(153 days)
The Orthofix Ankle Hindfoot Nailing System is intended to facilitate 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
- Post-traumatic arthrosis
- Previously infected arthrosis
- Charcot foot
- Severe endstage degenerative arthritis
- Severe defects after tumor resection
- Pantalar arthrodesis
The Orthofix Ankle Hindfoot Nailing System comprises a variety of implantable intramedullary nails with respective locking end caps and locking screws manufactured from titanium alloy (Ti6Al4V) which are intended to facilitate tibiotalocalcaneal arthrodesis (fusion). The system also includes instrumentation required for implantation and explantation of the implants.
Here's an analysis of the provided text regarding the Orthofix Ankle Hindfoot Nailing System, focusing on the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (from predicate device/standard) | Reported Device Performance (Orthofix Ankle Hindfoot Nailing System) |
|---|---|
| Mechanical properties consistent with ASTM F1264-03 for intramedullary fixation devices | Meets ASTM F1264-03 for Static Four-Point Bend, Static Torsion, and Bending Fatigue testing. |
| Substantial equivalence to predicate device (Biomet Phoenix Ankle Arthrodesis Nail System – K091976) in terms of general design dimensions, intended use, materials, and performance characteristics. | The study concluded that the Orthofix Ankle Hindfoot Nailing System is substantially equivalent to the predicate device based on similarities in design, materials, intended use, indications for use, and the results of mechanical testing. |
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 refer to a "test set" in the context of patient data. Therefore, questions about patient sample size and data provenance (country, retrospective/prospective) are not applicable to the type of study conducted here.
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 question is not applicable. The ground truth for mechanical testing is established by engineering standards (ASTM F1264-03) and the physical properties of the materials and device. Expert consensus related to clinical interpretation or diagnosis is not relevant for this type of submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable, as the study involves mechanical testing against a standard, not the interpretation of clinical data by multiple experts.
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 question is not applicable. The device is a physical intramedullary nailing system, not an AI or imaging diagnostic tool that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not applicable as the device is a physical medical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth used for this submission is based on:
- Engineering standards: Specifically, ASTM F1264-03 "Standard Specification and Test Methods for Intramedullary Fixation Devices."
- Performance of a legally marketed predicate device: The Biomet Phoenix Ankle Arthrodesis Nail System (K091976) serves as the benchmark for substantial equivalence.
8. The sample size for the training set
This question is not applicable. There is no "training set" in the context of mechanical testing of a physical device. Design and manufacturing processes are iterative but do not involve "training data" in the AI sense.
9. How the ground truth for the training set was established
This question is not applicable for the reasons stated above (no training set).
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.