(84 days)
As a pedicle screw system, it 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; © 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.
As a posterior, non-pedicle screw and hook system, and an anterolateral, intervertebral body screw system, the specific indications 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 levels of use are T1 to the Sacrum/Ilium. For anterior use, the levels of use are T10 to L3 for the double rod constructs, and T5 to L5 for the single rod constructs.
The SYNERGY™ Spinal System is intended to be used a part of a temporary construct that assists normal healing and is not intended to replace normal body structures. It is intended to help stabilize the spinal operative site during fusion procedures. It attaches to the spine posteriorly by means of hooks and/or screws joined with rods and anteriorly by means of vertebral screws joined with rods.
The posterior application components are grouped as follows:
- INTEGRAL TM 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 INTEGRALTM Open, Closed, Reduction and Variable Locking Screws are intended for pedicle fixation (see INDICATIONS).
- 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).
The anterior application components are grouped as follows:
- INTEGRAL™ Open and Closed Screws and Variable Locking Screws with Variable Locking Seats, with Hex Nuts and Set Screws.
- Vertebral Washers.
- Fixed Transverse Connectors with Set Screws.
- Rods.
- Instruments.
- Sterilizer case(s).
Material: The implantable components may be made from either titanium or stainless steel. The titanium version consists of surgical implant grade titanium alloy as described by ASTM Standard F136 (Ti 6A1-4V ELI), and commercially pure titanium, grade 2 as described by ASTM Standard F67 (CP Ti, Gr. 2). The stainless steel version consists of surgical implant grade stainless steel as described by ASTM standard F1314 (22-13-5 Stainless Steel), and surgical implant grade stainless steel as described by ASTM standard F138, Grade 2 (316L Stainless Steel).
The provided text is a 510(k) Summary and FDA clearance letter for the SYNERGY™ Spinal System- Closed VLS™. It describes the device, its indications, and substantial equivalence to previously cleared devices. However, this document does not contain information about acceptance criteria or a specific study proving the device meets those criteria in the way a diagnostic or AI/ML device would.
Instead, the submission for this spinal implant system focuses on demonstrating substantial equivalence to predicate devices. This typically involves showing that the new device has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness compared to a legally marketed predicate device. This is often achieved through engineering analysis, material certifications, and adherence to voluntary performance standards (like ASTM standards for materials) rather than clinical studies with defined acceptance criteria for diagnostic performance metrics.
Since the document does not present acceptance criteria or a study proving the device meets them in the context of diagnostic performance, I cannot fill in the requested table and answer the study-related questions.
Here's a breakdown of why the specific information requested is not present in this type of document:
- Type of Device: This is a spinal implant, a physical medical device for structural support, not a diagnostic or AI/ML product. The regulatory pathway for such devices focuses on bio-compatibility, mechanical integrity, and surgical utility.
- Regulatory Pathway: A 510(k) submission for substantial equivalence generally does not require prospective clinical trials with predefined performance metrics and acceptance criteria like those needed for novel diagnostic devices or pharmaceuticals. The "study" here refers to the engineering analysis and material testing to confirm the device's physical properties are comparable to existing, cleared devices.
- "Acceptance Criteria": For this type of device, "acceptance criteria" would relate to manufacturing quality, material specifications, and mechanical strength testing (e.g., fatigue strength, pull-out strength). These are implied by the use of ASTM standards and in-house SOPs, but specific numerical targets and measured performance data from a single comprehensive study are not typically summarized in the 510(k) summary provided.
- "Reported Device Performance": This would be in terms of its ability to stabilize the spine and the biomechanical integrity of the components, which is implicitly demonstrated through comparison to predicate devices and adherence to material/design standards.
- Clinical Studies (MRMC, Standalone): These are usually relevant for diagnostic devices that produce an output (e.g., an image interpretation, a risk score) that needs to be evaluated against a ground truth. For implants, the "performance" is its physical function in the body.
- Ground Truth: For implants, "ground truth" might relate to successful fusion rates or long-term structural integrity, but these are typically outcomes studied in post-market surveillance or larger clinical trials, not usually part of a 510(k) for substantial equivalence.
- Sample Size (Test/Training Set), Data Provenance, Experts, Adjudication: These terms are applicable to studies validating diagnostic or AI/ML algorithms, not the mechanical and material properties of a spinal implant.
Therefore, I must state that the provided text does not contain the information necessary to fulfill the request as formatted, because the device and regulatory submission type do not align with the questions asked.
§ 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.