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

DynaGraft® II Dental is derived from selected donated human borne tissue that has been processed into particles. The bone particles are subsequently demineralized using a hydrochloric acid process. The demineralized bone matrix (DBM) is combined with a reverse phase carrier and formulated to a gel or putty-like consistency.

AI/ML Overview

The provided text is a 510(k) summary for the DynaGraft® II Dental device. It describes the device, its intended use, and its substantial equivalence to predicate devices, but it does not contain acceptance criteria or study data demonstrating performance against specific metrics.

Therefore, I cannot fulfill your request for:

A table of acceptance criteria and the reported device performance: This information is not present in the document. The document notes "Pre-clinical animal data and clinical data demonstrate that DynaGraft® II support bone ingrowth and stimulates active bone formation in a variety of bony defects," but it does not provide specific performance metrics or acceptance criteria for these outcomes.
Sample size used for the test set and the data provenance: This information is not explicitly stated. The document mentions "clinical case studies" but does not specify their size or origin.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not present.
Adjudication method for the test set: This information is not present.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: This information is not present.
If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done: The device is a "human bone graft material," not an AI algorithm, so this question is not applicable.
The type of ground truth used: The document refers to "bone ingrowth and stimulates active bone formation" and "bone repair," which would likely be assessed through histological examination or imaging in pre-clinical and clinical studies. However, the specific methodology for establishing
"ground truth" (e.g., pathology, expert consensus) is not detailed.
The sample size for the training set: This information is not applicable as the device is not an AI algorithm requiring a training set.
How the ground truth for the training set was established: This information is not applicable.

Summary of what is available from the document:

Device Name: DynaGraft® II Dental
Intended Use: Bone filling material for augmentation or reconstructive treatment of the alveolar ridge, including filling defects after root resection, apicoectomy, and cystectomy; filling extraction sockets; elevation of the maxillary sinus floor; and treatment of periodontal defects.
Predicating Device: Tissue Bone Matrix Sponge (K960267) and autograft.
Basis for Substantial Equivalence: Similar design, construction, and function to predicate devices, with the main human component (donor DBM) being the same. Both are osteoconductive and have osteoinductive potential, providing a scaffold for bone ingrowth and stimulating bone growth. Differences in carriers (collagen for TBM vs. reverse phase carrier for DynaGraft II) were deemed not to affect safety or effectiveness as they are all resorbable and perform the same function.
Testing Mentioned: Pre-clinical animal data and clinical data, biocompatibility, extensive bench and animal testing, and clinical case studies to confirm device resorption and bone healing. It also states that "Demineralized bone has been used in clinical practice for more than 25 years with no remarkable safety issues."

Summary

Regulation Number and Section

§ 872.3930 Bone grafting material.

(a)
Identification. Bone grafting material is a material such as hydroxyapatite, tricalcium phosphate, polylactic and polyglycolic acids, or collagen, that is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.(b)
Classification. (1) Class II (special controls) for bone grafting materials that do not contain a drug that is a therapeutic biologic. The special control is FDA's “Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices.” (See § 872.1(e) for the availability of this guidance document.)(2) Class III (premarket approval) for bone grafting materials that contain a drug that is a therapeutic biologic. Bone grafting materials that contain a drug that is a therapeutic biologic, such as biological response modifiers, require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.