(71 days)
The AOS Retrograde Femoral Nail is intended for use in intramedullary fixation of fractures of the femur to include the following: Open and closed femoral fractures, Pseudoarthrosis and correction osteotomy, Pathologic fractures, impending pathologic fractures, and tumor resections, Supracondylar fractures, including those with severe comminution and intraarticular extension, ipsilateral femur fractures, bone lengthening, fractures proximal to a total knee arthroplasty or prosthesis, fractures distal to a hip joint, nonunions and malunions, and fractures resulting from osteoporosis.
The AOS Retrograde Femoral Nail System consists of Titanium Allov Rods. Screws and End Caps for femur fracture fixation.
The provided text describes a medical device, the "AOS Retrograde Femoral Nail System," and its submission for 510(k) clearance. However, it does not contain a study that proves the device meets acceptance criteria in the way typically required for AI/ML-based medical devices (i.e., with performance metrics like sensitivity, specificity, or F1-score derived from clinical data).
Instead, this document describes a traditional 510(k) submission for a mechanical medical device (an intramedullary fixation rod). The "acceptance criteria" here refer to demonstrating substantial equivalence to predicate devices through preclinical mechanical testing.
Therefore, I will interpret "acceptance criteria" as meeting the performance of predicate devices in mechanical testing and "study" as the preclinical mechanical testing performed.
Here's an analysis based on the provided text, modified to fit the context of a mechanical medical device:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Performance Goal) | Reported Device Performance |
|---|---|
| Substantially equivalent mechanical properties to predicate devices, based on ASTM F384. | The AOS Retrograde Femoral Nails and accessories are substantially equivalent to the predicates based on comparative mechanical testing per a test based on ASTM F384. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: The document does not specify the exact number of devices tested (sample size) for the preclinical mechanical testing. It mentions "The AOS Retrograde Femoral Nail System" was subjected to testing, implying a representative set.
- Data Provenance: The testing was preclinical (laboratory-based mechanical testing) and conducted by Advanced Orthopaedic Solutions, Inc., located in Torrance, CA, USA. This would be considered prospective, as the testing was done directly for this submission.
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 to preclinical mechanical testing. The "ground truth" for mechanical testing is established by standard engineering principles and test methods (e.g., ASTM F384), not by expert human interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable to preclinical mechanical testing. Adjudication methods are relevant for clinical studies where human interpretation or consensus is needed to establish ground truth or assess outcomes.
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, mechanical implant (intramedullary nail), not an AI/ML-based diagnostic or assistive software. Therefore, there are no "human readers" or "AI assistance" in the context of this device's performance evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The device is not an algorithm or AI system. Its performance is assessed as a standalone mechanical product in a laboratory setting. The "performance" described refers to its physical characteristics and durability.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" in this context is defined by the standardized mechanical test methods (ASTM F384). The performance of the predicate devices under these conditions serves as the reference for substantial equivalence.
8. The sample size for the training set
This question is not applicable. There is no AI/ML algorithm involved, so there is no "training set."
9. How the ground truth for the training set was established
This question is not applicable as there is no training set for an AI/ML algorithm.
§ 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.