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The Skeletal Dynamics Protean Fragment Plate System is intended for stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion and reconstructions of small bones of the hand, foot, wrist, ankle, humerus, scapula, finger, toe, and pelvis, particularly in osteopenic bone.

Device Description

The Skeletal Dynamics Protean Fragment Plate System is a set of titanium bone plates designed for stabilization and repair of small bone fragments. Included in the set are titanium bone screws, fixation pegs, cobalt chrome cannulated polyaxial screws, and specialized instrumentation. The Fragment Plates are available in 3 configurations and are made of medical grade titanium alloy. The system is provided non-sterilized in the user facility. The Skeletal Dynamics Protean Fragment Plate System is comprised of: Titanium alloy plates and screws, Cobalt chrome polyaxial screws, Stainless steel K-wires (for provisional fixation not for implantation), System specific instrumentation.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called the "Skeletal Dynamics Protean Fragment Plate System." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness through clinical studies with detailed acceptance criteria as one might find for new drug applications or high-risk medical devices requiring PMA.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not applicable in this context. The primary "study" is a preclinical mechanical testing study to show equivalence, not a clinical trial evaluating human performance or AI capabilities.

Here’s a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Criterion Type	Acceptance Criterion (Not explicitly stated as numerical, but implied as "substantially equivalent")	Reported Device Performance
Mechanical Performance	Substantially equivalent to the predicate device (DePuy Small Bone Locking Plate System (K081546)) in static and dynamic testing.	"Preclinical analysis and testing demonstrated that the Skeletal Dynamics Protean Fragment Plate System is substantially equivalent to the predicate device currently marketed. Mechanical testing which established equivalency included static and dynamic testing." The exact numerical results are not provided.
Intended Use	Identical or highly similar to the predicate device.	"The Skeletal Dynamics Protean Fragment Plate System is intended for stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion and reconstructions of small bones of the hand, foot, wrist, ankle, humerus, scapula, finger, toe, and pelvis, particularly in osteopenic bone." This is also considered substantially equivalent to the predicate.
Materials	Similar to predicate device; medical grade.	Titanium alloy plates and screws, Cobalt chrome polyaxial screws, Stainless steel K-wires. This is stated to be substantially equivalent to the predicate.
Design	Similar fundamental scientific technology to predicate device.	No specific design details against a criterion are given, but the overall design is stated to be substantially equivalent.
Sterility	Not explicitly detailed but implied to be manageable post-manufacturing by the user.	"The system is provided non-sterilized in the user facility." Stated as substantially equivalent to the predicate.
Packaging	Substantially equivalent to the predicate device.	Not detailed, but stated as substantially equivalent to the predicate.

2. Sample size used for the test set and the data provenance

Sample Size: Not specified. For mechanical testing of medical devices, "samples" typically refer to the number of devices or components subjected to a particular test. The document only states "Preclinical analysis and testing."
Data Provenance: Not applicable in the context of clinical data. This refers to in-vitro mechanical testing conducted by the manufacturer.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable. This is a mechanical device evaluation, not a clinical study involving expert interpretation of data or images. "Ground truth" would relate to precisely measured mechanical properties or failure points, not expert consensus on diagnoses.

4. Adjudication method for the test set

Not Applicable. There is no adjudication method described because there's no clinical data or expert interpretation involved in determining a "ground truth" through consensus.

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 bone plate system, not an AI or imaging diagnostic tool. No MRMC study was conducted.

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

Not Applicable. This is a hardware medical device, not an algorithm or AI.

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

For mechanical testing, the "ground truth" would be established by the physical testing parameters and measurements (e.g., force applied, displacement, cycles to failure, yield strength) as per recognized engineering standards (e.g., ASTM, ISO). The document does not specify which standards were followed, but these would define how performance is "measured."

8. The sample size for the training set

Not Applicable. This is a mechanical device, not an AI system that requires a "training set" of data.

9. How the ground truth for the training set was established

Not Applicable. No training set exists for this type of device submission.

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