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The indications for use of these internal fixation devices include:

• Fixation of subtrochanteric, intertrochanteric, ipsilateral neck/shaft, comminuted proximal femoral shaft fractures
• Femoral fixation required as a result of pathological disease
• Temporary stabilization of fractures of the femoral shaft ranging from the femoral neck to the supracondylar regions of the femur
• 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
• Fractures involving osteopenic and osteoporotic bone

The indications for use of this internal fixation device include:

• Open and closed tibial fractures
• Pseudoarthrosis and correction osteotomy
• Pathologic fractures, impending pathologic fractures, and tumor resections
• Fractures involving osteopenic and osteoporotic bone
• Nonunion and malunion
  The End Cap Lower Extremity and the Nail Holding Screw Tibia / Femur PF may also be used in conjunction with the T2 Alpha Femur Antegrade GT/PF Nailing System.

The IMN Screws System is intended to stabilize the intramedullary nail-bone construct for temporary stabilization.

The IMN Instruments System is intended to enable the implantation of intramedullary nail and screw.

A Special 510(k) submission is being supplied to the U.S. FDA to gain clearance for modifications to the existing T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha Tibia Nailing System, IMN Screws System and IMN Instruments System previously cleared in K180436. Modifications include an increase of shelf-life from 5 years to 10 years for the sterile implants and a change of dimensional specifications for the Advanced Locking Screw, Targeting Arm Femur GT and Targeting Arm Femur PF.

The T2 Alpha Femur Antegrade GT/PF Nailing System previously cleared in K180436 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 T2 Alpha Tibia Nailing System previously cleared in K180436 is a fracture fixation system and includes sterile implants (tibial nails in various diameter, compression screw tibia and end caps) as well as non-sterile instruments (targeting devices).

The IMN Screws System previously cleared in K180436 includes bone screws (locking screws and advanced locking screws) that are inserted through the intramedullary nail to stabilize the nail-bone construct.

The IMN Instruments System includes the distal targeting device femur antegrade previously cleared in K180436. There are also associated surgical instruments (class I devices) that support the implantation and extraction of intramedullary nails and screws.

This document describes a Special 510(k) Premarket Notification for modifications to existing intramedullary nailing systems (T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha Tibia Nailing System, IMN Screws System, and IMN Instruments System). The submission's purpose is to demonstrate substantial equivalence to the previously cleared predicate device (K180436) for these modifications.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

The document explicitly states: "No clinical testing of the T2 Alpha Femur Antegrade GT/PF Nailing System has been conducted." This indicates that there was no "test set" in the context of clinical performance evaluation. The data provenance supporting the modifications (shelf-life increase and dimensional changes) would be from in-house engineering and quality testing, likely conducted by Stryker Trauma GmbH in Schoenkirchen, Germany. These are likely retrospective data based on existing product infrastructure.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

As no clinical testing was conducted and the performance data primarily relates to engineering and quality assessments for modifications, there is no mention of "experts" establishing ground truth in the context of a clinical test set. The validation would have been performed by qualified engineers and quality control personnel within Stryker Trauma GmbH.

4. Adjudication Method for the Test Set:

Not applicable, as no clinical test set requiring adjudication by experts was used for this Special 510(k) submission.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC comparative effectiveness study was mentioned or performed. The submission is for modifications to an existing device, and clinical efficacy was not under evaluation, nor was comparison with human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Not applicable, as this device is a physical medical implant system, not a software algorithm or AI-powered device.

7. Type of Ground Truth Used:

The "ground truth" for this submission's modifications primarily relies on:

• Engineering specifications and data: For dimensional changes, ensuring the modified components still meet their intended design parameters.
• Packaging integrity and sterility data: For the shelf-life extension, ensuring the packaging maintains sterility and functionality over the new extended period.
• Risk analysis methodology: As per DIN EN ISO 14971, to confirm that the changes do not introduce new hazards or increase existing risks.

These are established through internal quality and engineering testing, not clinical outcomes, pathology, or expert consensus on patient data.

8. Sample Size for the Training Set:

Not applicable, as this is a physical medical device and not an AI/ML algorithm requiring a training set.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, for the reasons stated above.

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The T2® Recon Nail System indications include fixation of subtrochanteric, interochanteric, ipsilateral neck/shaft, communited proximal femoral shaft fractures, femoral fixation required as a result of pathological disease, and temporary stabilization of fractures of the femoral shaft ranging from the femoral neck to the supracondylar regions of the femur.

The T2® Recon Nail System is a family of IM (Intramedullary) Nails for various types of femoral fractures. This Special 510(k) submission is intended to address modifications to the T20 Recon Nail System cleared under K032898. The anterior curve is being modified as part of a line extension of the T2® Recon Nail System. The T2 Recon Nail System currently contains 2000mm anterior to posterior radius of curvature.

The provided document is a 510(k) summary for a medical device called the "T2® RECON NAIL SYSTEM LINE EXTENSION," an intramedullary nail for femoral fractures. The submission is for a modification to an existing device, specifically changing the anterior-to-posterior radius of curvature of the nail.

It is crucial to understand that this document does not describe a study involving algorithms, AI, or human readers/experts in the way your prompt asks. This is a mechanical device, and the "study" described is an engineering analysis to demonstrate mechanical safety and anatomical fit. Therefore, many of the requested categories are not applicable to this type of device submission.

Here's an attempt to address your prompt based on the provided text, with clear indications of which categories are not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample size for test set: Not applicable (N/A). This was an engineering analysis and mechanical testing, not a clinical study with human subjects or a dataset of images/medical records. The "test set" would be the physical devices or computational models used in the engineering analysis. The document does not specify a number of physical implants tested or simulations run.
• Data provenance: N/A. No country of origin is specified. The analysis is based on engineering principles and mechanical testing. The document states it was a "Summary of Data" for an "engineering analysis."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Number of experts: N/A. No experts were used to establish "ground truth" in the context of clinical interpretation or diagnosis. The "ground truth" for mechanical performance is established by engineering principles and physical testing.
• Qualifications of experts: N/A.

4. Adjudication method for the test set

• Adjudication method: N/A. This concept is typically relevant for studies where human readers independently assess data and their agreement needs to be resolved. This was an engineering analysis.

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

• MRMC study done: No. This is a modification to a mechanical implant, not an AI or diagnostic imaging device.
• Effect size: N/A.

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

• Standalone performance: No. This is a physical medical device, not a software algorithm.

7. The type of ground truth used

• Type of ground truth: The "ground truth" implicitly used for this device's performance assessment is based on established engineering principles and validated mechanical testing standards for orthopedic implants, ensuring the device meets predefined material properties, strength, and fatigue resistance under simulated physiological loads. This is distinct from clinical ground truth like pathology or expert consensus.

8. The sample size for the training set

• Sample size for training set: N/A. There is no concept of a "training set" in the context of this device modification. The design is based on established biomechanical principles and previous designs.

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

• How ground truth was established: N/A. (See point 8).

Summary of the "Study" from the Document:

The "study" conducted for this line extension was an engineering analysis combined with a Failure Mode Effect Analysis (FMEA) and prior mechanical testing. The purpose was to demonstrate that a change in the anterior-to-posterior radius of curvature from 2000mm to 1500mm does not negatively affect the safety and effectiveness of the T2® Recon Nail System. The analysis specifically investigated potential risks related to "anatomical fit" and "mechanical strength." The conclusion was that the proposed radius of curvature "does not affect device performance" and that the modified design is "substantially equivalent" to other marketed devices, including its predicate.

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