(119 days)
The AOS Tibial Nail System is intended to provide temporary stabilization of various types of fractures, malunions and nonunions of the tibia. The AOS Tibial Nail System is indicated for long bone fracture fixation of tibial fractures, which may include the following: transverse, oblique, spiral, segmental and comminuted fractures; fractures with bone loss and bone transport; open and closed fractures, pathologic fractures; corrective osteotomies; pseudarthrosis of the tibial shaft; nonunions, malunions, metaphyseal and epiphyseal fractures.
The AOS Tibial Nail is an intramedullary fixation device for the temporary fixation of fractures of the tibia and is intended as a load sharing device which may be removed once the fracture has healed. The AOS Tibial Nail is a titanium intramedullary nail system consisting of an intramedullary nail, proximal and distal locking screws and end caps. The Tibial Nail is a cannulated nail with a 10° proximal bend and a 3° distal bend. The proximal diameter of the nail is 11.5mm and it is produced in 8mm, 9mm, 10mm and 11mm distal diameters. The proximal end of the nail has two holes to accept the 5,0 mm cortical screw and one slot which also accept the 5.0mm cortical screw. The proximal end of the nail is threaded to accept an end cap. The distal end of the nail contains three cross locking holes which accept a 5.0mm cortical screw for diameter of 9mm, 10mm and 11mm and a 4.2mm screw for the 8mm diameter nail.
The provided document is a 510(k) Summary for the AOS Tibial Nail, an intramedullary fixation rod. This type of regulatory submission typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with specific acceptance criteria and performance metrics for a novel medical AI device.
Therefore, the information required for a medical AI device, such as acceptance criteria, reported performance, sample sizes for test and training sets, expert qualifications, ground truth establishment, and MRMC studies, is not present in this document.
The document states: "Mechanical testing has shown that the AOS Tibial Nail is substantially equivalent to the predicate device." This indicates that the "study" conducted was mechanical testing to compare the new device to existing, legally marketed devices, rather than a clinical study evaluating diagnostic performance.
Here's how to address each point based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics for a diagnostic device. The acceptance criterion is "substantial equivalence" to predicate devices, supported by mechanical testing.
- Reported Device Performance: The document only states that "Mechanical testing has shown that the AOS Tibial Nail is substantially equivalent to the predicate device." No specific performance numbers (e.g., accuracy, sensitivity, specificity, or mechanical strength values) are reported in this summary.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. This is a mechanical device, and the "test set" would refer to the physical nails subjected to mechanical testing. The document does not specify the number of nails tested or the origin of the data beyond "Mechanical testing."
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)
- Not applicable. Ground truth as typically understood for AI or diagnostic devices (e.g., expert consensus on images, pathology results) is not relevant for demonstrating substantial equivalence of a mechanical orthopedic device. The "ground truth" here would be the physical properties and performance of the predicate devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This concept is for diagnostic interpretation, not mechanical device comparison.
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
- No. This is completely irrelevant for a mechanical fixation device. An MRMC study is for evaluating diagnostic performance, typically of an AI system, with human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is a mechanical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable in the AI/diagnostic sense. The "ground truth" for demonstrating substantial equivalence of a mechanical device typically involves engineering specifications, material properties, and performance benchmarks of legally marketed predicate devices, against which the new device undergoes mechanical testing.
8. The sample size for the training set
- Not applicable. This is a mechanical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established
- Not applicable.
§ 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.