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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.

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.

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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 II System consists of a variety of polyaxial screws, fixed angle screws, rods, hooks, 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 document is a 510(k) summary for the NuVasive SpheRx II System, a pedicle screw system. It describes the device, its intended use, and states that mechanical testing was presented to demonstrate substantial equivalence to a predicate device.

However, the document explicitly states: "H. Summary of Clinical Tests (Not Applicable)."

Therefore, based on the information provided in this document, a comprehensive description of acceptance criteria and a study proving the device meets those criteria cannot be provided with the requested details, as no clinical study or specific performance metrics from non-clinical testing are detailed.

Here's what can be extracted and what is missing:

1. A table of acceptance criteria and the reported device performance

   • Not applicable / Not provided. The document only states "Mechanical testing was presented" without detailing specific acceptance criteria for these tests nor their results.

2. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

   • Not applicable / Not provided. No clinical or non-clinical test details are given to determine sample size or data 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)

   • Not applicable / Not provided. No information on expert involvement or ground truth establishment is mentioned.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

   • Not applicable / Not provided. No information on adjudication is mentioned.

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 / Not provided. This is a medical device, not an AI-based diagnostic tool. No MRMC study was mentioned.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

   • Not applicable / Not provided. This is a medical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

   • Not applicable / Not provided. No ground truth is mentioned. For a mechanical device, ground truth would typically relate to physical properties or performance standards, which are not detailed here beyond the general statement of "mechanical testing."

8. The sample size for the training set

   • Not applicable / Not provided. No training set is mentioned as this documentation pertains to a medical device, not a machine learning model.

9. How the ground truth for the training set was established

   • Not applicable / Not provided. No training set or associated ground truth is mentioned.

In summary: The document explicitly states that clinical tests are "Not Applicable" for this submission, and it only generally mentions "Mechanical testing was presented" without providing any specifics regarding acceptance criteria, methodology, or results of these tests. Therefore, it's impossible to answer most of the questions based on the provided text.

Ask a specific question about this device