(187 days)
Hemi-arthroplasty implant for the metatarsophalangeal joint for use in the treatment of patients with degenerative and post-traumatic arthritis in the metatarsal joint in the presence of good bone stock along with the following clinical conditions: hallux valgus or 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 or without bone cement.
The Arthrosurface MTP implant incorporates an articular resurfacing component and a taper post component that mate together via a morse taper interlock to provide stable and immobile fixation of the implant and stress bearing contact at the bone/prosthetic interface.
Per K132496, the MTP can be used in conjunction with the Arthrosurface Proximal Phalanx Implant as a Total Toe option. K132496 also cleared the most recent version of the mating articular component.
Fixation components are being included in the system that contain an additional ring of material intended to improve stabilization in a first metatarsal that presents with a distal bone void. The articulating component and taper configuration are unchanged. The phalangeal implant is unchanged.
I am sorry, but the provided text does not contain information about the acceptance criteria or a study that proves the device meets specific acceptance criteria in the manner you've outlined for an AI/algorithm-based medical device.
The document is a 510(k) premarket notification for the BOSS Toe Fixation System, which is a physical implant (a hemi-arthroplasty implant for the metatarsophalangeal joint).
Therefore, I cannot extract the following information from the provided text:
- A table of acceptance criteria and the reported device performance (for an algorithm)
- Sample size used for the test set and the data provenance (for an algorithm)
- Number of experts used to establish the ground truth for the test set and their qualifications (for an algorithm)
- Adjudication method (for an algorithm's ground truth)
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance
- If a standalone performance study was done (for an algorithm)
- The type of ground truth used (for an algorithm)
- The sample size for the training set (for an algorithm)
- How the ground truth for the training set was established (for an algorithm)
The document focuses on demonstrating substantial equivalence to an existing predicate device based on its indications for use, operating principle, materials, instrumentation, packaging, sterilization, and non-clinical tests (mechanical strength, cadaveric evaluation, bacterial endotoxins test). These tests are standard for a physical implant, not for an AI/algorithm.
§ 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.