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

The Stryker Trauma Pelvic Set consists of reconstruction plates, acetabulum plates, and symphysis-pubis plates. All reconstruction plates, acetabulum plates, and symphysis-pubis plates are available in 1.2mm, 2.0mm, and 2.5mm thicknesses. The symphysis-pubis plates are also available in a 12.5mm width and 1.2mm thickness. The subject components vary in length from 20mm to 200mm. The system also includes 3.5mm diameter and 4.5mm diameter screws. All devices in the system are provided both sterile and non-sterile.

AI/ML Overview

This document is a 510(k) Premarket Notification Summary for the Stryker Trauma Pelvic Set, a medical device. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of device performance metrics often associated with AI/ML devices (e.g., sensitivity, specificity, AUC).

Instead, this submission focuses on demonstrating substantial equivalence to a predicate device, which is a regulatory pathway for medical devices in the United States. In this context, "acceptance criteria" are related to satisfying the regulatory requirements to show that the new device is as safe and effective as a legally marketed predicate device.

Here's why the requested information cannot be provided from this document:

AI/ML Device Performance Metrics: The Stryker Trauma Pelvic Set is a set of bone fixation plates and screws, not an AI/ML diagnostic or predictive device. Therefore, metrics like sensitivity, specificity, AUC, or the concepts of "ground truth," "test set," "training set," "experts," or "adjudication methods" as applied to AI/ML performance are not relevant or discussed in this type of submission.
Substantial Equivalence: The "study" mentioned here is the comparison made by the manufacturer to demonstrate substantial equivalence to a predicate device (Synthes Pelvic Implant Set). The "proof" is the argument presented to the FDA that the devices are similar in design, materials, and intended use.
No Clinical Effectiveness Study (in the AI/ML context): This document does not detail a clinical study designed to measure the performance of the device in terms of diagnostic accuracy or a human-AI comparison. Substantial equivalence typically relies on technological comparison and, if needed, non-clinical bench testing or materials testing, rather than large-scale comparative clinical trials for performance metrics.

Based on the provided document, I can only extract information relevant to the regulatory approval process for a traditional medical device, not the performance evaluation of an AI/ML algorithm.

If this were an AI/ML device, the table would look like this (but the data is not available in the provided text):

Acceptance Criteria	Reported Device Performance
[e.g., Sensitivity ≥ X%]	[e.g., Y%]
[e.g., Specificity ≥ Z%]	[e.g., W%]
[Other relevant metrics]	[Reported values]

Here's what can be extracted from the document regarding the device and its regulatory submission:

A table of acceptance criteria and the reported device performance:
- Acceptance Criteria (Regulatory): The primary acceptance criterion for this 510(k) submission is that the Stryker Trauma Pelvic Set is substantially equivalent to the Synthes Pelvic Implant Set in design, materials, and intended use.
- Reported Device Performance: The document states, "The subject components of the Stryker Trauma Pelvic Set are substantially equivalent in design and intended use to the predicate device offered by Synthes." No specific performance metrics (e.g., mechanical strength benchmarks, clinical outcome data) are quantified and presented for comparison against a pre-defined acceptance threshold in this summary. The "performance" is implicitly deemed equivalent to the predicate.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable/Not mentioned in the context of device performance testing. This is a traditional medical device submission, not an AI/ML algorithm requiring a test dataset of patient data. The "test" here refers to the FDA's evaluation of the substantial equivalence claim.
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):
- Not applicable. There is no "test set" in the AI/ML sense, nor is there a "ground truth" established by experts for performance evaluation of a diagnostic or predictive algorithm.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable for a traditional medical device demonstrating substantial equivalence.
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 device is an implantable surgical kit, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a physical medical device, not a standalone algorithm.
The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- Not applicable in the AI/ML sense. The "ground truth" for this submission is the regulatory standard of substantial equivalence, which is assessed against the predicate device.
The sample size for the training set:
- Not applicable. There is no AI/ML model being "trained."
How the ground truth for the training set was established:
- Not applicable.

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.