(277 days)
Neo GBR System is intended to fixate and stabilize non-resorbable barrier membranes used for regeneration of tissue in the oral cavity or in dental situations that require membrane use or fixation.
The Neo GBR System is made of Titanium Alloy. This product is a sterilized single use medical device. This system consists of Tent screw and CTi Cover Screw. The function of the Tent Screw is temporarily Intraosseous Fixation Screw that places in the maxilla or mandible bone area to be combined with a titanium membrane of K 111761 and CT cover screw. Second surgery for removal is required. The product diameters are 2.0mm and the lengths are 7.2/8.7/10.2/11.7/13.2/15.2/18.2mm. The Tent Screw and CTi-Cover screw are always packaged together. But CTi-Cover Screw is packaged separately for the convenience. 4 pcs of Tent Screw can be packaged in a box as a bundle set.
The provided document does not describe a study that uses acceptance criteria to prove the device meets these criteria in the context of an AI/ML medical device. Instead, it is a 510(k) summary for the "Neo GBR System," which is an implantable medical device (intraosseous fixation screw or wire).
The document details bench testing conducted for the Neo GBR System to confirm its physical properties, but this testing is not an AI/ML performance study as typically described with acceptance criteria like sensitivity, specificity, or AUC, nor does it involve human readers or ground truth derived from expert consensus, pathology, or outcomes data in the way an AI/ML study would.
Here's an analysis based on the information available, noting the absence of AI/ML specific information:
1. Table of Acceptance Criteria and Reported Device Performance
The document mentions that "The testing results meet the requirements of its pre-defined acceptance criteria and intended uses." However, the specific quantitative acceptance criteria and the detailed performance results for each test (visual test, compressive loads, pull out, driving torque, and insertion-elimination tests) are not provided in this summary. It only states that they meet the requirements.
2. Sample Size Used for the Test Set and Data Provenance
This information is not available in the provided summary. The document mentions "bench testing," which implies physical tests on the manufactured device, not a test set of data (images, clinical records, etc.) as would be used for an AI/ML algorithm.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the device is a physical fixation system, not an AI/ML algorithm requiring expert interpretation for ground truth.
4. Adjudication Method for the Test Set
This information is not applicable for the same reason as above.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
This information is not applicable. The device is a physical implant, not an AI/ML system that enhances human reader performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable as it is not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance would be the physical properties and mechanical thresholds established for the device's function (e.g., maximum compressive load before failure, torque required for insertion/removal). The biocompatibility tests also have established standards (ISO 10993-1). However, specific quantitative values are not provided in the summary.
8. The Sample Size for the Training Set
This information is not applicable as the device is not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as above.
Summary of Non-Clinical Testing Performed (from the document):
- Tests: Visual test, compressive loads, pull out, driving torque, and insertion-elimination tests.
- Standards: Conducted in accordance with ASTM F543-13.
- Biocompatibility: Cytotoxicity, irritation, and sensitization tests in accordance with ISO 10993-1.
- Stability and Compatibility: Tests between the tent screw and CTi-cover screw to evaluate adaptation accuracy.
Conclusion from document: "The testing results meet the requirements of its pre-defined acceptance criteria and intended uses."
In essence, the provided document describes the regulatory submission for a physical medical device and does not contain the kind of AI/ML performance study information requested in the prompt.
§ 872.4880 Intraosseous fixation screw or wire.
(a)
Identification. An intraosseous fixation screw or wire is a metal device intended to be inserted into fractured jaw bone segments to prevent their movement.(b)
Classification. Class II.