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The Maestro® Wrist Plating System is indicated for fractures, fracture dislocations, osteotomies and non-unions of the distal radius and ulna.

The Maestro® Wrist Plating System is comprised of anatomic plates in four styles: Volar, Dorsal, Radial Lateral and Ulnar. Both locking and non-locking screws in multiple lengths as well as pegs are designed for use with the plates. Plate sizing and contouring was developed through the use of IntelliFIT, a Biomet technology which uses contour analysis to map patterns in complex bone on cadaveric specimens to determine plate countouring. (Note, the software was used to determine a set of pre-defined plate sizes and is not used to create individual, patient matched plates.)

The provided document describes a 510(k) submission for the "Maestro® Wrist Plating System," a medical device for bone fixation. Here's an analysis of the acceptance criteria and supporting studies based on the provided text:

Important Note: This document primarily focuses on demonstrating substantial equivalence to predicate devices for regulatory approval, rather than independent efficacy or performance studies involving human subjects in a clinical setting. For medical devices like bone fixation systems, regulatory approval often relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, often through mechanical testing and material characterization rather than clinical trials comparing outcomes.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated as a "sample size" in the context of clinical trials. For the Plate Strength testing, an "Engineering Analysis" was performed. This typically involves mechanical testing of a representative number of plates and screws to assess their strength and fatigue properties. The document does not specify the number of devices tested.
• Data Provenance: Not applicable in the context of clinical or patient data. The engineering analysis and material testing are conducted in a laboratory setting. There is no mention of country of origin for such data. The study is not retrospective or prospective in the clinical sense.

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

• This information is not applicable to the type of studies conducted. The "ground truth" for this device's performance is based on established engineering standards, material specifications (e.g., ASTM F-138, F-139, F-2503-08), and comparison to the mechanical properties of predicate devices through engineering analysis. There is no expert consensus on clinical outcomes or diagnoses to establish "ground truth" in this submission.

4. Adjudication Method for the Test Set

• Not applicable. There were no human readers or diagnostic interpretations requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No. An MRMC study was not conducted. This device is a bone fixation system, and its approval typically relies on mechanical and material equivalence rather than comparative effectiveness studies with human readers interpreting diagnostic images.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Not applicable. This device is a physical implant, not an algorithm or AI software, so the concept of "standalone performance" for an algorithm does not apply.

7. Type of Ground Truth Used

• The "ground truth" for the device's technical performance is based on:
  • Engineering Standards: Adherence to recognized ASTM standards for materials (F-138, F-139, F-2503-08) and performance evaluation.
  • Predicate Device Performance: The primary "ground truth" is the established performance of the legally marketed predicate devices (K093761, K040908), which the new device aims to meet or exceed in terms of mechanical strength and functional characteristics.

8. Sample Size for the Training Set

• Not applicable. This device is a physical medical implant, not an AI/ML algorithm. Therefore, there is no "training set" in the computational sense. The design of the plates ("plate sizing and contouring") utilized "IntelliFIT, a Biomet technology which uses contour analysis to map patterns in complex bone on cadaveric specimens." However, this is described as a design methodology to determine pre-defined plate sizes, not a machine learning training process for the device's function in the clinical setting. The number of cadaveric specimens used is not specified.

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

• Not applicable. As stated above, there is no "training set" for an AI/ML algorithm. The design process for the physical dimensions of the plates involved using "IntelliFIT" technology to analyze "patterns in complex bone on cadaveric specimens" to establish general contours and sizes for the plates. This informs the design of the product, but it is not a "training set" in the context of establishing ground truth for evaluating an algorithm's performance.

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