(312 days)
The Renovis S 100 Pedicle Screw System is 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 thoracic, lumbar, and sacral spine: failed previous fusion (pseudoarthrosis), spinal stenosis, degenerative spondylolisthesis with objective evidence of neurological impairment, spinal deformations such as scoliosis or kyphosis and loss of stability due to tumors or trauma (fracture and dislocation).
When used as a pedicle screw system, the Renovis S 100 Pedicle Screw System is intended for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebrae in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
As a posterior pedicle screw system designed for temporary stabilization of the posterior spine during the development of spinal fusion, the Renovis S 100 Pedicle Screw System is comprised of polyaxial pedicle screws, rods, and crosslinks. The S 100 System can be used for single or multiple level fixations
The screws are a top loading tulip design and are available in multiple diameters and lengths. Reduction screws are available for cases of spondylolisthesis where the short arms of the tulip of the standard screw are not long enough to engage the rods are available in straight and pre-lordosed (curved) configurations. The system also has variable and fixed crosslinks.
The purpose for this Premarket Notification is for the addition of iliac screws and connectors.
Here's a breakdown of the acceptance criteria and the study that proves the S 100 Pedicle Screw System meets them, based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria (Evaluation Metric) | Reported Device Performance (S 100 Pedicle Screw System) |
|---|---|
| Static Compression Strength | Equal to, or higher than, predicate devices |
| Dynamic Compression Strength | Equal to, or higher than, predicate devices |
| Static Torsion Strength | Equal to, or higher than, predicate devices |
Study Details
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- The document does not specify the sample size for the test set (number of devices tested).
- The data provenance is not explicitly mentioned, but the tests were performed "per ASTM F1717," which is an international standard for mechanical testing of spinal implant constructs. Without further information, it's presumed these were laboratory tests rather than human subject data.
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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):
- This is not applicable as the study involved mechanical testing against a standard (ASTM F1717) rather than human interpretation or clinical outcomes requiring expert ground truth.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable for mechanical testing. The results are quantitative and objective based on the ASTM standard.
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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:
- No MRMC study was conducted. The document explicitly states: "No clinical studies were performed." This is a mechanical device, not an AI-driven diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a mechanical pedicle screw system, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for the mechanical performance was the established mechanical properties and performance of legally marketed predicate devices, as well as the specifications outlined in ASTM F1717. The device's performance was compared to these existing standards and predicate devices.
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The sample size for the training set:
- Not applicable. This is a mechanical device, not a machine learning algorithm requiring a training set.
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How the ground truth for the training set was established:
- Not applicable as there was no training set.
Summary of the Study:
The study conducted for the S 100 Pedicle Screw System was a non-clinical, mechanical testing study designed to demonstrate substantial equivalence to predicate devices. The tests were performed according to ASTM F1717, which covers static and dynamic compression, and static torsion for spinal implant constructs.
The acceptance criteria were met by demonstrating that the mechanical performance (static and dynamic compression, static torsion) of the S 100 Pedicle Screw System was equal to, or higher than, the predicate devices. This means the device met or exceeded the established safety and performance benchmarks.
Since this was a physical medical device and not an AI or diagnostic tool, concepts like ground truth established by experts, clinical studies, MRMC studies, or training/test sets for algorithms are not applicable and were explicitly stated as not performed (e.g., "No clinical studies were performed"). The regulatory approval (510(k)) was based solely on demonstrating substantial equivalence through these non-clinical, mechanical tests.
§ 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.