(177 days)
The Syzygy Stabilization System is intended to provide immobilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and/or sacral spine, specifically as follows:
• When intended for pedicle screw fixation of the non-cervical posterior spine in skeletally mature patients the Syzygy Stabilization System is indicated for one of the following: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies); fracture; dislocation; scoliosis; kyphosis; spinal tumor; and/or failed previous fusion (pseudarthrosis).
· In addition, when used as a pedicle screw fixation system, the Syzygy Stabilization System is indicated for skeletally mature patients having degenerative spondylolisthesis with objective evidence of neurologic impairment and/or severe spondylolisthesis (grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; who are receiving fusions using autogenous bone graft only; who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and who are having the device removed after the development of a solid fusion mass.
The Syzygy Stabilization System consists of posted screws, couplers, and associated surgical instruments. The system is used in conjunction with the Amendia Savannah-T pedicle screw and rod system. The Syzygy posted screws are self-tapping with a cancellous thread design. They are available in cannulated and non-cannulated configurations, in a variety of diameters and lengths. The Syzygy posted screws are attached to the pedicles via couplers (medial and cranial) which accept and secure the longitudinal rods to build a rigid construct. The screws and couplers are manufactured from Ti-6AI-4V (ASTM F136) and are provided non-sterile for singleuse.
This document is a 510(k) premarket notification for the Syzygy Stabilization System, a medical device for spinal stabilization. The document does not describe the acceptance criteria or a study proving the device meets those criteria in the context of an AI/algorithm-based device performance evaluation, but rather for a traditional medical device (pedicle screw system).
Therefore, I cannot provide the requested information regarding AI device acceptance criteria and study details. The document focuses on mechanical testing of spinal implants and a cadaveric validation study to demonstrate substantial equivalence to predicate devices, which is typical for a 510(k) submission for this type of hardware.
Specifically, the document states:
- Acceptance Criteria & Device Performance: The document refers to "requirements as established by the test protocol and applicable ASTM standards" for mechanical tests, and "substantially equivalent to the Predicate" for the cadaveric validation study. However, it does not provide a table of numeric acceptance criteria or specific device performance metrics in a way that would be applicable to an AI device.
- Study Types: The studies performed were:
- Static Axial Compression Bending (ASTM F1717-14)
- Static Axial Tension Bending (ASTM F1717-14)
- Static Torsion (ASTM F1717-14)
- Dynamic Axial Compression Bending (ASTM F1717-14)
- Dynamic Axial Tension Bending (ASTM F1717-14)
- A Cadaveric validation study.
- The document does not include information on:
- Sample size used for a test set (in the context of AI data splits)
- Data provenance (country of origin, retrospective/prospective)
- Number or qualifications of experts for ground truth
- Adjudication method
- Multi-reader multi-case (MRMC) comparative effectiveness study
- Standalone algorithm performance
- Type of ground truth (expert consensus, pathology, outcomes data, etc. in an AI context)
- Sample size for a training set
- How ground truth for a training set was established
The information provided pertains to the mechanical and general performance characteristics of a physical spinal implant system, not the performance of an AI or algorithmic medical device.
§ 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.