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The StabiLink™ MIS Spinal Fixation System is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1-S1). It is intended for plate fixation/ attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radio-graphic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); tumor. It is not intended for stand-alone use.

Device Description

The Stabilink™ MIS Spinal Fixation System is a posterior, non-pedicle supplemental fixation device, intended for use in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion. The system is implanted via a posterior approach to the spine. The StabiLink™ MIS Spinal Fixation System includes various sizes of Titanium plate constructs. There is instrumentation for implantation and a sterilization tray for steam sterilization. The implants are non-sterile and single use. The instrumentation is non-sterile and reusable.

AI/ML Overview

The provided text describes a 510(k) summary for a medical device called the "StabiLink™ MIS Spinal Fixation System." This document does not describe the acceptance criteria and study for an AI/ML device but rather a traditional spinal fixation system. As such, many of the requested elements for AI/ML device evaluation are not applicable.

However, I can extract information relevant to the performance evaluation for this traditional medical device:

1. Table of Acceptance Criteria and Reported Device Performance

For this traditional medical device, the "acceptance criteria" are implied by the performance standards and comparison to predicate devices, rather than explicit numerical thresholds for metrics like sensitivity or specificity. The study aims to demonstrate substantial equivalence to legally marketed predicate devices.

Acceptance Criteria (Implied)	Reported Device Performance
Meets ASTM F1717 standard for posterior non-cervical non-pedicle systems.	The StabiLink™ MIS Spinal Fixation System was tested to the ASTM F1717 standard.
Performance in static and dynamic axial compression bending equivalent or better than predicate devices.	Results from direct comparison demonstrate substantial equivalence for static and dynamic axial compression bending.
Performance in static and dynamic torsion equivalent or better than predicate devices.	Results from direct comparison demonstrate substantial equivalence for static and dynamic torsion.
Performance in static tension testing (using foam blocks) equivalent or better than predicate devices.	Results from direct comparison demonstrate substantial equivalence for static tension testing.
Adequate resistance to lateral loading of component interconnection mechanisms (dissociation testing).	Dissociation testing was completed. (Implied adequate performance as part of overall substantial equivalence conclusion).
Same intended use and indications for use as predicate systems.	The StabiLink™ MIS Spinal Fixation System has the same intended use and indications for use.
Same or very similar technological characteristics and principles of operation as predicate systems.	The StabiLink™ MIS Spinal Fixation System has the same or very similar technological characteristics and principles of operation.
Minor differences do not raise issues of safety or effectiveness.	The minor differences do not raise any issues of safety or effectiveness.

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

This is not applicable as the study involves mechanical testing of a physical device, not an AI/ML model evaluating patient data. The "test sets" would be the physical implants subjected to various loads. The provenance would be the materials and manufacturing process of the device itself.

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

Not applicable. "Ground truth" in this context refers to the physical properties and performance of the device under specific test conditions, which are measured using standardized engineering methods, not human expert interpretation of data.

4. Adjudication Method for the Test Set

Not applicable. This concept is relevant for studies involving human interpretation or subjective assessment. Mechanical testing relies on objective measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is for evaluating human reader performance with and without AI assistance, which is not relevant to a physical spinal fixation device.

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

Yes, in a sense. The "standalone" performance here refers to the device's mechanical performance under specified test conditions, independent of human interaction during operational use beyond implantation. The study focused on the physical characteristics and performance of the device itself.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance evaluation is established by standardized mechanical testing protocols (e.g., ASTM F1717) using specific testing equipment and methods. The measurements produced by these tests (e.g., load-to-failure, displacement, fatigue life) are compared against the performance of predicate devices.

8. The Sample Size for the Training Set

Not applicable. There is no concept of a "training set" for a traditional mechanical device like this.

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

Not applicable. There is no training set. The "ground truth" for the performance evaluation is established by the results of the standardized mechanical tests and the comparative performance against the predicate devices.

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