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NovoGen Wound Matrix 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-Moh's surgery, post-laser surgery, podiatric, wound dehiscence)
• · Trauma wounds (abrasions, lacerations, partial thickness burns, and skin tears)
• · Draining wounds

NovoGen Wound Matrix is a an absorbable, non-pyrogenic, sterile, single use device intended for use in local management of cutaneous wounds. It is manufactured from bovine type I collagen and 45S5 bioactive glass. When hydrated with wound exudate or sterile water, this product transforms into a soft conforming layer which is naturally incorporated into the wound over time.

The provided text describes the NovoGen Wound Matrix, a medical device, and its substantial equivalence determination by the FDA. However, it does not contain a study that proves the device meets specific acceptance criteria in the way described in the prompt (e.g., performance metrics, sample sizes, expert adjudication, MRMC studies, or standalone algorithm performance).

Instead, it outlines the device's characteristics, its comparison to a predicate device, and a summary of non-clinical performance testing. The "acceptance criteria" here are implicitly related to demonstrating substantial equivalence to a predicate device based on similar intended use, technological characteristics, and safety and performance testing.

Here's a breakdown of the information provided, formatted to address your request as much as possible, with explicit notes where the requested information is not present:

1. Table of Acceptance Criteria and Reported Device Performance

Since there are no explicitly stated numerical acceptance criteria or thresholds in the document, this table will reflect the types of performance tests conducted and their qualitative results as stated in the submission.

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

• Porcine Wound Healing Study: "A full thickness porcine wound healing study" - Sample size (number of animals or wounds) is not specified. Data provenance is animal study (porcine).
• Biocompatibility (ISO 10993-1): Sample size not specified. Provenance is in vitro and in vivo (e.g., animal tests for systemic toxicity, implantation).
• Human Repeat Insult Patch Test (HRIPT): "Based on the test population who completed the study" - Sample size (number of human subjects) is not specified. Provenance is prospective human study. Specific country of origin is not specified.

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

This type of information is not provided in the document. The studies performed (animal, biocompatibility, HRIPT) would typically involve trained personnel, but the specific number and qualifications of "experts" to establish a ground truth in the sense of clinical interpretation are not mentioned, as these are primarily laboratory and animal studies.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This information is not applicable/not provided. The studies described are not of a diagnostic nature requiring expert adjudication of results.

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

An MRMC study was not done. This device is a wound matrix, not an AI-assisted diagnostic tool for human readers.

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

This is not applicable. The device is a physical wound matrix, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Porcine Wound Healing Study: The "ground truth" for wound healing would be based on direct observation and measurement of wound closure, tissue regeneration, and potentially histopathology in the porcine model. It's compared to a predicate device and untreated controls for equivalence.
• Biocompatibility Studies: Ground truth is established by standardized laboratory test results against established safety thresholds (e.g., cell viability in cytotoxicity, immune response in sensitization, absence of fever in pyrogenicity).
• HRIPT: Ground truth is clinical observation of skin reactions (irritation/sensitization) in human subjects.

8. The sample size for the training set

This is not applicable as the device is not an AI/machine learning algorithm requiring a training set.

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

This is not applicable as the device is not an AI/machine learning algorithm.

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NovaBone IRM - Bioactive Synthetic Bone Graft is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. NovaBone IRM (Irrigation Resistant Matrix) is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e. the extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.

NovaBone IRM is an osteoconductive bioactive device used for grafting osseous defects. It is a premixed composite of bioactive calcium-phospho-silicate particulate and a synthetic, absorbable binder. The bioactive particulate is composed solely of elements that exist naturally in normal bone (Ca, P, Na, Si, O). The device requires no mixing or preparation prior to application. NovaBone IRM is supplied ready-to-use, to be applied directly to the intended graft site. The binder is then absorbed from the site such that only the bioactive particulate remains.

Upon absorption of the binder, the remaining particulate material undergoes a timedependent kinetic modification of the surface that occurs when implanted in living tissue. Specifically, a series of surface reactions results in the formation of a calcium phosphate layer on the particles that is substantially equivalent in composition and structure to the hydroxyapatite found in bone mineral. This apatite layer provides scaffolding onto which the patient's new bone will grow, allowing complete repair of the defect. Animal testing has demonstrated that the majority of the particulate material is absorbed within six months of implantation, with >98% of the material being absorbed by twelve months. The timeframe for full absorption in humans has not been determined, but is expected to be at least twelve months.

The provided document is a 510(k) premarket notification from the FDA regarding the NovaBone IRM device. It details the device's indications for use, technological characteristics, and a conclusion of substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria or a study that specifically proves the device meets those criteria in the context of an AI/ML device.

The document describes a medical device (bone void filler) and its regulatory clearance process, not an AI/ML system. Therefore, most of the requested information about acceptance criteria for AI algorithms, test set sample sizes, expert ground truth establishment, MRMC studies, standalone performance, and training set details are not applicable to this document's content.

Here's how I would answer based on the provided text, highlighting what is present and what is absent:

Acceptance Criteria and Device Performance (as inferred from a non-AI context):

The document focuses on demonstrating substantial equivalence to a previously cleared predicate device (NovaBone Putty K112773). For a traditional medical device like NovaBone IRM, the "acceptance criteria" are implicitly met by demonstrating that it is as safe and effective as the predicate device.

The performance is primarily evaluated through:

• Biocompatibility: Supporting safety.
• Functional in vivo results: Demonstrating performance in a rabbit femoral defect model. This shows the device's ability to resorb and be replaced by bone during the healing process, and fill osseous defects.
• Technological Characteristics: Matching the composition and particle sizes to cleared devices.

Table of Acceptance Criteria and Reported Device Performance (as inferred for this specific device):

Responses to Specific Questions (Many are not applicable to this document as it's not an AI/ML device):

1. A table of acceptance criteria and the reported device performance:

   • See the table above. The "acceptance criteria" are implicitly those necessary to demonstrate substantial equivalence to a predicate device, primarily focusing on safety and function as a bone void filler.

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

   • The document mentions "Animal testing" and "a rabbit femoral defect model." It does not specify the precise sample size (number of rabbits) or exact data provenance beyond being an animal model. There is no "test set" in the context of an AI/ML algorithm.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

   • Not applicable. This is not an AI/ML device requiring expert ground truth for image interpretation. The "ground truth" for this device's performance would be the biological outcome in the rabbit model (e.g., bone formation, material resorption), likely assessed by pathologists or researchers in the field, but the document does not detail this.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not applicable. This is not an AI/ML device relying on diagnostic interpretations.

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 is a physical medical device, not an AI/ML system that assists human readers.

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

   • Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):

   • For the animal study, the "ground truth" would be direct biological observation and analysis (e.g., histology, imaging) of the defect sites in the rabbits, which falls under "pathology" or "outcomes data" in a broad sense. The document states: "Animal testing has demonstrated that the majority of the particulate material is absorbed within six months of implantation, with >98% of the material being absorbed by twelve months." This is an outcome.

8. The sample size for the training set:

   • Not applicable. This is not an AI/ML device; there is no "training set" in the AI sense.

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

   • Not applicable. As there's no AI training set, there's no ground truth establishment for it.

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