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The Nitinol Compression Plating System™ is indicated for:

• Fractures of various bones, including the clavicle, pelvis, scapula, long bones (humerus, radius, ulha, femur, tibia and fibula), and small bones such as metacarpals, metatarsals and phalanges.

The BME Nitinol Compression Plating System™ (NCP) consists of a sterile bone plate offered in various configurations (outlined below) and sterile titanium screws. The Nitinol bone plate is situated on two bones, across the fracture site, with titanium locking screws extending through the plate and cortex. The Nitinol bone plate is activated at room temperature upon release from a constraining instrument. In its final configuration, the plate actively provides continuous compression across the fusion site.
The NCP system contains plates and screws in the same shapes and sizes as those offered in the GPC system. The configurations of the BME system include Straight, T-shaped and X-shaped implants.
The main difference between the BME Nitinol Compression Plating System™ and the primary predicate, GPC Medical Bone Fixation Plates and Screw System™ is that the NCP plate component is made of Nitinol and provides active compression while the GPC plate is made of titanium alloy (Ti-6Al-4V) and does not provide active compression. The second difference is that the BME implants are offered sterile and for single use, while GPC Medical offers their products as non-sterile. BME Nitinol Compression Plating System™ is a fully sterilized kit comprised of the bone plate, titanium screws, sizing templates and instruments. The GPC Bone Plates and Bone Screws are offered non-sterile in reusable trays.

Here's a breakdown of the acceptance criteria and study information for the Nitinol Compression Plating System™ based on the provided document:

The document describes a 510(k) premarket notification for a Class II medical device, indicating that the primary goal of the studies was to demonstrate substantial equivalence to existing predicate devices, rather than establishing standalone performance against specific clinical efficacy metrics. Therefore, the "acceptance criteria" are predominantly related to mechanical and material performance benchmarks compared to predicates, and the "study" involves bench testing to demonstrate this equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) submission, "acceptance criteria" are typically defined by the performance of the predicate device or established ASTM standards. The "reported device performance" is the finding of substantial equivalence to these criteria.

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

• Sample Size for Test Set: The document mentions "The test device is the representative worst-case condition for all configurations" (Page 5). While it specifies the part number NP-35S-5 for the tested device, it does not explicitly state the number of samples tested for each benchmark. It implies that a sufficient number was tested to represent the worst-case and draw conclusions.
• Data Provenance: The data provenance is from bench testing conducted by BioMedical Enterprises, Inc. (BME). This is not clinical data, so it doesn't involve countries of origin or retrospective/prospective distinctions.

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

This section is not applicable as the described studies are bench tests, not clinical studies involving "ground truth" established by medical experts. The "ground truth" here is the adherence to engineering standards and comparison to predicate device performance.

4. Adjudication Method for the Test Set

This section is not applicable as the described studies are bench tests, not clinical studies requiring adjudication of outcomes by experts.

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

This is not applicable. The device is a physical bone plating system, not an AI-powered diagnostic or decision-support tool. Therefore, MRMC studies involving human readers and AI assistance are irrelevant to this submission.

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

This is not applicable. The device is a physical bone plating system, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for these studies is:

• Engineering Standards: Specifically, ASTM F382(2008) e1, ASTM F2129-08, and ASTM F3044-14.
• Predicate Device Performance: The observed mechanical and material performance characteristics of the GPC Medical Bone Fixation Plates and Screw System™ and BME Speed Triad™ (K133844).

8. The Sample Size for the Training Set

This section is not applicable. The described studies are bench tests for a physical medical device. There is no "training set" in the context of machine learning or AI models. The design and manufacturing process would involve internal development and testing, but not a "training set" in this sense.

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

This section is not applicable for the reasons stated in point 8.

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