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The Affixus® Tibial Nailing System is indicated for temporary stabilization and fixation of tibial fractures and osteotomies including proximal. metaphyseal. and distal shaft fractures. closed fractures, open fractures, pathologic fractures, non-unions, malunions and deformity corrections.

The Affixus® Antegrade Femoral Nailing System is indicated for temporary stabilization and fixation of femoral fractures and osteotomies including proximal, metaphyseal, and distal shaft fractures, trochanteric and subtrochanteric fractures, closed fractures, pathologic fractures, non-unions, malunions and deformity corrections.

The Affixus Tibial Nailing System and the Affixus Antegrade Femoral (AF) Nailing System are long bone nailing systems that offer implants designed to treat a range of tibial and femoral fractures from simple to complex, with versatile locking options. They restore the shape of preinjured bone and are available in a variety of lengths and diameters to meet assorted anatomical needs. Screws and End Caps are included in the system. All implants are made of Ti-6Al-4V. The Affixus platform of instrumentation is designed to provide options and flexibility for many intraoperative approaches while maintaining ease of use and commonality.

This is a 510(k) premarket notification for a medical device, specifically the Affixus Tibial and Antegrade Femoral Nailing System. These notifications are submitted to the FDA to demonstrate that a device is substantially equivalent to a legally marketed predicate device, meaning it is at least as safe and effective.

The provided text does not contain the detailed information necessary to complete all sections of your request regarding acceptance criteria and a study that proves the device meets those criteria, particularly in the context of an AI/algorithm-based device. This document is for a traditional medical implant, not an AI software as a medical device (SaMD).

Therefore, many of the requested fields are not applicable or cannot be extracted from the given text. However, I can provide information based on what is available.

Here's the breakdown of what can be inferred and what is missing:

Acceptance Criteria and Device Performance Study

As this is a 510(k) for a physical medical implant (intramedullary fixation rod), the concept of "acceptance criteria" and "device performance" in the context of an AI/algorithm is not directly applicable in the same way. Instead, the "acceptance criteria" can be interpreted as demonstrating substantial equivalence to predicate devices through various non-clinical tests. The "device performance" is demonstrated by meeting the standards and benchmarks set by these tests.

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

Explanation of Performance: The document explicitly states: "The information provided herein demonstrates that: any differences do not raise different questions of safety and effectiveness; and the proposed device is at least as safe and effective as the legally marketed predicate devices." This is the ultimate "performance" metric for a 510(k) submission, achieved by passing the listed non-clinical tests and demonstrating material, design, packaging, and sterilization similarity to predicate devices. The specific values or pass/fail thresholds for each test are not provided in this summary, but the successful submission implies they were met.

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

• Sample Size: Not specified in the provided text. For mechanical testing of implants, sample sizes typically adhere to relevant ASTM standards.
• Data Provenance: Not specified in the provided text. These are non-clinical lab tests, so country of origin for "data" is typically the testing lab's location. The tests are prospective in the sense that they are specifically conducted for the 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)

• Not Applicable. This is a physical implant, not an AI/algorithm requiring expert-established ground truth on image data or other patient data. The "ground truth" for these tests are the defined mechanical properties and physical characteristics as per the ASTM standards.

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

• Not Applicable. This is a physical implant. The mechanical tests are objective measurements, not subject to adjudication by human interpreters.

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 is for a physical implant. No AI component is mentioned, and therefore, no MRMC study or human reader improvement with AI assistance is relevant.

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

• Not Applicable. This is for a physical implant. No algorithm is mentioned.

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

• Mechanical Test Standards: The "ground truth" for the non-clinical tests are the specified mechanical properties and performance requirements outlined in the referenced ASTM standards (e.g., ASTM F1264, ASTM F543, ASTM F2182, etc.). These standards define acceptable ranges for strength, fatigue, torque, etc., which the device must meet or exceed.

8. The sample size for the training set

• Not Applicable. This is for a physical implant; there is no "training set" in the context of an AI/machine learning model.

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

• Not Applicable. As there is no training set, this question is not relevant.

Summary of what the document does indicate for this physical device:

The submission highlights that the Affixus Tibial and Antegrade Femoral Nailing System is deemed substantially equivalent to predicate devices based on:

• Similar indications for use.
• Similar technological characteristics (materials, design features, packaging, sterilization).
• Successful completion of a battery of non-clinical mechanical and MR compatibility tests.

The goal of this 510(k) is to demonstrate that the new device does not raise new questions of safety or effectiveness compared to legally marketed predicate devices. The listed non-clinical tests are the evidence used to support this claim.

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The Apex Tibial Nailing system is intended for temporary fixation of the fractures of the tibia. The Apex nail is indicated for used in adult patients for treatment of:

• · Open and closed tibial fractures, including simple, severely comminuted, spiral, large oblique, and segmental fractures;
• · Fractures involving osteopenic or osteoporotic bone;
• · Fractures with bone loss;
• Pseudoarthosis, nonunion, and malunion;
• · Correction osteotomy;
• · Pathologic fractures and prophylactic nailing of impending pathologic fractures; and
• · Reconstruction following tumour resection.

The Apex Tibial Nailing System is a tibial intramedullary fixation system designed to be implanted and interlocked proximally and distally using bone screws by means of a provided reusable surgical instrumentation kit. Like many of the currently-marketed intramedullary nails, the Apex Nail offers several different proximal and distal locking options from which the surgeon may choose, depending on the fracture. An insert within the proximal nail stem maintains the torsional stability of static locking when the construct is locked in a dynamization mode. The Apex Tibial Nailing System includes a tibial nail, bone screws and endcaps of varying sizes. All parts of the system are manufactured from Titanium 6AL4VELi. The Apex Tibial Nail, screw and endcap are available in varying lengths and diameters.

This document describes the regulatory approval for a medical device called the "Apex Tibial Nailing System." It is a 510(k) premarket notification, which means the device is being compared to existing, legally marketed predicate devices to demonstrate substantial equivalence. Therefore, the information provided focuses on comparative data and adherence to established standards rather than a clinical study establishing new performance metrics.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation of "Acceptance Criteria" in this context: For a 510(k) submission, the "acceptance criteria" are typically defined by recognized consensus standards (like ASTM standards) that apply to the device type. The reported performance is the assertion that the device successfully passed these standardized tests and met all specified requirements within those standards.

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

The document does not explicitly state the "sample size used for the test set" in terms of number of devices or clinical cases. The testing described is non-clinical performance testing (mechanical and material testing, per ASTM standards). Therefore, the data provenance is from laboratory testing rather than patient data, and it is retrospective in the sense that the testing was conducted on manufactured devices before this submission.

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

This information is not applicable to this document. The "ground truth" for the non-clinical performance testing is established by the specifications and methodologies outlined in the ASTM standards themselves, rather than through expert consensus on clinical cases.

4. Adjudication Method for the Test Set

This information is not applicable. Since the testing is non-clinical and objective (e.g., strength, fatigue, material composition), an adjudication method for a "test set" in the sense of clinical data interpretation is not relevant.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This submission is for a medical implant and relies on non-clinical performance testing and substantial equivalence to predicate devices, not on AI assistance to human readers.

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

No, a standalone algorithm performance study was not done. This device is a mechanical implant, not an AI or software algorithm.

7. The Type of Ground Truth Used

For the non-clinical performance testing, the "ground truth" is defined by the specifications and requirements within the referenced ASTM standards (ASTM F1264-16 and ASTM F543-07), as well as the parameters for "Full construct fatigue testing." These standards define acceptable material properties, mechanical strength, and fatigue resistance for intramedullary fixation devices and bone screws.

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" in the context of this device, as it is a mechanical implant and not an AI or machine learning model that requires training data.

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

This information is not applicable for the reasons stated above.

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