(150 days)
The T2 Tibial Nailing System is intended to provide temporary stabilization of various types of fractures, malunion and nonunion of the tibia. The nails are inserted using an opened or closed technique and can be statically, dynamically and compressed locked.
The T2 Tibial Nailing System is indicated for long bone fracture fixation, specifically tibial fracture fixation, which may include the following:
- Open and closed tibial fractures
- Pseudoarthodosis and correction osteotomy
- Pathologic fractures, impending pathologic fractures, and tumor resections
- Nonunion and malunion
This Traditional 510(k) submission is being supplied to the US FDA to include a modified targeter device and its components as Class II accessories as part of the Suprapatellar Instrument (SPI) System included in the T2 Tibial Nailing System, previously cleared under K003018 as the Titan Tibial Nail. The T2 Tibial Nailing System was determined substantially equivalent via 510/k) K003018 and included tibial nails and associated accessories such as locking screws. compression screws and end caps. There are three nail designs for the T2 Tibial Nail: Proximal. Standard, and Distal. These T2 tibial nails are fabricated from titanium and are available sterile. The T2 tibia targeter devices are intended to be used as part of the T2 Tibial Nailing System. In addition, this submission addresses a modification made to some components of the targeting device.
Here's an analysis of the provided text regarding the acceptance criteria and study for the T2 Tibial Nailing System:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Performance Standard | Reported Device Performance |
|---|---|---|
| Mechanical Performance | Stiffness Testing | Substantially equivalent to predicate device |
| Bending Load | Substantially equivalent to predicate device | |
| Transferable Torque of Connections | Substantially equivalent to predicate device | |
| Transferable Torque between Nail and Nail Adapter | Substantially equivalent to predicate device | |
| Impulse Test | Substantially equivalent to predicate device | |
| Drop Test | Substantially equivalent to predicate device | |
| Biocompatibility/Safety | (Not explicitly stated, assumed to be covered by predicate) | "The subject device is substantially equivalent in intended use, materials and performance characteristics to the predicate devices." |
| Functional/Clinical | Cadaveric Testing | Substantially equivalent to predicate device |
| Clinical Testing | Not required for this submission |
Explanation of the Acceptance Criteria and Performance:
The primary acceptance criterion used for the T2 Tibial Nailing System, particularly for the modified targeter device and its components, was substantial equivalence to legally marketed predicate devices. This means that the new device, when subjected to the same tests as the predicate, performed comparably and met the established standards. The reported device performance for all non-clinical tests (Stiffness, Bending Load, Torque, Impulse, Drop, Cadaveric) was that the subject device (the modified targeter and its components) was "substantially equivalent to the predicate device currently cleared for marketing."
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated in the provided text for any of the non-clinical tests. For cadaveric testing, a sample size would typically be mentioned, but it is not here.
- Data Provenance: The testing was "Non-clinical laboratory testing" and "Cadaveric Testing." There is no indication of country of origin for the data or whether it was retrospective or prospective, though non-clinical lab and cadaveric testing are inherently prospective in nature.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not applicable (N/A) as no clinical study requiring expert ground truth assessment was performed. The evaluation relied on non-clinical engineering and cadaveric testing, and a determination of substantial equivalence to a predicate device.
4. Adjudication Method for the Test Set
- This information is not applicable (N/A) as no clinical study requiring adjudication of expert opinions was performed.
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, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done.
- This device is a medical implant (intramedullary fixation rod, targeter) and does not relate to AI or human image interpretation. Therefore, this question is not applicable to the submitted information.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No, a standalone (algorithm only) performance study was not done.
- This device is a medical implant and mechanical accessory, not an algorithm or AI device. Therefore, this question is not applicable.
7. The Type of Ground Truth Used
- For the non-clinical tests, the "ground truth" was established by engineering standards and benchmarks derived from the performance of the predicate device. The goal was to demonstrate that the new device's performance (e.g., stiffness, bending load, torque) met or exceeded these established benchmarks, indicating substantial equivalence.
- For the cadaveric testing, the "ground truth" would be related to the anatomical and mechanical outcomes observed during the procedure, demonstrating the device's functional performance in a simulated surgical environment compared to the predicate.
8. The Sample Size for the Training Set
- This information is not applicable (N/A). This device is not an AI/ML algorithm that requires a training set. The evaluation was based on non-clinical testing of physical components.
9. How the Ground Truth for the Training Set Was Established
- This information is not applicable (N/A) as there was 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.