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Collacare Dental 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
• surgical wounds and traumatic wounds

Collacare Dental is a conformable collagen matrix manufactured from purified type I collagen derived from bovine Achilles tendon. Collacare Dental is supplied sterile and non-pyrogenic, in various sizes, and for single use only.

The provided text discusses the Collacare Dental device, its intended use, and its substantial equivalence to predicate devices, but it does not contain any information about acceptance criteria or a study proving that the device meets such criteria.

The document is a 510(k) Summary for a medical device submitted to the FDA. The purpose of a 510(k) submission is to demonstrate that the device is substantially equivalent to a legally marketed predicate device, not necessarily to prove its performance against specific acceptance criteria through a dedicated study.

Here's a breakdown of what is and isn't present in relation to your request:

Information NOT present in the document:

• Acceptance Criteria for Device Performance: The document does not define any specific performance metrics (e.g., sensitivity, specificity, accuracy, healing rates, etc.) with corresponding acceptance thresholds.
• Study Proving Acceptance Criteria: There is no description of a study designed to test the Collacare Dental device against performance acceptance criteria.
• Reported Device Performance: Since there are no acceptance criteria or a study, there's no reported performance data against such metrics.
• Sample Size for Test Set: No test set is mentioned, thus no sample size.
• Data Provenance: No data from specific tests are presented.
• Number of Experts/Qualifications for Ground Truth: Not applicable as there's no performance study described.
• Adjudication Method: Not applicable.
• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No such study is mentioned or referenced.
• Standalone Performance Study: No standalone performance study details are provided.
• Type of Ground Truth Used: Not applicable.
• Sample Size for Training Set: Not applicable.
• Ground Truth Establishment for Training Set: Not applicable.

What the document does describe instead of a performance study against acceptance criteria:

The document focuses on demonstrating Substantial Equivalence based on:

1. Materials of Construction: It explicitly states, "Collacare Dental is substantially equivalent in materials of construction to Collagen Sponge (K092805), Collagen Wound dressing - Oral (K040403), Salicept Oral Patch (K012126)..." and later, "...the materials of construction and finished product material match that of Collagen Sponge (K092805)."
2. Intended Use: The intended uses for Collacare Dental are listed and are presumed to be similar to the predicate devices.
3. Biocompatibility: It states, "There are no new biocompatibility issues arising with the use of Collacare Dental as the materials of construction and finished product material match that of Collagen Sponge (K092805). A complete biocompatibility evaluation was undertaken in line with the requirements of ISO 10993-1." This implies a biocompatibility assessment was done, but it's not a performance study of the device's efficacy against specific clinical outcomes.

Conclusion:

Based on the provided text, the device Collacare Dental gained market clearance through substantial equivalence to existing predicate devices, primarily by demonstrating similar materials of construction, intended use, and a satisfactory biocompatibility assessment. The document does not describe specific performance acceptance criteria or a study designed to prove the device meets such criteria through quantitative performance metrics.

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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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