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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 AFFIXUS® Natural Nail® System Humeral nails are temporary fixation intramedullary nails designed for fixation and stabilization of fractures or osteotomies of the humerus. They restore the shape of preiniured bone and are available in a variety of lengths and diameters to meet assorted anatomical needs. Nail caps are available to protect the nail threads from tissue ingrowth and extend the nail length if necessary. Each of the intramedullary nails is secured by a series of screws that pass through holes in the nail.

The AFFIXUS Humeral Nails are indicated for use in a variety of fractures, such as:

• · Proximal fractures (proximal short and long nails only)
• · Diaphyseal fractures (proximal long, antegrade/retrograde nails)
• · Open and closed fractures
• · Comminuted fractures
• · Nonunions and malunions
• · Pathologic fractures

The Affixus Natural Nail System Humeral nails are temporary fixation intramedullary nails designed for fixation and stabilization of fractures or osteotomies of the humerus. They restore the shape of preinjured bone and are available in a variety of lengths and diameters to meet assorted anatomical needs.

Nail caps are available to protect the nail threads from tissue ingrowth and extend the nail length if necessary. Each of the intramedullary nails is secured by a series of screws that pass through holes in the nail. Nails and nail caps are made from Tivanium® Ti-6Al-4V alloy. Screws are also made from Tivanium alloy. Package labels indicate the material of each component.

Selected components of the Affixus Natural Nail System are colour coded to aid in identifying which components should be used together. Refer to the colour coding chart and/or surgical technique for more detailed instructions on the use of Affixus Natural Nail System components.

The provided text is an FDA 510(k) clearance letter and a 510(k) Summary for the Affixus® Natural Nail® System Humeral Nail. This device is an intramedullary fixation rod, which is a physical device used for stabilizing fractures.

The requested information (acceptance criteria, study details, sample sizes, expert qualifications, etc.) is typically associated with the evaluation of AI/ML-based medical devices or diagnostic tools, where performance is measured against a ground truth and often involves human reader studies.

For the Affixus® Natural Nail® System Humeral Nail, an intramedullary fixation rod, the concept of "acceptance criteria" and "study that proves the device meets the acceptance criteria" as requested is not applicable in the same way it would be for an AI diagnostic device.

Here's why and how to interpret the provided document:

• This is a physical medical device clearance, not an AI/ML device clearance. The FDA document is about a Class II medical device (intramedullary fixation rod) for fixing humeral fractures not a software.
• Substantial Equivalence: The clearance is based on substantial equivalence to a previously cleared predicate device (K181827). This means the FDA determined the new device is as safe and effective as the predicate without raising new questions of safety or effectiveness.
• Performance Data: The 510(k) Summary explicitly states:
  • "Non-clinical performance and conclusions were not needed for this device."
  • "Clinical data and conclusions were not needed for this device."
  • This is because the device is largely identical to its predicate, and any minor modifications did not warrant new performance data.
• Acceptance Criteria for Physical Devices: For physical devices like this, acceptance criteria typically involve engineering specifications, biocompatibility, mechanical testing (e.g., fatigue, torsional strength, bending strength), and sterilization validation, rather than diagnostic performance metrics like sensitivity, specificity, or AUC against a ground truth. These tests ensure the device meets required functional and safety standards. However, the document states "performance testing" was done to address differences, but it doesn't detail these tests or criteria because no new questions of safety/effectiveness were raised.

Therefore, it is not possible to extract the requested information (table of acceptance criteria, study details, sample sizes, expert qualifications, etc.) from this document for the following reasons:

1. Nature of the Device: It's a physical implant, not a diagnostic AI.
2. Regulatory Pathway: 510(k) clearance based on substantial equivalence, especially for minor modifications, often relies on existing data for the predicate device and does not always require new extensive performance studies for the modified device if no new questions of safety or effectiveness are raised.
3. Explicit Statement: The document clearly states that non-clinical and clinical performance data were not needed for this submission.

In summary, the provided document does not contain the specific type of acceptance criteria and study details (especially related to human-in-the-loop, MRMC, or standalone performance against a ground truth) that would be relevant for an AI/ML diagnostic device. The "performance data" mentioned in the document refers to the demonstration that "any differences do not raise new questions of safety and effectiveness as established with performance testing" and that the devices are "at least as safe and effective as the legally marketed predicate devices." This implies that prior engineering and safety testing for the predicate device were sufficient, and no new, extensive clinical or non-clinical performance studies were required for this specific 510(k) submission to prove substantial equivalence.

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