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

ANCHORMAN is a PEEK cortical tibial suspensory fixation device, and functions via the looping of a biological or artificial tendon graft through the loop component of the device. The tendon graft is then pulled through the tibial and femoral tunnels. The wing components of the device rest on the tibial cortex, facilitating tensioning on the femoral side (if required). The device then provides tibial suspensory fixation, supporting the graft until aperture healing occurs and the graft integrates with the bone, at which point the device does not bear load and is redundant.

AI/ML Overview

This document describes a premarket notification (510(k)) for the ANCHORMAN Tibial Ligament Fixation Device. The submission focuses on demonstrating substantial equivalence to a predicate device, the Arthrex Inc., Retrobutton.

Here's an analysis of the provided information regarding acceptance criteria and the study:

Key Takeaway: The device discussed is a medical implant (Tibial Ligament Fixation Device), not an AI/software as a medical device (SaMD). Therefore, the provided text does not contain information related to AI/SaMD testing methods such as test sets, expert ground truth adjudication, MRMC studies, or standalone algorithm performance. Instead, it focuses on mechanical, chemical, and physical performance of a physical medical device.

Therefore, the requested information regarding AI/SaMD specific testing (points 2, 3, 4, 5, 6, 7, 8, 9) is not applicable to this document. I will answer based on the information that is present for this physical device.

1. Table of Acceptance Criteria and Reported Device Performance

For this medical device, the "acceptance criteria" are implied by demonstrating substantial equivalence to the predicate device in terms of mechanical, chemical, physical, and handling characteristics. The reported device performance is presented in terms of comparative in-vitro testing.

Acceptance Criteria (Implied for Substantial Equivalence to Predicate)	Reported ANCHORMAN Device Performance
Mechanical Characteristics	Comparative in-vitro testing on human cadaveric tibiae was performed. The results for ANCHORMAN were compared to that of the predicate (Retrobutton). The results showed that ANCHORMAN possesses mechanical characteristics necessary to demonstrate substantial equivalence. Specifically, for relevant performance/clinical characteristics which may be affected by size (UTS, initial and cyclic displacement, and stiffness), ANCHORMAN's performance was confirmed to be equivalent with reference to clinically identified failure levels.
Chemical Characteristics	Although ANCHORMAN (made of PEEK) and the predicate (made of UHMWPE and Titanium Ti6Al4V) are composed of different materials and thus have chemical differences, both materials are long-established implant materials. Confirmatory biocompatibility testing verified their suitability. Comparative in-vitro testing further showed that the chemical differences do not raise any new questions of safety and effectiveness.
Physical Characteristics	Although ANCHORMAN and the predicate have different designs and materials, direct comparative performance testing in cadaveric tibiae confirmed that, when considering relevant performance/clinical characteristics affected by size (UTS, initial and cyclic displacement, and stiffness), ANCHORMAN's performance is equivalent with reference to the clinically identified failure levels.
Handling Characteristics	Direct comparative performance testing in human cadaveric tibiae confirmed that, when implanted properly, the relevant performance/clinical characteristics affected by size (UTS, initial and cyclic displacement, and stiffness) are equivalent with reference to the clinically identified failure levels. A cadaveric usability study for ANCHORMAN demonstrated the appropriateness of this technique for users, even in worst-case insertion and removal circumstances. These differences do not raise any new questions of safety and effectiveness.

Regarding AI/SaMD specific questions (Not Applicable to this device):

Sample size used for the test set and the data provenance: Not applicable. (No AI test set).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. (No expert ground truth for an AI test set).
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. (No AI test set adjudication).
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. (No human readers or AI involved with this physical device).
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. (No algorithm).
The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. (The "ground truth" for this device's performance is based on direct mechanical and physical testing against pre-defined clinical failure levels and comparison to a predicate device).
The sample size for the training set: Not applicable. (No AI training set).
How the ground truth for the training set was established: Not applicable. (No AI training set ground truth).

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.