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ologen™ Collagen Matrix is intended for the management of wounds including: surgical wounds, trauma wounds, second degree burns, partial and full-thickness wounds, pressure ulcers, venous ulcers, vascular ulcers, diabetic ulcers, oral wounds and sores.

ologen™ Collagen Matrix (K173223) proposed device has 9 models which differ in sizes and shapes but with the same composition. Different specifications are all intended for wound dressing. Which specification should be applied is determined by the physician according to the size, depth, location, type of wound and his/hers preference. The lists the specifications and shapes of all 9 models refer to Instruction for Use.
single-use sterile
Environment of Use: healthcare facility/hospital
ologen™ Collagen Matrix is a biodegradable material composed of collagen. It is indicated for the management of wounds. ologen™ Collagen Matrix is obtained from porcine hide and the matrix structure has a porous configuration made of ≥90% cross-linked lyophilized porcine collagen and

The provided text describes the 510(k) premarket notification for the "ologen™ Collagen Matrix" device. This document is a regulatory submission to the FDA, asserting that the new device is substantially equivalent to existing predicate devices.

However, the provided text does not describe a study involving a device that uses artificial intelligence or machine learning. The "ologen™ Collagen Matrix" is a medical device for wound management, consisting of a collagen matrix. The performance data section describes standard biological and material characteristic tests rather than performance metrics for an AI/ML algorithm.

Therefore, I cannot provide the requested information about acceptance criteria for an AI device, sample sizes for test sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance, as these concepts are not applicable to the device described in the input.

The document details performance data related to material characteristics and biocompatibility of the collagen matrix. Here's a summary of that information:

Summary of Performance Data for ologen™ Collagen Matrix (Non-AI/ML Device):

Regarding the other requested points (AI/ML specific):

1. Sample size used for the test set and data provenance: Not applicable to this device. The 'test set' here refers to samples of the collagen matrix itself for material and biological testing, not a dataset for an AI model.
2. Number of experts used to establish the ground truth and qualifications: Not applicable. Ground truth for an AI model is not relevant here. The 'ground truth' for this device's performance comes from standardized biological and material science testing protocols.
3. Adjudication method: Not applicable.
4. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable, as this is not an interpretive/diagnostic device.
5. Standalone (algorithm only) performance: Not applicable, as there is no algorithm.
6. Type of ground truth used: For this device, the "ground truth" refers to established scientific and regulatory standards for biocompatibility, material composition, and stability, as defined by international standards (e.g., ISO 10993) and pharmacopeial monographs (e.g., USP).
7. Sample size for the training set: Not applicable, as there is no AI model to train.
8. How the ground truth for the training set was established: Not applicable.

In conclusion, the provided text describes a traditional medical device (collagen matrix wound dressing) and its regulatory submission, which focuses on demonstrating substantial equivalence to a predicate device through material characterization and biocompatibility testing, not AI/ML performance.

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Aongen™ Dental is intended for use in dental surgical procedures as a resorbable material for open wounds to aid in wound healing post surgery.

Aongen™ Dental Collagen Matrix is a white, resorbable matrix manufactured from porcine type I collagen and glycosaminoglycan. The function of glycosaminoglycan is water absorption. The device is supplied sterile and for single use only. Aongen™ Dental Collagen Matrix functions in a manner similar to the predicates.

The provided text describes the 510(k) summary for the Aongen™ Dental Collagen Matrix. It outlines the device description, indications for use, and a summary of tests conducted to demonstrate biocompatibility and performance. However, this document does not contain information typically associated with acceptance criteria or study details for a device whose performance is measured in terms of metrics like sensitivity, specificity, or accuracy, which would be relevant for software or diagnostic devices.

The Aongen™ Dental Collagen Matrix is a physical medical device (resorbable matrix for dental surgical procedures) and its evaluation focuses on biocompatibility and substantial equivalence to predicate devices, rather than performance metrics of an AI or diagnostic algorithm.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts, MRMC studies, standalone performance, training set size, ground truth for training set) are not applicable to the type of device and study described in this 510(k) summary.

Here's the information that can be extracted and a clear indication of what is not applicable based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device (collagen matrix), acceptance criteria are typically related to safety profiles like biocompatibility and sterility, rather than analytical performance metrics common in AI or diagnostic systems. The "reported device performance" here refers to meeting these safety standards.

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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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