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The T2 Alpha Femur Retrograde Nailing System is intended for temporary stabilization of bone segments or fragments until bone consolidation has been achieved.

The T2 Alpha Femur Antegrade GT/PF Nailing System is intended for temporary stabilization of bone segments or fragments until bone consolidation has been achieved.

The T2 Tibial Locking Nail is intended to provide temporary stabilization of various types of fractures, malunions 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 Femoral Nail System is intended to provide strong and stable internal fixation with minimal soft tissue irritation. This device is utilized as an aid to healing, not as a substitute for normal intact bone and tissue.

The T2 Supracondylar Nail System is intended to provide strong and stable internal fixation with minimal soft tissue irritation. This device is utilized as an aid to healing, not as a substitute for normal intact bone and tissue.

This Traditional 510(k) submission is being supplied to the U.S. FDA to gain clearance to market the T2 Alpha Femur Retrograde Nailing System and update the Indications for Use for T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Tibial Nailing System, T2 Femoral Nail System, and T2 Supracondylar Nail System to include the compatibility of components with the T2 Alpha Femur Retrograde Nailing System.

This submission encompasses multiple systems (T2 Alpha Femur Retrograde Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Tibial Nailing System, T2 Femoral Nail System, and T2 Supracondylar Nail System) that have similar intended use and will be used together during the surgical procedure.

The T2 Alpha Femur Retrograde Nailing System is a fracture fixation system and includes sterile implants (intramedullary nails in various diameter and sizes, compression screw, and end caps) as well as non-sterile instruments (targeting devices). The femoral nails, compression screw and end caps are made of titanium alloy (Ti6A14V ELI) as per ASTM F136.

Additionally, the T2 Alpha Femur Retrograde Nailing System will be used with the existing locking screws most recently cleared in K200880 (Titan Tibial Nailing System), the locking screws and advanced locking screws of IMN Screws System (K191271), the condyle screws and nuts most recently cleared in K200880 (T2 Femoral Nail System), the Compression Screw Femur most recently cleared in K191271 (T2 Alpha Antegrade GT/PF Nailing System), and the end caps most recently cleared in K200880 (T2 Supracondylar Nail System), The T2 Alpha Femur Retrograde Nailing System is intended for use with IMN Screws System and IMN Instruments System.

The T2 Alpha Femur Antegrade GT/PF Nailing System most recently cleared in K191271 is a fracture fixation system and includes sterile implants (femoral nails in various diameter and sizes, compression screw femur, set screws and end caps) as well as non-sterile instruments (targeting devices).

The sterile implants (Femoral Nail GT, Femoral Nail PF, Compression Screw Femur, and End Cap GT/PF, Set Screws) are made of titanium alloy (Ti6A14V ELI) per ASTM F136. The set screws are manufactured from titanium alloy (Ti6A14V ELI) per ASTM F136 and PEEK. The targeting devices are manufactured from stainless steel, PEEK unreinforced as well as PEEK with 30% and 50% carbon fibers.

The T2 Alpha Femur Antegrade GT/PF Nailing System will be used with the locking screws most recently cleared in K200880 (Titan Tibial Nail) that have subsequently also received clearance for use in locking femoral nailing systems (K200880), the Lag Screw Recon of T2 Recon System (K200880), the End Cap Lower Extremity and the Nail Holding Screw Tibia / Femur PF of T2 Alpha Tibia Nailing System (K191271), the locking screws and advanced locking screws of IMN Screws System (K191271), the distal targeting device femur antegrade of IMN Instruments System (K191271) as well as the surgical instruments of IMN Instruments System and T2 Instruments System (510(k) exempt devices).

The T2 Tibial Locking Nail is a cylindrical tube manufactured from titanium alloy and slightly bowed to accommodate the shape of the tibia. Locking screws, compression screws and various end caps are manufactured from titanium alloy and are used with the nails. The T2 Tibial Locking Nail is available in two versions, each differing from the other only in diameter, length and number and orientation of screw holes.

The T2 Femoral Nail is a cylindrical, cannulated titanium allow tube, slightly bowed to accommodate the shape of the femur. The T2 Femoral Nail may be inserted into the femoral canal using either a retrograde or antegrade surgical approach.

The T2 Supracondylar Nails are retrograde nails with a one-piece round profiled shaft design. The nails are cannulated and have a closed-section design with proximal rounded end. The T2 Supracondylar Nail is available in two versions: Short and Long. The T2 Supracondylar nails are available in lengths from 170 mm to 440 mm and in diameters from 9 mm to 14 mm. The T2 Supracondylar Nail System offers nails in varying lengths, a combination of locking screws, condyle screws, nuts and end caps.

This is a 510(k) premarket notification for multiple intramedullary nailing systems, not a study describing the acceptance criteria and performance of a device, especially not one using AI or requiring human-in-the-loop performance. Therefore, most of the requested information regarding acceptance criteria for an AI/device, sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance simply does not apply to this document.

The document primarily focuses on establishing substantial equivalence to previously cleared predicate devices for various bone fixation systems. The "performance data" section refers to mechanical and material testing, not human performance or AI performance.

Here's an attempt to answer the relevant questions based only on the provided text, while acknowledging that many questions are not applicable to this type of submission.

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present acceptance criteria in a table format with corresponding device performance values as would be typical for clinical or AI-based performance studies. Instead, it states that "Comparative mechanical testing to the predicate systems demonstrated substantial equivalence." and "Mechanical testing demonstrated that the T2 Alpha Femur Retrograde Nailing System is equivalent to the predicate devices (K200880, K101622)."

The specific performance tests conducted were:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This document describes a premarket notification for a medical device (intramedullary nailing system), not an AI/software device that would typically have a "test set" of patient data. The performance data provided is mechanical and material testing. Therefore, information about patient data sample size, country of origin, or retrospective/prospective nature is not applicable. The sample sizes for the mechanical tests would be specific to each test protocol but are not detailed in this summary.

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. Manual bone fixation devices do not typically involve experts establishing "ground truth" for patient data in the same way as an AI diagnostic device. The evaluation of these devices is primarily through engineering, mechanical, and material testing against established standards and predicate devices.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This question is not applicable. There is no "test set" of patient data or clinical observations requiring adjudication for this type of device submission.

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 document is for mechanical bone fixation devices and does not involve AI or human "readers" (e.g., radiologists, pathologists). No MRMC study or AI assistance is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This question is not applicable. This submission is for physical medical devices (intramedullary nailing systems), not an algorithm or AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For mechanical testing, the "ground truth" refers to established engineering standards (e.g., ASTM F1264, F2052, F2213, F2182, F2119) and the performance characteristics of the predicate devices. The device's performance is compared against these benchmarks to demonstrate substantial equivalence.

8. The sample size for the training set

This question is not applicable. This is not an AI/machine learning device, so there is no training set.

9. How the ground truth for the training set was established

This question is not applicable. This is not an AI/machine learning device, so there is no training set or ground truth establishment method for one.

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