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Synthes Large External Fixation Clamps - MR Safe are indicated for use in construction of an external fixation frame for treatment of long bone and pelvic fractures that require external fixation. Specifically, the Synthes MR Safe Large External Fixation Clamps and their accessories are 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; 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; Unilateral rectilinear bone segment transport or leg lengthening

Synthes MR Safe Large External Fixation Clamps are components of an external fixation frame that form a construct intended to treat long bone and pelvic fractures. They are all made from non-magnetic materials and are intended for use in the MR environment. Frame components for these MR Safe devices are designed for use with Synthes Ø11.0 mm carbon fiber rods and Synthes Schanz screws in diameters of 4.0 - 6.0 mm.

The provided document is a 510(k) Summary for a medical device (Synthes Large External Fixation Clamps - MR Safe) seeking clearance from the FDA. It does not contain information about acceptance criteria or specific studies proving the device meets those criteria in the context of algorithm performance evaluation.

This document focuses on the mechanical and MRI safety aspects of the device, which are evaluated through different types of testing (e.g., material testing, MRI compatibility assessments) rather than clinical studies with human readers or ground truth established by experts as would be the case for an AI/algorithm-based device.

Therefore, I cannot provide the requested information from this document because it is not relevant to the type of performance evaluation typically associated with acceptance criteria for AI or algorithm-driven medical devices.

Here's why and what kind of information is present instead:

• Device Type: The device is a "Large External Fixation Clamp - MR Safe," which is a physical, non-electronic, non-AI medical implant/component.
• Approval Basis: FDA clearance for such devices is primarily based on demonstrating substantial equivalence to a previously legally marketed predicate device. This involves comparing design, materials, indications for use, and performance claims.
• "Performance" in this context: Refers to mechanical properties (e.g., strength, durability) and MRI safety (e.g., magnetic field interactions, RF heating, image artifact). These are typically assessed through bench testing and simulations, not human reader studies or algorithm performance metrics like AUC, sensitivity, specificity.

To directly answer your request based on the lack of relevant information in the provided text:

1. Table of acceptance criteria and reported device performance: Not applicable/provided in the context of AI/algorithm performance. The document describes the device and its intended use but does not present a table of quantitative performance metrics against acceptance criteria that would apply to an AI system. The performance described is its MR-safe property, which is a design characteristic.
2. Sample size for the test set and data provenance: Not applicable. There is no test set of medical images or patient data to evaluate an algorithm.
3. Number of experts used to establish the ground truth for the test set and qualifications: Not applicable, as there is no algorithm requiring ground truth annotation from experts.
4. Adjudication method: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. This type of study is for evaluating human performance improvement with AI assistance, which is not relevant to a physical external fixation clamp.
6. Standalone (algorithm only) performance study: Not applicable. The device is a physical clamp, not an algorithm.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: Not applicable. There is no algorithm to train.
9. How the ground truth for the training set was established: Not applicable.

The document states that the device is "MR Safe" and lists materials (Stainless steel, titanium alloy, cobalt alloy). Its performance evaluation would revolve around demonstrating that these materials and the device design do not pose risks in an MRI environment (e.g., excessive heating, strong magnetic attraction, significant image artifact) and that the clamp functions mechanically as intended. This type of evaluation is fundamentally different from that of an AI/ML algorithm.

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