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

Dental Collagen Wound Dressings are soft, white to off-white, resorbable collagen dressings produced from cross-linked, purified collagen derived from bovine hide. The thickness and pore structure of the device allow it to absorb fluids and blood at the defect site. Dental Collagen Wound Dressings are supplied sterile, non-pyrogenic, and are for single use only.

AI/ML Overview

This document is a 510(k) summary for NovaBone Products, LLC's Dental Collagen Wound Dressing (NovaTape and NovaPlug), seeking substantial equivalence to a legally marketed predicate device. The information provided is for regulatory clearance and focuses on demonstrating equivalence, rather than establishing new performance criteria for a novel device. As such, the structure of the provided text does not directly align with a typical acceptance criteria study for a novel device.

However, based on the provided text, I can extract and infer information to address your request in the context of demonstrating substantial equivalence to a predicate device.

Here's the breakdown:

1. Table of Acceptance Criteria and Reported Device Performance

For this 510(k), the "acceptance criteria" is essentially demonstrating equivalence to the predicate device in key areas. The "reported device performance" refers to how NovaTape/NovaPlug compares to the predicate.

Acceptance Criteria (Equivalence to Predicate K040403)	Reported Device Performance (NovaTape/NovaPlug)
Intended Use	Temporary topical wound dressing for oral wounds and sores.
Target Population	Individuals requiring acute or short-term dressings for protection of oral wounds.
Where Used	Intended for hospital, clinic, or dental office use.
Indicated Sites	Denture sores, Oral Ulcers (non-infected or viral), Periodontal surgical wounds, Suture sites, Burns, Extraction sites, Surgical wounds, Traumatic wounds.
Preparation	No preparation required.
Application	Can be applied directly to the site.
Device Action	On application, the dressing absorbs local wound fluids to maintain a moist wound environment to aid wound healing.
Resorption Time	Resorbs within approximately 14 days.
Biocompatibility	Biocompatible (did not raise any issues of biological safety in ISO 10993 tests).
Mechanical Performance	Wound covering only; no mechanical performance characteristics.
Package Format	Provided Sterile, Single Barrier Format.
Device Forms	Tape & Plug.
Collagen Material Safety (BSE Risk)	Sourced from Geographical BSE Risk I country; manufacturing processes have sufficient viral inactivation capacity. No new issues of safety presented compared to predicate.
Sterilization Method	E-beam irradiation / SAL 10-6. (Predicate uses Gamma irradiation, but packaging and SAL are equivalent, so no new issues).

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

The primary "test set" for performance equivalence was an animal study:

Sample Size: The document does not explicitly state the number of animals (minipigs) used in the study. It refers to a "porcine (minipig) model."
Data Provenance: The study was an animal study (in vivo) conducted in compliance with GLP regulation (21 CFR Part 58). The country of origin is not specified, but GLP compliance implies a controlled, prospective study environment.

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

The document does not mention the use of human experts to establish ground truth in the context of an animal study for performance assessment. The "ground truth" for the animal study was based on histological findings and observations of local reaction and material absorption, likely assessed by veterinary pathologists or similar specialists. However, their specific number or detailed qualifications are not provided.

4. Adjudication Method for the Test Set

Again, as the study is an animal performance study focused on histological and observational comparison, a human-reader adjudication method (like 2+1, 3+1) is not typically applicable or described here. The evaluation of histological findings would be performed by trained professionals following established pathology protocols.

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

No, an MRMC comparative effectiveness study was not done. This device is a physical wound dressing, not an AI-powered diagnostic or assistive tool. Therefore, the concept of human readers improving with AI assistance is not applicable.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. As stated above, this is a physical medical device (wound dressing), not an algorithm or AI.

7. The Type of Ground Truth Used

For the animal performance study: The ground truth was established through histological findings and direct observation of local tissue reaction and material absorption in the minipig model. This is a form of biological/pathological ground truth.
For biocompatibility: Ground truth was established through standardized in vitro and in vivo biocompatibility tests in accordance with ISO 10993.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/machine learning model, so there is no "training set." The development of the device would involve materials science and engineering principles, not data training.

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

Not applicable. (See point 8).

In summary, this 510(k) emphasizes demonstrating that the NovaTape/NovaPlug device is substantially equivalent to a predicate device, focusing on a robust comparison of materials, intended use, and performance in an animal model and biocompatibility testing, rather than establishing novel performance criteria with human subject data.

Summary

Regulation Number and Section

N/A