(72 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 1. degeneration of the disc confirmed by patient history and radiographic studies)
- Degenerative spondylolisthesis with objective evidence of neurologic impairment 2.
- Fracture 3.
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- Dislocation
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- Scoliosis
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- Kyphosis
- Spinal tumor and/or 7.
- Failed previous fusion (pseudoarthrosis) 8.
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:
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- 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 2.
- Spondylolisthesis 3.
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- Spinal deformities
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- Fracture
- Pseudoarthosis 6.
- Tumor resection and/or 7.
- Failed previous fusion 8.
The NuVasive SpheRx System consists of a variety of polyaxial screws, fixed angle 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.
This appears to be a 510(k) summary for a medical device (NuVasive SpheRx System) that is a pedicle screw system, not an AI/ML device. Therefore, the concepts of acceptance criteria, test sets, ground truth, experts, and training sets in the context of an AI/ML study do not directly apply to this document.
The "studies" presented here are non-clinical mechanical tests to demonstrate the structural integrity and performance of the physical implants. The "acceptance criteria" are implied by the successful completion and presentation of these mechanical tests, indicating the device meets established standards for strength, durability, and biocompatibility for spinal implants.
Here's an attempt to interpret your request in the context of the provided document, noting the fundamental difference in the type of device:
Since the provided document is a 510(k) summary for a pedicle screw system (physical implant) and not an AI/ML device, the concepts of acceptance criteria, test sets, ground truth, experts, and training sets as they relate to AI/ML performance are not applicable. The device's performance is assessed through mechanical and material testing, not through algorithmic evaluation on medical images or data.
Therefore, the following information cannot be extracted from the document:
- A table of acceptance criteria and reported device performance for an AI/ML model.
- Sample size used for the test set and data provenance for an AI/ML model.
- Number of experts used to establish ground truth and their qualifications for an AI/ML model.
- Adjudication method for an AI/ML model.
- Multi-reader multi-case (MRMC) comparative effectiveness study and effect size for an AI/ML model.
- Standalone (algorithm only) performance for an AI/ML model.
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for an AI/ML model.
- Sample size for the training set for an AI/ML model.
- How the ground truth for the training set was established for an AI/ML model.
What can be inferred from the document regarding "acceptance" for this physical device:
The "acceptance criteria" for the NuVasive SpheRx System as described in this 510(k) would revolve around its substantial equivalence to a predicate device and the successful completion of non-clinical mechanical tests.
1. Acceptance Criteria and Device Performance (Interpreted for a Physical Device):
| Acceptance Criteria (Implied) | Reported Device Performance (from document) |
|---|---|
| Substantial Equivalence to Predicate Device for Intended Use and Operation | "The subject device has indications for use identical to those of its predicate, and employs the same principles of operation." |
| Mechanical Performance (Strength, Durability, Biocompatibility as per standards) | "Mechanical testing was presented." (Note: Specific results are not detailed in this summary but would have been submitted to the FDA for review and acceptance). |
| Manufacturing Quality Systems | Implied by FDA clearance, which requires compliance with Good Manufacturing Practices (21 CFR Part 820). |
2. Study Proving Acceptance Criteria (Non-Clinical Mechanical Tests):
- Sample size for the test set: Not explicitly stated in this summary. Mechanical tests typically involve multiple samples of components and assembled constructs.
- Data provenance: Not applicable in the geopolitical sense. These are laboratory-generated results from physical testing of device components.
- Number of experts used to establish ground truth: Not applicable. Material and mechanical properties are assessed against engineering standards and specifications.
- Adjudication method: Not applicable. Mechanical test results are quantitative measurements against predefined thresholds.
- MRMC study: Not applicable for a physical implant.
- Standalone performance: The "standalone" performance refers to the device's mechanical integrity as tested in a lab setting, independent of human interaction during testing, but this term is typically used for AI/ML.
- Type of ground truth: Engineering specifications, material properties standards (e.g., ISO, ASTM), and performance data of the predicate device.
- Sample size for the training set: Not applicable (no "training set" for physical implants in this context).
- How the ground truth for the training set was established: Not applicable.
In summary, this document describes a traditional medical device (implantable hardware) clearance process, not the evaluation of an AI/ML medical device. Therefore, the specific questions about AI/ML performance metrics cannot be answered from the provided text.
§ 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.