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The NuVasive CoRoent Lumbar System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The System is designed for use with autogenous bone graft to facilitate fusion and supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbar spine. Patients with previous non-fusion spinal surgery at involved level may be treated with the devices are to be used in patients who have had at least six months of non-operative treatment.

The CoRoent Lumbar System (L and XL platforms) is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.

The NuVasive® CoRoent System is manufactured from PEEK-OPTIMA® Optima LT1 (Polyether-ether-ketone) conforming to ASTM standard F2026, Ti-6Al-4V ELI conforming to ASTM standard F136/1472 or Tantalum conforming to ASTM standard F560 or ISO 13782. These implants are available in a variety of shapes and configurations for PLIF/TLIF, XLIF and ALIF approaches, with heights ranging from 6 - 24 mm, widths ranging from 9 - 42 mm, lengths ranging from 20-65 mm and lordotic angles ranging from 0° - 20°, to suit the individual pathology and anatomical conditions of the patient. The hollow aperture allows for packing of autogenous bone graft. Teeth on the superior and inferior surface of the implants provide resistance to expulsion.

Both the subject device and its accessory surgical instruments are packaged as non-sterile, to be sterilized by the end user. In addition, the implants are also offered in sterile packaged versions.

Here's a breakdown of the acceptance criteria and study information for the NuVasive® CoRoent® System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

This information is not applicable as no human clinical data was used for this 510(k) submission. The performance data was based on nonclinical testing.

3. Number of Experts and Qualifications for Ground Truth (Test Set)

This information is not applicable as ground truth related to human observation or clinical outcomes was not established for a test set in this submission. The "ground truth" for nonclinical testing would be the ASTM standards themselves and the inherent properties of the materials and design compared to predicate devices.

4. Adjudication Method (Test Set)

This information is not applicable as there was no human-reviewed test set requiring adjudication.

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

No, a multi-reader multi-case comparative effectiveness study was not done. The submission explicitly states, "No clinical studies were conducted."

6. Standalone (Algorithm Only) Performance Study

This information is not applicable as this is a medical device (intervertebral body fusion system) composed of physical materials, not an algorithm or software requiring standalone performance evaluation.

7. Type of Ground Truth Used

The ground truth used for demonstration of substantial equivalence was based on:

• ASTM Standards: F2077 (for static and dynamic axial compression and compression shear) and F2267 (for subsidence testing). These established engineering standards serve as the "ground truth" for mechanical performance of intervertebral body fusion devices.
• Predicate Device Performance: The "ground truth" was also implicitly derived from the established performance of legally marketed predicate devices. The NuVasive CoRoent System aimed to meet the same criteria as these already cleared devices.

8. Sample Size for the Training Set

This information is not applicable as there was no training set in the context of an algorithm or machine learning. The "training" in this context would be the design and engineering process to ensure the device met the specified ASTM standards and matched the characteristics of predicate devices.

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

This information is not applicable as there was no training set in the context of an algorithm or machine learning. The design and manufacturing process for the device was informed by material science, biomechanical engineering principles, and the performance characteristics of previously cleared predicate devices and established ASTM standards.

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Intervertebral Body Fusion

The NuVasive CoRoent System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The System is designed for use with autogenous bone graft to facilitate fusion.

The CoRoent L and XL platforms are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar devices are to be used in patients who have had at least six months of non-operative treatment. The System is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbar spine.

The CoRoent S platforms are intended for use for anterior cervical interbody fusion in patients with cervical degenerative disc disease (DDD) at one level from levels C2-C3 to C7- T1. The cervical devices are to be used in patients who have had at least six weeks of non-operative treatment. The System is intended to be used with supplemental fixation and autogenous bone graft only to facilitate the fusion.

Partial Vertebral Body Replacement

The NuVasive CoRoent System may also be used as a partial vertebral body replacement device indicated for use in the thoracolumbar spine (T1 to L5) to replace a diseased or damaged vertebral body caused by tumor or fracture, to restore height of a collapsed vertebral body, and to achieve decompression of the spinal cord and neural tissues. The System is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the thoracic and lumbar spine. Allograft or autograft material may be used at the surgeon's discretion.

The NuVasive CoRoent System is an implantable device manufactured from PEEK and titanium alloy that is available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient.

This is a spinal implant system (NuVasive CoRoent System), not an AI/ML powered device, so most of the requested information (acceptance criteria, study details, ground truth, training/test sets, expert evaluation, MRMC studies) is not applicable.

However, I can provide the relevant information from the document as it pertains to a traditional medical device submission:

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

For this type of device (spinal implant), acceptance criteria are primarily based on demonstrating substantial equivalence to previously cleared predicate devices in terms of:

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

• Not Applicable. This submission is for a spinal implant system and does not involve AI/ML algorithms or a "test set" in the context of algorithm performance. The evaluation is against predicate devices and mechanical testing.

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. There is no "ground truth" establishment in the context of an AI/ML algorithm for this device. The regulatory review process involves FDA experts evaluating the 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 spinal implant, not an AI-assisted diagnostic or therapeutic tool. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed or is relevant.

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

• Not Applicable. This is a physical device, not an algorithm.

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

• Not Applicable. There is no "ground truth" as it would apply to an AI/ML algorithm. The "truth" for this submission is established through mechanical testing demonstrating performance characteristics (e.g., strength, durability) and detailed comparison to existing, cleared predicate devices to support substantial equivalence.

8. The sample size for the training set

• Not Applicable. This device does not involve a training set for an AI/ML model.

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

• Not Applicable. See point 8.

Summary of Study:

The document states: "Data was provided which demonstrated the NuVasive CoRoent System to be substantially equivalent to previously cleared devices. The substantial equivalence is based upon equivalence in indications for use, design, material, and function." It also mentions "Mechanical testing was presented."

No clinical tests were applicable or conducted for this 510(k) submission, indicating that the clearance was based on non-clinical data and comparison to predicates.

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Intervertebral Body Fusion

The NuVasive CoRoent System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The System is designed for use with autogenous bone graft to facilitate fusion.

The CoRoent L and XL platforms are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar devices are to be used in patients who have had at least six months of non-operative treatment. The System is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbar spine.

Partial Vertebral Body Replacement

The NuVasive CoRoent System may also be used as a partial vertebral body replacement device indicated for use in the thoracolumbar spine (T1 to L5) to replace a diseased or damaged vertebral body caused by tumor or fracture, to restore height of a collapsed vertebral body, and to achieve decompression of the spinal cord and neural tissues. The System is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the thoracic and lumbar spine. Allograft or autograft material may be used at the surgeon's discretion.

The NuVasive CoRoent System is an implantable device manufactured from PEEK and titanium alloy that is available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient.

The provided text is a 510(k) summary for the NuVasive CoRoent System, an intervertebral body fusion device.

This document describes the device, its intended use, and states that substantial equivalence was demonstrated through non-clinical mechanical testing.

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

Therefore, based on the provided text, there is no information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert adjudication, or MRMC studies. The approval for this device was based on substantial equivalence to a predicate device and non-clinical mechanical testing, not on clinical performance metrics or studies involving human data or expert review as you've requested.

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The NuVasive CoRoent System is a partial vertebral body replacement device indicated for use in the thoracolumbar spine (T1 to L5) to replace a diseased vertebral body resected or excised for the treatment of a collapsed, damaged, or unstable vertebral body(s) due to tumor or trauma and to achieve decompression of the spinal cord and neural tissues. The System is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the thoracic and lumbar spine. Allograft or autograft material may be used at the surgeon's discretion.

The NuVasive CoRoent System is an implantable PEEK vertebral body replacement device indicated for use in the thoracic and lumbar spine (i.e., T1 to L5) to replace a diseased vertebral body resected or excised for the treatment of a collapsed, damaged, or unstable vertebral body(s) due to tumor or trauma and to achieve decompression of the spinal cord and neural tissues.

The device is available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient.

The NuVasive CoRoent System is a partial vertebral body replacement device indicated for use in the thoracolumbar spine (T1 to L5) to replace a diseased vertebral body resected or excised for the treatment of a collapsed, damaged, or unstable vertebral body(s) due to tumor or trauma and to achieve decompression of the spinal cord and neural tissues. The System is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the thoracic and lumbar spine. Allograft or autograft material may be used at the surgeon's discretion.

The provided text is a 510(k) summary for the NuVasive CoRoent System, a vertebral body replacement device. It does not describe acceptance criteria or a study proving that the device meets acceptance criteria. Instead, it focuses on demonstrating substantial equivalence to predicate devices based on design, materials, indications for use, and mechanical testing.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts and their qualifications for ground truth.
4. Adjudication method for the test set.
5. MRMC comparative effectiveness study results.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

The document explicitly states: "H. Summary of Clinical Tests (Not Applicable)." This indicates that no clinical studies were performed for this 510(k) submission to demonstrate the device meets specific performance criteria against a ground truth from human data. The assessment was based on non-clinical (mechanical) testing and comparison to predicate devices.

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