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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 T2 Alpha Femur Retrograde Nailing System is intended for temporary stabilization of bone segments or fragments until bone consolidation has been achieved.

The T2 Alpha Femur Antegrade GT/PF Nailing System is intended for temporary stabilization of bone segments or fragments until bone consolidation has been achieved.

The T2 Tibial Locking Nail 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 Femoral Nail System is intended to provide strong and stable internal fixation with minimal soft tissue irritation. This device is utilized as an aid to healing, not as a substitute for normal intact bone and tissue.

The T2 Supracondylar Nail System is intended to provide strong and stable internal fixation with minimal soft tissue irritation. This device is utilized as an aid to healing, not as a substitute for normal intact bone and tissue.

This Traditional 510(k) submission is being supplied to the U.S. FDA to gain clearance to market the T2 Alpha Femur Retrograde Nailing System and update the Indications for Use for T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Tibial Nailing System, T2 Femoral Nail System, and T2 Supracondylar Nail System to include the compatibility of components with the T2 Alpha Femur Retrograde Nailing System.

This submission encompasses multiple systems (T2 Alpha Femur Retrograde Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Tibial Nailing System, T2 Femoral Nail System, and T2 Supracondylar Nail System) that have similar intended use and will be used together during the surgical procedure.

The T2 Alpha Femur Retrograde Nailing System is a fracture fixation system and includes sterile implants (intramedullary nails in various diameter and sizes, compression screw, and end caps) as well as non-sterile instruments (targeting devices). The femoral nails, compression screw and end caps are made of titanium alloy (Ti6A14V ELI) as per ASTM F136.

Additionally, the T2 Alpha Femur Retrograde Nailing System will be used with the existing locking screws most recently cleared in K200880 (Titan Tibial Nailing System), the locking screws and advanced locking screws of IMN Screws System (K191271), the condyle screws and nuts most recently cleared in K200880 (T2 Femoral Nail System), the Compression Screw Femur most recently cleared in K191271 (T2 Alpha Antegrade GT/PF Nailing System), and the end caps most recently cleared in K200880 (T2 Supracondylar Nail System), The T2 Alpha Femur Retrograde Nailing System is intended for use with IMN Screws System and IMN Instruments System.

The T2 Alpha Femur Antegrade GT/PF Nailing System most recently cleared in K191271 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 sterile implants (Femoral Nail GT, Femoral Nail PF, Compression Screw Femur, and End Cap GT/PF, Set Screws) are made of titanium alloy (Ti6A14V ELI) per ASTM F136. The set screws are manufactured from titanium alloy (Ti6A14V ELI) per ASTM F136 and PEEK. The targeting devices are manufactured from stainless steel, PEEK unreinforced as well as PEEK with 30% and 50% carbon fibers.

The T2 Alpha Femur Antegrade GT/PF Nailing System will be used with the locking screws most recently cleared in K200880 (Titan Tibial Nail) that have subsequently also received clearance for use in locking femoral nailing systems (K200880), the Lag Screw Recon of T2 Recon System (K200880), the End Cap Lower Extremity and the Nail Holding Screw Tibia / Femur PF of T2 Alpha Tibia Nailing System (K191271), the locking screws and advanced locking screws of IMN Screws System (K191271), the distal targeting device femur antegrade of IMN Instruments System (K191271) as well as the surgical instruments of IMN Instruments System and T2 Instruments System (510(k) exempt devices).

The T2 Tibial Locking Nail 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.

The T2 Femoral Nail is a cylindrical, cannulated titanium allow tube, slightly bowed to accommodate the shape of the femur. The T2 Femoral Nail may be inserted into the femoral canal using either a retrograde or antegrade surgical approach.

The T2 Supracondylar Nails are retrograde nails with a one-piece round profiled shaft design. The nails are cannulated and have a closed-section design with proximal rounded end. The T2 Supracondylar Nail is available in two versions: Short and Long. The T2 Supracondylar nails are available in lengths from 170 mm to 440 mm and in diameters from 9 mm to 14 mm. The T2 Supracondylar Nail System offers nails in varying lengths, a combination of locking screws, condyle screws, nuts and end caps.

This is a 510(k) premarket notification for multiple intramedullary nailing systems, not a study describing the acceptance criteria and performance of a device, especially not one using AI or requiring human-in-the-loop performance. Therefore, most of the requested information regarding acceptance criteria for an AI/device, sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance simply does not apply to this document.

The document primarily focuses on establishing substantial equivalence to previously cleared predicate devices for various bone fixation systems. The "performance data" section refers to mechanical and material testing, not human performance or AI performance.

Here's an attempt to answer the relevant questions based only on the provided text, while acknowledging that many questions are not applicable to this type of submission.

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

The document does not explicitly present acceptance criteria in a table format with corresponding device performance values as would be typical for clinical or AI-based performance studies. Instead, it states that "Comparative mechanical testing to the predicate systems demonstrated substantial equivalence." and "Mechanical testing demonstrated that the T2 Alpha Femur Retrograde Nailing System is equivalent to the predicate devices (K200880, K101622)."

The specific performance tests conducted were:

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

This document describes a premarket notification for a medical device (intramedullary nailing system), not an AI/software device that would typically have a "test set" of patient data. The performance data provided is mechanical and material testing. Therefore, information about patient data sample size, country of origin, or retrospective/prospective nature is not applicable. The sample sizes for the mechanical tests would be specific to each test protocol but are not detailed in this summary.

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)

This question is not applicable. Manual bone fixation devices do not typically involve experts establishing "ground truth" for patient data in the same way as an AI diagnostic device. The evaluation of these devices is primarily through engineering, mechanical, and material testing against established standards and predicate devices.

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

This question is not applicable. There is no "test set" of patient data or clinical observations requiring adjudication for this type of device submission.

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

This question is not applicable. The document is for mechanical bone fixation devices and does not involve AI or human "readers" (e.g., radiologists, pathologists). No MRMC study or AI assistance is mentioned.

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

This question is not applicable. This submission is for physical medical devices (intramedullary nailing systems), not an algorithm or AI.

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

For mechanical testing, the "ground truth" refers to established engineering standards (e.g., ASTM F1264, F2052, F2213, F2182, F2119) and the performance characteristics of the predicate devices. The device's performance is compared against these benchmarks to demonstrate substantial equivalence.

8. The sample size for the training set

This question is not applicable. This is not an AI/machine learning device, so there is no training set.

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

This question is not applicable. This is not an AI/machine learning device, so there is no training set or ground truth establishment method for one.

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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 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 T2 Femoral Nail is indicated for long bone fracture fixation specifically femoral fracture fixation which may include the following: Open and closed femoral fractures, Pseudoarthrosis and correction osteotomy, Pathologic fractures, impending pathologic fractures, and tumor resections, Supracondylar fractures, including those with intra-articular extension, Ipsilateral femur fractures, Fractures proximal to a total knee arthroplasty, Fractures distal to hip joint, Nonunions and malunions.

The T2 Supracondylar Nail System is indicated for: Open and closed femoral fractures, Pseudoarthrosis and correction osteotomy, Pathologic fractures, impending pathologic fractures, and tumor resections, Supracondylar fractures including those with intra-articular extension, Fractures distal to total hip prosthesis, Nonunions and malunions.

The T2 Recon Nail is indicated for: Subtrochanteric fractures, Intertrochanteric fractures, Ipsilateral neck/shaft fractures, 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.

The T2 Greater Trochanter Nail is indicated for long bone fracture fixation, which may include the following: Open and closed femoral fractures, Pseudarthrosis and correction osteotomy, Pathologic fractures, impending pathologic fractures, and tumor resections, Ipsilateral femur fractures, Fractures proximal to a total knee arthroplasty, Nonunions and malunions.

The T2 Ankle Arthrodesis Nail is intended for tibiotalocalcaneal arthrodesis (fusion) and to provide stabilization of the hindfoot and ankle including the transverse tarsal joints coupling the mid-foot to the hindfoot. Examples of specific indications include: Post-traumatic or primary Arthrosis, Previously infected arthrosis (second degree), Revision of Failed Ankle Arthrodesis, Failed Total Ankle Replacement, Avascular Necrosis of the Talus (requiring tibiocalcaneal arthrodesis), Neuroarthropathy or Neuromuscular Deformity or other neuromuscular disease with severe deformity or instability of the ankle, Rheumatoid Arthritis with severe deformity such as rheumatoid hindfoot, Osteoarthritis, Nonunions or Pseudarthrosis of hindfoot and distal tibia, Malunited tibial pilon fracture, Charcot foot, Severe endstage degenerative arthritis, Severe defects after tumor resection, Pantalar arthrodesis.

The T2 Arthrodesis Nail is intended for long bone internal fixation, which may include the following: Aseptic failed total knee arthroplasty, Open and closed femoral fractures, Pseudoarthrosis and correction osteotomy, Pathological fractures, impending pathological fractures, and tumor resections, Ipsilateral femur fractures, Failed external fixation, nonunions and malunions, Periarticular fractures where repair is not possible, Knee arthrodesis.

The T2 Tibial Nailing System is a cylindrical tube manufactured from titanium alloy and slightly bowed to accommodate the shape of the tibia. Locking screws, compression screws and an end cap are manufactured from titanium alloy and are used with the nails. The T2 Tibial Nailing System is available in three versions, each differing from the other only in diameter, length and number and orientation of screw holes.

The T2 Femoral Nail is a cylindrical, cannulated titanium alloy tube, slightly bowed to accommodate the shape of the femur. The T2 Femoral Nail may be inserted into the femoral canal using either a retrograde or antegrade surgical approach.

The T2 Supracondylar Nails are retrograde nails with a one-piece round profiled shaft design. The nails are cannulated and have a closed-section design with proximal rounded end. The T2 Supracondylar Nail is available in two versions: Short and Long. The T2 Supracondylar nails are available in lengths from 170 mm to 440 mm and in diameters from 9 mm to 14 mm. The T2 Supracondylar Nail System offers nails in varying lengths, a combination of locking screws, condyle screws, nuts and end caps.

The T2 Recon Nail System is a family of nails for various types of femoral fractures. The system includes Recon Nails in various lengths and diameters (both left and right versions), Lag Screws, Locking Screws, end caps, an Antegrade Set Screw and other accessories for use with the nails.

The T2 Greater Trochanter Nail (GTN) is a cylindrical, cannulated titanium alloy tube, slightly bowed to accommodate the shape of the femur. The T2 GTN may be inserted into the femoral canal using either a retrograde or antegrade surgical approach.

The T2 Ankle Arthrodesis Nail is a fluted, cannulated, titanium alloy nail and has a compression screw to provide internal compression of the upper ankle joint. The nail is inserted using an open or closed technique and can be locked in static, dynamic or compression mode. The T2 Ankle Arthrodesis Nail and accessories are intended for single use only. The T2 Ankle Arthrodesis Nail is available in left and right version in diameters 10 mm to 13 mm with the length ranging from 150 mm to 480 mm in increments of either 20mm or 50 mm. It has a 5 "lateral bend.

The T2 Arthrodesis Nails have a one-piece round profiled shaft design. The nails are cannulated and have a closed-section design with distal rounded end. The T2 Arthrodesis Nail is available in lengths from 540 mm to 780 mm in 40 mm increments, and in diameters from 10 mm to 15 mm.

This document describes the Stryker GmbH T2 Nail Systems, which are intramedullary fixation rods. The submission is a Traditional 510(k) Premarket Notification (K200880).

Here's an analysis of the provided text, focusing on the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria described for this device are not explicitly enumerated in a numerical or pass/fail table format within the provided excerpt. Instead, the "acceptance criteria" are implied by the nature of a 510(k) submission, which aims to demonstrate substantial equivalence to existing legally marketed predicate devices.

The reported device performance is demonstrated by showing that the newer components (IMN Locking Screws) perform equal to or higher than the previously cleared components (T2 Locking Screw) in various test disciplines.

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

• Test Set Sample Size: The document does not specify a numerical sample size for the "computational assessment" or "various test disciplines." It mentions "constructs of T2 nails and IMN Locking Screws" were compared to "constructs of T2 nails used with T2 Locking Screw." For the T2 Femoral Nail System, "new Student t-tests were performed with the corrected data input" and "the 09mm Synthes Solid Femoral Nail (K923580), which was tested in the same manner and statistically compared to the T2 Femoral Nails." These phrases imply testing was conducted on an unspecified number of physical or computational models.
• Data Provenance: The data appears to be from retrospective testing and analysis, as it refers to comparisons with "previously cleared" components and "reevaluation of the dynamic fatigue strength testing." There is no mention of country of origin for the data; typically, such non-clinical testing would be conducted in the manufacturer's R&D facilities or contracted labs, likely within the regions where the manufacturing or development is centered (e.g., Switzerland, as per the Sponsor's address, and/or the US).

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

This submission relies on non-clinical (benchtop) testing and computational assessment, not clinical data or expert visual assessment of medical images for ground truth. Therefore, the concept of "experts" establishing ground truth for a test set in the way it would apply to AI/imaging devices is not directly applicable here. The "ground truth" is defined by the objective, measurable mechanical properties and performance characteristics established through engineering principles and testing standards. Regulatory bodies (like the FDA) evaluate this data.

4. Adjudication Method for the Test Set

Not applicable, as this is non-clinical testing. Adjudication methods like "2+1" or "3+1" are typically used for clinical study data where multiple human readers are involved in assessing outcomes or classifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not conducted. The submission explicitly states: "Clinical testing was not required for this submission." MRMC studies are typically performed for diagnostic or AI devices where human reader performance is a key variable. This device is a mechanical implant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable. The device is a mechanical implant (intramedullary fixation rod), not an algorithm or AI. The performance demonstrated is intrinsic to the device's physical and mechanical properties.

7. The Type of Ground Truth Used

The ground truth for this device's performance is established by objective, measurable mechanical properties and performance characteristics derived from:

• Computational assessments (e.g., "IMN Screws DOF 25-039 Functional Interface Analysis-Locking Screws").
• Mechanical testing (e.g., "dynamic fatigue strength testing").
• Statistical comparisons against predicate devices ("Student t-tests").

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set. The data presented is from verification and validation testing of a mechanical device.

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

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

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The T2 Tibial Nailing System is intended to provide temporary stabilization of various types of fractures, malunion 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
• Pseudoarthodosis and correction osteotomy
• Pathologic fractures, impending pathologic fractures, and tumor resections
• Nonunion and malunion

This Traditional 510(k) submission is being supplied to the US FDA to include a modified targeter device and its components as Class II accessories as part of the Suprapatellar Instrument (SPI) System included in the T2 Tibial Nailing System, previously cleared under K003018 as the Titan Tibial Nail. The T2 Tibial Nailing System was determined substantially equivalent via 510/k) K003018 and included tibial nails and associated accessories such as locking screws. compression screws and end caps. There are three nail designs for the T2 Tibial Nail: Proximal. Standard, and Distal. These T2 tibial nails are fabricated from titanium and are available sterile. The T2 tibia targeter devices are intended to be used as part of the T2 Tibial Nailing System. In addition, this submission addresses a modification made to some components of the targeting device.

Here's an analysis of the provided text regarding the acceptance criteria and study for the T2 Tibial Nailing System:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation of the Acceptance Criteria and Performance:

The primary acceptance criterion used for the T2 Tibial Nailing System, particularly for the modified targeter device and its components, was substantial equivalence to legally marketed predicate devices. This means that the new device, when subjected to the same tests as the predicate, performed comparably and met the established standards. The reported device performance for all non-clinical tests (Stiffness, Bending Load, Torque, Impulse, Drop, Cadaveric) was that the subject device (the modified targeter and its components) was "substantially equivalent to the predicate device currently cleared for marketing."

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

• Sample Size: Not explicitly stated in the provided text for any of the non-clinical tests. For cadaveric testing, a sample size would typically be mentioned, but it is not here.
• Data Provenance: The testing was "Non-clinical laboratory testing" and "Cadaveric Testing." There is no indication of country of origin for the data or whether it was retrospective or prospective, though non-clinical lab and cadaveric testing are inherently prospective in nature.

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

• This information is not applicable (N/A) as no clinical study requiring expert ground truth assessment was performed. The evaluation relied on non-clinical engineering and cadaveric testing, and a determination of substantial equivalence to a predicate device.

4. Adjudication Method for the Test Set

• This information is not applicable (N/A) as no clinical study requiring adjudication of expert opinions was 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

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done.
• This device is a medical implant (intramedullary fixation rod, targeter) and does not relate to AI or human image interpretation. Therefore, this question is not applicable to the submitted information.

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

• No, a standalone (algorithm only) performance study was not done.
• This device is a medical implant and mechanical accessory, not an algorithm or AI device. Therefore, this question is not applicable.

7. The Type of Ground Truth Used

• For the non-clinical tests, the "ground truth" was established by engineering standards and benchmarks derived from the performance of the predicate device. The goal was to demonstrate that the new device's performance (e.g., stiffness, bending load, torque) met or exceeded these established benchmarks, indicating substantial equivalence.
• For the cadaveric testing, the "ground truth" would be related to the anatomical and mechanical outcomes observed during the procedure, demonstrating the device's functional performance in a simulated surgical environment compared to the predicate.

8. The Sample Size for the Training Set

• This information is not applicable (N/A). This device is not an AI/ML algorithm that requires a training set. The evaluation was based on non-clinical testing of physical components.

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

• This information is not applicable (N/A) as there was no training set for an AI/ML algorithm.

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