(29 days)
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.
§ 888.3730 Toe joint phalangeal (hemi-toe) polymer prosthesis.
(a)
Identification. A toe joint phalangeal (hemi-toe) polymer prosthesis is a device made of silicone elastomer intended to be implanted to replace the base of the proximal phalanx of the toe.(b)
Classification. Class II.