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The Aongen™ Collagen Matrix is intended for the management of wounds including:

• . surgical wounds
• trauma wounds t
• draining wounds .
• . second degree burns
• partial and full-thickness wounds .
• . pressure ulcers
• . venous ulcers
• vascular ulcers .
• . diabetic ulcers
• oral wounds and sores .

The Aongen™ Collagen Matrix is a biodegradable material composed of collagen. It is indicated for the management of wounds. The device is supplied sterile and for single use only.

The provided document describes a medical device called "Aongen™ Collagen Matrix," which is a wound dressing. The document is a 510(k) summary, indicating the device underwent a premarket notification process for substantial equivalence to legally marketed predicate devices.

Here's an analysis of the acceptance criteria and the study as per your request:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not provide specific details on the sample size used for the biocompatibility tests or product characterization studies, nor does it specify the data provenance (e.g., country of origin, retrospective or prospective). It simply states that "Tests were conducted to evaluate the biocompatibility" and refers to "product characterization studies."

This type of information is typically detailed in the full 510(k) submission, which is not fully included here. The summary provided is high-level.

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

This information is not applicable and not provided in this document. The device is a wound dressing, and the studies mentioned are laboratory-based (biocompatibility and product characterization), not clinical studies requiring expert interpretation of results to establish ground truth in the way it's done for diagnostic AI.

4. Adjudication Method for the Test Set:

This information is not applicable and not provided. As mentioned above, the studies are laboratory-based, not clinical studies involving human readers or interpretation of complex data that would require adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices where human interpretation is a key component, often comparing human performance with and without AI assistance. The Aongen™ Collagen Matrix is a wound dressing, and its evaluation focused on material properties and biological compatibility.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Not applicable. This device is a physical wound dressing, not an algorithm or software. Therefore, there is no "standalone" algorithm performance to evaluate.

7. The Type of Ground Truth Used:

For the biocompatibility studies, the "ground truth" was established by compliance with the ISO 10993 standard. This standard outlines a series of tests (e.g., cytotoxicity, sensitization, irritation) and their acceptance criteria to ensure a material is biologically safe for its intended use. The results of these tests, as interpreted against the ISO 10993 requirements, formed the ground truth for biocompatibility.

For the product characterization studies (implied by "substantial equivalence"), the ground truth would typically be established by comparing the physical, chemical, and performance characteristics of the Aongen™ Collagen Matrix to those of the predicate devices. This involves material testing to ensure similar properties and performance.

8. The Sample Size for the Training Set:

This information is not applicable as the device is a physical product (wound dressing) and not an AI or machine learning model that requires a training set.

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

This information is not applicable for the same reasons as point 8.

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Collagen Wound Dressing - Oral is indicated for the management of oral wounds and sores, including:

• Denture sores
• Oral ulcers (non-infected or viral)
• Periodontal surgical wounds
• Suture sites
• Burns
• Extraction sites
• Surgical wounds
• Traumatic wounds

Collagen Wound Dressing - Oral is a white to off-white, absorbent, microfibrillar collagen matrix. The product is supplied sterile and for single use only.

I am sorry, but the provided text does not contain information about acceptance criteria or a study proving that a device meets those criteria. The document is a 510(k) summary for a Collagen Wound Dressing-Oral, which is a regulatory document from the FDA. It discusses the device's classification, indications for use, and substantial equivalence to predicate devices, but it does not include details on performance studies with acceptance criteria, sample sizes, expert qualifications, or ground truth methodologies.

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Collagen Topical Wound Dressing is indicated for the management of moderately to heavily exudating wounds and to control minor bleeding.

Collagen Topical Wound Dressing may be used for the management of exudating wounds such as:

• . Pressure ulcers
• Venous stasis ulcers .
• Diabetic ulcers .
• Acutc wounds, for example trauma and surgical wounds .
• . Partial-thickness burns

Collagen Topical Wound Drcssing is an opaque, absorbent, collagen membrane matrix intended for topical use. The product is supplied sterile and for single use only.

This document describes the Collagen Topical Wound Dressing and its regulatory submission. It is a 510(k) premarket notification, which means the device is seeking clearance based on substantial equivalence to a legally marketed predicate device, rather than proving its safety and effectiveness through extensive clinical trials as would be required for a PMA.

Therefore, the submission does not contain the typical information about acceptance criteria, efficacy studies with human subjects, or AI performance metrics that your questions are asking for. Instead, the focus is on demonstrating that the new device is fundamentally similar to existing, cleared devices.

Here's an analysis of the provided text in the context of your questions:

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

• Not applicable for this type of submission. This submission does not provide acceptance criteria in terms of performance metrics (like sensitivity, specificity, accuracy, etc.) for addressing specific clinical outcomes. Instead, it focuses on demonstrating substantial equivalence to a predicate device.
• The "performance" reported is primarily in relation to safety and material characteristics.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not applicable. This submission does not involve a clinical "test set" in the sense of patient data for efficacy evaluation. The "tests" mentioned are biocompatibility and in vitro product characterization. No information on sample size or data provenance for these types of tests is provided in this summary.

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. There is no "ground truth" establishment by medical experts for a clinical test set in this 510(k) summary. The evaluation focuses on manufacturing, material, and biocompatibility standards.

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

• Not applicable. No clinical test set requiring adjudication by experts is described.

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 topical wound dressing, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study with human readers and AI assistance is entirely irrelevant to this submission.

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

• Not applicable. As stated above, this is a physical medical device, not an algorithm or AI product.

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

• Not applicable in the clinical sense. The "ground truth" for this submission revolves around established biocompatibility standards (ISO 10993-1) and the technical characteristics of the predicate device. The "truth" is that the device meets these standards and is sufficiently similar to an already cleared product.

8. The sample size for the training set

• Not applicable. This submission does not involve a "training set" of data for an algorithm.

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

• Not applicable. This submission does not involve a "training set" of data for an algorithm.

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