(78 days)
The AIM® Titanium Supracondylar Nail is intended for use in intramedullary fixation of supracondylar fractures of the femur, including those with severe comminution and intraarticular involvement, osteoporosis, nonunions, malunions, pathologic, and fractures proximal to total knee arthroplasty or prosthesis. In addition, the AIM® Titanium Supracondylar Nail is indicated for use in tibiotalocalcaneal fusions and treatment of trauma to the hindfoot and distal tibia. Indications include: Revision after failed ankle arthrodesis with subtalar involvement; Absent talus (Tibio Calcaneal Arthrodesis); Post traumatic/primary arthrosis involving both ankle and subtalar joints; A rheumatoid hindfoot; Avascular necrosis of the talus; Previously infected arthrosis, second degree; Failed total arthroplasty.
The AIM® Titanium Supracondylar Nail is a straight, cannulated intramedullary nail available in diameters of 10 and 12mm and lengths of 15, 20, 25, and 30cm. Holes in the nail allow for proximal and distal locking. The distal locking screws have a diameter of 6.5mm. The proximal locking screws have a diameter of 4.5mm. An endcap is also provided. The endcap threads into the distal end of the nail to prevent bony ingrowth and facilitate attachment of removal instrumentation. The AIM® Titanium Supracondylar Nail, proximal and distal locking screws, and endcap are all manufactured from Ti-6A1-4V alloy.
Based on the provided text, the acceptance criteria and the study that proves the device meets the acceptance criteria are described as follows:
1. Acceptance Criteria and Reported Device Performance:
The document focuses on demonstrating substantial equivalence based on mechanical properties. The acceptance criterion is that the device should be "as stiff or stiffer" compared to a common method of fixation.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| As stiff or stiffer than crossed lag screws | Tested as stiff or stiffer in comparison to the common method of fixation, crossed lag screws. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the sample size used for the mechanical "test set." It is a mechanical performance study, not a clinical trial with patient data, so "data provenance" in terms of country of origin or retrospective/prospective is not applicable in the way it would be for AI/clinical studies.
3. Number of Experts and Qualifications:
Not applicable. This was a mechanical engineering test, not a study requiring expert clinical assessment for ground truth.
4. Adjudication Method for the Test Set:
Not applicable. This was a mechanical engineering test.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No. This is a 510(k) submission for a medical implant (intramedullary nail) and involves a mechanical performance study, not an AI device. Therefore, an MRMC comparative effectiveness study comparing human readers with and without AI assistance is not relevant.
6. Standalone Algorithm Performance:
No. This submission is for a physical medical device, not an algorithm or AI.
7. Type of Ground Truth Used:
The "ground truth" in this context is the mechanical stiffness of the comparative fixation method (crossed lag screws). This would be established through established biomechanical testing protocols and engineering principles.
8. Sample Size for the Training Set:
Not applicable. This is a mechanical performance test of a physical device, not an AI model that requires a "training set."
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for a mechanical device. The "ground truth" for the performance comparison (stiffness of crossed lag screws) would be established through biomechanical testing of those screws according to accepted engineering standards.
§ 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.