(42 days)
The Aesculap Craniofacial Plate and Screw System is intended for use in selective trauma of the mid-face and craniofacial skeleton; craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.
The Aesculap Craniofacial Plate and Screw System consists of various sizes and shapes of plates and several lengths of 1.5mm screws (to include 1.8mm emergency screws). The screws are manufactured from Titanium forged alloy Ti6Al4V and the plates from CP Titanium (Ti Grade 2).
The provided document, K060492, is a 510(k) summary for the "Aesculap Craniofacial Plate & Screw System." This document describes the device, its intended use, and claims substantial equivalence to previously cleared devices. It does not present a study proving the device meets specific acceptance criteria in the context of an AI/human reader performance study.
Instead, the "Performance Data" section briefly mentions mechanical testing. Therefore, I cannot fulfill the request as it pertains to AI/human reader performance, sample sizes for training/test sets, expert adjudication, or MRMC studies.
However, I can extract the information related to the mechanical performance testing that was conducted.
Here's the information based on the provided document, addressing the relevant sections:
Acceptance Criteria and Device Performance (Mechanical Testing)
| Test Type | Acceptance Criteria (from ASTM Standard) | Reported Device Performance |
|---|---|---|
| Screws: Pull-out | Performed per ASTM F543 | Not explicitly stated in the document, but implicitly met for 510(k) clearance |
| Screws: Torque | Performed per ASTM F543 | Not explicitly stated in the document, but implicitly met for 510(k) clearance |
| Plates: Bending | Performed per ASTM F382 | Not explicitly stated in the document, but implicitly met for 510(k) clearance |
Note: The document states that the tests were performed "per ASTM F543 for pull-out and torque" and "per ASTM F382 for bending." This indicates that the device's performance was evaluated against the standards outlined in these ASTM specifications. For a 510(k) clearance, the implied acceptance criterion is that the device met the relevant performance requirements of these standards to be considered substantially equivalent. The specific quantitative results of these tests and the exact acceptance thresholds are not detailed in this summary.
Regarding the AI/human reader specific questions, the document does not contain this information:
- Sample sizes used for the test set and the data provenance: Not applicable, as this is not an AI/human reader study.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method for the test set: Not applicable.
- If a multi-reader, multi-case (MRMC) comparative effectiveness study was done: No, this was not done. This document describes a medical device (craniofacial plates and screws), not an AI algorithm for diagnostic imaging.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the mechanical testing, the "ground truth" would be the specified physical properties and performance metrics defined within the ASTM standards.
- The sample size for the training set: Not applicable, as there is no training set for mechanical testing of this type of device.
- How the ground truth for the training set was established: Not applicable.
§ 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.