Search Results

The PERIMETER® C Spinal System is intended to be used for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc who have had six weeks of non-operative treatment. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. Additionally, the PERIMETER® C Spinal System implants are to be used with autogenous bone graft and supplemental fixation and implanted via an open, anterior approach.

The CAPSTONE® Spinal System is indicated for interbody fusion with autogenous bone graft in patients with Degenerative Disc Disease (DDD) at one or two levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. Additionally, the CAPSTONE® Spinal System is indicated in the setting of spinal deformity as a supplement to pedicle screw fixation in patients diagnosed with degenerative scoliosis. These implants may be implanted via an open or a minimally invasive posterior approach. Alternatively, these implants may also be implanted via an anterior and/or transforaminal approach. These implants are to be used with autogenous bone graft. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared by the FDA for use in the lumbar spine.

The CAPSTONE® L Spinal System is designed to be used with autogenous bone graft to facilitate interbody fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine. The CAPSTONE® L Spinal System is used for patients diagnosed with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants may be implanted via a minimally invasive lateral approach.

The PERIMETER® Interbody Fusion Device is indicated for interbody fusion with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants may be implanted via a variety of open or minimally invasive approaches. These approaches include anterior, lateral and oblique. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared for use in the lumbar spine.

The PERIMETER® C Spinal System consists of PEEK spacers with tantalum markers of various widths and heights, which can be inserted between two cervical vertebral bodies to give support and correction during cervical interbody fusion procedures. Additionally, the superior and inferior surfaces of the implant are designed with teeth which interact with the surface of the vertebral endplates to aid in resisting expulsion. The hollow geometry of the implants allows them to be packed with autogenous bone graft and is to be used with supplemental fixation in all procedures.

The CAPSTONE® PEEK Spinal System consists of PEEK cages with tantalum markers of various widths and heights, which can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. Additionally, the superior and inferior surfaces of the implant are designed with teeth which interact with the surface of the vertebral endplates to aid in resisting expulsion. The hollow geometry of the implants allows them to be packed with autogenous bone graft.

The CAPSTONE® L Spinal System consists of PEEK cages of various widths and heights, which include Tantalum markers. These devices can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. Additionally, the superior and inferior surfaces of the implant are designed with teeth which interact with the surface of the vertebral endplates to aid in resisting expulsion. The hollow geometry of the implants allows them to be packed with autogenous bone graft.

The PERIMETER® Interbody Fusion Device consists of PEEK cages with tantalum markers of various widths and heights which can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. Additionally, the superior and inferior surfaces of the implant are designed with teeth which interact with the surface of the vertebral endplates to aid in resisting expulsion. The hollow geometry of the implants allows them to be packed with autogenous bone graft. The PERIMETER® Interbody Device is to be used with supplemental fixation instrumentation.

The provided document is a 510(k) premarket notification for Medtronic Sofamor Danek MRI Update for PEEK Interbody Fusion Devices. The primary purpose of this submission is to obtain MRI safety labeling for these devices and provide instructions on how to perform MRI scans on them. It asserts that the devices are "MR Conditional" according to ASTM F2503.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: The document repeatedly mentions "worst case implants" were used for testing. However, it does not specify the exact number of implants constitutive of this "worst case" test set for any of the ASTM standards.
• Data Provenance: The document does not specify the country of origin of the data. The testing was non-clinical and conducted in accordance with FDA Guidance "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment." It's reasonable to infer the testing was conducted in a laboratory setting, likely in the USA where Medtronic Sofamor Danek is based. The data would be prospective for the purpose of this 510(k) submission, as it was specifically generated to demonstrate MRI safety for these devices.

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

• This information is not provided in the document. The testing described focuses on non-clinical, objective measurements defined by ASTM standards. These standards themselves establish the "ground truth" for MR safety parameters through their methodologies. There is no mention of human experts establishing a ground truth for the test set data in the context of MRI safety.

4. Adjudication Method for the Test Set:

• None specified. The testing involves physical measurements adhering to established ASTM standards, not subjective evaluation requiring adjudication by multiple experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

• No, an MRMC comparative effectiveness study was not done. This submission is for MRI safety labeling of interbody fusion devices, which are passive implants. An MRMC study would be relevant for diagnostic imaging interpretation or active devices with AI assistance, neither of which applies here.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

• Not applicable. This device is a passive implant (interbody fusion device), not an algorithm or an AI-powered diagnostic tool. The performance evaluated is the physical interaction of the implant with MRI fields, not an algorithm's output.

7. The Type of Ground Truth Used:

• The ground truth relies on objective physical measurements and adherence to established industry standards (ASTM F2052, F2213, F2119, F2182, F2503) for assessing MRI safety of passive metallic medical implants. These standards provide the methodology and criteria for evaluating displacement force, torque, image artifacts, and RF-induced heating.

8. The Sample Size for the Training Set:

• Not applicable. This is a non-clinical evaluation of a physical device's interaction with an MRI environment, not a machine learning model. Therefore, there is no "training set."

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

• Not applicable. As there is no training set, this question is not relevant.

Ask a specific question about this device

The CAPSTONE® L Spinal System is designed to be used with autogenous bone graft to facilitate interbody fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine. The CAPSTONE® L Spinal System is used for patients diagnosed with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants may be implanted via a minimally invasive lateral approach.

The CAPSTONE® L Spinal System consists of spacers of various widths and heights made of PEEK with tantalum markers. The spacers can be inserted between two lumbar or lumbo-sacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The implant has non-lordotic and 6° lordotic options. The superior and inferior surfaces of the implant are designed with teeth that interact with the surface of the vertebral endplates to aid in resisting expulsion. The hollow geometry of the implants allows them to be packed with autogenous bone graft. The implants are provided sterile by gamma irradiation, and are to be used with supplemental fixation. CAPSTONE® L Spinal System is used with new reusable instrumentation that enables the surgeon to implant the devices via a lateral approach.

The CAPSTONE® L Spinal System is a medical device designed for lumbar interbody fusion surgeries. The submission document focuses on demonstrating substantial equivalence to predicate devices through non-clinical mechanical testing.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample size (number of implants tested) for each mechanical test. It only mentions that "All mechanical testing met the predetermined acceptance criteria." The data provenance is from non-clinical tests performed by Medtronic Sofamor Danek. This is retrospective in the sense that the device was manufactured, and then tested, rather than a prospective study design with human subjects.

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

Not applicable. This study involves mechanical testing of a physical device, not subjective interpretation of data (e.g., images) by experts. The "ground truth" for these tests is the physical behavior of the device under defined loads, measured by standard testing equipment.

4. Adjudication Method for the Test Set

Not applicable. As noted above, this study involves mechanical testing, which does not require an adjudication method by experts. The results are quantitative measurements against predefined criteria.

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 is not an AI/software device and therefore no MRMC study or assessment of human reader improvement with AI assistance was performed.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is a physical intervertebral body fusion device, not a software algorithm.

7. The Type of Ground Truth Used

The ground truth used for these tests is based on established engineering principles, FDA guidance documents, and standardized test methods (ASTM F2077, ASTM F2267). The "ground truth" essentially refers to the expected mechanical performance parameters derived from these standards and comparison to the predicate device's known performance.

8. The Sample Size for the Training Set

Not applicable. This is a physical device undergoing mechanical testing, not a machine learning model requiring a training set.

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

Not applicable. As this is not a machine learning study, there is no training set or ground truth in that context.

Ask a specific question about this device