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The AUTOBAHN™ Tibial Nail is indicated for stabilization of fractures in skeletally mature patients, specifically fractures of the proximal and distal tibial shaft, open and closed tibial shaft fractures, certain pre- and postisthmic fractures, non-unions, pseudarthrosis, corrective osteotomies, prophylactic nailing of impending pathological fractures, tumor resections, simple long bone fractures, severely comminuted, spiral, large oblique and segmental fractures, polytrauma and multiple fractures, reconstruction, following turnor resection and grafting, supracondylar fractures, and bone lengthening and shortening.

The AUTOBAHN™ Trochanteric Nail is indicated for treatment of fractures in adults and adolescents (12-21 years of age) in which the growth plates have for the following indications: basal neck fractures, fixation of stable and unstable intertrochanteric, and subtrochanteric fractures, pathologic fractures (including prophylactic use) in both trochanteric and diaphyseal regions, combinations of pertrochanteric, basal neck fractures. Iong subtrochanteric fractures, turnor resections, from trauma, nonunions, malunions, and revision procedures.

AUTOBAHN™ Antegrade/Retrograde 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, supracondylar fractures, including those with intra-articular extension, ipsilateral femultibia 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 bone, compound and simple shaft fractures, proximal, metaphyseal, and distal shaft fractures, closed supracondylar fractures involving femoral condyles, comminuted fractures with bone loss, and periprosthetic fractures.

The AUTOBAHN™ Nailing System is a family of intramedullary nails and screws designed to be used for internal bone fixation. The implants are available in various lengths and diameters to accommodate a wide range of patient anatomy. The nails are secured with locking screws and all devices are manufactured from titanium alloy, cobalt chromium molybdenum alloy, or titanium molybdenum alloy, and may include radiolucent PEEK polymer inserts.

This FDA 510(k) summary describes a medical device, the AUTOBAHN™ Nailing System, which is an intramedullary fixation rod. The summary aims to demonstrate its substantial equivalence to previously cleared predicate devices, rather than establishing de novo safety and effectiveness through clinical studies against specific acceptance criteria. Therefore, several aspects of your request (e.g., sample sizes for test/training sets, expert qualifications, MRMC studies, ground truth details) are not explicitly addressed in this type of submission.

However, I can extract the information available from the document that is relevant to acceptance criteria and performance, focusing on the engineering and mechanical testing methods typically used for this class of device.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not specified. The document refers to "engineering analysis and mechanical testing" which typically involves a number of samples tested per identified constraint or critical performance characteristic. Specific sample sizes for each test type (e.g., how many nails/screws for static bending) are not provided.
• Data Provenance: Not applicable in the context of clinical data proving device performance on human subjects. This involves in vitro mechanical testing and engineering analysis. The testing was conducted by Globus Medical Inc. for its device.

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

• Not applicable as this is a mechanical testing and engineering analysis submission, not a study involving human or expert assessment of clinical outcomes or images. "Ground truth" in this context would be the measured mechanical properties of the device and comparison to predicate device characteristics.

4. Adjudication Method for the Test Set

• Not applicable as this device submission relies on mechanical testing and engineering analysis, not expert adjudication of results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No, an MRMC comparative effectiveness study was not done. This submission focuses on the mechanical and technological equivalence of the device, not on diagnostic or clinical effectiveness that would involve human readers.

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

• Not applicable. This device is an intramedullary Nailing System, a physical implant, not a software algorithm.

7. The Type of Ground Truth Used

• The "ground truth" for demonstrating substantial equivalence for this device would be:
  • Mechanical Test Results: The measured mechanical properties (e.g., strength, fatigue life) of the AUTOBAHN™ Nailing System based on standardized testing methods (ASTM F1264).
  • Material Properties: The chemical composition and physical properties of the materials used.
  • Predicate Device Characteristics: The established design, intended use, material composition, function, and range of sizes of the legally marketed predicate devices.
  • Standard Compliance: Adherence to relevant standards like ASTM F1264 and ANSI/AAMI ST-72:2011.

8. The Sample Size for the Training Set

• Not applicable. This is not an AI/ML device that requires training data.

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

• Not applicable. This is not an AI/ML device.

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