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These devices are implantable bone plates and bone screws for facial procedures including: 1. Fractures - 2. Osteotomies - 3. Reconstructive procedures - 4. Revision procedures where other treatments or devices have failed

The Biomet Microfixation Facial PreBent Plates with Virtual Surgical Planning is comprised of a variety of titanium plates with shapes and sizes designed for internal fixation for Facial reconstruction procedures. The plates include variations of straight, angle, curved, L-shape, Tshape, double T-shape, Z-shape, Y-shape, double Y-shape, H-shape, triangle, square, rectangle, matrix, orbital floor, LeFort, and chin options with various lengths and thickness. Plates are offered flat or pre-bent plates are contoured by Biomet Microfixation per surgeon specifications or patient specific anatomical model and include patient specific guides and instruments, of the VSP System (K120956, cleared December 12, 2012). The VSP System is used by Medical Modeling to create the guides, instrumentation and a patient specific anatomical model from CT scans provided by a surgeon. Medical Modeling uses the surgeon information to create the anatomical patient specific model. The anatomical patient specific model is then used to aide in proper alignment and bending of the plates previously cleared under K121589 (cleared 9/21/12). This bending process is conducted at Biomet Microfixation based on our process specification and inspection criteria previously cleared with K121589.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Biomet Microfixation Facial PreBent Plates with Virtual Surgical Planning:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not applicable. No clinical or non-clinical testing was performed as the device was deemed substantially equivalent based on its identical characteristics to a previously cleared predicate device, with an additional pre-bending service.
• Data Provenance: Not applicable. No test set data was generated for this submission. The rationale for substantial equivalence relied on the predicate device's existing clearance and the verification process for the pre-bending.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

• Not applicable. No test set was used, and therefore no ground truth was established by experts for a test set. The pre-bent plate's congruence to the anatomical model is verified through an internal inspection process by Biomet Microfixation, which aligns with their process specification and inspection criteria.

4. Adjudication Method for the Test Set

• Not applicable. No test set was used.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable. This device is a physical bone plate and not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This device is a physical medical implant, not an algorithm.

7. The Type of Ground Truth Used

• For the verification of the pre-bent plates, the "ground truth" is the patient-specific anatomical model created by Medical Modeling from CT scans. The plates are 100% verified against this model. This is essentially a form of design verification/conformance to a patient-specific digital template/model.
• For the overall device clearance, the ground truth is implicitly tied to the established safety and effectiveness of the predicate device (K121589).

8. The Sample Size for the Training Set

• Not applicable. This document describes a medical device (bone plates) submission, not an AI algorithm that requires a training set. The "VSP System" mentioned generates patient-specific anatomical models and guides, but the submission does not detail its development as an AI system requiring a 'training set'.

9. How the Ground Truth for the Training Set Was Established

• Not applicable, as no training set for an algorithm is described.

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