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

This submission covers minor design modifications and line extensions of the Zimmer Periarticular Locking Plate System. The Zimmer Periarticular Locking Plate System is a plate and screw system intended for internal fracture fixation. The low-profile locking plates are anatomically contoured and have threaded holes that accept locking screws to create a stable, fixed angle construct.

AI/ML Overview

The provided document describes the predicate device and the Zimmer Periarticular Locking Plate System, but does not provide acceptance criteria or a study demonstrating that the device meets those criteria.

Instead, the document is a 510(k) premarket notification summary, which focuses on demonstrating substantial equivalence to a predicate device. This type of submission relies heavily on non-clinical performance data and does not typically include a detailed report of clinical acceptance criteria met by the device.

Here's what can be extracted and what information is missing based on your request:

Missing Information (Not provided in the document):

1. A table of acceptance criteria and the reported device performance: This document does not specify quantitative acceptance criteria for device performance. It states that "All testing passed" for biocompatibility and that performance testing included "engineering analysis, as well as dynamic/fatigue construct testing, evaluation of screw torsional failure strength, driving torque, and axial pull out strength," and that "the results...demonstrate that the devices are safe and effective and substantially equivalent to the predicate devices." No specific thresholds or performance values are reported to form such a table.
2. Sample size used for the test set and the data provenance: This information is not provided for the non-clinical tests mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as this device does not involve expert-based ground truth establishment in the context of clinical image analysis or diagnostics.
4. Adjudication method for the test set: Not applicable for the non-clinical tests described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, an MRMC study was not done. The document explicitly states: "Clinical data and conclusions were not needed for these devices to show substantial equivalence." This means there was no human-in-the-loop study with human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device (orthopedic plate and screw system), not an algorithm or AI.
7. The type of ground truth used: For the non-clinical tests, the "ground truth" would be established by the physical and mechanical properties being measured and compared against engineering specifications or predicate device performance. For biocompatibility, it's established by ISO standards.
8. The sample size for the training set: Not applicable, as this is a physical medical device, not an AI/ML algorithm requiring a training set.
9. How the ground truth for the training set was established: Not applicable for the same reason as above.

Information provided (related to non-clinical performance):

Device Name: Zimmer® Periarticular Locking Plate System
Purpose of Submission: Minor design modifications and line extensions of the existing Zimmer Periarticular Locking Plate System (K042598, K082078, K111039).
Non-Clinical Performance Tests Performed:
- Shelf Life: Accelerated aging testing
- Biocompatibility: Testing per ISO 10993-1 and Good Laboratory Practices (21 CFR 58)
- Performance Testing: Engineering analysis, dynamic/fatigue construct testing, evaluation of screw torsional failure strength, driving torque, and axial pull out strength.
Conclusion of Non-Clinical Performance: "The results of non-clinical performance testing demonstrate that the devices are safe and effective and substantially equivalent to the predicate devices."
Clinical Data: "Clinical data and conclusions were not needed for these devices to show substantial equivalence."

In summary, the document outlines a 510(k) clearance process based on substantial equivalence to predicate devices, supported by non-clinical testing. It does not provide the kind of detailed acceptance criteria and study results you would expect for a new diagnostic device or AI algorithm, particularly in a multi-reader multi-case or standalone performance context.

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.