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The Stryker Spine TRIO+ Spinal Fixation System is intended for posterior, noncervical pedicle and non-pedicle fixation to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion 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);
• 트 Spondylolisthesis;
• l Trauma (i.e., fracture or dislocation);
• I Spinal stenosis;
• 트 Curvatures (i.e., scoliosis, kyphosis, and/or lordosis);
• . Tumor:
• 트 Pseudoarthrosis; and
• l Failed previous fusion.

The Stryker Spine TRIO+ Spinal Fixation System is intended to be used in conjunction with the OSS/DIAPASON or Opus Rods, Xia pre-bent rods and the Multi-Axis Cross Connector.

This 510(k) is intended to introduce a line extension to the existing TRIO+ Spinal System. The line extension consists of additional lengths for the 4.5 mm diameter and 5.5 mm diameter standard post screws.

The provided text describes a Special 510(k) Premarket Notification for a line extension to the TRIO+ Spinal Fixation System. This is a medical device submission, and the focus of such a submission is to demonstrate substantial equivalence to a legally marketed predicate device, primarily through engineering analysis and comparison of device characteristics and intended use.

Therefore, the concepts of "acceptance criteria," "study that proves the device meets the acceptance criteria," "sample size," "ground truth," "experts," "adjudication," "multi-reader multi-case study," and "standalone performance" do not directly apply in the context of this specific regulatory document.

Medical devices like the TRIO+ Spinal Fixation System are typically evaluated for mechanical performance, biocompatibility, and substantial equivalence to predicate devices. The "study" in this context refers to engineering analyses and testing to ensure the new components meet established standards and perform comparably to existing, approved components.

Here's a breakdown of why these AI/Machine Learning related questions are not applicable to the provided document and what information is present:

Not Applicable AI/Machine Learning Concepts:

• Acceptance Criteria & Reported Device Performance (Table): There are no specific AI model performance metrics (e.g., accuracy, sensitivity, specificity) or "acceptance criteria" for such metrics listed. The "performance" is about mechanical strength, material properties, and functionality of a spinal implant.
• Sample Sized used for the test set and the data provenance: There is no "test set" in the sense of a dataset for an AI model. The "testing" involves mechanical and possibly biological evaluations, not data analysis for AI.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: "Ground truth" in this context would refer to the true state of the spine for diagnostic purposes, which is not what this device is. This device is a treatment system.
• Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
• If a multi reader multi case (MRMC) comparative effectiveness study was done: MRMC studies are for evaluating diagnostic performance of imaging interpretations, often comparing human readers with and without AI assistance. This device is a surgical implant, not a diagnostic tool or AI software.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device, not an algorithm.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): "Ground truth" does not apply in the context of an orthopedic implant.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

What is present in the document related to the device's evaluation:

• Device Name: TRIO+ Spinal Fixation System - Line Extension
• Description of Modification: Additional lengths for 4.5 mm and 5.5 mm diameter standard post screws.
• Intended Use / Indications for Use: Posterior, noncervical pedicle and non-pedicle fixation to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion for various spinal conditions (Degenerative disc disease, Spondylolisthesis, Trauma, Spinal stenosis, Curvatures, Tumor, Pseudoarthrosis, Failed previous fusion).
• Predicate Devices: Stryker Spine TRIO Spinal Fixation System (K052971), Stryker Spine TRIO and TRIO+ Spinal Systems (K062698, K070368), Medtronic Sofamor Danek TSRH Spinal System (K020699, K021170).
• Demonstration of Equivalence: The document states, "Engineering analysis was completed for the subject screw components and demonstrates equivalence to the predicate product as well as compliance with FDA's Guidance for Spinal System 510(k)'s May 3, 2004." This is crucial for a 510(k) submission, as it forms the basis for regulatory clearance. It confirms that the device meets the safety and effectiveness profile of already-approved devices through engineering testing and comparison, not through clinical trials or AI performance evaluations as implied by the questions.
• Regulatory Clearance: The FDA's letter (K100737 dated April 12, 2010) states that the device is "substantially equivalent" to legally marketed predicate devices, allowing it to be marketed.

In summary, the provided text describes a regulatory submission for a physical medical device, not an AI/ML-driven diagnostic or treatment software. Therefore, the questions about AI acceptance criteria, ground truth, expert adjudication, and various study types related to AI performance are not relevant to this document. The "study" mentioned is an "engineering analysis" to demonstrate mechanical and functional equivalence to existing devices.

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