(20 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 Nails are intramedullary fixation devices for the temporary fixation of various types of fractures of the tibia and are intended as load sharing devices which may be removed once the fracture has healed. The AOS Tibial Nail System consists of titanium intramedullary nails, proximal and distal locking screws, and end caps. This Special 510(k) proposes the addition of 12mm and 13mm diameter nails to the system.
The provided document is a 510(k) summary for the AOS 12mm and 13mm Tibial Nails, which is an intramedullary fixation device. This submission is a "Special 510(k)" which typically means that the changes to the device (the addition of new sizes) do not raise new questions of safety and effectiveness and can be demonstrated through reliance on predicate device data and design controls.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Equivalence to Predicate Device: The 12mm and 13mm Tibial Nails should have similar strength characteristics to the predicate nails (AOS Tibial Nail System, K070444). | The proposed nails "do not present a worst-case scenario with respect to strength characteristics" compared to the predicate nails. |
| Material Equivalence: Made of the same material as the predicate device (Ti-6Al-4V ELI, per ASTM F136). | The proposed nails are made of "the same material (Ti-6Al-4V ELI, per ASTM F136) as the predicate nails." |
| Indications for Use Equivalence: Same indications for use as the predicate device. | The proposed nails "have the same indications for use" as the predicate device. |
| Geometry and Design Similarity: Similar in geometry and design to the predicate device. | The proposed nails are "similar in geometry and design" to the predicate device. |
| Fundamental Scientific Technology Equivalence: Same fundamental scientific technology as the predicate device. | The proposed nails "have the same fundamental scientific technology" as the predicate device. |
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 states that "physical testing was deemed unnecessary" because the proposed nails were determined to be substantially equivalent in strength and geometry to the predicate nails. Therefore, there was no specific "test set" of device samples for physical performance testing against which acceptance criteria were directly measured in this submission. The evaluation was primarily based on a comparison to the predicate device's established performance and material specifications.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. As indicated above, no physical testing and thus no "ground truth" establishment by experts on device performance was conducted in this 510(k) submission. The "ground truth" for the predicate device would have been established during its original clearance, but that information is not provided here.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. No physical testing was conducted, so no adjudication method was used for a test set.
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
Not applicable. This is a medical device for orthopedic fixation (tibial nails), not an AI-assisted diagnostic or imaging device. Therefore, no MRMC study or evaluation of human reader improvement with AI assistance was performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" in this context is the established performance and safety of the predicate device (AOS Tibial Nail System, K070444). The submission relies on the concept of substantial equivalence, meaning that the new devices are considered safe and effective because they are sufficiently similar to a device already legally marketed. For the predicate device, ground truth would have been established through a combination of:
- Pre-clinical mechanical testing (e.g., fatigue, static strength)
- Material characterization
- Potentially clinical experience or literature (though not explicitly stated in this summary for the predicate)
8. The sample size for the training set
Not applicable. There is no "training set" in the context of this traditional medical device submission.
9. How the ground truth for the training set was established
Not applicable. There is no "training set" or explicit "ground truth" establishment for a training set in this submission. The assessment is based on comparison to an already cleared predicate device.
§ 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.