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The SYNERGY Spinal System implants are intended to be used as a temporary construct that assists normal healing and are not intended to replace normal body structures. They are intended to stabilize the spinal operative site during fusion procedures and should be removed after fusion.

The implants are attached to the spine posteriorly by means of hooks and/or screws joined with rods and anteriorly by means of vertebral screws joined with rods.

As a pedicle screw system the SYNERGY Spinal System is intended only for patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the screws fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass. The levels of screw fixation are L3 to S1/Ilium.

In addition, the pedicle screw system may also be used 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 spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

As a posterior, non-pedicle, screw and hook system, and an anterolateral, intervertebral body screw system, the specific indications for the SYNERGY Spinal System are:

1. Degenerative Disc Disease (as defined by chronic back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies).
2. Idiopathic scoliosis.
3. Kyphotic deformities of the spine.
4. Paralytic scoliosis and/or pelvic obliquity.
5. Lordotic deformities of the spine.
6. Neuromuscular scoliosis associated with pelvic obliquity.
7. Vertebral fracture or dislocation.
8. Tumors.
9. Spondylolisthesis.
10. Stenosis.
11. Pseudarthrosis.
12. Unsuccessful previous attempts at spinal fusion.

For posterior, non-pedicle, screw use, the SYNERGY screws and lateral connectors are intended for sacral/iliac attachment only, and the SYNERGY hooks and transverse connectors are intended for posterior thoracic and/or lumbar use only. As a whole, the levels of use are T1 to the Sacrum/Ilium.

The Bullet End Rods are intended for use with the Jackson Intrasacral Fixation Technique.

The Adjustable Length Rod is intended for in situ adjustment after placement of the hooks or screws during spinal fusion surgery.

For anterior use, the recommended levels of attachment are: T10 to L3 for the double rod constructs and T5 to L5 for the single rod constructs. The 4.75 mm diameter rod system can be used in single and double rod constructs while the 6.35 mm diameter rod system is to only be used in single rod constructs. In all cases, instrumentation must be at least 1 cm from any major vessel.

The Polaris™ BE Rods are manufactured from CP titanium or stainless steel in a diameter of 6.35mm. Two styles of rods are available, double bullet-ended and single bullet-ended where the opposite end is blunt like standard rods. This tip design facilitates the use of an intrasacral surgical technique (Jackson Intrasacral Fixation Technique). Lengths vary from 6 to 60cm.

This submission is for Polaris™ BE Rods, which are spinal rods made from CP titanium or stainless steel, designed for use in spinal fusion procedures. The submission states that "No clinical testing is necessary for a determination of substantial equivalence." Therefore, there is no study that proves the device meets acceptance criteria.

The following information is what can be extracted from the provided text based on your request, even though the core request regarding acceptance criteria and a proving study is not met by the document.

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable. The submission explicitly states "No clinical testing is necessary for a determination of substantial equivalence." The device is deemed substantially equivalent based on similarities in materials, design, sizing, and indications to predicate devices. There are no explicitly defined acceptance criteria or performance metrics reported from a study within this document.

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

Not applicable. No dedicated test set was used for a study proving acceptance criteria. A paper containing retrospective outcome data for intrasacral rod fixation is mentioned as provided, but details about the sample size, country of origin, or how it relates to proving acceptance criteria for this specific device are not given. This paper is presented as supplementary information rather than a primary study demonstrating performance against acceptance criteria for the Polaris™ BE Rods.

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

Not applicable. No ground truth establishment by experts for a test set is described, as no such study was conducted for this device's substantial equivalence determination.

4. Adjudication Method for the Test Set

Not applicable. No adjudication method is mentioned as no test set was used for a study proving acceptance criteria for this device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

Not applicable. This device is a physical spinal rod, not an AI-assisted diagnostic or therapeutic tool. Therefore, an MRMC comparative effectiveness study with or without AI assistance is irrelevant and not mentioned.

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

Not applicable. This device is a physical spinal rod, not an algorithm.

7. The Type of Ground Truth Used

Not applicable. No ground truth type is specified, as no study requiring ground truth establishment was conducted for this device. The basis for approval is substantial equivalence to predicate devices, focusing on materials, design, sizing, and indications.

8. The Sample Size for the Training Set

Not applicable. There is no training set mentioned, as this device does not involve machine learning or AI.

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

Not applicable. As there is no training set, there is no mention of how ground truth for it was established.

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