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TRIGEN MAX Tibial Nail System:

The TRIGEN MAX Tibial Nail is indicated for stable and unstable fractures that occur in and between the proximal and distal third of the tibia, including the shaft.

INTERTAN MAX Hip Fracture Nail System:

The INTERTAN MAX Nails are indicated for fractures of the femur including:

· Fractures of the femur including simple shaft fractures, comminuted shaft fractures, spiral shaft fractures, and segmental shaft fracture; subtrochanteric fractures; intertrochanteric fractures;

ipsilateral femoral shaft/neck fractures; and intracapsular fractures

• · Polytrauma and multiple fractures
• · Prophylactic nailing of impending pathologic fractures
• · Reconstruction following tumor resection and grafting.

The Smith & Nephew TRIGEN MAX Tibial Nail and INTERTAN MAX Hip Fracture Nail systems consist of implant intramedullary nails, screws, nail caps, buttress plate, washers and their corresponding US Class II instrumentation. The TRIGEN MAX Tibial Nail system is designed to address fractures of the tibia and the INTERTAN MAX Hip Fracture Nail system is designed to address fractures of the proximal femur.

The provided text is an FDA 510(k) clearance letter and associated summary for the TRIGEN MAX Tibial Nail System and INTERTAN MAX Hip Fracture Nail System. This document does not describe a study involving an AI/software device that requires specific acceptance criteria for performance metrics like sensitivity, specificity, or AUC.

Instead, this clearance is for mechanical bone fixation appliances and accessories, which are physical medical devices. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to non-clinical (benchtop) performance evaluations and biocompatibility testing to demonstrate substantial equivalence to predicate devices, not AI algorithm performance.

Therefore, I cannot provide a response with the requested information template (table of acceptance criteria with reported device performance, sample size for test set, number of experts for ground truth, adjudication method, MRMC study, standalone performance, ground truth type, training set sample size, and ground truth establishment for training set) because those metrics and study types are relevant for AI/software medical devices, which this submission is not for.

The document explicitly states: "No clinical tests were performed to support safety and efficacy of the subject devices. The performance bench evaluations and tests were used as a basis for the determination of substantial equivalence. The results of each evaluation or test show that when compared to the predicate devices have demonstrated substantially equivalent performance."

The types of "acceptance criteria" for these devices are related to mechanical properties and material compatibility, derived from standards like ASTM and ISO. These are not presented in a quantitative performance table like for an AI device.

To summarize, based on the provided document:

• This submission is for physical metallic bone fixation appliances, not an AI/software device.
• Therefore, the requested information template for AI device performance and validation studies is not applicable.
• The "studies" performed were non-clinical benchtop tests (e.g., Finite Element Analysis, Insertion/Removal Torque, Fatigue Testing, Biocompatibility).
• The "acceptance criteria" are implied by meeting the requirements of the referenced ASTM and ISO standards for substantial equivalence to predicate devices.

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AUTOBAHN® EVO Femoral Nails are indicated for long bone fracture fixation in skeletally mature patients, specifically femoral fracture fixation, which may include the following: open and closed femoral fractures, pseudoarthrosis and correction osteotomy, pathologic fractures, impending pathologic fractures, tumor resections, supracondylar fractures, including those with intra-articular extension, ipsilateral hip/shaft fractures, ipsilateral femur/tibia fractures, fractures proximal to a total knee arthroplasty, fractures distal to hip joint, nonunions and malunions, poly trauma patients, fractures in the morbidly obese, fractures involving osteopenic and osteoporotic bone, compound and simple shaft fractures, proximal, metaphyseal, and distal shaft fractures, segmental fractures, closed supracondylar fractures, fractures involving femoral condyles, comminuted fractures with bone loss, and periprosthetic fractures. In addition, the AUTOBAHN® EVO Antearade Nails are intended for use in adolescents (12-21 years) in which the growth plates have fused.

The AUTOBAHN® Nailing System is a family of intramedullary nails, screws and washers designed to be used for internal bone fixation. The AUTOBAHN® EVO implants include femoral nails (antegrade and retrograde) and locking screws available in various lengths and diameters to accommodate a wide range of patient anatomy; the nails are secured with locking screws. Washers and nuts are also available. Devices are manufactured from titanium allov, cobalt chrome allov, and stainless steel.

The provided document describes a 510(k) premarket notification for the AUTOBAHN® EVO Femoral Nails and does not contain information about acceptance criteria or a study proving that an AI/device meets such criteria.

The document is a regulatory submission for a medical device (intramedullary fixation rod) and focuses on demonstrating substantial equivalence to previously cleared predicate devices through mechanical testing and comparison of technological characteristics. It does not involve AI, image analysis, or performance metrics typically associated with AI/ML device evaluations. Therefore, I am unable to extract the requested information based on the provided text.

The information sought in your request, such as a table of acceptance criteria, sample size for test sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth establishment, and training set details, are all relevant to the evaluation of AI/ML-based medical devices, which this document does not concern.

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DePuy Synthes Tibial Nail Advanced System:

The Tibial Nail Advanced implants are intended for treatment of fractures in adolescents (12-21) in which the growth plates have fused. Specifically, the implants are indicated for:

• · Open and closed proximal and distal tibial fractures
• Open and closed tibial shaft fractures
• · Tibial malunions and nonunions

DePuy Synthes Locking Screws for Medullary Nails, 4.0 and 5.0 mm:

DePuy Synthes Locking Screws are used for the static and dynamic interlocking of femoral, humeral and tibial nails.

DePuy Synthes Tibial Nail Advanced System:
The DePuy Synthes Tibial Nail Advanced System is a system comprised of intramedullary nails, locking screws, end caps implants, as well as system-specific insertion instruments. The Tibial Nail Advanced System is intended to be used for temporary fixation and stabilization of tibia. This system enables three different surgical approaches for the insertion of the nailing implant in the tibia: suprapatellar. parapatellar, and infrapatellar. The implants are manufactured from titanium alloys and provided in a range of dimensions to match individual patient anatomy. The intramedullary nailing implants are cannulated and can be inserted over a reaming rod. The nailing implants are offered in a range of proximal and distal shaft diameters and lengths to accommodate patient anatomy and surgical need related to the specific fracture patterns and locations. The nails will be manufactured from titanium alloy (Ti-6Al-4V) and polyetherketone (PEEK).

DePuy Synthes Locking Screws for Medullary Nails, 4.0 and 5.0 mm:

The DePuy Synthes Locking Screws for Medullary Nails, 4.0 and 5.0 mm have a diameter of 5 mm available in lengths ranging from 26 up to 120 mm and a diameter of 4 mm available in lengths ranging from 18 up to 80 mm. These implantable devices are fully threaded at the shaft and are self-tapping. The locking screws feature either a standard screw head or a low-profile screw head. The screws are made from titanium alloy (Ti-6Al-7Nb).

This appears to be a 510(k) summary for a medical device (DePuy Synthes Tibial Nail Advanced System and Locking Screws). These submissions typically focus on demonstrating substantial equivalence to a predicate device rather than presenting detailed studies with specific acceptance criteria, sample sizes, and expert adjudication for AI/software performance.

Therefore, the requested information regarding AI/software performance studies, acceptance criteria, sample sizes for test/training sets, expert ground truth establishment, adjudication methods, and MRMC studies is not present in the provided document.

This document describes a traditional medical device (implants and screws for bone fixation) and its non-clinical performance data (mechanical testing, biocompatibility, MRI safety), comparing it to predicate devices. There is no mention of any AI or software component in this device.

Table of Acceptance Criteria and Reported Device Performance:

Since this document describes a physical medical device (implants and screws) and not an AI/software device, the acceptance criteria and performance are based on non-clinical tests comparing it to predicate devices. The document states that the new device is "substantially equivalent" to predicate devices, meaning it performs at least as safely and effectively.

Regarding AI/Software specific questions:

1. Sample size used for the test set and the data provenance: Not applicable. This document does not describe an AI/software device or a test set of data.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth for an AI/software test set is mentioned.
3. Adjudication method for the test set: Not applicable. No adjudication for an AI/software test set is mentioned.
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: Not applicable. No AI component is described.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. No AI component is described.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for these devices would be established by physical measurements and engineering standards.
7. The sample size for the training set: Not applicable. No AI component is described.
8. How the ground truth for the training set was established: Not applicable. No AI component is described.

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