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

LIGAFIX® are resorbable cannulated screws made of ceramic (β-ΤCP) / polymer (Poly Lactic Acid) composite and designed for the interference fixation of grafts in anterlor cruciate ligament reconstruction.

To better fit the surgeon's needs and surgical preferences and patient's anatomy the full range of LIGAFIX Interference screws comprise:

2 material specifications: LIGAFIX® 30 (30% TCP/70% PLA) and LIGAFIX® 60 (60% o TCP/40% PLA)
3 head design: standard reduced -- rounded ಂ
Diameters from 7 mm to 11 mm 0
Lengths from 20 mm to 35 mm ಂ

LIGAFIX® interference screws are supplied sterile and individually packaged In double heat sealed pouches.

AI/ML Overview

This 510(k) Special submission is for an extension of the range of products for the LIGAFIX® Resorbable Interference Screw. It focuses on demonstrating substantial equivalence to previously cleared devices (K050407 and K061262) rather than presenting a de novo study with new acceptance criteria and performance data for a novel device.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment, which are typical for studies validating the performance of a new device, are largely not applicable in the context of this specific 510(k) submission.

This submission asserts that the expanded product range (new material specifications, head designs, diameters, and lengths) of the LIGAFIX® Interference Screws shares the "same fundamental scientific technology, operating principle and intended use" as the predicate devices. The review process for such a submission typically involves evaluating whether the new product variations introduce any new questions of safety or effectiveness that would necessitate new performance studies. Since this document is a 510(k) summary, it doesn't contain detailed study reports.

Here's a breakdown of why most of the requested points cannot be answered from the provided text, and what can be inferred:

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

Not Applicable in this context. The document does not provide a table of acceptance criteria or reported device performance for a new study. The submission relies on the substantial equivalence to previously cleared devices which would have undergone performance testing during their initial clearance. The "performance" being demonstrated here is the similarity to the predicate devices.

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

Not Applicable. No new test set or associated data provenance is mentioned as this is a Special 510(k) for an expansion of an existing device line, not a new device requiring a new clinical or performance study.

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. No test set or ground truth establishment by experts is described in this submission.

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

Not Applicable. No test set or adjudication method 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

Not Applicable. This device is a resorbable interference screw, not an AI-powered diagnostic or assistive technology. Therefore, MRMC studies or AI-related effectiveness are entirely irrelevant.

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

Not Applicable. As above, this is a physical medical device, not an algorithm.

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

Not Applicable. No new ground truth is established for this submission. The "ground truth" for the clearance of the predicate devices would have been based on established engineering principles, biocompatibility testing, mechanical testing, and potentially animal or clinical studies to demonstrate safety and effectiveness for their intended use.

8. The sample size for the training set

Not Applicable. This is not an AI/machine learning device; thus, there is no "training set."

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

Not Applicable. No training set is involved.

Summary

Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.