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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 indications for use of these internal fixation devices include:

• Fixation of subtrochanteric, ipsilateral neck/shaft, comminuted proximal femoral shaff 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.

The T2 Alpha Tibia Nailing System is a fracture fixation system and includes sterile implants (intramedullary nails in various diameter, compression screw and end caps) as well as non-sterile instruments (targeting devices). The sterile implants are made of titanium alloy (Ti6A14V ELI) as per ASTM F136. The T2 Alpha Tibia Nailing System will be used with the locking screws cleared in K003018 (Titan Tibial Nail) and K172774 (IMN Screws System). Further, End Cap Lower Extremity and the Nail Holding Screw Tibia / Femur PF of T2 Alpha Tibia Nailing System can be used with T2 Alpha Femur Antegrade GT/PF Nailing System (K172774). The T2 Alpha Tibia Nailing System will be used with the existing instruments previously cleared in K131365 (T2 Tibial Nailing System) and 510(k) exempt devices. The T2 Alpha Tibia Nailing System is intended for use with IMN Screws System and IMN Instruments System.

The IMN Screws System includes bone screws (locking screws previously cleared in K172774 and advanced locking screws) that are inserted through the intramedullary nail to stabilize the nail-bone construct. The screws are made of titanium alloy (Ti6A14V ELI) as per ASTM F136. The IMN Screws System is intended for use with T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System and IMN Instruments System.

The IMN Instruments System includes distal targeting device femur antegrade previously cleared in K172774 as well as surgical instruments that support the implantation and extraction of intramedullary nails and screws. The IMN Instruments System is intended for use with T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System and IMN Screws System.

The T2 Alpha Femur Antegrade GT/PF Nailing System previously cleared in K172774 is a fracture fixation system and includes sterile implants (femoral nails in various diameter and sizes, compression screw, set screws and end caps) as well as non-sterile instruments.

The T2 Alpha Femur Antegrade GT/PF Nailing System will be used with the locking screws originally cleared in K003018 (Titan Tibial Nail) that have subsequently also received clearance for use in locking femoral nailing systems (K010801, T2 Femoral Nail System) as well as locking screws previously cleared in K172774 (IMN Screws System) and the T2 Lag Screw Recon previously cleared in K032898 (T2 Recon Nail System). Further, it will be used with the existing instruments previously cleared in K172774 (IMN Instruments System) and 510(k) exempt devices. The T2 Alpha Femur Antegrade GT/PF Nailing System is intended for use with IMN Screws System and IMN Instruments System.

The provided document is a 510(k) Premarket Notification for a medical device, specifically orthopaedic implants and instruments (T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, and IMN Instruments System).

This document does not describe a study involving an AI or software-as-a-medical-device (SaMD) product that requires human-in-the-loop or standalone performance evaluation with clinical data and expert ground truth. Instead, it focuses on demonstrating substantial equivalence of traditional medical devices to previously cleared predicate devices through bench testing and biocompatibility assessments. Therefore, most of the requested information regarding acceptance criteria, sample sizes for test/training sets, expert qualifications, ground truth establishment methods, MRMC studies, and effect sizes of AI assistance are not applicable to this type of submission.

The document describes non-clinical performance data primarily from bench testing to demonstrate the substantial equivalence of the new devices or line extensions to previously cleared devices.

Here's a breakdown of the applicable and non-applicable information based on the provided text:

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

The document does not provide a quantitative table of acceptance criteria and reported device performance in the format typically seen for AI/SaMD studies. Instead, it states that "Testing demonstrated that T2 Alpha Tibia Nailing System is equivalent in mechanical performance to the predicate devices (K003018, K082770, and K040762)." Similar statements are made for the other systems.

The types of tests performed indicate the implicit acceptance criteria:

• T2 Alpha Tibia Nailing System:
  • Testing of mechanical properties per ASTM F1264
  • Fatigue strength testing (proximal and distal)
  • Cut-out testing
  • Targeting accuracy testing
  • Biocompatibility testing (ISO 10993-1, -5, -18)
  • Bacterial Endotoxin Testing
• IMN Screws System (advanced locking screws):
  • Testing of mechanical properties as per ASTM F543
  • Biocompatibility assessment (ISO 10993-1)
  • Bacterial Endotoxin Testing
• IMN Instruments System:
  • Performance testing in cadaver lab
  • Compatibility evaluation
  • Biocompatibility testing (ISO 10993-1, -5, -18)
• T2 Alpha Femur Antegrade GT/PF Nailing System:
  • Compatibility assessment

The reported "performance" is primarily a statement of equivalence or suitability to the predicate devices based on these tests. No specific numerical thresholds or results are presented.

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

This information is not provided in typical AI/SaMD study terms. The "test set" here refers to samples of the physical medical devices used in bench testing. The document does not specify the number of physical samples tested for each mechanical or biocompatibility test. Data provenance in terms of 'country of origin of data' or 'retrospective/prospective' is not relevant as it's not a clinical study on human subjects with data collection over time.

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)

Not applicable. Ground truth in the context of this submission refers to the established mechanical properties, biocompatibility standards, and functional performance of the devices as measured by standardized tests. It does not involve expert readers reviewing clinical cases.

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

Not applicable. There is no adjudication method described as it is not a clinical study requiring consensus among multiple readers.

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

Not applicable. This submission is for traditional medical devices (implants and instruments), not an AI/SaMD product. Therefore, no MRMC study or AI assistance evaluation was performed.

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

Not applicable. This document describes physical medical devices, not an algorithm.

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

The "ground truth" for this submission is established through objective, standardized bench testing for mechanical properties, biocompatibility standards (e.g., ISO standards), and functional performance (e.g., targeting accuracy, cadaver lab performance). It is not derived from expert consensus on medical images, pathology, or clinical outcomes data.

8. The sample size for the training set

Not applicable. This is not an AI/ML product that requires a training set.

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

Not applicable. This is not an AI/ML product that requires a training set.

In summary, this 510(k) submission for conventional orthopaedic devices focuses on demonstrating substantial equivalence through non-clinical bench testing and adherence to recognized standards, rather than clinical studies or evaluations of AI performance. Therefore, most of the detailed questions about acceptance criteria, sample sizes, expert involvement, and ground truth establishment methods as typically understood for AI/SaMD products are not relevant to this document.

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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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