Search Results

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.

Ask a specific question about this device

The BioPoly Lesser Toe Hemiarthroplasty implant is intended to replace the distal metatarsal surface in patients with degenerative and post-traumatic arthritis in the MTP joint in the presence of good bone stock and integrity of the phalangeal base, along with the following clinical conditions: hallux limitus, hallux rigidus, and an unstable or painful metatarsal/phalangeal (MTP) joint. The device is a single use implant intended to be used with bone cement.

The BioPoly Lesser Toe Hemiarthroplasty Implant is a hemiarthroplasty device specifically designed to restore the articular surface of the lesser metatarsal bones in patients with degenerative and post-traumatic arthritis.

The implant is comprised of BioPoly (UHMWPE/hyaluronic acid) direct compression molded onto a Ti-6A1-4V stem. A porous stem option is available, which additionally contains OsteoSync™ Ti, a porous titanium (CP Ti) material.

The provided text describes the 510(k) summary for the BioPoly Lesser Toe Hemiarthroplasty Implant, which is a medical device and not an AI/ML algorithm. Therefore, many of the requested categories related to AI/ML device studies (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable.

However, I can extract the acceptance criteria and performance data for the mechanical testing of the device.

Acceptance Criteria and Device Performance for BioPoly Lesser Toe Hemiarthroplasty Implant

Explanation for non-applicable AI/ML categories:

• Sample size used for the test set and the data provenance: Not applicable. This concerns mechanical testing of a physical implant, not data-driven evaluation of an AI/ML model.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical properties is established through standardized engineering tests, not expert consensus on medical images or clinical data.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for mechanical testing.
• 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. No human reader involvement or AI assistance is mentioned.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The ground truth for the performance claims is based on established engineering test standards and predefined acceptance criteria for mechanical properties (e.g., fixation strength, shear strength, fatigue resistance, wear characteristics).
• The sample size for the training set: Not applicable. This is not an AI/ML device that requires a training set.
• How the ground truth for the training set was established: Not applicable.

Ask a specific question about this device