ground truth establishment for training/test sets, expert qualifications, adjudication methods, and sample sizes for training/test sets for AI/ML) is not available in this document.

However, I can extract the acceptance criteria and performance related to the device function and biocompatibility as described in the summary:

Acceptance Criteria and Reported Device Performance

Study Details (as per available information):

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

   • Biocompatibility (Human Repeat Insult Patch Test - HRIPT): 120 male and female subjects (18-70 years old) were enrolled. 114 subjects completed the study.
   • Wound Healing Study: "A full thickness porcine wound healing study" was conducted. The specific number of animals or wounds used is not provided, but it's an animal study (porcine model).
   • Data Provenance: Not explicitly stated for all tests, but the HRIPT involved human subjects. The wound healing study used porcine data. The other material characterization and biocompatibility tests are laboratory-based. It's assumed these studies were conducted by or for SiOxMed. LLC.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" for these tests are objective measurements (e.g., passing/failing biocompatibility standards, instrumental analysis results, wound healing assessment in an animal model). No expert panel for establishing ground truth as understood in AI/ML performance studies is described.

4. Adjudication method for the test set: Not applicable and not described. The tests conducted are objective laboratory and animal studies, and a human adjudication method is not relevant.

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 matrix, not an AI/ML powered diagnostic or assistive technology for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML algorithm.

7. The type of ground truth used:

   • Biocompatibility: Established by compliance with international standards (ISO 10993 series) and specific test methodologies, with predefined pass/fail criteria (e.g., non-cytotoxic, non-sensitizing).
   • Functional/Material Characterization: Established by instrumental analysis (FTIR, XRD, SEM) and physical property measurements (absorption).
   • Wound Healing: Established by comparison to a predicate device and untreated control sites in an animal model, likely involving histological or macroscopic assessment of healing, which is a form of outcome data in a controlled setting.

8. The sample size for the training set: Not applicable. This document does not describe an AI/ML device that requires a training set.

9. How the ground truth for the training set was established: Not applicable. This document does not describe an AI/ML device.

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