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The BESPA Charcot System is indicated for fracture fixation, reconstruction procedures, arthrodesis, and osteotomies of various bones and bone fragments in the foot and ankle, including metatarsals and tarsals. For example, medial and/or lateral column fusion as a result of neuropathic osteoarthropathy (Charcot). The BEPSA Charcot System is intended for use in adult populations. The device is for prescription use only.

The BESPA Charcot System is offered non-sterile and consists of implants and system-specific instruments.

The Segmental Column is composed of various modular cylindrical components which screw together to create an implant assembly of the surgeon's desired features. The system contains transverse screws of various lengths. The implant construct has a compression capability.

All implants are made of titanium alloy.

This document, K202326, is a 510(k) summary for the BESPA Charcot System. It describes a medical device, which is a metallic bone fixation fastener, and its substantial equivalence to predicate devices. The document does not describe a study involving an AI or algorithm-only device, nor does it present acceptance criteria and performance data in the typical format for AI/ML device submissions.

Therefore, I cannot extract the information required in your request regarding acceptance criteria, device performance, sample sizes, ground truth, or MRMC studies for an AI/ML device.

Here's why and what information can be extracted:

• Device Type: The BESPA Charcot System is a physical medical implant (metallic bone fixation fastener for Charcot deformity). It is not an AI/ML software device.
• Performance Data Section (10. Performance Data): This section explicitly states, "There are no clinical data generated and held by the manufacturer, i.e., no premarketing or post-market clinical studies or animal studies have been performed." Instead, substantial equivalence is demonstrated through:
  • Biocompatibility (10.1): Assessment based on raw material data, biocompatibility testing according to ISO 10993 standards, and published literature for Ti-6AI-4V ELI material.
  • Mechanical Testing (10.2): This is the closest to "acceptance criteria" and "device performance" in this document, but it's for a physical device, not an AI. The testing was performed to "demonstrate equivalence to other cleared fixation devices and bone screws, or to meet physiologically relevant acceptance criteria, according to the standards below."

In summary, based on the provided text, I cannot answer the questions about AI/ML device performance, sample sizes, ground truth, or MRMC studies because the document pertains to a physical orthopedic implant, not an AI/ML diagnostic or therapeutic device.

However, I can provide information about the mechanical testing mentioned:

1. A table of acceptance criteria and the reported device performance (for mechanical testing of the physical implant):

Note: The document states "Testing was performed to demonstrate equivalence... or to meet physiologically relevant acceptance criteria" according to these standards. It does not provide specific numerical values for the acceptance criteria or the test results achieved by the BESPA Charcot System.

The following questions cannot be answered from the provided text as they relate to AI/ML device studies, which were not conducted for this physical implant:

2. Sample sized used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
4. Adjudication method
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
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

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