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The Biomet Phoenix™ Ankle Nail System and the Biomet® Ankle Arthrodesis Nail are indicated for tibiotalocalcaneal arthrodesis (fusion).

Specific indications include:

1. Avascular necrosis of the talus
2. Failed total ankle arthroplasty
3. Trauma (malunited tibial pilon fracture)
4. Severe deformity or instability as a result of talipes equinovarus, cerebral vascular accident, paralysis or other neuromuscular disease
5. Revision ankle arthrodesis
6. Neuroarthropathy
7. Rheumatoid arthritis
8. Osteoarthritis
9. Pseudoarthrosis
10. Post-traumatic arthrosis
11. Previously infected arthrosis
12. Charcot foot
13. Severe endstage degenerative arthritis
14. Severe defects after tumor resection
15. Pantalar arthrodesis

The Biomet Phoenix™ Ankle Nail System is an intramedullary nail system (nails and screws) comprised of Ti-6Al-4V and UHMWPE. The Biomet® Ankle Arthrodesis Nail System is an intramedullary nail system (nails and screws) comprised of T-6Al-4V.

This is a 510(k) premarket notification for a medical device (intramedullary fixation rod), not a study evaluating device performance against acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study design, ground truth, and expert involvement is not present in this document.

Here's what can be inferred from the provided text:

1. A table of acceptance criteria and the reported device performance

• This document is a 510(k) submission, indicating a review by the FDA for substantial equivalence to a predicate device, not a clinical study with predefined acceptance criteria and performance reporting in the typical sense.
• The letter states, "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent...". This implies that the device met the regulatory acceptance criterion of being substantially equivalent to a predicate device.
• No specific performance metrics are reported in this document.

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

• Not applicable. This is not a clinical study involving a test set of 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)

• Not applicable. The document refers to "input from surgeons who have reviewed the surgical technique" for contraindications, but this is not related to establishing ground truth for a test set in a clinical performance study.

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

• Not applicable.

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

• Not applicable. This document does not describe such a study and the device is an intramedullary fixation rod, not an AI diagnostic tool.

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

• Not applicable.

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

• Not applicable.

8. The sample size for the training set

• Not applicable.

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

• Not applicable.

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