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The STARFIRE™ Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine:

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;
deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis); .
. tumor;
pseudoarthrosis; and .
. failed previous fusion

Device Description

The Choice Spine STARFIRE™ Pedicle Screw System is a top-loading, polyaxial screw spinal fixation system including polyaxial screws, rods, and connectors. The components are provided clean and non-sterile. Various sizes of the implants are provided.

AI/ML Overview

The following information is extracted from the provided text regarding the Choice Spine STARFIRE™ Pedicle Screw System:

1. Table of Acceptance Criteria and Reported Device Performance

Test Type	Acceptance Criteria (Implied)	Reported Device Performance
Static Compression Bending	Equivalence in bending loads and stiffness to predicate systems.	Cannulated STARFIRE pedicle screw constructs were equivalent, with respect to bending loads and stiffness, to non-cannulated predicate pedicle fixation systems.
Compression Bending Fatigue	Equivalent or greater endurance strength compared to predicate systems.	Cannulated STARFIRE pedicle screw constructs had equivalent or greater endurance strength compared to non-cannulated predicate pedicle fixation systems.
Static Torsional	Ability to resist loads greater than the range required for the human lumbar spine.	Cannulated STARFIRE pedicle screw constructs, without cross-connectors, were able to resist loads greater than the range of resistance required for the human lumbar spine.

2. Sample Size for Test Set and Data Provenance

The document does not explicitly state the sample size used for each specific test or the "data provenance" in terms of country of origin or retrospective/prospective nature. It refers to "Mechanical testing" and "Test results," which implies the testing was conducted on physical samples of the device and predicate devices.

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

This information is not applicable to this type of device. The "ground truth" for the performance tests of a pedicle screw system is based on objective mechanical testing data and established ASTM standards, not expert interpretations of clinical data or images.

4. Adjudication Method for the Test Set

This information is not applicable as the tests are objective mechanical performance tests, not subjective assessments requiring adjudication.

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 typically conducted for diagnostic imaging devices where human readers interpret medical images.

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

No, a standalone algorithm performance study was not done. This device is a physical pedicle screw system, not an AI or software algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the performance of the STARFIRE™ Pedicle Screw System was established through objective mechanical testing according to the guidelines outlined in ASTM F1717-09 "Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model."

8. The Sample Size for the Training Set

This information is not applicable. This device is a physical medical implant, not an AI model or software that requires a "training set."

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

This information is not applicable as there is no "training set" for this device.

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