(53 days)
The INNOVERSE Spinal System is a posterior, noncervical pedicle fixation system intended to provide immobilization and stabilization of spinal segments in skeletally-mature patients as an adjunct to fusion by autogenous bone graft in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar and sacral spine:
- Severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra
- Degenerative spondylolisthesis with objective evidence of neurological impairment
- Trauma (i.e., fracture or dislocation)
- Spinal stenosis
- Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
- Tumor
- Pseudoarthrosis
- Failed previous fusion
The INNOVERSE Spinal System is a top-loading multiple component, posterior spinal fixation system and minimally invasive surgery system which consist of variety pedicle screws, rods, set screws, connectors and cross link. Implant components are available in a variety sizes and can be rigidly locked into a variety of different configurations to suit the individual pathology and anatomical conditions of the patient. Pedicle Screw is provided in Modular type (Tulip is provided in a separated state and assembled after screw insertion.) and pre-assembly type (Tulips are supplied assembled.). All pedicle screws have self-tapping function in INNOVERSE Spinal System. The tulip accommodates a 5.5 and 6.0 mm diameter rod in Ti Alloy and CoCr for increased construct rigidity. The INNOVERSE Spinal System allows surgeons to build a spinal implant construct to stabilize and promote spinal fusion. The INNOVERSE Spinal System components are supplied non-sterile, single use and are fabricated from medical grade titanium alloy (ASTM F136) and medical grade cobalt-chromium-molybdenum alloy (ASTM F1537).
The provided document is a 510(k) premarket notification summary for the INNOVERSE Spinal System. The device is a posterior, noncervical pedicle fixation system and is categorized as a Class II medical device. The submission focuses on demonstrating substantial equivalence to a predicate device rather than providing clinical trial data for AI performance. Therefore, many of the requested criteria related to AI device evaluation (such as sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance) are not applicable to this particular document.
Here's a breakdown of the information that can be extracted from the provided text, and where certain requested information is not available:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Performance Testing) | Reported Device Performance |
|---|---|
| Static compression bending (according to ASTM F1717) | "demonstrate that the performance of the INNOVERSE Spinal System is substantially equivalent to the predicate device." |
| Static torsion (according to ASTM F1717) | "substantially equivalent to the predicate device." |
| Compression bending fatigue (according to ASTM F1717) | "substantially equivalent to the predicate device." |
| Axial gripping capacity (according to ASTM F1798) | "substantially equivalent to the predicate device." |
| Axial torque gripping capacity (according to ASTM F1798) | "substantially equivalent to the predicate device." |
Note: The document states that the new device's performance is "substantially equivalent" to that of the predicate device for each test. Specific numerical thresholds or detailed results for individual tests are not provided in this summary but would be present in the full 510(k) submission.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not applicable as this submission is for a mechanical spinal system, not an AI/software device that would typically use data sets for performance evaluation in the way described. The "tests" here refer to mechanical engineering tests of the device itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable for the same reasons as above. Ground truth, in the context of this device, would relate to the physical properties and performance of the hardware, which are evaluated through standardized mechanical testing methods, not expert consensus on data.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable as this submission is for a mechanical spinal system, not an AI/software device. Mechanical tests follow predefined protocols (e.g., ASTM standards) rather than requiring expert adjudication of results in the way clinical data might.
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
This information is not applicable. This is a submission for a spinal implant system, not an AI-assisted diagnostic or therapeutic device that would involve human readers or AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable as this submission is for a mechanical spinal system, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For this mechanical device, the "ground truth" or reference for evaluating its performance comes from established ASTM standards (ASTM F1717, ASTM F1798) and comparison to the predicate device's previously cleared performance.
8. The sample size for the training set
This information is not applicable as this submission is for a mechanical spinal system, not an AI/software device that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable for the reasons stated above.
§ 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.