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The ARBOR™ External Fixation System is indicated for use in construction of an external fixation frame for the treatment of pediatric and adult fractures and/or reconstruction of long bones (including metacarpal and metatarsal), and the pelvis.

The ARBOR™ External Fixation System is intended for:

• Stabilization of open or closed fractures with soft tissue injuries;
• Polytrauma;
• Vertically stable pelvic fractures or as a treatment adjunct for vertically unstable pelvic fractures;
• Arthrodesis and osteotomies with soft tissue problems;
• Revision procedures where other devices have been unsuccessful including failures of total joints;
• Neutralization of fractures stabilized with limited internal fixation;
• Non-unions/septic non-unions;
• Intraoperative reduction/stabilization tool to assist with indirect reduction;
• Correction of deformity; and
• Unilateral rectilinear bone segment transport or leg lengthening.

The ARBOR™ External Fixation System is comprised of Schanz pins, external fixation clamps, and bars. The pins and bars are available in various sizes, and the fixation clamps are available in several designs all capable of use with any size pins and bars.

This document describes the regulatory clearance of a medical device, the ARBOR™ External Fixation System, based on its substantial equivalence to previously cleared predicate devices. It does not present a study proving the device meets specific acceptance criteria through clinical or AI-driven performance metrics.

Therefore, I cannot provide a detailed answer to your request in the format you've outlined because the provided text describes a 510(k) premarket notification which relies on demonstrating similarity to existing devices, rather than presenting novel performance data from an independent study with an AI component or a clinical trial.

Here's why I cannot fulfill your request based on this document:

• No AI Component: The document describes a traditional mechanical external fixation system. There is no mention of any artificial intelligence (AI) or machine learning (ML) components, nor any software algorithms that would require a study with acceptance criteria related to AI performance (e.g., sensitivity, specificity, AUC).
• No Clinical Study Data with Acceptance Criteria: The performance data section refers to mechanical testing (ASTM F543, F1541 for pins, bars, clamps, including insertion torque, pullout, static torsion, static axial compression), bacterial endotoxin testing, biocompatibility, and MRI testing. These are engineering and material safety tests, not clinical performance studies with patient outcomes or diagnostic accuracy metrics. The key takeaway is substantial equivalence to predicates, not novel performance claims.
• No Human Reader Study (MRMC): Since there's no diagnostic or AI component, there are no human readers involved in interpreting images, and thus no MRMC study.
• No Ground Truth Establishment: Ground truth in the context of diagnostic AI refers to adjudicated labels for medical images or patient outcomes. For a mechanical device, performance is evaluated against engineering standards and material properties.

To directly address your points based on the absence of the requested information in this specific document:

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

   • Acceptance Criteria (Implied for Mechanical Device): Substantial equivalence in:
     • Mechanical properties (e.g., static torsion, static axial compression within ranges similar to predicates).
     • Biocompatibility.
     • Material composition.
     • Functional characteristics.
   • Reported Device Performance: "Performance data demonstrates substantial equivalence to the predicate devices" for mechanical tests. Specific numerical values are not provided as this is a summary for regulatory clearance, not a research paper.

2. Sample size used for the test set and the data provenance: Not applicable in the context of an AI-driven or clinical diagnostic study. The "test set" here refers to the actual physical devices subjected to mechanical and materials testing. The provenance would be the manufacturer's testing labs.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a diagnostic AI is established by clinical experts. For a mechanical device, performance is measured against engineering specifications.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

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 as there is no AI component or human reader interpretation involved.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable as there is no algorithm or AI component.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For this mechanical device, the "ground truth" relates to meeting established engineering and material standards (e.g., ASTM F543, F1541 for mechanical strength; ANSI/AAMI ST-72:2011 for bacterial endotoxin; ASTM F2052, F2182, F2213 for MRI compatibility).

8. The sample size for the training set: Not applicable as there is no AI model that requires a training set.

9. How the ground truth for the training set was established: Not applicable as there is no AI model or training set.

In summary, the provided FDA 510(k) clearance document is for a traditional mechanical medical device, not an AI-enabled one. The "study" mentioned refers to engineering and biocompatibility testing, designed to demonstrate the device's equivalence to existing products, rather than a clinical trial or AI performance study with human readers and ground truth establishment.

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