(17 days)
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, 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:
- Degenerative Disc Disease (as defined by chronic back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies).
- Idiopathic scoliosis.
- Kyphotic deformities of the spine.
- Paralytic scoliosis and/or pelvic obliquity.
- Lordotic deformities of the spine.
- Neuromuscular scoliosis associated with pelvic obliquity.
- Vertebral fracture or dislocation.
- Tumors.
- Spondylolisthesis.
- Stenosis.
- Pseudarthrosis.
- 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:
- Integral™ Open, Closed, Angled Closed and Reduction Screws, Variable Locking Screws with Variable Locking Seats, and Iliac Screws with Nuts and Set Screws. Only the Integral™ Open, Closed, Reduction and Variable Locking Screws are intended for pedicle fixation.
- Open and Closed Spinal Hooks with Sliders, C-rings and Set Screws.
- Adjustable and Fixed Transverse Connectors with Set Screws.
- Closed and Axial Rod Connectors with Set Screws.
- Lateral Connectors with Set Screws.
- Rods and Adjustable Length Rods and Set Screws.
- Instruments.
- Sterilizer case(s).
Anterior Application:
- Integral™ Open and Closed Screws and Variable Locking Screws with Variable Locking Seats, with Nuts and Set Screws.
- Vertebral Washers.
- Fixed Transverse Connectors with Set Screws.
- Rods.
- Instruments.
- Sterilizer case(s).
NOTE: While the Variable Locking Screws and some fasteners (nuts 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.
NOTE: The Adjustable Length Rod is intended for in situ adjustment after placement of the hooks or screws during spinal fusion surgery.
The Adjustable Length Rod is intended for use as part of either a single or double rod assembly. The Adjustable Length Rod allows for distraction at a central location once the bone anchors have been secured.
The provided text describes a 510(k) premarket notification for the Synergy™ Ti Fenestrated Integral™ Open Screws spinal implants and discusses their substantial equivalence to a predicate device. It does not contain information about a study proving the device meets specific acceptance criteria in terms of performance metrics like sensitivity, specificity, or accuracy compared to a ground truth.
Instead, the "nonclinical tests" discussed refer to mechanical testing to ensure the physical properties and strength of the implant.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided text, specific acceptance criteria and performance metrics (e.g., sensitivity, specificity, accuracy) are NOT mentioned for the device itself in a clinical context. The "performance" discussed is related to the mechanical integrity of the implant.
| Acceptance Criteria (Type of Test) | Reported Device Performance |
|---|---|
| Functional Requirements (Mechanical Testing) | "Mechanical testing indicates that the Synergy Ti Fenestrated Integral Open Screws meet or exceed all functional requirements and support their suitability for use." (Qualitative statement) |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable to a clinical or AI performance study. The "test set" in this context refers to the samples used for mechanical testing. The sample size for these mechanical tests is not specified.
The data provenance (country of origin, retrospective/prospective) is not relevant as this is a mechanical engineering evaluation, not a clinical data study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable. "Ground truth" in the context of clinical performance or AI evaluation typically refers to expert diagnoses or pathological findings. For mechanical testing, the "ground truth" is established by engineering standards and test protocols, not human experts making diagnostic judgments on a test set.
4. Adjudication Method for the Test Set
Not applicable to mechanical testing. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among human readers or experts in clinical studies, which is not what was performed here.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done. The submission focuses on demonstrating substantial equivalence through mechanical testing and comparison of design, materials, indications for use, and surgical approach to a predicate device. There is no mention of human readers improving with or without AI assistance.
6. Standalone (Algorithm Only) Performance Study
No standalone performance study (algorithm only) was done. This submission is for a physical medical device (spinal implant), not an algorithm or AI system.
7. Type of Ground Truth Used
For the mechanical testing, the "ground truth" would be the established engineering standards and requirements for spinal implants. There is no mention of expert consensus, pathology, or outcomes data being used as ground truth for evaluating the device's mechanical performance.
8. Sample Size for the Training Set
Not applicable. This is not an AI or machine learning device, so there is no concept of a "training set" in this submission.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an AI/ML model for this device.
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.