(42 days)
The Instinct Java spinal fixation system is designed for spinal fixation procedures in skeletally mature patients performed through a posterior approach. The Instinct Java spinal fixation system is indicated for the temporary realignment and stabilization of one or more intervertebral segments from the thoracic spine to the sacrum until bony fusion is obtained.
The Instinct Java spinal fixation system is indicated to achieve bony fusion via osteosynthesis at thoracic, lumbar and/or lumbosacral levels of the spine in documented cases of degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, spinal stenosis, kyphotic or lordotic spinal deformities, scoliosis, tumor and pseudoarthrosis, or for revision of a failed previous fusion.
The Instinct Java System is a temporary implant system used to correct spinal deformity in skeletally mature patients and facilitate the biological process of spinal fusion. This system is intended for non-cervical posterior use in the thoracic, lumbar and sacral areas of the spine. The Instinct Java spinal fixation system is indicated to achieve bony fusion via osteosynthesis at thoracic, lumbar and/or lumbosacral levels of the spine in documented cases of degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, spinal stenosis, kyphotic or lordotic spinal deformities, scoliosis, tumor and pseudoarthrosis or for revision of a failed previous fusion.
The system consists of implants and instruments. The implants consist of monoaxial and polvaxial pedicle screws of varying diameters and lengths, blockers, pre-contoured and straight rods, and transverse connectors of varying lengths. All implants are made of titanium alloy, with the exception of one commercially pure titanium component within the transverse connectors.
Re-usable surgical instruments are provided to facilitate placement of the implants.
In addition, the Instinct Java System is compatible with the transverse connectors currently cleared for the market as part of the Sequoia Spinal System, identified in K082032. Furthermore, the Instinct Java may be connected to the NexLink Band & In-Line Rod Connector, identified in K062505, K060634, K052566, K052247, K031985.
The implants and instruments are provided non-sterile. Instructions for Use are provided that contain validated cleaning and sterilization instructions for the user.
This system is intended to provide stabilization until a solid spinal fusion develops. The system may then be removed, per the surgeon's discretion. This decision should be made based on the risk/benefit ratio for each patient.
The subject of this 510(k) is the addition of screw and rod lengths, an alternative thread design on the pedicle screw head, a new driver, and new instrument containers and implant caddies.
The provided text describes a 510(k) premarket notification for a medical device, specifically the Zimmer Spine Instinct™ Java® System. This document focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria and proving performance through a study in the context of an AI/ML device.
Therefore, the following information cannot be extracted from the provided text:
- Acceptance Criteria and Reported Device Performance (Table): The document does not define specific performance metrics or acceptance criteria for a new device's function, nor does it report the device's performance against such criteria. It focuses on the equivalence of mechanical properties to existing devices.
- Sample size for the test set and data provenance: No test set information is provided.
- Number of experts and qualifications for ground truth: No ground truth establishment is described.
- Adjudication method: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
- Standalone (algorithm only) performance: Not applicable.
- Type of ground truth used: Not applicable.
- Sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
What the document does provide in relation to "acceptance criteria" and "study":
The document states that substantial equivalence was confirmed through mechanical testing, which served as the "study" to demonstrate that the new device meets the performance characteristics of its predicates.
Acceptance Criteria (Implicit) and Reported "Device Performance":
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Conformance with ASTM F-1717:2011a (Dynamic Compression Bending) | Conformed with the requirements of ASTM F-1717:2011a (Dynamic Compression Bending) |
| Conformance with ASTM F-1717:2011a (Static Torsion Testing) | Conformed with the requirements of ASTM F-1717:2011a (Static Torsion Testing) |
| Conformance with ASTM F-1798:97 (2008) (Axial Gripping Capacity) | Conformed with the requirements of ASTM F-1798:97 (2008) (Axial Gripping Capacity) |
| Adequate Static Tightening Torque | Demonstrated adequate static tightening torque |
| Validated cleaning and sterilization instructions | Cleaning and sterilization instructions were validated for non-sterile components |
Explanation:
The "acceptance criteria" in this context are the standards and requirements set forth by the specified ASTM standards and the need for validated cleaning/sterilization. The "reported device performance" is simply that the device conforms to these standards and that the instructions were validated. This is not a quantitative reporting of performance metrics but rather a qualitative statement of compliance.
§ 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.