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The Gamma4 System is indicated for the treatment of stable and unstable fractures as well as for stabilization of bones and correction of bone deformities in the intracapsular, trochanteric, subtrochanteric and shaft regions of the femur (including osteoporotic and osteopenic bone).

The Gamma3 System is indicated for the treatment of stable and unstable fractures as well as for stabilization of bones and correction of bone deformities in the intracapsular, trochanteric, subtrochanteric and shaft regions of the femur (including osteoporotic and osteopenic bone). The U-Blade Lag Screw is also indicated for rotationally unstable fractures.

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

The T2 Tibial Nailing System 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 Tibial Nailing System is indicated for long bone fracture fixation, specifically tibial fracture fixation, which may include the following: Open and closed tibial fractures, Pseudoarthrosis and correction osteotomy, Pathologic fractures, impending pathologic fractures, and tumor resections, Nonunion and malunion. The Locking Screws may also be used in conjunction with the T2 Alpha Systems.

This Traditional 510(k) submission is being supplied to the U.S. FDA to gain clearance to market the Gamma4 System and align labeling across the Gamma3 System, IMN Screws System and T2 Tibial Nailing System.

This submission encompasses multiple systems (Gamma4 System, Gamma3 System, IMN Screws and T2 Tibial Nailing System) that have similar intended use and/or will be used together during the surgical procedure.

The Gamma4 System is a hip fracture nailing system and includes sterile implants (Trochanteric and Long Nails in various diameters and sizes, Lag Screws, and End Caps) as well as non-sterile instruments (targeting devices). The nails, lag screws and end caps are made of titanium alloy (Ti6Al4V ELI) as per ASTM F136. The targeting device is manufactured from stainless steel per AISI 431, carbon fiber reinforced PEEK and PEEK unreinforced. The Gamma4 System will be used with the existing Locking Screws and Advanced Locking Screws of IMN Screws System (K193308), the Distal Targeting Device Femur Antegrade and Adjusting Device Femur Antegrade of IMN Instruments System (K191271), the ADAPT Clip of the Gamma3 System (K200869) as well as the surgical instruments of T2 Tibia Nailing System (510(k) exempt devices).

The Gamma3 System most recently cleared in K200869 is a hip fracture nailing system and includes sterile implants (Trochanteric Nails, Long Nails, standard Lag Screws, U-Blade Lag Screw set, distal locking screws, a set screw and end caps in various diameter and sizes) as well as non-sterile instruments (targeting devices). The sterile implants (nails, set screw and end cap) are available in titanium allov (Ti-6Al-4V ELI) per ASTM F136 and stainless-steel alloy per ASTM F1586. The targeting devices are manufactured from stainless steel and carbon fiber reinforced PEEK. The Gamma3 System is used with the IMN Ø5 mm locking screws most recently cleared in K193308 as well as other instruments associated with implantation of the Gamma3 System and standard Class I exempt surgical instruments.

The IMN Screws System, most recently cleared in K193308, includes bone screws (Locking Screws and Advanced Locking Screws) that are inserted through the intramedullary nail to stabilize the nail-bone construct. The Ø5 mm Locking Screws and Advanced Locking Screws are inserted through the distal locking holes of the Gamma4 nails. All screws are made of titanium alloy (Ti6Al4V ELI) per ASTM F136. Refer to Attachment 15-5 for the list of devices that are compatible with the IMN Screws System.

The T2 Tibial Locking Nail, most recently cleared in K203819, 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.

Here's an analysis of the provided text regarding acceptance criteria and supporting studies, formatted to answer your questions:

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

The provided document is a 510(k) summary for intramedullary fixation rods and related screws. It focuses on demonstrating substantial equivalence to predicate devices rather than establishing specific quantitative acceptance criteria for device performance. Therefore, a table of acceptance criteria and reported device performance in the traditional sense of diagnostic accuracy or clinical outcomes is not provided in this document.

Instead, the document details non-clinical testing performed to demonstrate substantial equivalence by assessing mechanical and physical properties. The implicit "acceptance criteria" for these tests would be that the subject devices perform comparably to, or within acceptable limits of, the predicate devices or established standards. The reported "performance" is that these tests were conducted and support the claim of substantial equivalence.

Non-Clinical Testing and Implied Performance:

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

The document explicitly states: "Non-Clinical Testing" and then lists various mechanical and physical tests performed. It also states: "CLINICAL TESTING: Clinical testing was not required for this submission."

Therefore, there is no "test set" in the sense of patient data or clinical samples. The testing involved mechanical specimens and engineering evaluations. The document does not specify sample sizes for these non-clinical tests or the country of origin of the data, as it's typically standard engineering test data rather than patient-derived data. The tests are prospective in the sense that they were conducted specifically for this submission.

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)

Since there was no clinical test set and no human-in-the-loop performance evaluation, there were no experts used to establish ground truth in the context of diagnostic or clinical interpretation. The "ground truth" for the non-clinical tests would be the established engineering standards (e.g., ASTM F1264) and the performance of the predicate devices. The "experts" involved would be engineers and testing personnel interpreting these results, but they are not described in the context of clinical ground truth establishment.

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

Not applicable. As no clinical test set or human interpretation was involved, no adjudication method was necessary or performed.

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 medical devices (intramedullary rods and screws), not AI software. No MRMC studies were conducted, and there is no mention of AI assistance.

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

Not applicable. This is not an AI algorithm. The performance evaluation was entirely non-clinical (mechanical and physical testing) to demonstrate substantial equivalence of the hardware devices.

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

For the non-clinical tests, the "ground truth" is based on:

• Established Engineering Standards: Specifically ASTM F1264 for mechanical properties.
• Performance of Legally Marketed Predicate Devices: The subject devices' performance was compared against the known performance characteristics of the predicate devices (Gamma3 System (K200869), T2 Alpha Femur Antegrade GT/PF Nailing System (K203819), Zimmer Natural Nail System Cephalomedullary Nails (K192312), IMN Screws System (K193308), T2 Tibial Nailing System (K203819)). The expectation is that the new devices perform equivalently or acceptably within the context of these established predicates.

8. The sample size for the training set

Not applicable. As this is not an AI device, there is no training set. The devices are physical implants, and their performance is evaluated through engineering testing, not machine learning.

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

Not applicable, as there is no training set for this type of device submission.

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The Gamma3 System is indicated for the treatment of stable and unstable fractures as well as for stabilization of bones and correction of bone deformities in the intracapsular, trochanteric and shaft regions of the femur (including osteoporotic and osteopenic bone).

The U-Blade Lag Screw is also indicated for rotationally unstable fractures.

The Gamma3 System consists of Trochanteric Nails, Long Nails, standard Lag Screws, U-Blade Lag Screws, end caps, set screws, distal locking screws, and instrumentation. The purpose of this traditional 510(k) is to update and consolidate system indications and intended use, update MR labeling to reflect new testing, update the mechanical testing analysis, and reference Ø5mm IMN Screws System Locking Screws as compatible components. Additional labeling changes were also made, including operative technique consolidation, safety information updates, and the addition of the MR Conditional symbol to package labels.

This document is a 510(k) premarket notification for the Stryker Trauma GmbH Gamma3 System, an intramedullary fixation rod system. This device is not an AI/ML device, and therefore does not have acceptance criteria, a study that proves the device meets acceptance criteria, test set information, expert ground truth establishment, adjudication methods, MRMC studies, or standalone performance information.

Here's the relevant information based on the provided text:

1. Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not applicable. This document refers to non-clinical laboratory testing, not clinical studies with human test sets. The "test set" for mechanical and MR compatibility testing would refer to the physical devices tested, but specific quantities are not provided in this summary.
• Data Provenance: Not applicable for human data. The non-clinical testing was performed in a laboratory setting.

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

• Not applicable. This device is a medical implant, and its performance is evaluated through mechanical and materials testing, not through expert review of data/images.

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

• Not applicable. This device is a medical implant, and its performance is evaluated through mechanical and materials testing, not through adjudication of human perceptions.

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 is a medical implant (intramedullary fixation rod system), not an AI/ML diagnostic or assistive device. No MRMC study was conducted.

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

• Not applicable. This is a medical implant, not an algorithm or AI/ML product.

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

• Ground Truth Type: Not applicable in the context of expert review or diagnostic accuracy. For mechanical and MR compatibility testing, the "ground truth" would be established by the physical properties and behavior of the materials and device under controlled laboratory conditions, as defined by recognized industry standards (e.g., ASTM F2052, F2213, F2182, F2119) and FDA guidance.

8. The sample size for the training set:

• Not applicable. This device is a medical implant, not an AI/ML product that requires a training set.

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

• Not applicable. This device is a medical implant, not an AI/ML product.

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