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The Skeletal Dynamics GEMINUS Volar Distal Radius Plate System is intended for fixation of fractures and osteotomies of the distal radius.

The Geminus Volar Distal Radius Plate System contains bone plates for the repair of distal volar radial fractures. Included in the set are titanium bone screws, fixation pegs, fragment plates, and specialized instrumentation. Also included are a Hook Plate Extension to buttress a volar marginal fragment, and cannulated cobalt chrome polyaxial locking screws for trajectories different than those of the fixed angled bone plates.

The Geminus Volar Distal Radius Plate is available in 6 sizes and is made of medical grade titanium alloy. Cortical locking screws affix the plate to the diaphysis, fixed angle pegs are used for distal bone fragments. The titanium Hook Plate Extension locks to the plate by a means of titanium screw. The system is provided non-sterile and is sterilized in the user facility.

The Geminus Volar Distal Radius Plate System is comprised of:

• · Titanium alloy plates, washers and screws
• · Cannulated cobalt chrome polyaxial locking screws
• · Titanium alloy hook plate extension
• · Stainless steel k-wires (for provisional fixation not for implantation)
• · System specific instrumentation.

The provided text describes a medical device, the Skeletal Dynamics GEMINUS Volar Distal Radius Plate System, and its clearance through the 510(k) pathway. This pathway relies on demonstrating substantial equivalence to predicate devices, rather than performing clinical studies to establish specific acceptance criteria and performance metrics for the device itself in terms of diagnostic accuracy or clinical outcomes.

Therefore, many of the requested elements for describing acceptance criteria and a study that proves the device meets them are not applicable in this context. The 510(k) summary focuses on preclinical performance testing to demonstrate equivalence, not clinical performance.

Here's an analysis based on the provided text, addressing elements that are applicable and explaining why others are not:

Acceptance Criteria and Reported Device Performance

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not Applicable / Not Provided: The text describes preclinical mechanical testing rather than testing on a clinical "test set" of patients or data. Mechanical tests typically involve a specific number of manufactured units or samples for laboratory testing. The sample size for these mechanical tests is not specified, nor is data provenance in the clinical sense (country, retrospective/prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not Applicable: This device is a bone fixation plate, not a diagnostic imaging device or AI algorithm that requires expert ground truth for interpretation. Mechanical testing typically involves engineers and quality assurance personnel, but "ground truth" in the clinical imaging sense is not relevant here.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable: Adjudication methods are used for resolving disagreements in expert interpretations, primarily in clinical studies or evaluations of diagnostic performance. This is irrelevant for mechanical testing of a medical implant.

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: An MRMC study is relevant for evaluating the impact of AI on human reader performance, typically in diagnostic tasks. This device is a surgical implant and does not involve AI or human reading tasks.

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

• Not Applicable: This device is a metallic bone fixation system, not an algorithm.

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

• Not Applicable: For mechanical testing, the "ground truth" would be established engineering principles, material specifications, and regulatory standards for device performance, against which the device's mechanical behavior is measured. No clinical "ground truth" type (like pathology or outcomes data) is identified as this is not a clinical study.

8. The sample size for the training set

• Not Applicable: This device is not an AI/ML algorithm that requires a "training set."

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

• Not Applicable: As stated above, there is no training set for this device.

Summary of the 510(k) for the GEMINUS Volar Distal Radius Plate System:

The 510(k) clearance for the Skeletal Dynamics GEMINUS Volar Distal Radius Plate System relies on demonstrating substantial equivalence to existing predicate devices already on the market. This means the device met acceptance criteria related to having the same intended use, indications for use, materials, fundamental scientific design, performance characteristics (including preclinical mechanical testing), sterility, and packaging as its predicates. The key finding is that the device does not present any new issues of safety or effectiveness compared to the predicate devices. The performance testing conducted was preclinical mechanical testing (static and dynamic), which was deemed sufficient to establish this equivalency. No clinical studies involving human subjects, diagnostic performance evaluation, or AI algorithms were part of this 510(k) submission.

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The Skeletal Dynamics GEMINUS Volar Distal Radius Plate System is intended for fixation of fractures and osteotomies of the distal radius.

The Skeletal Dynamics GEMINUS Volar Distal Radius Plate System contains bone plates for the repair of distal volar radial fractures. Included in the set are titanium bone screws, fixation pegs, fragment plates, and specialized instrumentation. Also included are cannulated cobalt chrome polyaxial locking screws for trajectories different than those of the fixed angled bone plates.

The GEMINUS Plate System is available in 6 sizes and is made of medical grade titanium alloy. Cortical locking screws affix the plate to the diaphysis and fixed anale pegs are used for distal bone fragments. The system is provided non-sterile and is sterilized in the user facility.

The Skeletal Dynamics GEMINUS Plate System is comprised of:

• · Titanium alloy plates, washers and screws
• · Cannulated cobalt chrome polyaxial locking screws
• · Stainless steel k-wires (for provisional fixation not for implantation)
• · System specific instrumentation.

The provided text describes a 510(k) premarket notification for a medical device, the "Skeletal Dynamics GEMINUS Volar Distal Radius Plate System." This submission is for a mechanical device (bone fixation plate system), not an AI/software-as-a-medical-device (SaMD). Therefore, many of the requested categories related to AI/SaMD studies (like AI performance metrics, sample sizes for test/training sets, expert ground truth, MRMC studies) are not applicable.

The "study" described in this document is performance testing, specifically static and fatigue testing of the mechanical device. The acceptance criteria for such a device are typically established based on recognized industry standards for orthopedic implants and direct comparison to a predicate device.

Here's an attempt to answer the questions based on the provided document, noting where information is not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified in terms of number of physical test units. Mechanical testing typically involves a specific number of samples to achieve statistical significance, but the exact count isn't in this summary.
• Data Provenance: Not applicable in the context of patient data. The "data" here comes from mechanical laboratory testing of the device components/system.

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

• Not applicable as this is a mechanical device. "Ground truth" in this context would be engineering specifications and standards for mechanical performance, not expert medical opinion on clinical cases. The testing would be performed by qualified engineers or technicians in a laboratory setting.

4. Adjudication Method for the Test Set

• Not applicable for mechanical device testing. The results of static and fatigue tests are quantitative measurements assessed against pre-defined engineering standards or comparative data from predicate devices.

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 is a mechanical orthopedic implant, not an AI or SaMD.

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

• Not applicable. This is a mechanical orthopedic implant, not an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• The "ground truth" for evaluating this device's performance would be recognized engineering standards for orthopedic implants (e.g., ASTM standards for static and fatigue testing of bone plates) and comparative data from the legally marketed predicate devices. The goal is to demonstrate that the new device performs at least as well as, or equivalently to, the predicate devices under these standard mechanical tests.

8. The Sample Size for the Training Set

• Not applicable. This is a mechanical device, not an AI or SaMD requiring a training set.

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

• Not applicable. This is a mechanical device, not an AI or SaMD.

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