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The BioPoly Radial Head Implant is indicated for:

• · Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain. crepitation, and decreased motion at the radio-humeral and or proximal radio-ulnar joint with:
  • o joint destruction and/or subluxation visible on x-ray; and/or
  • o resistance to conservative treatment
• · Primary replacement after fracture of the radial head
• · Symptomatic sequelae after radial head resection
• · Revision following failed radial head arthroplasty

The BioPoly Radial Head Implant is a hemiarthroplasty device designed to restore the articular surface and spacing of the proximal head of the radius in patients following fracture resection and/or degenerative disability The implant is supplied with head diameters of 20mm, 23mm, and 26mm; and stem diameters of 6mm, 7mm, 8mm, +3mm, and +6mm height offsets for the radius in patients following fracture, resection, and/or degenerative disability.

This document is a 510(k) Premarket Notification from the FDA regarding the BioPoly Radial Head Implant. It certifies the device's substantial equivalence to previously marketed predicate devices. The document outlines the device's intended use and provides a summary of non-clinical tests conducted.

However, the provided text does not contain any information about a study proving the device meets acceptance criteria through human-in-the-loop performance, nor does it refer to an AI/ML powered device. The acceptance criteria discussed are for non-clinical, mechanical, and material properties of the implant itself, not related to an AI's performance or a clinical study that would involve the elements requested in the prompt (e.g., sample size for test set, expert ground truth, MRMC study, standalone performance of an algorithm).

Therefore, I cannot fulfill the request as it pertains to AI/ML device performance and related clinical study design (sample size, expert adjudication, MRMC, etc.). The document focuses on the mechanical and material aspects of a physical implant and its substantial equivalence to predicate devices, which is a different regulatory pathway than for AI/ML-powered medical devices.

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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.

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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.

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