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:

• 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.

Ask a specific question about this device

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 DBR II 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.

The provided text describes a 510(k) premarket notification for a medical device called the NuVasive SpheRx DBR II System. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and reported device performance.

Therefore, many of the requested details about acceptance criteria, performance metrics, and study methodologies for proving device performance are not present in this type of regulatory submission. This document primarily focuses on equivalence to an already approved device.

Here's an analysis of the available information:

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

This information is not provided in the document. The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device, not on directly reporting performance against specific acceptance criteria for a new clinical or diagnostic capability. The mechanical testing mentioned (Section G) would have its own acceptance criteria, but these are not detailed in this summary.

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

This information is not applicable or not provided. Since no clinical performance study for an AI/diagnostic device is described, there's no "test set" in that context. The document mentions "Mechanical testing was presented" (Section G), but details about the samples used for these tests (e.g., number of implant components, types of forces applied) are not explicitly given in this summary, nor is the 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)

This information is not applicable or not provided. There is no "test set" requiring expert ground truth in the context of an AI/diagnostic device performance study described here.

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

This information is not applicable or not provided. There is no "test set" requiring adjudication in the context of an AI/diagnostic device performance study described here.

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

This information is not applicable or not provided. The device described is a spinal pedicle screw system, not an AI-assisted diagnostic tool.

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

This information is not applicable or not provided. The device is a physical implant, not a standalone algorithm.

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

This information is not applicable or not provided. As above, there is no "ground truth" establishment in the context of an AI/diagnostic device performance study described here.

8. The sample size for the training set

This information is not applicable or not provided. The device is a physical implant, not an AI model, so there's no "training set."

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

This information is not applicable or not provided. As above, there is no "training set" or "ground truth" establishment in this context.

Summary of the Device and Study (as presented in the document):

The NuVasive SpheRx DBR II System is a spinal pedicle screw system. The submission is a 510(k) premarket notification affirming its substantial equivalence to the predicate device, the SpheRx II System.

• Acceptance Criteria for 510(k) Substantial Equivalence: The primary "acceptance criterion" for this type of submission is demonstrating that the new device is as safe and effective as a legally marketed predicate device. This is achieved by showing that it has the same intended use, similar technological characteristics, and that any differences in technological characteristics do not raise new questions of safety or effectiveness.
• Study Proving Acceptance Criteria: The study for this 510(k) submission was a comparison to a predicate device supported by non-clinical mechanical testing.
  • Comparison to Predicate: The document states, "The subject SpheRx DBR II System is substantially equivalent to the SpheRx II System currently distributed commercially in the U.S. by NuVasive." It further notes, "The subject device has indications for use identical to those of its predicate, and employs the same principles of operation."
  • Mechanical Testing: Section G states: "Summary of Non-Clinical Tests: Mechanical testing was presented." The specific results or methodologies of this testing are not detailed in this summary, but would have been included in the complete 510(k) submission to demonstrate that the new device's mechanical properties are suitable for its intended use and comparable to the predicate.
  • Clinical Tests: Section H explicitly states: "Summary of Clinical Tests (Not Applicable)." This confirms that no clinical studies were performed to prove the device's performance because substantial equivalence was demonstrated through comparison to a predicate and non-clinical testing.

Ask a specific question about this device

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 text is a 510(k) summary for the NuVasive SpheRx II System, a pedicle screw system. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain any information regarding acceptance criteria, device performance, or a study proving that the device meets acceptance criteria.

Specifically:

• No acceptance criteria table or reported device performance data is present.
• No information on sample size, data provenance, number of experts for ground truth, or adjudication methods is provided.
• No multi-reader multi-case (MRMC) comparative effectiveness study or standalone performance study is mentioned.
• The type of ground truth used for any study (which is not described) is not specified.
• No information on training set sample size or how ground truth for a training set was established is available.

The only "testing" mentioned is a "Summary of Non-Clinical Tests" which states: "Mechanical testing was presented." There is no further detail about what mechanical tests were performed, what the results were, or what the acceptance criteria for those tests were. The "Summary of Clinical Tests" explicitly states "(Not Applicable)".

Therefore, based on the provided text, I cannot fulfill the request to describe acceptance criteria and the study that proves the device meets them.

Ask a specific question about this device

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