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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 and shaft regions of the femur (including osteoporotic and osteopenic bone). The RC Lag Screw is also indicated for rotationally unstable fractures.

This Traditional 510(k) submission is being supplied to the U.S. FDA to gain clearance to market new devices into the Gamma4 System, add new indications for use for the RC Lag Screws and update the current surgical technique to include an optional section to use bone void fillers.

The Gamma4 System was previously cleared in K222309, 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 subject devices (Intermediate Nails and RC Lag Screw) are also sterile implants in various diameters and sizes as well as a non-sterile Intermediate Targeting Sleeve. All nails and screws are made of titanium alloy (Ti6Al4V ELI) as per ASTM F136 and the targeting device is manufactured from stainless steel per AISI 431, carbon fiber reinforced PEEK and PEEK unreinforced.

The provided document, K230512, is a 510(k) premarket notification for the Stryker Gamma4 System. This document focuses on demonstrating substantial equivalence to already legally marketed predicate devices, rather than proving the device meets specific performance criteria through clinical studies involving human patients or complex AI algorithm evaluations.

Therefore, the details requested about acceptance criteria and a study proving a device meets these criteria, especially concerning human-in-the-loop performance, AI algorithm training, and expert adjudication, are not present in this document.

The document explicitly states on page 6: "CLINICAL TESTING: Clinical testing was not required for this submission."

The non-clinical testing mentioned is primarily focused on mechanical performance and equivalence to predicate devices, such as:

• Targeting accuracy testing
• Bending Fatigue Strength per ASTM F1264
• Construct Fatigue Strength Testing
• Cut-out testing
• Torsional Stiffness per ASTM F1264
• MR evaluation

These tests are designed to show that the new Gamma4 System performs mechanically similarly to its predecessors, not to assess human or AI performance in a clinical setting.

Consequently, I cannot provide the requested information from the given document, as it does not contain details about a study designed to prove the device meets acceptance criteria related to a human-in-the-loop system, AI performance metrics, or complex clinical outcome data.

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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 and shaft regions of the femur (including osteoporotic and osteopenic bone).

This Traditional 510(k) submission is being supplied to the U.S. FDA to gain clearance to market two (2) new accessory devices into the Gamma4 System: Plus Targeting Arm and Plus Nail Holding Screw.

The Gamma4 System was previously cleared under K213328, 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 Gamma4 System has two (2) types of targeting devices: (1) Proximal Targeting Arm (consisting of Targeting Sleeve and Nail Holding Screw) previously cleared in K213328 and (2) the subject devices, Plus Targeting Arm (consisting of the Plus Nail holding Screw and Targeting Sleeve, previously cleared in K213328). The previously cleared Proximal Targeting Arm has less of an extension out from the axis of the nail, whereas the subject device is more rounded and extends out further to ensure sufficient tissue clearance. Both targeting devices are manufactured from stainless steel per AISI 431, carbon fiber reinforced PEEK and PEEK unreinforced.

This is a 510(k) premarket notification for an orthopaedic device (intramedullary fixation rod system), specifically for an update to accessory devices (Plus Targeting Arm and Plus Nail Holding Screw) for an already cleared system. Therefore, the information provided focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of diagnostic performance or AI accuracy.

As such, many of the requested categories for AI/diagnostic device studies do not apply directly to this submission.

Here's an analysis based on the provided text:

The device in question is not an AI/Software as a Medical Device (SaMD) or a diagnostic device. It is an intramedullary fixation rod system with new accessory devices. Therefore, metrics like sensitivity, specificity, NPV, PPV, number of experts, ground truth, MRMC studies, or standalone algorithm performance are not applicable to this type of submission.

However, I can extract information related to the acceptance criteria and the (non-clinical) study performed for this specific device type:

Acceptance Criteria and Reported Device Performance

Details on the "Study" (Non-Clinical Testing)

The submission refers to "Non-Clinical Testing" rather than a clinical study or a study related to AI performance.

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

   • Sample Size: Not explicitly stated for the "Targeting accuracy testing." This sort of non-clinical testing for mechanical devices typically involves a defined number of test samples per configuration, but the specific number isn't in this summary.
   • Data Provenance: Not applicable in the sense of patient data. It would be lab-generated data from mechanical testing.

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

   • Not applicable. "Ground truth" in the context of mechanical device testing refers to the actual performance or known standard measured against. This would be established by engineering specifications and metrology, not expert consensus in the medical sense.

3. Adjudication method for the test set:

   • Not applicable. Adjudication methods like 2+1 are for reconciling expert opinions, which isn't relevant for mechanical performance testing of an intramedullary rod system. Results are typically quantitative measurements compared to predefined engineering tolerances.

4. 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:

   • No, an MRMC comparative effectiveness study was explicitly not done. The device is a physical orthopedic implant system, not a diagnostic imaging or AI-assisted product.

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

   • No, this is not an algorithm or AI product.

6. The type of ground truth used:

   • For the "Targeting accuracy testing," the ground truth would be based on engineering specifications and metrological measurements, comparing the actual targeting performance against the design intent and acceptable tolerances.

7. The sample size for the training set:

   • Not applicable. This is not a machine learning or AI device.

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

   • Not applicable. There is no training set for this type of device.

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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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