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

This Traditional 510(k) submission is being supplied to the U.S. FDA to obtain authorization to market additional plates within the AxSOS 3 Ti Locking Plate System. The AxSOS 3 Ti Locking Plate System includes anatomically contoured monoaxial locking plates. The 5.0mm System consists of the Distal Lateral Femur Plates (K123964). The 4.0mm System comprises the Proximal Lateral Tibia Plate, Proximal Medial Tibia Plate, Distal Medial Tibia and Distal Anterolateral Tibia Plate (K123964 & K141121). This submission adds the Proximal Lateral Humerus Plate to the 4.0mm System of the AxSOS 3 Ti Locking Plate System. The system includes three (3) types of screws available in various diameter and thread length: locking, cortical, and cancellous (K 123964 & K133440). The plates have been designed with holes that can accommodate either a locking or non-locking screw at the peri-articular end and along the shaft of the plates also have an oblong hole located at the metaphyseal junction used to aid in positioning. The subject components will be available sterile and non-sterile.

The associated accessories include:

Aiming Block, Proximal Lateral Humerus, Right ●
. Aiming Block, Proximal Lateral Humerus, Left
X-Ray Template, Proximal Lateral Humerus ●
Tag for Proximal Humerus Plate Insert ●
. Proximal Lateral Humerus Insert

AI/ML Overview

The provided text is a 510(k) Pre-market Notification for the AxSOS 3 Ti Locking Plate System. This document focuses on demonstrating substantial equivalence to a predicate device for regulatory approval, rather than describing a study that proves the device meets specific acceptance criteria based on clinical outcomes or AI performance.

Therefore, many of the requested elements are not applicable to the information contained in this FDA submission.

Here's an analysis based on the provided text:

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

The document does not specify quantitative acceptance criteria in terms of clinical performance or a direct comparison of the subject device's performance against such criteria. Instead, it demonstrates substantial equivalence to a predicate device through non-clinical testing.

Acceptance Criteria	Reported Device Performance
Mechanical Properties (Bending Fatigue)	Substantially equivalent to predicate device (Synthes (USA) LCP Proximal Humerus Plates, Long, K041860) as determined by biomechanical testing per ASTM F382-99.
Biocompatibility	Met requirements for Cytotoxicity, Sensitization, and Irritation tests according to FDA Blue Book Memorandum #G95-1 and ISO 10993-1.
Intended Use	Same as the predicate device: long bone fracture fixation (diaphyseal, metaphyseal, epiphyseal, extra- and intra-articular fractures, non-unions and malunions, normal and osteopenic bone, osteotomies).
Technological Characteristics	Similar to predicate device in design, materials (Titanium alloy Ti6Al4V-ELI), and operational principles.

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

Test Set (for non-clinical testing): Not explicitly stated, but the testing would involve a sample of the manufactured plates and screws. The number is typically determined by the testing standard (e.g., ASTM F382-99 requirements).
Data Provenance: The testing was non-clinical laboratory testing. The submission is from Stryker Trauma AG, Switzerland, but the testing itself would likely be conducted in a controlled lab environment, potentially by the manufacturer or a contracted lab. The document does not specify the country of origin of the raw test data. It is prospective testing designed to support regulatory submission.

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 is not applicable. This submission does not involve expert review or establishment of ground truth in the context of diagnostic performance (e.g., for an AI algorithm). The "ground truth" here is the established performance benchmarks of the predicate device and the requirements of recognized standards like ASTM F382-99 and ISO 10993.

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

Not applicable, as this is not a study involving human reader performance or diagnostic accuracy.

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 is a medical device for fracture fixation, not an Artificial Intelligence (AI) diagnostic or assistive tool.

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

Not applicable. This is not an AI algorithm.

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

The "ground truth" in this context refers to:

Mechanical Performance: Established mechanical properties and fatigue limits as defined by the ASTM F382-99 standard and the performance characteristics of the legally marketed predicate device (Synthes (USA) LCP Proximal Humerus Plates, Long, K041860).
Biocompatibility: Criteria outlined in FDA Blue Book Memorandum #G95-1 and the ISO 10993-1 standard.

8. The sample size for the training set

Not applicable. This is not an AI algorithm requiring a training set.

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

Not applicable. This is not an AI algorithm requiring a training set.

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.