(56 days)
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
| Acceptance Criteria Category | Device Performance (Reported) |
|---|---|
| Initial Fixation Strength | Met the predetermined acceptance criterion and exceeded the predicate fixation strength. |
| Shear Testing (Interface Strength) | Met the predetermined acceptance criterion. |
| Fatigue Testing (Fatigue Resistance) | Met the predetermined acceptance criterion. |
| Wear Testing (Against Cartilage) | Met the predetermined acceptance criterion. The results showed significantly less wear of the BioPoly material when compared to the predicate material (CoCrMo) against cartilage. Additionally, the amount of cartilage wear was significantly less when articulating with BioPoly than when articulating with CoCrMo. |
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.
§ 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.