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

OSTEON is a synthetic resorbable osteoconductive bone graft substitute composed of beta-Tricalcium Phosphate (B -TCP). Hydroxyapatite(HA) and OSTEON presents ત્વ interconnected porosity structure, similar to that of human cancellous bone. OSTEON is available as irregular shaped powders of size 0.3~2.0 mm. It is supplied sterile.

AI/ML Overview

This 510(k) summary does not contain information typically found in a study demonstrating device performance against specific acceptance criteria. This document is a premarket notification for a bone grafting material (OSTEON) and focuses on establishing substantial equivalence to a predicate device (MBCP™).

Therefore, I cannot extract the requested information (acceptance criteria, reported device performance, sample sizes, expert details, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details) from the provided text because these elements are not present.

The document primarily states:

Device Description: OSTEON is a synthetic resorbable osteoconductive bone graft substitute composed of beta-Tricalcium Phosphate (β-TCP) and Hydroxyapatite (HA).
Intended Use: As a bone grafting material to fill, augment or reconstruct periodontal or oral/maxillofacial defects (e.g., periodontal/infrabony defects, ridge augmentation, extraction sites, sinus lifts, cystic cavities).
Comparison to Predicate Device: OSTEON has similar technological characteristics (main material, indication for use, and design) to MBCPTM.
Safety and Performance: "OSTEON has been subjected to extensive safety, performance, and product validations prior to release. Safety tests including biocompatibility have been performed to ensure the devices comply with the applicable International and US regulations." (However, the specific results or criteria are not detailed).
Conclusion: "Based on the information provided in this premarket notification GENOSS Co., Ltd. concludes that OSTEON is safe and effective and substantially equivalent to predicate devices as described herein."

For medical device clearances based on substantial equivalence, the primary "acceptance criteria" is typically demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than meeting specific quantitative performance metrics against a defined gold standard in a clinical study presented within the 510(k) summary itself. The burden of proof primarily lies in showing similar technological characteristics and indications for use, supported by general safety (e.g., biocompatibility) and performance data, not necessarily complex multi-reader studies or detailed performance metrics.

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.