FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

This Special 510(k) submission is intended to address a material modification and design modifications to the predicate Trochanteric Gamma® Nail System. The subject device, named the Trochanteric Dyax Nail System, is a line extension of the Trochanteric Gamma® Nail System. The predicate Trochanteric Gamma® Nail System is fabricated from stainless steel. The subject Trochanteric Dyax Nail System is fabricated from titanium alloy. The design change for the nail involves changing the proximal diameter and changing the distal screw hole diameter and configuration. The 5 mm diameter fully threaded locking screws from the T2 Nail System will be compatible with the Trochanteric Dyax Nail.

AI/ML Overview

This 510(k) submission (K013524) describes a line extension of an existing medical device, the Trochanteric Gamma® Nail System. The new device, the Trochanteric Dyax Nail System, is a modification of the predicate device, primarily in the material used (titanium alloy instead of stainless steel) and minor design changes to the proximal diameter and distal screw hole configuration.

Therefore, the submission focuses on demonstrating substantial equivalence to the predicate device, rather than providing extensive de novo clinical studies with detailed acceptance criteria and performance metrics for a novel AI system. The information requested in your prompt (AI-specific details like sample sizes for test/training sets, expert ground truth, MRMC studies) is not applicable to this type of device submission, which is for an orthopedic implant.

Here's an explanation based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria: For a line extension of an orthopedic implant, the primary "acceptance criterion" is demonstrating substantial equivalence to a legally marketed predicate device. This means the new device must have the same intended use, similar technological characteristics, and raise no new questions of safety or effectiveness. The specific criteria typically involve showing that the material change and design modifications do not negatively impact the device's mechanical properties, biocompatibility, and clinical performance when compared to the predicate. This is often established through mechanical testing, material characterization, and biocompatibility testing.
Reported Device Performance: The document does not provide a table of performance metrics in the way one would for an AI device. Instead, the "performance" is implicitly demonstrated by the FDA's finding of substantial equivalence. The summary states: "The subject Trochanteric Dyax Nails are substantially equivalent to the existing design of Trochanteric Gammas Nails which were determined substantially equivalent via the 510(k) process." This statement serves as the "report" that the device meets the criteria for market clearance. Mechanical testing data (fatigue, torsion, bending, etc.) would have been submitted to the FDA to support this claim, but those specific results are not included in this public summary.

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

Not Applicable (N/A) for an AI test set. This is an orthopedic implant. The "test set" would refer to mechanical test specimens, not patient data in the context of AI. The document does not specify the number of mechanical test specimens.
Data Provenance: N/A for AI. For an orthopedic implant, data provenance would relate to the source of materials, manufacturing processes, and potentially, clinical experience with the predicate device (though not a formal "data set" in the AI sense).

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

N/A. Ground truth in the context of AI refers to expert-labeled data. For a mechanical device, performance is evaluated through engineering tests, not expert consensus on images or other data. The "ground truth" would be the measured physical properties and performance under simulated loads.

4. Adjudication Method for the Test Set:

N/A. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among human readers or experts in AI studies. For a mechanical device, test results are typically analyzed against predefined engineering specifications.

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:

N/A. This is a core component of AI device evaluation and is not relevant to a line extension for an orthopedic implant.

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

N/A. This applies to AI algorithms. The Trochanteric Dyax Nail is a physical implant.

7. The Type of Ground Truth Used:

N/A (for AI ground truth). For this device, the "ground truth" for demonstrating substantial equivalence would be:
- Mechanical Test Results: Data from physical tests (e.g., fatigue, static bending, torsional strength) demonstrating that the titanium alloy nail performs comparably or better than the stainless steel predicate.
- Material Characterization: Chemical composition and physical properties of the titanium alloy.
- Biocompatibility Testing: Ensuring the new material is safe for implantation.
- Clinical History of Predicate: The established safety and effectiveness of the existing Trochanteric Gamma® Nail provides the basis for comparison.

8. The Sample Size for the Training Set:

N/A. There is no "training set" for an orthopedic implant.

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

N/A. There is no "training set" for an orthopedic implant.

In summary, the provided document is a 510(k) premarket notification for an orthopedic implant line extension, not an AI device. Therefore, the questions related to AI-specific evaluation methodologies are not applicable. The "study" that proves the device meets acceptance criteria in this context refers to the manufacturing, laboratory testing (mechanical, biocompatibility), and regulatory review process that leads to a substantial equivalence determination by the FDA.

Summary

Regulation Number and Section

§ 888.3020 Intramedullary fixation rod.

(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.