(737 days)
The SYNERGY™ Posterior Spinal System, when using the screws as pedicle screws, 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.
Except for situations where screws are attached to the pedicles of the lumbar and sacral spine via a posterior approach for the treatment of severe spondylolisthesis (Grade 3 and Grade 4) at the L5-S1 vertebral joint, the specific indications for the SYNERGY™ Posterior 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 treated in combination with anterior instrumentation.
- 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.
The SYNERGY™ Posterior Spinal System implants are intended to stabilize the spinal operative site during the development of a solid fusion with bone graft, and are intended to be removed after the development of a solid fusion mass. The implantable portions are made from surgical implant grade stainless steel, commercially pure titanium, and titanium alloy meeting ASTM specifications. The surgical instruments are made from 17-4, 420, 440 and 455 series stainless steels (ASTM F-899-84 and A276-91). Established medical grade plastics (Ultem and Radel) are used to construct the handles, cases, etc. The system is made up of INTEGRAL™ screws, spinal hooks, adjustable and fixed transverse connectors, closed and axial rod connectors, lateral connectors, rods, instruments, and sterilization case(s).
This document is a 510(k) Summary of Safety and Effectiveness for the SYNERGY™ Posterior Spinal System. It describes the device, its intended use, indications, contraindications, and comparisons to predicate devices. However, this document does not contain acceptance criteria or detailed study results demonstrating that the device meets specific performance criteria.
Here's why and what information is missing based on your request:
1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated in the document. For a medical device, these would typically include specific performance metrics like strength, fatigue life, corrosion resistance, biocompatibility, etc., often with numerical thresholds or pass/fail conditions.
- Reported Device Performance: The document mentions that the implants are made from materials meeting ASTM specifications and have "excellent strength, fatigue and corrosion resistance characteristics." It also states "mechanical testing" was done, but no specific results or performance values are provided.
- Missing Information: Quantitative data from mechanical tests (e.g., maximum load at failure, cycles to failure in fatigue tests), specific corrosion rates, or biocompatibility test results.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not mentioned.
- Data Provenance: Not mentioned. It's implied that "mechanical testing" and "pre-production quality assurance planning and engineering analysis" were performed by CROSS® Medical Products, Inc., but details on where (e.g., country) or how (retrospective/prospective) are absent. This document focuses on the summary of safety and effectiveness based on equivalence, not a detailed research study protocol or results.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This device is a surgical implant, not a diagnostic or AI-driven device that requires "ground truth" established by human experts in the context of image interpretation or similar tasks. The "truth" for this device lies in its material properties, mechanical performance, and clinical safety/effectiveness for its intended use, typically assessed through engineering tests and clinical experience with predicate devices.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. See point 3.
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:
- Not Applicable. This is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is not an algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable. For a spinal implant, the "ground truth" for proving substantial equivalence primarily relies on:
- Material Specifications: Adherence to established ASTM standards for surgical implant materials.
- Mechanical Testing: Demonstrating equivalent (or superior) mechanical properties (strength, fatigue) compared to predicate devices, often simulated or in vitro.
- Design Similarity: Comparison of features and dimensions to legally marketed predicate devices.
- Clinical Experience/Literature: Relying on the known safety and effectiveness of the predicate devices for similar indications.
- The document states "mechanical testing" was performed, and "engineering analysis" was used to establish substantial equivalence.
8. The sample size for the training set:
- Not Applicable. This device does not use a "training set" in the machine learning sense. The "training" for such a device typically refers to the accumulated knowledge and design principles from prior similar devices and material science.
9. How the ground truth for the training set was established:
- Not Applicable. See point 8.
In summary:
This 510(k) summary is a regulatory document asserting "substantial equivalence" to predicate devices, a common pathway for medical device approval. It focuses on demonstrating that the new device is as safe and effective as existing legally marketed devices, primarily through:
- Similarity in design and intended use.
- Use of well-known, established materials (meeting ASTM specifications).
- Mechanical testing (though no specific results are provided in this summary).
- Comparison of indications and contraindications.
The level of detail requested in your prompt regarding specific acceptance criteria, test set sizes, ground truth establishment, and MRMC studies is typically found in detailed test reports, design verification and validation documents, or clinical study reports, which are part of the full 510(k) submission but are not always included in the publicly available summary documents.
§ 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.