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

The MaxLock Extreme® System Distal Radius Plates and Screws are a modification to the previously cleared Modular Foot System to include site-specific plates and screws for distal radius fixation. The plates are offered in different lengths and sizes. The screws are offered in different diameters and lengths. All implantable components are manufactured from implant grade titanium alloy. The MaxLock Extreme® System Distal Radius Plates and Screws have the same technological characteristics as the predicate devices.

AI/ML Overview

The provided text describes a medical device submission (K102156) for the "MaxLock Extreme® System Distal Radius Plates and Screws." This is a Class II medical device, and the submission is a 510(k) premarket notification, which means the manufacturer is claiming substantial equivalence to an already legally marketed device (predicate device).

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Mechanical Equivalence to Predicate Device	The OrthoHelix plate performed better than the clinically successful legally marketed predicate device.
Screws meet specified requirements for intended use	A screw bending moment study verified that the screws are equivalent to the predicate and meet specified requirements.

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

The text explicitly states: "Mechanical testing was conducted to confirm that the MaxLock Extreme® System Distal Radius Plates and Screws are equivalent to the predicate and meet the specified requirements for their intended use."

Test Set Sample Size: Not specified. The document refers to "mechanical testing" and "a screw bending moment study" but does not provide details on the number of devices or components tested.
Data Provenance: Not specified. The testing was conducted by the submitter (OrthoHelix Surgical Designs, Inc.). The location (e.g., country of origin) of the testing is not mentioned, nor is whether the data is retrospective or prospective. Given it's a device premarket notification, it's generally prospective testing specifically performed for this submission.

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

Number of Experts: Not applicable for this type of submission. Mechanical testing of a medical device (like a bone plate and screws) does not typically involve human experts establishing a "ground truth" in the way clinical studies or diagnostic AI algorithms do. Instead, the "ground truth" or standard for acceptance is based on established engineering principles, regulatory standards, and performance of the predicate device.
Qualifications of Experts: N/A.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. As discussed above, mechanical testing doesn't involve subjective human assessment requiring adjudication. The comparison is against objective, measurable mechanical properties of a predicate device and industry-accepted benchmarks.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices or AI algorithms where human interpretation of images or data is involved. This submission concerns mechanical fixation devices.
Effect Size of Human Readers Improvement with AI: N/A, as no such study was performed or is relevant here.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

Standalone Performance: No, a standalone "algorithm only" study was not done. This device is a physical implant, not a software algorithm.

7. The Type of Ground Truth Used

Ground Truth Type: For mechanical testing, the "ground truth" or benchmark is the performance of the legally marketed predicate devices and generally accepted mechanical performance standards for bone fixation devices. The tests are designed to show that the new device performs at least as well as, or better than, the predicate. The text states: "Mechanical testing was conducted to confirm that the MaxLock Extreme® System Distal Radius Plates and Screws are equivalent to the predicate and meet the specified requirements for their intended use."

8. The Sample Size for the Training Set

Training Set Sample Size: Not applicable. This device is a physical implant, not a machine learning model or algorithm that requires a "training set" in the conventional sense.

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

Ground Truth Establishment for Training Set: Not applicable, as there is no training set for this type of device.

In summary:

This 510(k) submission primarily relies on mechanical testing to demonstrate substantial equivalence of a bone fixation device. The acceptance criteria are that the new device's mechanical properties (like strength and bending moment) are at least equivalent to, or superior to, those of the predicate devices already on the market and meet "specified requirements for their intended use." The study conducted was mechanical testing and a screw bending moment study. No clinical studies involving patients, human readers, or AI algorithms were part of this specific submission to demonstrate substantial equivalence.

Summary

Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.