(90 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 spinc; (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 houk system, and an anterolateral, intervertebral body screw system, the specific indications for the Synergy Spinal System are:
- Degenerative Disc Disease (as defined by discogenic origin with degeneration of the disc confirmed by hitory and radiographic studies).
- Idiopathic scoliosis.
- Kyphotic deformities of the spine.
- Paralytic scoliosis and/or pelvic obliquity.
- Lordotic deformities of the spinc.
- 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/Hium.
For anterior use, the recommended levels of attachment are: 110 - 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:
- Integrai™ 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.
- 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.
- Instruments.
- Sterilizer case(s).
Anterior Application:
- Integral™ Open and Closed Screws and Variable Locking Screws with Variable Locking Seats, with Hex Nuts and Sct Screws.
- Vertebral Washers.
- Fixed Transverse Connectors with Set Screws.
- Rods.
- Instruments.
- 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.
This document is a 510(k) summary for the Synergy™ D2 Spinal Implants. It focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. Therefore, it does not contain information about a clinical study with acceptance criteria, sample sizes for test or training sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance.
The "discussion of nonclinical tests" section states:
"Data regarding the functional performance of the proposed Synergy D2 Spinal Implants has been generated. Testing included unilateral construct fatiguc testing in axial compression. The data indicates that the proposed Synergy D2 Spinal Implants meet or exceed all functional requirements and support their suitability for use."
Based on this, here's what can be extracted and what information is missing:
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Meet "all functional requirements" for spinal implants | "meet or exceed all functional requirements" |
| Suitability for use as a spinal implant | "support their suitability for use" |
| Pass "unilateral construct fatigue testing in axial compression" | Data generated, and results indicate compliance (specific metrics not provided) |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not applicable. This was a non-clinical, mechanical testing study, not a study involving patient data or a test set in the AI/clinical study sense.
- Data Provenance: N/A (Mechanical testing in a lab setting).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth for mechanical testing is based on engineering specifications and physical measurements, not expert consensus on medical images or clinical outcomes.
4. Adjudication method for the test set:
- Not applicable for this type of non-clinical mechanical testing.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This device is a physical spinal implant, not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is a physical medical device.
7. The type of ground truth used:
- For the mechanical testing, the ground truth would be established by validated engineering standards and specifications for spinal implant performance (e.g., fatigue strength, axial compression limits).
8. The sample size for the training set:
- Not applicable. This is a physical device, not an AI model.
9. How the ground truth for the training set was established:
- Not applicable.
In summary, the provided text describes a 510(k) submission for a physical medical device (spinal implants) based on non-clinical mechanical testing to demonstrate substantial equivalence. It does not involve AI or clinical studies in the way requested by the prompt for AI/diagnostic devices.
§ 888.3070 Thoracolumbosacral pedicle screw system.
(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when 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: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.