(177 days)
Aongen™ Dental is intended for use in dental surgical procedures as a resorbable material for open wounds to aid in wound healing post surgery.
Aongen™ Dental Collagen Matrix is a white, resorbable matrix manufactured from porcine type I collagen and glycosaminoglycan. The function of glycosaminoglycan is water absorption. The device is supplied sterile and for single use only. Aongen™ Dental Collagen Matrix functions in a manner similar to the predicates.
The provided text describes the 510(k) summary for the Aongen™ Dental Collagen Matrix. It outlines the device description, indications for use, and a summary of tests conducted to demonstrate biocompatibility and performance. However, this document does not contain information typically associated with acceptance criteria or study details for a device whose performance is measured in terms of metrics like sensitivity, specificity, or accuracy, which would be relevant for software or diagnostic devices.
The Aongen™ Dental Collagen Matrix is a physical medical device (resorbable matrix for dental surgical procedures) and its evaluation focuses on biocompatibility and substantial equivalence to predicate devices, rather than performance metrics of an AI or diagnostic algorithm.
Therefore, many of the requested categories (e.g., sample size for test set, number of experts, MRMC studies, standalone performance, training set size, ground truth for training set) are not applicable to the type of device and study described in this 510(k) summary.
Here's the information that can be extracted and a clear indication of what is not applicable based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
For this type of device (collagen matrix), acceptance criteria are typically related to safety profiles like biocompatibility and sterility, rather than analytical performance metrics common in AI or diagnostic systems. The "reported device performance" here refers to meeting these safety standards.
| Acceptance Criterion (Test) | Reported Device Performance (Result) |
|---|---|
| Agar Diffusion Test | Non-cytotoxic |
| Salmonella Typhimurium and Escherichia Coli Reverse Mutation Assay | Not mutagenic |
| Rodent Bone Marrow Micronucleus Assay | Non-clastogenic |
| Hemolysis – Rabbit Blood | Non-hemolytic |
| Intramuscular Implantation Test | No local toxic effects after implantation |
| Intracutaneous Injection Test | Negligible irritant |
| Kligman Maximization Test | No sensitization |
| Rabbit Pyrogen Test | Non-pyrogenic |
| Systemic Injection Test | No toxic effects |
| Heavy Metal Test | Within acceptance level |
| Sterility Test | Sterile |
| LAL Test |
N/A