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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 having the screws fixed or attached to the lumbar and sacral spine; (c) who are receiving fusions using autogenous bone graft only; 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 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 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 - L3 for the double rod constructs and T5 - L5 for the single rod construct. The 4.75 mm diameter rod system can be used in single and double rod constructs while the 6.35mm 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 Synergy™ Spinal System components are grouped as follows:

Posterior Application:

1. Integral™ Open, Closed, Angled Closed and Reduction Screws, Variable Locking Screws with Variable Locking Seats, and Iliac Screws, with Hex Nuts and Set Screws. Only the Integral™ Open, Closed, Reduction and Variable Locking Screws are intended for pedicle fixation.
2. Open and Closed Spinal Hooks with Sliders, C-rings and Set Screws.
3. Adjustable and Fixed Transverse Connectors with Set Screws.
4. Closed and Axial Rod Connectors with Set Screws.
5. Lateral Connectors with Set Screws.
6. Rods.
7. Instruments.
8. Sterilizer case(s).

Anterior Application:

1. Integral™ Open and Closed Screws and Variable Locking Screws with Variable Locking Seats, with Hex Nuts and Set Screws.
2. Vertebral Washers.
3. Fixed Transverse Connectors with Set Screws.
4. Rods.
5. Instruments.
6. Sterilizer case(s).

NOTE: While the Variable Locking Screws and some fasteners (nut and set screws) are used for both the 6.35mm and 4.75mm rod sizes, the remaining components (except for those connector components that are designed to join the two rod sizes) are designed for specific rod diameters.

The medical device in question is the Synergy™ Adjustable Length Rod, a component of the Synergy™ Spinal System.

Here's an analysis of its acceptance criteria and the study that proves its performance, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

• Note: The document does not specify quantitative acceptance criteria (e.g., specific load cycles, displacement limits) for "functional requirements" or "fatigue testing." It only states that the device "meets or exceeds" them.

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

• Sample Size: The document does not explicitly state the sample size (number of devices or tests performed) for the unilateral construct fatigue testing. It refers to "Data regarding the functional performance...have been generated," implying multiple tests.
• Data Provenance: Not specified. It's likely that the testing was conducted internally by Interpore Cross International or a contracted lab, but the country of origin is not mentioned. The testing is nonclinical, not involving human subjects, therefore, no retrospective or prospective human data is involved.

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

• This question is not applicable as the study described is a nonclinical, mechanical performance test, not a study involving human subjects or requiring expert interpretation of medical data (like imaging or pathology). The "ground truth" for mechanical testing is established by engineering standards and test methodology.

4. Adjudication Method for the Test Set:

• This question is not applicable for the same reasons as point 3. Adjudication methods are relevant for studies comparing human interpretations, typically in clinical settings.

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

• No, an MRMC comparative effectiveness study was not done. The document describes nonclinical mechanical testing, not a clinical study involving human readers or patient cases.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

• This question is not applicable. The device is a physical spinal implant, not an algorithm or AI system.

7. The Type of Ground Truth Used:

• The "ground truth" for this nonclinical study was engineering standards and established mechanical testing protocols for spinal implants, specifically focusing on fatigue resistance. The device's performance was compared against these predefined functional requirements.

8. The Sample Size for the Training Set:

• This question is not applicable as there is no mention of a training set. The study described is a mechanical performance test, not a machine learning study that would involve training data.

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

• This question is not applicable for the same reasons as point 8.

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