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The Stryker Spine Trio® Plate System is intended for posterior, noncervical (T10-S1) pedical and nonpedical fixation of the spine for the following indications: Degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); Spondylolisthesis; Trauma (i.e., fracture or dislocation); Spinal stenosis; Curvatures (i.e., scoliosis, kyphosis, and/or lordosis); Tumor; Pseudoarthrosis; and Failed previous fusion.

The Stryker Spine Trio® Spinal Fixation System is intended for posterior, noncervical pedicle and non-pedicle fixation of the spine. The Stryker Spine Trio® Spinal Fixation System is indicated for: Degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); Spondylolisthesis; Trauma (i.e., fracture or dislocation); Spinal stenosis; Curvatures (i.e., scoliosis, kyphosis, and/or lordosis); Tumor; Pseudoarthrosis; and Failed previous fusion. The Trio® Spinal Fixation System is intended to be used in conjunction with the OSS Diapason Rods, Opus Spinal System Rods, and the Multi-Axis Cross Connectors.

The Stryker Spine Trio®+ Spinal System is intended for posterior, noncervical pedicle and non-pedicle fixation of the spine. The Stryker SpineTrio®+ Spinal System is indicated for: Degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); Spondylolisthesis; Trauma (i.e., fracture or dislocation); Spinal stenosis; Curvatures (i.e., scoliosis, kyphosis, and/or lordosis); Tumor; Pseudoarthrosis; and Failed previous fusion. The Trio + Spinal System is intended to be used in conjunction with the OSS Diapason Rods, Opus Spinal System Rods, Xia " Pre-bent Rods, and the Multi-Axis Cross Connectors.

Device Description

The Stryker Spine Trio® Plate System is comprised of spinal screws, plates and locking components, fabricated from Titanium alloy.

The Stryker Spine Trio® Spinal Fixation System is comprised of spinal screws, rods, and offset connectors, fabricated from Titanium alloy.

The Stryker Spine Trio®+ Spinal System contains spinal screws, rods, and connectors, fabricated from Titanium alloy.

AI/ML Overview

The provided submission does not include information about acceptance criteria or a study proving the device meets acceptance criteria in the way typically found for AI/ML-based medical devices.

This document describes a 510(k) premarket notification for the Stryker Spine Trio® Plate System, Trio® Spinal Fixation System, and Trio®+ Spinal System. This is a traditional medical device (spinal fixation system) and not an AI/ML-based device. The "study" mentioned refers to mechanical testing in compliance with FDA's Guidance for Spinal System 510(k)s, not a clinical study involving human or AI performance evaluation.

Therefore, the requested information elements related to AI/ML device performance (like sample sizes for test/training sets, experts, adjudication methods, MRMC studies, standalone performance, and ground truth establishment) are not applicable to this submission.

Here's a breakdown based on the characteristics of this traditional medical device submission:

1. Table of Acceptance Criteria and Reported Device Performance

Criteria Category	Acceptance Criteria (N/A for AI/ML)	Reported Device Performance (N/A for AI/ML)
Material Properties	Compatibility with Titanium alloy standards, mechanical strength, fatigue resistance.	Implied: Passed mechanical testing, demonstrating sufficient strength and durability as per FDA guidance for spinal systems. The device is fabricated from Titanium alloy.
Biocompatibility	Biocompatibility with human tissue.	Implied: Met biocompatibility standards for implantable devices made of Titanium alloy, as it's a predicate-based submission.
Sterilization	Ability to be sterilized.	Implied: Sterilization methods are suitable for the device as an implantable medical device.
Functional Equivalence	Equivalent mechanical performance to predicate devices.	Stated: "Testing in compliance with FDA's Guidance for Spinal System 510(k)'s May 3, 2004 was performed... and was presented in their respective predicate 510(k)s."
Indications for Use	Expanded Class III indications (NKB) are appropriate and consistent with predicate devices and FDA guidance.	Stated: The submission "addresses the additional Class III indications associated with product code NKB." The expanded indications were "modeled on the suggested indications for use statement for posterior thoracolumbar systems... suggested by FDA in FDA's 'Guidance for Industry and FDA Staff: Spinal System 510(k)s,' dated May 3, 2004."

Explanation: For this type of traditional spinal implant, the "acceptance criteria" are primarily established through bench testing (mechanical, material, biocompatibility) to demonstrate substantial equivalence to predicate devices and adherence to relevant FDA guidance and recognized standards. The submission highlights that no new components are being introduced; rather, it is seeking approval for additional Class III indications based on existing predicate device testing and FDA guidance. There is no performance reported in terms of diagnostic accuracy or clinical outcomes of the device itself beyond its mechanical integrity and intended use alignment.

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

Not applicable. This submission is for a traditional spinal fixation system, not an AI/ML device that would have a "test set" of data in the AI/ML context. The testing referenced is bench/mechanical testing to demonstrate substantial equivalence.

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)

Not applicable. See point 2.

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

Not applicable. See point 2.

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 not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

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

Not applicable in the AI/ML sense. For this device, the "ground truth" for demonstrating safety and effectiveness relies on established engineering principles, material science, and the functional performance of predicate devices in accordance with FDA guidance for spinal systems. It's about meeting mechanical and material performance specifications rather than diagnostic truth.

8. The sample size for the training set

Not applicable. This is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

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