Search Results

ABCcolla® Collagen ADM Scaffold is intended to be used for management of wounds. including venous ulcers, pressure ulcers, chronic vascular ulcers, diabetic ulcers, tunneled undermined wounds (donor site/ grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, and skin tears), first and second-degree burns, draining wounds.

ABCcolla® Collagen ADM Scaffold is a decellularized porcine collagen biomaterial from porcine dermis. When applied on a wound, this product helps absorb wound exudates and maintain a moist wound environment.

This document is a 510(k) premarket notification for the ABCcolla® Collagen ADM Scaffold, a medical device for wound management. The core of the submission is to demonstrate the substantial equivalence of the new device to a legally marketed predicate device, ABCcolla® Collagen Matrix (K162348), and a reference device, Cook® ECM Powder (K152033).

Based on the provided text, the "acceptance criteria" and the "study that proves the device meets the acceptance criteria" are not related to an AI/ML-driven device's performance in terms of diagnostic accuracy or a clinical study in humans with a traditional statistical endpoint and acceptance criteria. Instead, the "acceptance criteria" for this specific device (a collagen scaffold for wound management) are primarily focused on benchmarking against a predicate device to demonstrate "substantial equivalence" as required by the FDA 510(k) pathway. The "study" here refers to the pre-clinical testing and characterization that demonstrates the new device has similar technological characteristics and performance to the predicate device, and any differences do not raise new questions of safety or effectiveness.

Here's an interpretation of the requested information based on the provided document:

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

For a 510(k) submission, "acceptance criteria" are not typically framed as specific performance metrics and thresholds like sensitivity/specificity for an AI device. Instead, the acceptance is based on demonstrating that the new device is "substantially equivalent" to a legally marketed predicate device. This is achieved by comparing various characteristics.

Here's a table based on the "Substantial Equivalence Comparison Table" in the document, interpreting "acceptance criteria" as demonstrating "sameness" or "differences that do not raise new questions of safety/effectiveness" compared to the predicate/reference devices:

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

The document mentions one performance study: "A study was performed where the ABCcolla® Collagen ADM Performance Data Scaffold is performed in full thickness skin defect rat model."

• Sample size: Not specified. It only mentions "rat model," not the number of rats.
• Data provenance: Not specified regarding country of origin. This is a pre-clinical animal study, not human data.
• Retrospective or prospective: This would be a prospective animal study as it describes an experiment being "performed."

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)

This section is not applicable as the provided document does not describe a clinical study in humans or an AI/ML device relying on expert-adjudicated ground truth. The "study" mentioned is an animal model for safety/performance, not human diagnostic interpretation.

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

This is not applicable. There is no human expert adjudication involved for the "full thickness skin defect rat model."

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

This is not applicable. The device is a collagen scaffold for wound management, not an AI/ML-driven diagnostic or assistive technology for human readers. No MRMC study was conducted or mentioned.

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 medical device (collagen scaffold), not an algorithm or software. It does not have a "standalone" performance in the context of AI/ML.

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

For the mentioned performance data (rat model):

• The "ground truth" would likely be based on histopathology and/or gross observation/measurements of wound healing in the rat model, as is typical for such pre-clinical studies. The document states "The results of the study show that device is safe in its application," implying direct observation and measurement of tissue response.

8. The sample size for the training set

This is not applicable. There is no "training set" as this is not an AI/ML device.

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

This is not applicable. There is no "training set."

In summary: The provided document is an FDA 510(k) clearance letter for a biological medical device (collagen scaffold), not an AI/ML device. Therefore, many of the requested points related to AI/ML evaluation (like expert ground truth, MRMC studies, training/test sets, etc.) are not relevant to this type of submission. The "acceptance criteria" are demonstrating substantial equivalence primarily through comparison of materials, design, intended use, and pre-clinical biocompatibility and safety testing against a predicate device.

Ask a specific question about this device