Search Results

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.

Ask a specific question about this device

The Flow-Nail is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric, intertrochanteric, and high subtrochanteric fractures and combinations of these fractures. The Flow-Nail can also be used to deliver injectable bone void fillers to a surgical site.

The Flow-Nail is a dynamic compression trochanteric nail system and includes an intramedullary nail, a fenestrated lag screw, anti-rotation screw, cortical screws, a cap and accompanying surgical instruments. The Flow-Nail components are made of titanium alloy (Ti-6Al-4V) conforming to ASTM F136. The purpose of this Special 510(k) is to add the 10mm IM Nail to the Flow-Nail System. The IM Nail (10mm) is manufactured from Ti-6Al-4V per ASTM F136. The components are provided non-sterile, for single use, by prescription only.

The provided text is a 510(k) premarket notification letter from the FDA regarding a medical device called "Flow-Nail." It contains information about the device's classification, indications for use, and a summary of the 510(k) submission, including predication and performance testing.

However, the document does not contain any information about an AI-powered device or a study involving acceptance criteria, ground truth, expert readers, or multi-reader multi-case (MRMC) comparative effectiveness studies. The performance testing mentioned is mechanical testing (compression bending strength) per ASTM standards for an intramedullary fixation rod, not an AI or imaging device.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as the necessary information is absent from the provided text.

Ask a specific question about this device