Search Results

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:

1. Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
2. Degenerative spondylolisthesis with objective evidence of neurologic impairment
3. Fracture
4. Dislocation
5. Scoliosis
6. Kyphosis
7. Spinal tumor and/or
8. 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:

1. Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
2. Spinal stenosis
3. Spondylolisthesis
4. Spinal deformities
5. Fracture
6. Pseudoarthosis
7. Tumor resection and/or
8. Failed previous fusion

The NuVasive SpheRx PPS 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.

Here's an analysis of the provided 510(k) premarket notification for the NuVasive SpheRx PPS System, focusing on the requested information regarding acceptance criteria and study details.

Crucial Caveat: This 510(k) submission (K090981) for the NuVasive SpheRx PPS System explicitly states in Section H: "Summary of Clinical Tests (Not Applicable)." This means that no clinical studies were performed or are being presented in this specific 510(k) for this device for regulatory approval. Therefore, many of the requested points, particularly those related to clinical performance, ground truth, sample sizes for test/training sets, and human reader studies, cannot be addressed from this document because they simply don't exist within this submission.

The path to market for this device relies on substantial equivalence to a predicate device (the SpheRx System currently distributed commercially in the U.S. by NuVasive) and non-clinical mechanical testing.

Acceptance Criteria and Study Details for NuVasive SpheRx PPS System (K090981)

1. Table of Acceptance Criteria and Reported Device Performance

Since this 510(k) relies on substantial equivalence and non-clinical mechanical testing, the acceptance criteria are generally related to the mechanical properties and performance being equivalent to or exceeding those of the predicate device, as well as adherence to recognized industry standards for spinal implant systems. The document doesn't provide specific quantitative acceptance criteria or detailed reported device performance values in a table format. However, the implicit acceptance criteria are that the mechanical tests demonstrate the device is safe and effective for its intended use and performs at least as well as the predicate.

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: Not applicable/Provided. This submission does not include clinical data. For mechanical testing, the "sample size" would refer to the number of physical devices or components tested. This detail is not provided in the 510(k) summary.
• Data Provenance: Not applicable/Provided. As no clinical studies were performed, there is no clinical data provenance (e.g., country of origin, retrospective/prospective). The data submitted for this 510(k) primarily relates to non-clinical mechanical testing.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Not applicable. No clinical test set with corresponding ground truth established by experts is mentioned in this 510(k). Mechanical testing results do not typically involve this type of expert ground truth establishment.

4. Adjudication Method for the Test Set

• Not applicable. No clinical test set requiring adjudication is mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No. This 510(k) does not include a MRMC comparative effectiveness study. As a hardware device (spinal implant), this type of study is generally not applicable, as it's typically used for imaging-based diagnostic or screening devices.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Not applicable. This device is a physical spinal implant system, not a software algorithm or AI-based device. Therefore, a standalone algorithm performance study is irrelevant.

7. Type of Ground Truth Used

• Not applicable for clinical data. For mechanical testing, the "ground truth" would be established by validated test methods and measurements conforming to industry standards (e.g., ASTM, ISO) to assess properties like fatigue life, pull-out strength, and torsional strength.

8. Sample Size for the Training Set

• Not applicable. As this device is not an AI/ML algorithm or system component that requires training data, there is no "training set."

9. How the Ground Truth for the Training Set Was Established

• Not applicable. See point 8.

Summary of Device Approval Basis:

The NuVasive SpheRx PPS System received 510(k) clearance based on substantial equivalence to an already legally marketed predicate device (the SpheRx System by NuVasive). The submission included:

• Identical Indications for Use: The new device shares the exact same indications for use as the predicate.
• Same Principles of Operation: The device functions on the same core mechanical and physiological principles as the predicate.
• Non-Clinical Mechanical Testing: This testing was presented to demonstrate that the new device meets or exceeds the performance characteristics of the predicate, ensuring its safety and effectiveness for its intended use. The specific details of these tests and their results are not provided in this public summary, but they were sufficient for FDA to determine substantial equivalence.

The FDA's letter explicitly states: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent... You may, therefore, market the device, subject to the general controls provisions of the Act." This confirms that no clinical studies were deemed necessary for this clearance.

Ask a specific question about this device