(34 days)
When used as a pedicle screw fixation system, the NuVasive SpheRx Spinal 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 the posterior thoracic, lumbar, and sacral spine:
- Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
- Degenerative spondylolisthesis with objective evidence of neurologic impairment
- Fracture
- Dislocation
- Scoliosis
- Kyphosis
- Spinal tumor and/or
- Failed previous fusion (pseudoarthrosis)
The NuVasive SpheRx Spinal System is also indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebral joint in skeletally mature patients receiving fusion by autogenous bone graft, having the device fixed or attached to the lumbar and sacral spine (L3 to sacrum), with removal of the implants after attainment of a solid fusion.
When used as an anterolateral non-pedicle screw system in the thoracic and lumbar spine, the NuVasive SpheRx Spinal System is also intended for the following indications:
- Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
- Spinal stenosis
- Spondylolisthesis
- Spinal deformities
- Fracture
- Pseudoarthosis
- Tumor resection and/or
- Failed previous fusion
The NuVasive SpheRx DBR II System consists of a variety of polyaxial screws, rods, locking nuts, and transverse connectors. Implant components can be rigidly locked into a variety of different configurations to suit the individual pathology and anatomical conditions of the patient.
The provided text describes a 510(k) premarket notification for a medical device called the NuVasive SpheRx DBR II System. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and reported device performance.
Therefore, many of the requested details about acceptance criteria, performance metrics, and study methodologies for proving device performance are not present in this type of regulatory submission. This document primarily focuses on equivalence to an already approved device.
Here's an analysis of the available information:
1. A table of acceptance criteria and the reported device performance
This information is not provided in the document. The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device, not on directly reporting performance against specific acceptance criteria for a new clinical or diagnostic capability. The mechanical testing mentioned (Section G) would have its own acceptance criteria, but these are not detailed in this summary.
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 or not provided. Since no clinical performance study for an AI/diagnostic device is described, there's no "test set" in that context. The document mentions "Mechanical testing was presented" (Section G), but details about the samples used for these tests (e.g., number of implant components, types of forces applied) are not explicitly given in this summary, nor is the provenance.
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)
This information is not applicable or not provided. There is no "test set" requiring expert ground truth in the context of an AI/diagnostic device performance study described here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable or not provided. There is no "test set" requiring adjudication in the context of an AI/diagnostic device performance study described here.
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 or not provided. The device described is a spinal pedicle screw system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable or not provided. The device is a physical implant, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This information is not applicable or not provided. As above, there is no "ground truth" establishment in the context of an AI/diagnostic device performance study described here.
8. The sample size for the training set
This information is not applicable or not provided. The device is a physical implant, not an AI model, so there's no "training set."
9. How the ground truth for the training set was established
This information is not applicable or not provided. As above, there is no "training set" or "ground truth" establishment in this context.
Summary of the Device and Study (as presented in the document):
The NuVasive SpheRx DBR II System is a spinal pedicle screw system. The submission is a 510(k) premarket notification affirming its substantial equivalence to the predicate device, the SpheRx II System.
- Acceptance Criteria for 510(k) Substantial Equivalence: The primary "acceptance criterion" for this type of submission is demonstrating that the new device is as safe and effective as a legally marketed predicate device. This is achieved by showing that it has the same intended use, similar technological characteristics, and that any differences in technological characteristics do not raise new questions of safety or effectiveness.
- Study Proving Acceptance Criteria: The study for this 510(k) submission was a comparison to a predicate device supported by non-clinical mechanical testing.
- Comparison to Predicate: The document states, "The subject SpheRx DBR II System is substantially equivalent to the SpheRx II System currently distributed commercially in the U.S. by NuVasive." It further notes, "The subject device has indications for use identical to those of its predicate, and employs the same principles of operation."
- Mechanical Testing: Section G states: "Summary of Non-Clinical Tests: Mechanical testing was presented." The specific results or methodologies of this testing are not detailed in this summary, but would have been included in the complete 510(k) submission to demonstrate that the new device's mechanical properties are suitable for its intended use and comparable to the predicate.
- Clinical Tests: Section H explicitly states: "Summary of Clinical Tests (Not Applicable)." This confirms that no clinical studies were performed to prove the device's performance because substantial equivalence was demonstrated through comparison to a predicate and non-clinical testing.
§ 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.