Search Results
Found 1 results
510(k) Data Aggregation
(57 days)
BIOMET PHOENIX ANKLE NAIL SYSTEM
The Biomet Phoenix™ Ankle Nail System is indicated for tibiotalocalcaneal arthrodesis (fusion).
Specific indications include:
- Avascular necrosis of the talus
- Failed total ankle arthroplasty
- Trauma (malunited tibial pilon fracture)
- Severe deformity or instability as a result of talipes equinovarus, cerebral vascular accident, paralysis or other neuromuscular disease
- Revision ankle arthrodesis
- Neuroarthropathy
- Rheumatoid arthritis
- Osteoarthritis
- Pseudoarthrosis
The Biomet Phoenix™ Nail System is an intramedullary nail system comprised of Ti-6Al-4V and UHMWPE.
This document describes the Biomet Phoenix™ Ankle Nail System, an intramedullary nail system for tibiotalocalcaneal arthrodesis (ankle fusion). The 510(k) summary indicates that the device's substantial equivalence was established through non-clinical testing.
Here's an analysis of the provided information, focusing on acceptance criteria and the study:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Performance (Non-Clinical Testing): The device should be functional within its intended use. | Engineering analyses comparing the Biomet Phoenix™ Ankle Nail System to a predicate device were conducted. The results indicated that the Biomet Phoenix™ Ankle Nail System was functional within its intended use. |
| Technological Characteristics: The materials, design, and sizing of the device should be similar or identical to predicate devices. | The technological characteristics (materials, design, sizing) of the Biomet Phoenix™ Ankle Nail System are similar or identical to the predicate devices. |
2. Sample Size Used for the Test Set and the Data Provenance:
- Sample Size: Not applicable. The primary evidence for substantial equivalence came from engineering analyses and comparisons to predicate devices, not studies with a "test set" of patient data.
- Data Provenance: Not applicable for patient data. The non-clinical testing involved engineering analyses.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
- Not applicable. No clinical test set requiring expert ground truth establishment was conducted. The evaluation was based on engineering principles and comparison to predicate devices.
4. Adjudication Method for the Test Set:
- Not applicable. There was no clinical test set requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No MRMC comparative effectiveness study was done. The submission explicitly states: "Clinical Testing: None provided as a basis for substantial equivalence."
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance):
- Not applicable. This device is a medical implant (intramedullary nail), not an AI algorithm or diagnostic tool. Its performance is related to its mechanical properties and design, not an algorithm's output.
7. Type of Ground Truth Used:
- Engineering Principles and Predicate Device Characteristics: The "ground truth" for demonstrating the device's functionality and substantial equivalence was based on established engineering principles applied during the non-clinical tests and direct comparison of the device's characteristics (materials, design, sizing) to those of legally marketed predicate devices.
8. Sample Size for the Training Set:
- Not applicable. There was no training set in the context of an AI/ML algorithm. The evaluation was based on non-clinical testing and comparison to predicate devices.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. There was no training set. The "ground truth" for the non-clinical testing would have been derived from established biomechanical testing standards and expected performance based on the predicate devices.
Ask a specific question about this device
Page 1 of 1