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

The Zimmer Universal Locking System is a plate and screw system intended for internal fracture fixation. The plate selection consists of dual compression, reconstruction, tubular, straight "T" and "L" plate configurations. Plates accommodate either standard or locking screws via figure-8 shaped holes.

AI/ML Overview

This document is a 510(k) summary for the Zimmer Universal Locking System: 2.7 mm Locking Plates and Screws. It describes a medical device, its intended use, and its comparison to a predicate device. The review of this document indicates some limitations in providing a comprehensive answer to the detailed questions about acceptance criteria and a study that proves device meets criteria, as the document does not contain that level of detail, especially concerning clinical study methodology, statistical analysis, or ground truth establishment relevant for AI/software-as-a-medical-device (SaMD) evaluations.

Here's a breakdown of the information available and what is not explicitly stated in the provided text:

Key Takeaway: This document is a 510(k) premarket notification for a traditional medical device (bone plates and screws), not a software or AI-driven medical device. Therefore, many of the questions related to AI/SaMD study methodologies (like ground truth, expert consensus, MRMC studies, training/test set sample sizes, data provenance for AI models) do not apply directly to this submission. The "Performance Data" section specifically mentions "Non-Clinical Performance and Conclusions," indicating laboratory testing, not clinical studies in the context of typical AI/SaMD evaluations.

Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Stated or Implied)	Reported Device Performance
Safety	"found to be safe"
Effectiveness	"found to be effective"
Substantial Equivalence to Predicate Device (K063303)	"The Zimmer Universal Locking System: 2.7mm plates and screws have the same intended use, similar performance characteristics and are similar in design to the predicate devices." (Confirmed by FDA's substantial equivalence determination)
Material Composition	Tivanium® Ti-6Al-4V Alloy, CP Grade Titanium (Implied criterion met by device description)
Intended Use	Indicated for temporary internal fixation and stabilization of osteotomies and fractures, including: Comminuted, Supracondylar, Extra-articular fractures, Fractures in osteopenic bone, Nonunions, Malunions. (Implied criterion met by device description)
Mechanical Performance (Non-Clinical)	"The results of non-clinical (laboratory) performance testing demonstrate that the device is safe and effective." (Specific quantitative performance metrics or acceptance limits are not provided in this summary.)

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

Sample Size: Not applicable in the context of typical AI/SaMD test sets. The "performance data" refers to non-clinical (laboratory) testing, which would involve a number of physical device samples tested under controlled conditions. The specific number of samples tested is not provided in this summary.
Data Provenance: Not applicable in the context of clinical data for AI/SaMD. The performance data comes from "non-clinical (laboratory) performance testing." The country of origin for this testing is not specified, but the submitter is based in the USA.

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

This question is not applicable to this 510(k) submission. Ground truth established by experts is a concept relevant to the evaluation of AI/software medical devices, which process and interpret data (e.g., images, signals). This device is a physical implant (bone plates and screws). The "ground truth" for its performance would be established through engineering specifications, material science testing, and biomechanical evaluations, not expert clinical consensus on data interpretation.

4. Adjudication Method for the Test Set

This question is not applicable to this 510(k) submission. Adjudication methods (like 2+1, 3+1) are for resolving discrepancies in expert interpretations of data in AI/SaMD studies. The performance assessment here is based on physical/mechanical testing.

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

This question is not applicable to this 510(k) submission. MRMC studies are specific to evaluating the impact of AI in clinical workflows, typically with human readers interpreting cases. This device is a physical implant; it does not involve human readers interpreting data.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable to this 510(k) submission. This is a physical device, not an algorithm.

7. The Type of Ground Truth Used

This question is not directly applicable in the AI/SaMD sense. For a physical device like bone plates and screws, the "ground truth" for its safety and effectiveness is established through:
- Engineering specifications and material properties: Conformance to industry standards, material strength, fatigue life, corrosion resistance, etc.
- Biomechanical testing: Laboratory simulations to demonstrate adequate strength, stiffness, and stability for internal fixation, often comparing against predicate devices or known clinical requirements for bone fixation.
- Clinical experience with predicate devices: The "substantial equivalence" claim relies on the predicate device's established safety and effectiveness.

8. The Sample Size for the Training Set

This question is not applicable to this 510(k) submission. Training sets are used to develop AI/machine learning models. This is a physical device, not an AI model.

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

This question is not applicable to this 510(k) submission, for the same reasons as (8).

Summary of the Study:

The "study" referenced in this 510(k) summary is non-clinical (laboratory) performance testing. The document states:

"The results of non-clinical (laboratory) performance testing demonstrate that the device is safe and effective."

This testing would have involved evaluating the physical and mechanical properties of the Zimmer® Universal Locking System: 2.7 mm Locking Plates and Screws to ensure they met the required specifications for bone fixation. The safety and effectiveness are also substantiated by demonstrating substantial equivalence to a legally marketed predicate device (Zimmer Universal Locking System, 2.7mm Plates and Screws, K063303). The specific details of these laboratory tests (e.g., types of tests, number of samples, exact methodology, detailed results, specific acceptance criteria beyond "safe and effective") are not provided in this public summary document.

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.