FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

Collagen Dental Wound Dressings are absorbent, porous, collagen matrices engineered from highly purified type I collagen derived from porcine Achilles tendon. The Collagen Dental Wound Dressings are applied directly to the wound and protect the wound and delicate new tissue. Collagen Dental Wound Dressings are supplied sterile, non-pyrogenic, in various sizes, and for single use only.

AI/ML Overview

This appears to be a 510(k) summary for a medical device (Collagen Dental Wound Dressings), which focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study. Therefore, some of the requested information (like MMRC studies, sample sizes for test/training sets with ground truth, expert qualifications) is not typically detailed in this type of submission.

Here's an attempt to extract and infer the information based on the provided text:

Acceptance Criteria and Device Performance Study

The primary study conducted to assess the Collagen Dental Wound Dressings was a comparison to predicate devices through in vitro and in vivo (biocompatibility) tests, along with referencing the clinical history of the predicate devices. The device's performance is demonstrated by its substantial equivalence to the legally marketed predicate devices, Collacare Dental (K110388) and Collagen Wound Dressing - Oral (K040403).

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria (Inferred from equivalence claim)	Reported Device Performance
Technological Characteristics	Similar intended use, purified starting material (Type I collagen), form, sizes, physical integrity to predicate devices.	The Collagen Dental Wound Dressings and their predicates have similar technological characteristics, including intended use, purified starting material (Type I collagen), form, sizes, and physical integrity.
Biocompatibility	Meet applicable FDA Blue Book Memorandum G95-1 and ISO 10993-1 standards for biological evaluation of medical devices.	The products passed all applicable FDA Blue Book Memorandum G95-1 and ISO 10993-1 testing for the biological evaluation of medical devices.
Viral Safety	Demonstrate viral inactivation to ensure product safety.	Viral inactivation studies were performed to ensure the viral safety of the product. (Specific acceptance thresholds for viral inactivation are not provided in this summary but are implied to have been met).
Material Properties	Demonstrate acceptable material properties (e.g., absorption, porosity, physical integrity) through in vitro characterization.	In vitro characterization studies evaluated material properties, biological properties, chemical, and physical properties. (Specific results not detailed but implied to be acceptable for equivalence).
Safety	No unacceptable risks identified through in vitro, in vivo (biocompatibility), and viral inactivation studies.	The results of the in vitro product characterization studies, in vitro and in vivo biocompatibility studies, and viral inactivation studies show that Collagen Dental Wound Dressings are safe.

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

Test Set Sample Size: Not applicable in the context of a traditional clinical study with a "test set" of patients/samples designed to evaluate performance against specific endpoints in humans. The "tests" here refer to in vitro and in vivo (animal or lab) studies.
Data Provenance: The studies were non-clinical (in vitro and in vivo biocompatibility, viral inactivation). The clinical history of the predicate devices was referenced, implying retrospective use of existing clinical data from those older devices. The country of origin for the non-clinical studies is not specified but would likely be the manufacturing or testing facilities used by Collagen Matrix, Inc. in the US.

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

This is not applicable as there was no traditional clinical "test set" with human data requiring expert ground truth establishment for this 510(k) submission. The evaluation relied on non-clinical data and comparison to existing predicate devices.

4. Adjudication Method for the Test Set

Not applicable, as there was no clinical test set requiring adjudication of findings.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. The submission explicitly states: "No clinical tests were performed on the product, however clinical history of the predicate device was referenced in the submission."

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 a software algorithm, so the concept of an "algorithm only" performance study does not apply.

7. The Type of Ground Truth Used

For the non-clinical studies (in vitro and in vivo biocompatibility, viral inactivation), the "ground truth" was established by the scientific and regulatory standards (e.g., ISO 10993-1, FDA Blue Book Memorandum G95-1) and the successful completion of the tests according to established protocols.
For the equivalence claim, the "ground truth" was the established safety and effectiveness profile of the legally marketed predicate devices, as evidenced by their clinical history.

8. The Sample Size for the Training Set

Not applicable. There was no "training set" in the context of an AI/algorithm.

9. How the Ground Truth for the Training Set was Established

Not applicable. There was no "training set."

Summary

Regulation Number and Section

N/A