Search Results

The BioPoly Great Toe Hemiarthroplasty implant is intended to replace the distal metatarsal surface of the great toe of patients with degenerative and post-traumatic arthritis in the presence of good bone stock 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 Great Toe Hemiarthroplasty Implant is a hemi-arthroplasty device specifically designed to restore the articular surface of the first metatarsal bone in patients with degenerative and post-traumatic arthritis.

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

The provided text describes a 510(k) premarket notification for the BioPoly Great Toe Hemiarthroplasty Implant. This document focuses on the substantial equivalence of the device to existing predicate devices, rather than an AI/ML medical device. Therefore, a table for "acceptance criteria and reported device performance" as typically understood for AI/ML devices (e.g., sensitivity, specificity, AUC) and other details about an AI/ML study are not applicable or extractable from this document.

However, I can extract the performance testing summaries for the device as described, which demonstrate its mechanical and material properties.

Performance Testing Summary for BioPoly Great Toe Hemiarthroplasty Implant (Not an AI/ML device)

Non-Applicable Sections for this Device (as it is not an AI/ML medical device):

The following information is specifically requested for Artificial Intelligence/Machine Learning (AI/ML) medical devices and is not applicable to the BioPoly Great Toe Hemiarthroplasty Implant, which is a physical implant, not a software device that relies on AI/ML algorithms for its function. Therefore, the document does not contain information on these points:

1. Sample size used for the test set and the data provenance: Not applicable.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
3. Adjudication method for the test set: Not applicable.
4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
6. The type of ground truth used: Not applicable.
7. The sample size for the training set: Not applicable.
8. How the ground truth for the training set was established: Not applicable.

Ask a specific question about this device

Hemi arthroplasty implant for first metatarsophalangeal joint for use in the treatment of patients with degenerative and post-traumatic arthritis in the first metatarsal joint in the presence of good bone stock along with the following clinical conditions; hallux valgus or 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 CAP™ Great Toe Resurfacinq Hemi-arthroplasty implant is a cobalt chrome alloy, 2-piece implant to supplement first metatarsal phalangeal joint arthroplasty. The implant is designed to provide a smooth surface for the first metatarsophalangeal joint as a the treatment of patients with degenerative and post-traumatic arthritis in the first metatarsal joint in the presence of good bone stock along with the following clinical conditions; hallux valqus or 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 CAP™ Great Toe Resurfacing Hemi-arthroplasty implant consists of two components, a taper post component and an articular component, that mate together via a taper interlock to provide stable and immobile fixation of the implant and stress bearing contact at the bone/prosthetic interface.

The first implant component is a Taper Post manufactured of a Ti-6AI-4V ELI alloy per ASTM F136. The Taper Post has a tapering distal tip, a full-length cannulation, and a proximal female taper bore.

The second implant is an articular component manufactured of a Cobalt-Chromium-Molybdenum alloy per ASTM F799 and ASTM F1537. The articular component has a bone contact surface that is coated with a CP Titanium coating and a polished articular bearing surface.

The provided text describes the safety and effectiveness of the CAP™ Great Toe Resurfacing Hemi-arthroplasty implant. It is a medical device, and the information presented here pertains to its mechanical performance and substantial equivalence to previously marketed devices, not to the performance of a software or AI/ML-based device. Therefore, many of the requested categories for AI/ML device studies are not applicable.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• The document describes non-clinical mechanical testing of the device components. It does not mention a "test set" in the context of patient data or clinical data.
• The sample sizes for the mechanical tests are not explicitly stated in the provided text.
• Data provenance is not applicable as this relates to mechanical testing, not patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• This is not applicable as the study involves mechanical testing of an implant, not a diagnostic or prognostic device requiring expert interpretation of data. The "ground truth" here is the physical and mechanical properties of the device as measured against established engineering standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• This is not applicable since the testing is mechanical and does not involve adjudication of expert opinions.

5. 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

• This is not applicable as the device is an orthopedic implant, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• This is not applicable as the device is a physical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• The "ground truth" for this device, in the context of the described testing, is adherence to established industry standards and guidelines for mechanical properties and material performance (e.g., ASTM F1814, ASTM F897, ISO 7206-9, and relevant CDRH Guidance Documents for implants).

8. The sample size for the training set

• This is not applicable; there is no "training set" as this is a physical medical device, not an AI/ML algorithm.

9. How the ground truth for the training set was established

• This is not applicable.

Ask a specific question about this device