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

Collacare Dental is a collagen matrix, conformable and resorbable, 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. Sizes available include the following:
Dental Sponges: 3.6cm x 1.8cm, 2.5cm x 2.5cm and 2.5cm x 5cm
Dental Cone: Height-17mm Ø Top - 10mm Ø Bottom - 14mm

AI/ML Overview

This document is a 510(k) Pre-market Notification for Collacare Dental, a collagen dental matrix. It's a regulatory submission to the FDA, not a study report with acceptance criteria and performance metrics in the typical sense for an AI/CADe device.

Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment is not present and not applicable to this type of document.

The document primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices through a comparison of features and a summary of performance testing related to biocompatibility and viral reduction. It doesn't report on specific clinical performance metrics (e.g., sensitivity, specificity, accuracy) of the device in treating oral wounds or sores, as it's a medical device composed of material rather than a diagnostic algorithm.

Here's a breakdown based on the provided document, addressing what is present and what is not applicable:

1. Table of acceptance criteria and the reported device performance

This document does not define specific quantitative "acceptance criteria" for clinical performance (e.g., statistical thresholds for wound healing rates, reduction in pain, etc.) nor does it report on such device performance. Instead, the "acceptance criteria" for this 510(k) submission are implicitly demonstrating substantial equivalence to predicate devices.

The reported "performance" is more about the device's characteristics and safety aspects, rather than clinical efficacy metrics:

Feature / Test	Acceptance Criteria (Implied by Substantial Equivalence)	Reported Device Performance
Biocompatibility (Cytotoxicity, Sensitization, Irritation, Systemic Toxicity, Pyrogenicity)	No new biocompatibility issues compared to predicate (Collacare Dental K110388).	Testing undertaken, demonstrating no new issues as materials match predicate.
Collagen Type and Purity	No denaturing during manufacturing process.	Evaluated to show no denaturing.
Viral Reduction	Viral deactivation within acceptable safety range.	Assessments conducted, showing deactivation within acceptable range.
Materials (Type I Collagen, Bovine Achilles Tendon)	Identical to predicate device (K110388).	Matches predicate.
Biodegradable, Biocompatible, Non-pyrogenic, Sterile (Irradiation)	Identical to predicate devices.	All match predicate specifications.
Intended Use	Consistent with predicate devices.	Matches predicate.
Physical Sizes	Similar to predicate devices, with some variations. Demonstrated by listing the sizes.	New sizes (3.6cm x 1.8cm, Height-17mm, etc.) listed and accepted.

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 document is a 510(k) for a medical device (collagen matrix), not an AI/CADe device. There is no "test set" in the context of diagnostic performance evaluation. The "testing" mentioned is laboratory-based (biocompatibility, viral inactivation) on the device material itself, not human subjects data.

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. See point 2.

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

Not Applicable. See point 2.

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 is not an AI/CADe device, so MRMC studies are not relevant.

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

Not Applicable. This is not an AI/CADe device.

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

Not Applicable. For the biocompatibility and viral reduction tests, the "ground truth" would be established by validated laboratory assays and recognized safety standards for those specific tests, rather than clinical consensus or pathology.

8. The sample size for the training set

Not Applicable. This is a medical device, not an AI model, so there is no training set.

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

Not Applicable. See point 8.

Summary of the Study (as described in the document):

The "study" in this context is a series of laboratory-based tests to demonstrate the safety and material properties of the Collacare Dental device, primarily by showing it is substantially equivalent to existing, legally marketed predicate devices.

Biocompatibility Testing: Included cytotoxicity, sensitization, irritation, systemic toxicity, and pyrogenicity. The conclusion was that there were no new biocompatibility issues compared to the predicate device (Collacare Dental K110388).
Collagen Type and Purity Evaluation: Conducted to ensure no denaturing occurred during the manufacturing process.
Viral Reduction Assessments: Performed to demonstrate viral deactivation within an acceptable safety range.

The purpose of these tests was to support the claim of substantial equivalence to predicate devices, thereby meeting the regulatory requirements for premarket notification as defined in CFR21, Part 807. The FDA acknowledged this in the letter dated May 1, 2014, stating that the device is "substantially equivalent."

Summary

Regulation Number and Section

N/A