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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 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.

This Traditional 510(k) submission is being supplied to the U.S. FDA to gain clearance to market the T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, and IMN Instruments System. This submission encompasses multiple systems that have similar intended use and will be used together during the surgical procedure.

T2 Alpha Femur Antegrade GT/PF Nailing System: The T2 Alpha Femur Antegrade GT/PF Nailing System is a fracture fixation system and includes sterile implants (intramedullary nails in various diameter and sizes, compression screw, set screws and end caps) as well as non-sterile instruments (targeting devices). The femoral nails, compression screw and end caps are made of titanium alloy (Ti6Al4V ELI) as per ASTM F136. The set screws are manufactured from titanium alloy (Ti6Al4V ELI) as per ASTM F136 and PEEK.

IMN Screws System: The IMN Screws System includes locking screws that are inserted through the intramedullary nail to stabilize the nail-bone construct. The locking screws are made of titanium alloy (Ti6Al4V ELI) as per ASTM F136.

IMN Instruments System: The IMN Instruments System includes instruments that support the implantation and extraction of intramedullary nails and screws.

This FDA 510(k) summary describes the substantial equivalence of the Stryker Trauma GmbH devices: T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, and IMN Instruments System, to predicate devices. The document details performance data, but does not provide specific acceptance criteria or reported device performance in a table format, nor does it detail a study proving the device meets acceptance criteria in the way one might expect for a diagnostic or AI device. Instead, the studies aim to demonstrate mechanical equivalence and biocompatibility to existing, legally marketed predicate devices.

Here's an attempt to extract and synthesize the requested information, noting where specific details are not provided in the document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria with corresponding reported device performance values in a table format for clinical efficacy or diagnostic accuracy. Instead, the "acceptance criteria" are implied by the successful completion of various non-clinical tests demonstrating equivalence to predicate devices, biocompatibility, and MR Conditional status.

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

This is a non-clinical submission for mechanical and biocompatibility testing of medical devices (intramedullary nails, screws, and instruments). Therefore, the concept of a "test set" in the context of clinical data or diagnostic accuracy (e.g., patient samples) does not apply. The tests described are bench tests or laboratory assessments of materials and mechanical functionality.

• Sample Size for Tests: Not explicitly detailed for each specific test. The document generally states "Non-clinical testing was performed..."
• Data Provenance: The tests are non-clinical, meaning they were conducted in a laboratory setting. The country of origin for the data is implied to be Germany, where the manufacturer (Stryker Trauma GmbH) is located. The tests are "retrospective" in the sense that they are performed on manufactured components rather than gathered from prospective clinical trials.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable to a non-clinical submission for mechanical and biocompatibility testing. Ground truth in this context refers to established material standards (e.g., ASTM F136, ASTM F543, ASTM F1264) and biological safety guidelines (ISO 10993-1). Experts would be involved in designing and conducting these tests and interpreting the results against these standards, but not in establishing a "ground truth" derived from clinical judgment, pathology, or outcomes in the way one would for a diagnostic device.

4. Adjudication Method for the Test Set

This concept is not applicable. Adjudication methods (like 2+1, 3+1) are used in clinical studies or diagnostic accuracy studies where there might be disagreement among human readers or observers about a clinical finding or ground truth.

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

No MRMC study was performed or mentioned. The device is an orthopedic implant system and associated instruments, not an AI or diagnostic tool where human reader performance (with or without AI assistance) would be relevant.

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

Not applicable. This device is a physical implant and instrument system, not an algorithm or software requiring standalone performance testing.

7. Type of Ground Truth Used

The "ground truth" for the non-clinical tests described is based on:

• Mechanical Standards: ASTM F1264, ASTM F543, and the mechanical properties of the predicate devices. The goal is to demonstrate equivalence to these established standards and predicate devices.
• Biocompatibility Standards: International Standard ISO 10993-1.
• Material Standards: ASTM F136 for titanium alloys, and characteristics of PEEK.
• Endotoxin Limits: Specified endotoxin limits for sterile devices.

8. Sample Size for the Training Set

Not applicable. This is a non-clinical submission for physical medical devices. There is no AI algorithm or "training set" involved.

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

Not applicable for the same reason as above.

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The Gamma3 Target Devices are intended for use with the Trochanteric Nail or Long Length Gamma3 Nail. The Gamma3 and T2 Recon Distal Targeting Devices are intended for use with the Long Length Gamma3 Nail and T2 Recon Nail System. The Trochanteric Gamma3 Nail is indicated for fixation of stable and unstable intertrochanteric fractures, including but not limited to nonunion, malunion and tumor resections, while the Long Length Gamma3 Nail indication may include fractures resulting from trauma, nonunion, malunion, pathological fractures, impending pathological fractures, tumor resections and revision procedures. The T2 Recon Nail System indications include fixation of subtrochanteric, intertrochanteric, ipsilateral neck/shaft, comminuted 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.

This Traditional 510(k) submission is being supplied to the US FDA to address modifications made to the Gamma3 Target Device and addition of a new Distal Targeting Device to the Gamma3 (K043431) and T2 Recon Nail Systems (K102992) as well as the inclusion of the existing target devices in the Gamma3 and T2 Recon Nail Systems.

Here's an analysis of the provided 510(k) summary, aiming to extract the requested information about acceptance criteria and the study that proves the device meets them:

Core Finding: This 510(k) pertains to a medical device accessory (targeting devices for intramedullary nails), and as stated in the document, clinical testing was not required. The "study" largely consists of non-clinical, bench-top testing and engineering evaluations. Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study details) are not applicable in a clinical context.

Acceptance Criteria and Reported Device Performance

Detailed Breakdown of Study Information:

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

   • See table above. The detailed acceptance criteria, including specific numerical thresholds for accuracy and stiffness, are not explicitly stated in this 510(k) summary. The summary only lists the types of tests performed, implying they met internal or standard criteria for substantial equivalence.

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

   • Sample Size: Not applicable (N/A) for clinical test set, as no clinical testing was performed. For non-clinical (bench-top) testing, the sample sizes are not specified in the summary.
   • Data Provenance: Not applicable for clinical data. Non-clinical testing would have been conducted by Stryker Trauma AG or a contracted lab.

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):

   • Number of Experts: N/A, as no clinical testing was performed requiring expert ground truth in a diagnostic or clinical outcome context. For engineering evaluations, the "experts" would be the engineers performing the tests and evaluations.
   • Qualifications of Experts: N/A for clinical experts.

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

   • Adjudication Method: N/A, as no clinical testing was performed requiring adjudication of clinical data.

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: No, an MRMC study was not done. This device is a mechanical targeting accessory, not an AI-powered diagnostic tool, and no clinical comparative effectiveness study was performed or required.

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

   • Standalone Study: N/A. This device is a mechanical accessory; it does not have an "algorithm" in the sense of AI or image processing. Its performance is inherent to its mechanical design and function, used with a human surgeon.

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

   • Type of Ground Truth: N/A for clinical types. For non-clinical testing (accuracy, stiffness), the "ground truth" would be established by engineering specifications, validated measurement tools, and physical standards.

8. The sample size for the training set:

   • Training Set Sample Size: N/A. This is a mechanical device, not a machine learning model, so there is no "training set."

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

   • Training Set Ground Truth: N/A. There is no training set for this type of device.

Summary Conclusion from the Document:

The 510(k) summary clearly states: "Clinical testing was not required for this submission."

Therefore, the demonstration of substantial equivalence for the Gamma3 and T2 Recon Target Devices relies entirely on:

• Comparison of intended use, materials, and performance characteristics to predicate devices (K043431 Gamma3 Nail System and K102992 T2 Recon Nail System).
• Non-clinical laboratory testing (Conditioning, Targeting Accuracy, Stiffness).
• Engineering Evaluations (Accomodation for 480mm Nails in Distal Targeting Device).

The "study" proving the device meets acceptance criteria is the sum of these non-clinical tests and evaluations, which determined that the modified and new components were substantially equivalent to existing, cleared devices and did not alter the fundamental technology or safety/effectiveness.

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