(91 days)
When used as a pedicle screw fixation system, the NuVasive SpheRx MAS Deformity 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 MAS Deformity 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, reduction screws, offset connectors, 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 510(k) is for the additional sizes of screw shanks, tulips, lock screws, load rings, and split rings that have been added to the SpheRx II-Pedicle Screw System platform and are designated as SpheRx II - MAS Deformity Spinal System.
This document describes a 510(k) premarket notification for the NuVasive SpheRx II - MAS Deformity Spinal System, an orthopedic implant. The information provided focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving enhanced clinical performance or an AI-driven analysis. Therefore, many of the typical acceptance criteria and study details for AI/software as a medical device are not applicable here.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
For this particular device submission (a 510(k) for an orthopedic implant), the "acceptance criteria" are related to demonstrating substantial equivalence in terms of mechanical performance and technological characteristics to an already marketed predicate device.
| Acceptance Criteria (Performance) | Reported Device Performance (as stated in the document) |
|---|---|
| Biomechanical Performance: | |
| Static Compression Strength (per ASTM F1717) | "meets or exceeds the performance of the predicate device" |
| Dynamic Compression Strength (per ASTM F1717) | "meets or exceeds the performance of the predicate device" |
| Static Torsion Strength (per ASTM F1717) | "meets or exceeds the performance of the predicate device" |
| Technological Characteristics: | |
| Design, Intended Use, Material Composition, Function, Range of Sizes | "substantially equivalent and have the same technological characteristics to its predicate devices" |
2. Sample size used for the test set and the data provenance
The document does not specify a "test set" in the context of clinical data or AI model evaluation. The performance data is derived from non-clinical mechanical testing.
- Sample size for mechanical testing: Not explicitly stated in the document. ASTM F1717 standards would typically define the minimum number of samples for such tests.
- Data provenance: Not applicable in the context of country of origin for clinical data or retrospective/prospective study design, as this refers to bench testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable as the "test set" refers to mechanical testing, not a dataset requiring expert annotation for ground truth.
4. Adjudication method for the test set
This information is not applicable as the "test set" refers to mechanical testing, not data requiring expert adjudication.
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
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance, which is not the focus of this 510(k) submission for an orthopedic implant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm performance study was not done. This submission is for a physical medical device (spinal system), not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is established by validated mechanical testing standards (ASTM F1717), not expert consensus, pathology, or outcomes data. The "ground truth" essentially reflects the physical properties and performance characteristics defined by these standards.
8. The sample size for the training set
This information is not applicable. This document describes a physical medical device, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable. As above, there is no AI/ML training set mentioned in this document.
§ 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.