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

This device is also intended to be used as back-up fixation in ACL reconstruction in conjunction with other marketed devices in order to provide additional fixation strength in instances of questionable bone quality.

Device Description

The Arthrotek Resorbable No-Profile LactoSorb® L-15 Screw and Washer consists of a resorbable 6.5 mm screw that varies in length from 25 mm to 55 mm (5 mm increments) and a 18 mm diameter washer with eight spikes on the distal surface. The screw is machined from an 85% L-Lactide/15% Glycolide material that is a high viscosity copolymer. The washer is injection molded from the same material.

AI/ML Overview

The provided text is a 510(k) premarket notification for a medical device, the Arthrotek Resorbable No-Profile LactoSorb® L-15 Screw and Washer. This type of submission typically focuses on demonstrating substantial equivalence to a legally marketed predicate device through non-clinical testing, rather than presenting a clinical study with acceptance criteria and performance metrics for an AI-powered device.

Therefore, most of the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies is not applicable or cannot be extracted from this document.

Here's an analysis of what can be inferred from the provided text, and where the information is unavailable:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics for the device. The "acceptance criteria" for a 510(k) submission like this are demonstrating substantial equivalence to a predicate device.
Reported Device Performance: The document states "Non-clinical testing demonstrated statistical equivalence between this device and the predicate." No specific performance metrics or values are provided in the extracted text.

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

Test Set Sample Size: Not applicable. This was a non-clinical testing (likely mechanical or material testing) and did not involve a "test set" in the context of clinical data or AI evaluation.
Data Provenance: Not applicable. The "testing" referred to non-clinical evaluations.

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

Not applicable. As noted above, this was non-clinical testing, not a study requiring expert-established ground truth.

4. Adjudication Method for the Test Set:

Not applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No. The document explicitly states: "Clinical testing was not used to establish substantial equivalence." This means no human reader studies, with or without AI assistance, were performed or presented for this submission.

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

Not applicable. This is a physical medical device (screw and washer), not an algorithm or AI.

7. The Type of Ground Truth Used:

Not applicable for the reasons stated above. The "ground truth" for this device's approval was its equivalence to a predicate device based on non-clinical (e.g., mechanical, material) testing.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI device, so there is no training set.

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

Not applicable.

In summary, the provided document (a 510(k) premarket notification for a physical medical device) does not contain the type of information requested for evaluating an AI-powered device's performance against specific acceptance criteria in a clinical study setting. The approval was based on demonstrating substantial equivalence through non-clinical testing to a legally marketed predicate device.

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.