(24 days)
The subject and predicate devices are indicated for long bone fracture fixation, specifically femoral fracture fixation, which may include the following:
- Open and closed femoral fractures
- Pseudoarthrosis and correction osteotomy
- Pathologic fractures, impending pathologic fractures, and tumor resections
- Ipsilateral femur fractures
- Fractures proximal to a total knee arthroplasty
- Nonunions and malunions
The T2 (Greater Trochanter Nail) is a cylindrical, cannulated titanium alloy tube, slightly bowed to accommodate the shape of the femur. The T2 GTN may be inserted into the femoral canal using either a retrograde or antegrade surgical approach. The subject T2 GTN, like the predicate Osteo IC R/A Femoral Nail System known as the T2 Nail System, is a fracture fixation device comprised of femoral nails and the related locking screws, compression screws, and end caps. The subject and predicate devices are intended to assist with internal fracture fixation with minimal soft tissue irriation. This device is utilized as an aid to healing, not as a subsistute for normal intact bone and tissue.
This is a 510(k) premarket notification for a medical device (T2 Greater Trochanter Nail), not an AI/ML device. Therefore, the requested information about acceptance criteria, study details, and AI-specific metrics (like MRMC studies, standalone performance, training data, and ground truth establishment) is not applicable.
The document describes a submission for a modified intramedullary nail and focuses on demonstrating substantial equivalence to a predicate device. The "study" mentioned refers to mechanical testing to ensure the modified device has comparable properties to the predicate, not a clinical study involving human or AI performance.
Here's a breakdown of why each requested point cannot be answered with the provided text, along with what information is provided:
1. A table of acceptance criteria and the reported device performance
- Applicability: Not applicable for an AI/ML device.
- Information Provided: The document states, "Testing demonstrated comparable mechanical properties of the subject T2 GTN Femoral Nail System to the predicate T2 Nail in K010801." The types of tests conducted are listed: Functionality test, influence of cannulated compression screws on Fatigue Strength, 4-Point Bending Test, Dynamic Testing of Nail Strength, End Cap Testing, Dynamic Fatigue Strength of T2 GTN Nails, End Product Test of fully threaded screw and shaft screw, and Screw Insertion Test. Specific numerical acceptance criteria and performance data are not detailed 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)
- Applicability: Not applicable for an AI/ML device. This refers to mechanical testing of the device itself, not data used for an algorithm.
- Information Provided: No sample sizes for mechanical testing are provided in this summary. Data provenance for such tests (e.g., origin country) is generally irrelevant.
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)
- Applicability: Not applicable. There is no "ground truth" to be established by experts for a mechanical device in this context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Applicability: Not applicable. No adjudication is relevant for mechanical testing.
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
- Applicability: Not applicable. This device is a physical medical implant, not an AI system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Applicability: Not applicable. This device is a physical medical implant, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Applicability: Not applicable. No "ground truth" in this sense is involved. The "truth" for mechanical testing is adherence to engineering standards and comparison against the predicate device's established mechanical properties.
8. The sample size for the training set
- Applicability: Not applicable. There is no AI training set for this device.
9. How the ground truth for the training set was established
- Applicability: Not applicable. There is no AI training set for this device.
Summary of Relevant Information from the Provided Text:
- Device: T2 Greater Trochanter Nail (GTN)
- Modification: The nail entry point is in the greater trochanter for T2 GTN, whereas for the predicate T2 Femoral Nail A/R, it is in the piriformis fossa.
- Predicate Device: T2 Femoral Nail A/R (cleared under K010801)
- Demonstration of Equivalence: "Testing demonstrated comparable mechanical properties of the subject T2 GTN Femoral Nail System to the predicate T2 Nail in K010801."
- Tests Conducted: Functionality test, influence of cannulated compression screws on Fatigue Strength, 4-Point Bending Test, Dynamic Testing of Nail Strength, End Cap Testing, Dynamic Fatigue Strength of T2 GTN Nails, End Product Test of fully threaded screw and shaft screw, Screw Insertion Test.
§ 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.