(133 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 system consists of implants and instruments. The implants consist of monoaxial and polyaxial pedicle screws of varying diameters and lengths, iliac screws, reduction screws, open and closed offset connectors, blockers, pre-contoured and straight Titanium alloy and straight cobalt chromium rods, and transverse connectors of varying lengths. All implants are made of titanium alloy except for the addition of CoCrMo Alloy rods and one commercially pure titanium component within the transverse connectors. Re-usable surgical instruments are provided to facilitate placement of the implants.
The provided document is a 510(k) summary for the Zimmer Spine Instinct™ Java® System. It focuses on the substantial equivalence to predicate devices and does not describe a study involving patient data, clinical outcomes, or human readers for diagnostic purposes with AI assistance. Instead, it relies on engineering testing to demonstrate equivalence. Therefore, some of the requested information, such as expert ground truth, adjudication methods, MRMC studies, standalone performance with patient data, and training set information, is not applicable or available in this document.
Here's the information that can be extracted or deduced from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Methods) | Reported Device Performance (Results) |
|---|---|
| Compliance with ASTM F1717-11a | Performance confirmed through compliance with ASTM F1717-11a |
| Compliance with ASTM F1798-97 (2008) | Performance confirmed through compliance with ASTM F1798-97 (2008) |
| Dynamic and static axial compression bending | Determination of substantially equivalent performance characteristics |
| Static torsion | Determination of substantially equivalent performance characteristics |
| Axial and torsional gripping capacity | Determination of substantially equivalent performance characteristics |
| Flexion-extension moment | Determination of substantially equivalent performance characteristics |
| AP(x) static pullout | Determination of substantially equivalent performance characteristics |
| Validated cleaning and sterilization instructions | Provided for nonsterile components of the system |
2. Sample Size for the Test Set and Data Provenance
This document does not describe a test set involving patient data. The evaluation was based on engineering bench testing of the device components. Therefore, the concept of data provenance (e.g., country of origin, retrospective/prospective) is not applicable in this context. The "sample size" would refer to the number of device components tested, which is not specified but would be in line with the requirements of the ASTM standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. The ground truth for device performance was established through compliance with recognized engineering standards (ASTM F1717-11a and ASTM F1798-97 (2008)) and demonstrated physical characteristics, not expert interpretation of patient data.
4. Adjudication Method for the Test Set
Not applicable, as no human readers or diagnostic interpretations of patient data were involved in establishing the performance of the device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. This document does not describe a clinical study (MRMC or otherwise) involving human readers or AI assistance. The evaluation focuses on the mechanical and material equivalence of the device to predicate devices through engineering testing.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/algorithm-based device in the sense of image analysis or diagnostic decision-making. Its performance is based on mechanical properties and material composition.
7. The Type of Ground Truth Used
The ground truth used was based on engineering standards and physical measurements of the device's mechanical properties, such as axial compression bending, static torsion, gripping capacity, flexion-extension moment, and AP(x) static pullout, as defined by ASTM F1717-11a and ASTM F1798-97 (2008).
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this type of device evaluation.
§ 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.