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

The AxSOS 3 Ti system (also referred to as "AxSOS 3 Ti Locking Plate System") is a system used for internal fixation applications. The system includes anatomically contoured monoaxial locking plates, screws, blind screws, and auxiliary components. The plates have been designed with holes that can accommodate either locking or non-locking screws, holes for suture and/or Kirschner wires (K-wires). The screws come in 3 types (locking, cortical, and cancellous) and are available in several different diameters and lengths. Implants can be delivered sterile or nonsterile. The various plates and screws are manufactured from titanium alloy (ASTM F-136).

This traditional 510(k) submission is intended to introduce an additional component into the AxSOS 3 Ti System. The Variable Angle Extension Arm connector is an assembly made from an anodized titanium frame (Ti-6Al-4V, ASTM F136) and Co-Cr inlay (ASTM F1537, CoCr28Mo6). These preassembled Variable Angle Extension Arms can be affixed to the previously cleared Distal Lateral Femur Plates, the 5.0 mm narrow waisted compression plates, or the 5.0 mm broad waisted compression plates. The Variable Angle Extension Arms are affixed to the plate using the 4.0 mm blind screw and use a 4.0 mm locking screw to secure it into the desired targeted location of the fragment. These Variable Angle Extension Arms are used for periprosthetic fractures.

AI/ML Overview

The provided document is a 510(k) summary for the AxSOS 3 Ti device, a metallic bone fixation appliance. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting new clinical efficacy studies. Therefore, it does not contain the detailed information typically found in studies designed to prove a device meets specific acceptance criteria for performance in a clinical setting.

Based on the information provided, here's what can be inferred and what is not available:

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

This information is not explicitly provided in the document in the format of a table with specific acceptance criteria and reported device performance. The document states that "Bench testing was conducted comparing the cleared plates and screws with the Variable Angle Extension Arms against the predicate and reference devices." It also lists specific tests related to MR compatibility.

Acceptance Criteria Mentioned (Implicit/General): The implicit acceptance criterion is "substantial equivalence" to the predicate device in terms of design, indications for use, technological characteristics, and performance characteristics.
Reported Device Performance (Implicit/General): "Testing demonstrated that the subject device is substantially equivalent to the marketed predicate device."

For MR compatibility testing, the document lists the types of tests performed:

Magnetically Induced Displacement Force per ASTM F2052
Magnetically Induced Torque per ASTM F2213
Heating by RF Fields per ASTM F2182
Image Artifacts per ASTM F2119

However, the specific numerical results of these tests and the acceptance thresholds are not detailed in this summary.

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

Sample Size: The document does not specify the sample size for the bench testing. It refers to "cleared plates and screws with the Variable Angle Extension Arms" implying a set of device components were tested, but no numbers are given.
Data Provenance: The data provenance for the bench testing is not specified beyond it being "bench testing." It is not clinical data, so country of origin or retrospective/prospective nature is not applicable in the typical sense.

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)

This information is not applicable or provided. Since this is a 510(k) submission primarily relying on bench testing for substantial equivalence, clinical ground truth establishment by medical experts is not discussed.

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

This information is not applicable or provided. Adjudication methods are typically used in clinical studies involving interpretation of data by multiple experts. Since this is bench testing, such a method would not be relevant.

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

MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done.
Effect Size: Therefore, no effect size of human readers improving with or without AI assistance is provided or applicable. The device is a bone fixation appliance, not an AI-assisted diagnostic tool.

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

This information is not applicable. The AxSOS 3 Ti device is a physical medical implant, not an algorithm or software. Therefore, the concept of "standalone performance" for an algorithm is irrelevant.

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

The concept of "ground truth" as typically defined in clinical or AI studies (e.g., expert consensus, pathology) is not directly applicable to this 510(k) submission which focuses on the physical and mechanical properties of an implant. The "truth" in this context is established through engineering and materials standards (e.g., ASTM standards) and direct comparison to a predicate device's established performance through bench testing.

8. The sample size for the training set

This information is not applicable or provided. As this is a physical medical device and not an AI/ML algorithm, there is no "training set" in the computational sense.

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

This information is not applicable or provided for the same reason as point 8.

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.