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Foundation DRS Solo is indicated for the management of wounds including:

• · Full thickness and partial thickness wounds
• Pressure ulcers
• Venous ulcers
• · Ulcers caused by mixed vascular etiologies
• · Diabetic ulcers
• · First degree burns
• · Partial thickness burns (superficial second-degree burns)
• · Donor sites and other bleeding surface wounds
• · Abrasions
• · Trauma wounds (abrations, lacerations, skin tears)
• · Dehisced wounds
• · Surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence)

Foundation DRS Solo may be cut to size.

Foundation DRS Solo is a highly conformable, advanced wound care device comprising a porous matrix of chitosan derived from shellfish and sodium chondroitin sulfate, a glycosaminoglycan. The chitosan- glycosaminoglycan biodegradable, porous matrix provides a scaffold for cellular invasion and capillary growth. The device is applied on the surface of the wound, and provides a moist wound environment. The dressing may be replaced or may remain in place, acting as a scaffold to promote cellular infiltration and capillary growth as the dressing degrades.

This document, a 510(k) Premarket Notification summary for the Foundation Dermal Regeneration Scaffold (DRS) Solo, does not describe an AI/ML powered medical device or a study involving human readers and AI assistance for diagnostic purposes.

Instead, this document pertains to a medical device that is a dermal regeneration scaffold for wound management. The "acceptance criteria" discussed are related to the safety and performance of this physical wound dressing, not the accuracy or performance of an AI algorithm.

Therefore, I cannot provide the requested information about acceptance criteria for an AI device, sample size for test sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, as these concepts are not applicable to the device described in the provided text.

The "Summary of Nonclinical Testing" section (page 4-5) lists the studies conducted to demonstrate the safety and performance of the Foundation DRS Solo. These include biocompatibility tests, bacterial endotoxins testing, chemical characterization, sterilization validation, packaging validation, and a Wound Healing Study in a Porcine Model. The document states that "All tests found the device to meet study endpoints and meet acceptance criteria," but it does not specify what those exact acceptance criteria were for each test.

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PELNAC™ Bilayer Wound Matrix is indicated for the management of wounds including:

• · partial and full-thickness wounds,
• · 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, second-degree burns, and skin tears), and
• · draining wounds.
  The device is intended for one-time use.

PELNAC™ Bilayer Wound Matrix is a collagen-based wound matrix that consists of two layers: a porcine collagen sponge layer and a silicone film layer and is offered in two versions: 1. Meshed Type (i.e., fenestrated) and 2. Non-Meshed Type (i.e., non-fenestrated). The collagen sponge layer should be applied to the wound surface. Both versions of the device also contain a synthetic gauze material to add strength to the silicone film layer. When applied to full-thickness skin defects, PELNAC™ Bilayer Wound Matrix provides a scaffold for cellular invasion and capillary growth. PELNAC™ Bilayer Wound Matrix is offered in sheet form of various sizes and is provided terminally sterilized by ethylene oxide, is for single patient use, and can only be applied to a patient by a qualified doctor in a professional setting for the management of full-thickness skin defects as described in its product labeling.

This document is a 510(k) premarket notification for the PELNAC™ Bilayer Wound Matrix. It primarily focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study proving that an AI/software device meets specific performance acceptance criteria for diagnostic tasks.

Therefore, most of the requested information regarding acceptance criteria for AI/software, sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, and training set details are not applicable to this document. This submission is for a material device (wound matrix) and the "study" mentioned is a human repeat insult patch test (HRIPT) and a clinical follow-up for a tissue-based medical device.

However, I can extract information related to the device's safety and performance testing as presented in the document, which serves a similar role to "acceptance criteria" for a physical medical device.

Acceptance Criteria and Study for PELNAC™ Bilayer Wound Matrix

The "acceptance criteria" for this device are established through demonstrating its substantial equivalence to a legally marketed predicate device (AVAGEN Wound Dressing) and conformity to recognized standards and guidance. The "study" refers to non-clinical and clinical testing performed to support this claim.

1. Table of "Acceptance Criteria" and Reported Device Performance

Since this is a physical medical device and not an AI/software, the "acceptance criteria" are not reported as diagnostic performance metrics (e.g., sensitivity, specificity). Instead, they are related to biocompatibility, sterility, physical/chemical properties, and clinical safety/tolerance. The "reported device performance" indicates whether the device met these established safety and performance benchmarks.

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

• Non-Clinical (In vitro/Bench/Animal Studies): The document states "final finished samples of PELNAC™ Bilayer Wound Matrix" were tested, but specific sample sizes for these tests (biocompatibility, physical/chemical, sterility, packaging) are not provided.
• Clinical Data:
  • Human Repeat Insult Patch Test (HRIPT): 56 subjects.
  • Finger Degloving Injuries Pilot Study: 18 subjects.
• Data Provenance: Not explicitly stated for all non-clinical tests. For the clinical studies:
  • The HRIPT and the finger degloving study were likely conducted by or sponsored by the manufacturer (Gunze Limited), which is based in Japan. The document does not specify the country of origin for the clinical data points, nor whether they were retrospective or prospective studies, though the nature of HRIPT and follow-up studies typically implies a prospective design.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

• This device is a material device, not an AI/software. There is no "ground truth" to be established by experts in the context of image interpretation or diagnostic accuracy. The "ground truth" for the clinical study would be observed physiological responses to the device (irritation, sensitization, healing, lack of adverse immune response), assessed by qualified medical professionals involved in the study (e.g., dermatologists for HRIPT, surgeons for the finger injury study). The number and qualifications of these medical professionals are not specified in the provided text.

4. Adjudication Method for the Test Set:

• Not applicable for this type of medical device submission. Adjudication methods are typically relevant for human reader studies or expert consensus for ground truth establishment in AI/software evaluations. Clinical observations for this device would be direct assessments by the treating/evaluating clinicians.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and effect size:

• No, an MRMC comparative effectiveness study was not conducted. This type of study is relevant for diagnostic imaging AI, not for a wound matrix medical device. The "clinical studies" described (HRIPT, finger degloving) are safety and performance studies for a material device, not diagnostic effectiveness studies comparing human readers with and without AI assistance.

6. If a Standalone (algorithm only without human-in-the-loop performance) was done:

• Not applicable. This is not an algorithm or AI device.

7. The Type of Ground Truth Used:

• For Biocompatibility and Physical/Chemical Testing: The "ground truth" is adherence to established international standards (e.g., ISO 10993 series) and internal specifications, derived from scientific understanding of material safety and performance.
• For Clinical Studies (HRIPT, Finger Degloving): The "ground truth" is direct clinical observation and objective measurement of patient responses (e.g., absence of skin irritation/sensitization, absence of specific immune responses, healing progression, histological analysis reports). This is based on outcomes data and clinical assessment by medical professionals.

8. The Sample Size for the Training Set:

• Not applicable. This is not an AI/machine learning device. There is no "training set" in the context of algorithm development.

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

• Not applicable. As there is no training set for an algorithm, there is no ground truth establishment for it.

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Coreleader Colla-Pad Wound Dressing is indicated for the management of wounds including: partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/ undermined wounds, surgical wounds, (donor sites/grafts, post-Mohs surgery, post laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns, skin tears) and draining wounds.

Coreleader Colla-Pad is comprised of a porous matrix of cross-linked bovine collagen. Colla-Pad is made of highly absorbent material that converts to a soft, gel sheet that stays in intimate contact with the wound bed as it absorbs exudate t. The moisture held around the wound by Colla-Pad could provide a favorable wound healing environment. Coreleader Colla-Pad is easy to cut and apply. Cut to fit any size of acute or chronic wounds with light to heavy exudate. Coreleader Colla-Pad is a sterile topical wound dressing, packed in a foil pouch and a foil package and sterilized by r-ray radiation to a 10to SAL.

The provided text is a 510(k) summary for the Coreleader Colla-Pad, a collagen wound dressing. This document confirms the device's substantial equivalence to predicate devices for its intended use. However, it does not contain information about acceptance criteria, device performance studies, or clinical trial data as typically requested for AI/software devices.

The document discusses the device description, intended use, technological characteristics, and biocompatibility testing. The biocompatibility section mentions ISO 10993-11 for systemic toxicity, blood analysis, and histological analysis showing no inflammation reaction in test animals, but this is a safety assessment, not a performance study comparing the device against specific acceptance criteria for efficacy.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance: This information is not present in the provided text.
2. Sample sized used for the test set and the data provenance: Not applicable as a performance study with a test set is not described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
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, as this is not an AI/software device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI/software device.
7. The type of ground truth used: Not applicable, as performance efficacy is not detailed.
8. The sample size for the training set: Not applicable, as this is not an AI/software device.
9. How the ground truth for the training set was established: Not applicable, as this is not an AI/software device.

The 510(k) submission primarily focuses on demonstrating substantial equivalence in terms of intended use, technological characteristics, and safety (biocompatibility) compared to existing legally marketed devices, rather than presenting a detailed clinical performance study with specific acceptance criteria.

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