(135 days)
The ENNOVATE Spinal System is intended for anterior/anterolateral and posterior, non-cervical pedicle and non-pedicle fixation. Fixation is limited to skeletally mature patients and is intended to be used as an adjunct to fusion using autograft or allograft. The ENNOVATE System can be used in both an Open and Minimally Invasive Surgery (MIS). The device is indicated for treatment of the following acute and chronic instabilities or deformities.
- Degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies).
- Spondylolisthesis,
- Trauma (i.e., fracture or dislocation)
- Spinal Stenosis.
- Deformities or Curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
- Tumor.
- Pseudoarthrosis, and
- Failed previous fusion
The ENNOVATE Spinal System is an implant system used to correct spinal deformity and facilitate the biological process of spinal fusion. This system is intended for posterior use in the thoracic, lumbar and sacral areas of the spine. This system includes polyaxial screws of varying diameters and lengths, rod-to-rod and cross connectors of various styles and lengths. All implant components are top loading and top tightening. The implants in this system are manufactured from titanium alloy (Ti-6Al-4V), conforming to ISO 5832-3.
The ENNOVATE Spinal System is a spinal rod and screw system. This system's polyaxial screws can be rigidly locked into a wide range of configurations, therefore allowing each construct to be formed to the needs of an individual patient. Rods of this system may be shaped intraoperatively to correct or maintain proper spinal curvature.
This document describes a spinal system, not a device that would typically have acceptance criteria and performance metrics in the way an AI/ML or diagnostic device would. This is a 510(k) premarket notification for a medical device called the "ENNOVATE Spinal System," which is a metallic implant system for spinal fusion.
The document focuses on demonstrating substantial equivalence to existing predicate devices, rather than establishing novelty or specific performance criteria like sensitivity, specificity, or accuracy for a diagnostic tool.
Therefore, many of the requested categories are not applicable to this type of device and regulatory submission. I will explain why each category is not applicable and what information is provided in the document.
1. A table of acceptance criteria and the reported device performance
- Not Applicable. For a spinal implant system like the ENNOVATE Spinal System, "acceptance criteria" are typically related to mechanical and material performance standards, not diagnostic accuracy or clinical outcomes in the same way as an AI/ML device. The "performance" reported is compliance with these standards through mechanical testing.
| Acceptance Criteria (Mechanical / Material Standards) | Reported Device Performance |
|---|---|
| Mechanical Testing: | |
| Dynamic/Static compression (ASTM F1717-15) | Testing completed. |
| Static torsion (ASTM F1717-15) | Testing completed. |
| Dynamic compression/tension (ASTM F2193-14) | Testing completed. |
| Dynamic/Static flexion bending (ASTM F1798-13) | Testing completed. |
| Static rod grip (ASTM F1798-13) | Testing completed. |
| Static rod/cross rod torsion (ASTM F1798-13) | Testing completed. |
| Axial compression (ASTM F543-13) | Testing completed. |
| Pull out strength (ASTM F543-13) | Testing completed. |
| Driving torque (ASTM F543-13) | Testing completed. |
| Material Composition: | |
| Titanium alloy (Ti-6Al-4V) conforming to ISO 5832-3 | Meets standard. |
| Medical grade silicone, stainless steel, titanium alloy, and PEEK (for instruments) | Same materials as predicate devices. |
Note: The document states that "All required testing per 'Draft Guidance for the Preparation of Premarket Notifications (510(k)s) Applications for Orthopedic Devices-The Basic Elements' were done where applicable. In addition, testing per the guidance 'Spinal System 510(k)s May 3, 2004' was completed where applicable." This indicates that the device met the performance requirements outlined in these guidance documents, primarily through mechanical testing to demonstrate substantial equivalence.
The following sections are NOT APPLICABLE because this document describes a physical spinal implant system, not a diagnostic AI/ML device requiring clinical performance evaluation with ground truth.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. This is a mechanical device, not an AI/ML diagnostic. No 'test set' of clinical data for diagnostic performance is described. The 'test set' here refers to physical devices tested in a lab.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. Ground truth, in the context of expert review, is for diagnostic devices or AI, not for mechanical spinal implants.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. Adjudication methods are relevant for clinical endpoints or diagnostic interpretations, not for mechanical testing of an implant.
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 specific to AI/ML diagnostic tools, not an orthopedic implant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is specific to AI/ML diagnostic tools.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. Ground truth refers to the definitive determination of a condition for diagnostic purposes. For a spinal implant, the "truth" is whether it meets engineering specifications and functions mechanically as intended.
8. The sample size for the training set
- Not Applicable. This is for AI/ML models. No training set is involved for this mechanical device.
9. How the ground truth for the training set was established
- Not Applicable. As above, no training set or ground truth in this context.
§ 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.