(71 days)
For stabilization and support of bone grafts in dento-alveolar bony defect sites.
The Osteo-Mesh ™ TM-300 titanium ridge augmentation mesh is fabricated from Grade 1 titanium as described by ASTM-F-67 or its ISO equivalent. The Osteo-Mesh™ TM-300is supplied nonsterile in two sizes: 25 mm x 30 mm and 12 mm x 25 mm.
The biocompatibility of titanium has been established through a long history of use in a variety of implant devices. No additional biocompatibility testing has been performed with this device.
This document is a 510(k) premarket notification for a medical device, specifically a titanium mesh for bone graft stabilization. It does not contain information about a study proving the device meets acceptance criteria through performance metrics as would be expected for an AI/software-as-a-medical-device (SaMD) submission.
Instead, this document focuses on demonstrating substantial equivalence to a predicate device already on the market. The core argument for acceptance is that the device is similar in composition and intended use to existing, legally marketed devices.
Therefore, many of the requested categories (e.g., acceptance criteria, device performance, sample sizes, expert ground truth, MRMC studies, standalone performance, training set details) are not applicable to this type of device submission.
Here's an analysis based on the provided text, indicating where information is present and where it is not:
1. Table of Acceptance Criteria and Reported Device Performance
Not Applicable. This submission relies on substantial equivalence to a predicate device, not on meeting specific performance metrics through a clinical study or benchmark.
2. Sample Sizes Used for the Test Set and Data Provenance
Not Applicable. No test set or associated data are described for performance evaluation.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not Applicable. Ground truth establishment for a test set is not part of this type of submission.
4. Adjudication Method for the Test Set
Not Applicable. No test set is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
Not Applicable. This is not a software or AI device; therefore, an MRMC study is not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not Applicable. This is not an algorithm or AI device.
7. The Type of Ground Truth Used
Not Applicable. No ground truth is established in the context of device performance evaluation for this submission. The "ground truth" for this submission is the established safety and effectiveness of the predicate device.
8. The Sample Size for the Training Set
Not Applicable. This is not a machine learning or AI device, so there is no training set.
9. How the Ground Truth for the Training Set Was Established
Not Applicable. There is no training set.
Summary of Device Acceptance Rationale (Based on the document):
The acceptance of the Osteo-Mesh™ TM-300 is based on its substantial equivalence to a legally marketed predicate device, the OsteoMed TRAM™ (Titanium Ridge Augmentation Material) (K963394).
- Comparison Basis: The submission states that the Osteo-Mesh™ TM-300 is "similar in composition, and intended use" to the TRAM™.
- Composition: Both devices are made from Grade 1 titanium (ASTM-F-67 or ISO equivalent). The biocompatibility of titanium is cited as "established through a long history of use in a variety of implant devices."
- Intended Use: Both devices are "For stabilization and support of bone grafts in dento-alveolar bony defect sites."
The FDA's review concludes that the device is substantially equivalent to predicate devices, allowing it to be marketed under the general controls provisions of the Federal Food, Drug, and Cosmetic Act. This indicates that the safety and effectiveness are inferred from the predicate device's history and not from new, extensive performance studies detailed in this 510(k) summary.
§ 872.4760 Bone plate.
(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.