(28 days)
The Alphatec Femoral Trochanteric Nail (FTN) System is intended to treat stable and unstable fractures of the proximal femur including pertrochanteric fractures, intertrochanteric fractures, high subtrochanteric fractures and combinations of these fractures.
The Femoral Trochanteric Nail (FTN) System consists of an intramedullary nail, lag screw, distal static or dynamic screws. The proximal cap screw, optional and routers offered in diameters of 10, 12, or 14 mm. The diameter is 10 mm with distal diameters one for a lag screw and one for an anti-rotational proximal portion of the nail having the neck angle of 135°, 130° or 135°. All implants are manufactured from titanium alloy (Ti-6Al-4V ELI).
The provided text describes a 510(k) summary for the Femoral Trochanteric Nail (FTN) System. Here's an analysis of the requested information based on the text:
1. Table of Acceptance Criteria and Reported Device Performance
The submission states that the device is substantially equivalent to predicate devices. For mechanical performance, the acceptance criteria is implicitly set as being "at least comparable to, if not better than" the predicate devices.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Mechanical and dynamic performance comparable to or better than predicate devices. | "The test Mechanical and dyname the mechanical performance of the Alphatec FTN is at least comparable to, if not better than those of the predicate devices." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify sample sizes for mechanical testing or the provenance of the data (e.g., country of origin, retrospective or prospective). It simply states that "Mechanical and dynamic testing... was performed."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The study described is mechanical and dynamic testing, not a clinical study involving human experts establishing ground truth for patient outcomes.
4. Adjudication Method for the Test Set
This is not applicable as the described study is mechanical and dynamic testing, not a study requiring human adjudication for diagnostic accuracy or similar endpoints.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not conducted. The performance data presented relates to mechanical and dynamic testing of the device itself, not human reader performance with or without AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This question is not applicable as the device is a physical medical implant (Femoral Trochanteric Nail System), not an AI algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the mechanical and dynamic testing would refer to recognized engineering standards and specifications for intramedullary nails, and comparative data from the predicate devices. The testing aims to demonstrate the device's physical properties meet or exceed established benchmarks.
8. The Sample Size for the Training Set
This is not applicable. The device is a physical implant, not an AI algorithm that requires a training set. The mechanical testing itself doesn't involve a 'training set' in the machine learning sense.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the reasons stated above.
§ 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.