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The Accu-Joint Hemi Implant, a hemi-arthroplasty metatarsal head or phalangeal base implant for the metatarsophalangeal (MTP) joint, is indicated for use in the treatment of patients with degenerative and post-traumatic arthritis in the MTP joint in the presence of good bone stock, along with the following clinical conditions: Hallux Valgus. Hallux Rigidus, and an unstable or painful MTP ioint. The Accu-Joint Hemi Implant is intended to be used with bone cement.

The metatarsal head and phalangeal base may not be used together at the same joint.

The Accu-Joint Hemi Implant consists of a hemi-arthroplasty metatarsal head or phalangeal base intended to resurface the metatarsophalangeal joint. These components are used for hemi-arthroplasty and are not used together to create a joint. The Accu-Joint Hemi Implant is designed with a threaded shaft for intramedullary insertion. The implant has a driver pocket on the articular surface axially aligned with the threaded shaft. To accommodate a wide range of patient anatomies, various sizes are offered.

The purpose of this submission is to offer a sterile packaged option of the Accu-Joint Hemi Implant.

The provided text is a 510(k) Summary for the Accu-Joint Hemi Implant, focusing on an administrative change regarding the sterility of the device (from non-sterile to sterile packaged). It does not describe a study involving an AI/software device or a comparative effectiveness study with human readers.

Therefore, I cannot extract the information requested in your prompt regarding acceptance criteria, performance metrics, sample sizes for test/training sets, expert qualifications, or multi-reader multi-case studies, as these concepts are not applicable to the content of this document.

The document discusses:

• Device: Accu-Joint Hemi Implant (a toe joint prosthesis).
• Purpose of current submission (K240268): To offer a sterile packaged option of the Accu-Joint Hemi Implant, which was previously cleared as non-sterile (under K200951).
• Key finding: The device is substantially equivalent to its predicate (K200951, the non-sterile version of the same implant) because the change in sterility status does not affect its safety and effectiveness.
• Performance Data discussed: This pertains to validation of the sterilization process and sterile packaging, not the performance of an AI algorithm or human readers.
  • Sterilization Validation: Per ISO 11135.
  • Sterile Packaging Validation: Per ISO 11607-2, ASTM D4169, ASTM F188, and ASTM F1929.
  • Mechanical Testing: Screw testing per ASTM F543 and dynamic bending testing were previously performed for the predicate device (K200951) and were not repeated for this submission as the sterilization change does not affect mechanical performance.

In summary, this document is about a medical implant's sterility change, not an AI or software device. Thus, the specific questions posed about AI device acceptance criteria and study methodologies are not applicable here.

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The Accu-Joint Hemi Implant, a hemi-arthroplasty metatarsal head or phalangeal base implant for the metatarsophalangeal (MTP) joint, is indicated for use in the treatment of patients with degenerative and post-traumatic arthritis in the MTP joint in the presence of good bone stock, along with the following clinical conditions: Hallux Limitus, Hallux Valgus, Hallux Rigidus, and an unstable or painful MTP joint. The Accu-Joint Hemi Implant is intended to be used with bone cement.

The metatarsal head and phalangeal base may not be used together at the same joint.

The Accu-Joint Hemi Implant consists of a hemi-arthroplasty metatarsal head or phalangeal base intended to resurface the metatarsophalangeal joint. These components are used for hemiarthroplasty and are not used together to create a joint Hemi Implant is designed with a threaded shaft for intramedullary insertion. The implant has a driver pocket on the articular surface axially aligned with the threaded shaft. To accommodate a wide range of patient anatomies, various sizes are offered.

The provided text describes a 510(k) premarket notification for a medical device called the "Accu-Joint Hemi Implant," which is a toe joint phalangeal prosthesis. The document details the device's characteristics, indications for use, and performance data from non-clinical testing.

However, the provided text does not contain any information regarding acceptance criteria or a study that proves the device meets those criteria, as typically understood for an AI/ML-based device validation (which would involve metrics like sensitivity, specificity, F1-scores, ROC curves, etc.). The performance data mentioned refers to mechanical testing (static torsion, driving torque, static pullout, dynamic bending) of the physical implant itself, comparing its physical strength to predicate devices. There is no mention of "acceptance criteria" related to diagnostic or evaluative performance, nor details about a "study" involving a test set, expert ground truth, or MRMC studies.

Therefore, I cannot fulfill the request as the necessary information (acceptance criteria for diagnostic performance, test set details, ground truth establishment, expert involvement, and statistical findings of an AI/ML study) is absent from the provided text.

The text focuses on establishing substantial equivalence based on:

• Physical characteristics (materials, insertion method, size, hole)
• Indications for Use
• Mechanical strength testing (demonstrating it's sufficient for intended use and equivalent to predicates)

It's a clearance for a physical orthopedic implant, not an AI/ML diagnostic or assistive device, which explains the lack of the requested AI/ML specific validation information.

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