(62 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 II -Pedicle Screw System consists of a variety of polyaxial screws, rods, locking nuts, and transverse connectors. Implant components can be rigidly lockinto a variety of different configurations to suit the individual pathology and anatomical conditions of the patient.
This document is a 510(k) Premarket Notification for the NuVasive SpheRx II -Pedicle Screw System. It describes the device, its intended use, and its substantial equivalence to a predicate device.
Here's the breakdown of the requested information based on the provided text:
Important Note: This document pertains to a spinal pedicle screw system, which is a medical device for surgical implantation. The concept of "acceptance criteria" and "device performance" in this context refers to the mechanical properties and functionality of the physical implants, not an AI/software-based diagnostic or imaging device. Therefore, many of the requested fields (e.g., sample size for test set, experts for ground truth, adjudication method, MRMC study, training set) typically apply to software-based diagnostic devices and are not applicable here.
1. Table of Acceptance Criteria and Reported Device Performance
The document states that "Mechanical testing was presented" but does not provide specific acceptance criteria or detailed results of this mechanical testing within the provided text. It only indicates that the device is substantially equivalent to a predicate device.
| Acceptance Criteria (If mentioned) | Reported Device Performance (If mentioned) |
|---|---|
| Not specified in the provided text. | Mechanical testing was presented (details not provided). |
2. Sample size used for the test set and the data provenance
- Not Applicable. This is a hardware medical device (spinal screws). The testing would involve mechanical property tests on samples of the device, not a "test set" of patient data or images. The document does not specify the number of device samples tested.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This is a hardware medical device. There is no "ground truth" to be established by experts in the context of diagnostic interpretation for this type of device submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. See point 3.
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 device is a physical implant, not an AI or diagnostic tool. No MRMC study would be performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. See point 5.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable. For this hardware device, "ground truth" would refer to established engineering standards for mechanical properties (e.g., strength, fatigue life, torque), which would be evaluated through physical testing. The document does not detail these standards.
8. The sample size for the training set
- Not Applicable. This is a hardware device. There is no concept of a "training set" for mechanical testing of physical implants.
9. How the ground truth for the training set was established
- Not Applicable. See point 8.
Summary of Study (Based on available information):
The only study mentioned is a non-clinical mechanical testing of the device. The document states:
- Summary of Non-Clinical Tests: "Mechanical testing was presented."
- Summary of Clinical Tests: "(Not Applicable)."
This implies that the device's substantial equivalence and safety/effectiveness were demonstrated through engineering principles, material characterization, and mechanical performance tests, comparing it against the predicate device (SpheRx II System, K061778). No details of the mechanical tests (e.g., specific tests performed, number of samples, results, or acceptance criteria) are provided in the extracted text. The primary "proof" of meeting acceptance criteria (implicitly, the safety and effectiveness standards) is based on its substantial equivalence to the predicate device, which has already met regulatory requirements.
§ 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.