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The AOS ESTM Retrograde Femoral Nail is intended for use in intramedullary fixation of fractures of the femur to 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 severe comminution and intra- articular extension, ipsilateral femur fractures, bone lengthening, fractures proximal to a total knee arthroplasty or prosthesis, fractures distal to a hip joint, nonunions and fractures resulting from osteoporosis.

The AOS Extended Short™ (ES) Retrograde Femoral Nail is a single use, open reduction and internal fixation device, for the intramedullary fixation of fractures of the femur. The device is meant as a load sharing device, and it may be removed once the fracture has healed. The device consists of a nail, distal captured cortical and cancellous screws, proximal captured cortical screws, a locking spacer, fixation nuts and washers, and end caps.

This document describes the AOS ES™ Retrograde Femoral Nail, a device for intramedullary fixation of femoral fractures. The 510(k) summary provided here focuses on demonstrating substantial equivalence to a predicate device, rather than establishing de novo performance criteria against clinical outcomes. Therefore, the "acceptance criteria" discussed are primarily related to mechanical performance testing for substantial equivalence, not clinical accuracy or diagnostic performance.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly met by demonstrating "substantially equivalent performance" to the predicate device through functional testing and strength comparison analysis. Specific numerical acceptance criteria are not explicitly stated as this is a 510(k) submission for a Class II medical device, generally aiming for equivalence rather than new performance benchmarks.

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

• Sample Size: Not specified. The document only mentions "functional testing and strength comparison analysis" without detailing the number of units tested.
• Data Provenance: This refers to pre-clinical (benchtop) testing, not clinical data, as it's a device for mechanical fixation. Therefore, there's no "country of origin of the data" in the clinical sense, and the testing is inherent to the device's design and manufacturing process. It's a prospective design verification.

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

Not applicable. This is not a diagnostic device requiring expert interpretation of results to establish ground truth. Substantial equivalence was demonstrated through preclinical bench testing, where performance is measured against established engineering and mechanical standards.

4. Adjudication Method for the Test Set

Not applicable. Since the evaluation is based on mechanical performance testing against engineering standards or comparison to a predicate, there's no ambiguity requiring an adjudication method.

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

No, an MRMC comparative effectiveness study was not done. This device is a mechanical implant for fracture fixation, not a diagnostic or AI-assisted imaging device that would typically involve human readers.

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

Not applicable. This is a physical medical device (femoral nail), not an algorithm or AI.

7. The Type of Ground Truth Used

The "ground truth" for this type of device is established through:

• Engineering specifications and design requirements.
• Performance data from the predicate device to which substantial equivalence is being claimed.
• Established mechanical testing standards.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a "training set."

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

Not applicable, for the same reason as point 8.

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The AOS Antegrade and Retrograde Femoral Nail are intended for use in intramedullary fixation of fractures of the femur to 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 severe comminution and intraarticular extension, ipsilateral femur fractures, bone lengthening, fractures proximal to a total knee arthroplasty or prosthesis, fractures distal to a hip ioint, nonunions and malunions, fractures resulting from osteoporosis.

The AOS Humeral Nail is intended to treat stable and unstable proximal fractures of the humerus including two and three, and in some cases, four part humerus fractures. The Humeral Nail is also intended to treat proximal and distal one third fractures, midshaft fractures and pathological fractures.

The AOS Tibial Nail System is intended to provide temporary stabilization of various types of fractures, malunions, and nonunions of the tibia. The AOS Tibial Nail System is indicated for long bone fracture fixation of tibial fractures, which may include the following: transverse, oblique, spiral, segmental and comminuted fractures; fractures with bone loss and bone transport; open and closed fractures, pathologic fractures; corrective osteotomies; pseudarthrosis of the tibial shaft; nonunions, malunions, metaphyseal and epiphyseal fractures.

The AOS Trochanteric Nail is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric, intentrochanteric and high subtrochanteric fractures and combinations of these fractures. The long trochanteric nail is additionally indicated subtrochanteric fractures, pertrochanteric fractures associated with shaft fractures, pathologic fractures (including prophylactic use) in osteoporotic bone of the trochanteric and diaphyseal areas, long subtrochanteric fracture, ipsilateral femoral fractures, proximal and distal non-unions and malunions and revisions procedures.

AOS Nails are intramedullary fixation devices for the temporary fixation of various types of fractures of long bones and are intended as load sharing devices which may be removed once the fracture has healed. The AOS Nail Systems consist of titanium intramedullary nails, proximal and distal locking screws, and end caps.

This Special 510(k) proposes the addition of gamma terminally sterilized nails, screws, and end caps.

This document describes a Special 510(k) premarket notification for AOS Intramedullary Nails, focusing on the addition of gamma terminally sterilized nails, screws, and end caps.

1. Table of Acceptance Criteria and the Reported Device Performance:

The provided text does not include explicit acceptance criteria or reported device performance data in the manner typically seen for performance studies of medical devices that generate quantitative results (e.g., sensitivity, specificity, accuracy for diagnostic devices, or specific mechanical thresholds for implants tested against an established standard).

Instead, the document asserts substantial equivalence to predicate devices. The basis for substantial equivalence is that "The proposed nails have the same indications for use, geometry and design, have the same fundamental scientific technology, and are made of the same material (Ti-6AI-4V ELI, per ASTM F136) as the predicate nails. As detailed in the submission, the proposed nails only differ in sterilization method, which does not change the safety or effectiveness of the nails."

Therefore, the "acceptance criteria" can be inferred as meeting the criteria for substantial equivalence, primarily demonstrating that the change in sterilization method does not alter safety or effectiveness. The "reported device performance" is the assertion of equivalence to predicate devices, implying that their performance characteristics are maintained.

Inferred Acceptance Criteria:

• Maintenance of indications for use.
• Maintenance of geometry and design.
• Maintenance of fundamental scientific technology.
• Maintenance of material (Ti-6AI-4V ELI, per ASTM F136).
• Sterilization method (gamma terminal sterilization) does not negatively impact safety or effectiveness.

Reported Device Performance (based on substantial equivalence claim):

• The device performs effectively for intramedullary fixation of various long bone fractures, aligning with the predicate devices.
• Safety is maintained with the new sterilization method.

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

• Sample Size for Test Set: Not applicable (N/A). This submission is for a Special 510(k) based on substantial equivalence, not a performance study requiring a test set of data. The "test" is primarily a comparison against existing predicate devices and a justification that the change in sterilization does not alter performance.
• Data Provenance: Not explicitly stated as there is no new performance study with a test set. The data provenance implicitly refers to the information and performance of the established predicate devices, which are already legally marketed.

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

• Not applicable (N/A). No test set requiring expert ground truth establishment for performance evaluation is mentioned in this document.

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

• Not applicable (N/A). No test set or adjudication process is described.

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, an MRMC comparative effectiveness study was not done. This device is an intramedullary nail, not an AI-powered diagnostic or assistive tool.

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

• No, a standalone performance study was not done. This device is a surgical implant, not an algorithm.

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

• Not applicable (N/A). No new performance study requiring ground truth is described. The "ground truth" for the device's efficacy and safety is derived from the established performance and regulatory clearance of the predicate devices.

8. The sample size for the training set:

• Not applicable (N/A). This document does not describe a machine learning algorithm or a training set.

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

• Not applicable (N/A). This document does not describe a machine learning algorithm or a training set.

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