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510(k) Data Aggregation
(254 days)
The ANATOMIC PEEK device is indicated for 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. 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. This device is to be used in patients who have had six weeks of non-operative treatment. The ANATOMIC PEEK device is to be used with supplemental fixation. The ANATOMIC PEEK device is also required to be used with autograft and is to be implanted via an open, anterior approach.
The CORNERSTONE® PSR device is indicated for 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. 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. This device is to be used in patients who have had six weeks of non-operative treatment. The CORNERSTONE® PSR device is to be used with supplemental fixation. The CORNERSTONE® PSR device is also required to be used with autograft.
The PEEK PREVAIL™ Cervical Interbody Device is indicated 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. 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. The PEEK PREVAIL™ Cervical Interbody Device must be used with internal screw fixation provided by ZEPHIR® Anterior Cervical Screws. The PEEK PREVAIL™ Cervical Interbody Device implants are to be used with autograft and implanted via an open, anterior approach. This cervical device is to be used in patients who have had six weeks of non-operative treatment.
The CAPSTONE CONTROLTM 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. 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 CLYDESDALE® 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 CLYDESDALE® Spinal System is used for patients diagnosed with degenerative disc disease (DDD) at one or two contiguous levels from L2 to SI. 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 nonoperative treatment. These implants may be implanted via a minimally invasive lateral approach.
The CRESCENT® 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. 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 SOVEREIGN® Spinal System is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. 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 laparoscopic or an open anterior approach. The SOVEREIGN® interbody system may be used as a stand-alone device or in conjunction with supplemental fixation. When used as a stand-alone device, the SOVEREIGN® interbody device is intended to be used with the three titanium alloy fixed or variable angle screws. The accompanying cover plate MUST be used anytime the device is used with any number of variable angle screws. If the physician chooses to use less than three or none of the provided screws, then additional supplemental fixation for use in the lumbar spine must be used to augment stability.
The TELAMON® PEEK Spinal System is indicated for interbody fusion with autogenous bone graft in 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 nonoperative treatment. 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 ANATOMIC PEEK Cervical Fusion Implants consists of cages of various widths and heights which can be inserted between two cervical vertebral bodies to give support and correction during cervical interbody fusion surgeries. These implants are manufactured from implant grade polyetheretherketone (PEEK). The hollow geometry of the implants allows them to be packed with autogenous bone graft in cervical interbody fusion procedures. The ANATOMIC PEEK devices are intended to be implant via an open anterior approach and used with supplemental fixation and autogenous bone graft.
The CORNERSTONE® PSR Cervical Fusion Implants consist of cages of various widths and heights, which can be inserted between two cervical vertebral bodies to give support and correction during cervical interbody fusion surgeries. These implants are manufactured from implant grade PEEK. The hollow geometry of the implants allows them to be packed with autogenous bone graft in cervical fusion procedures. The CORNERSTONE® PSR device is to be used with supplemental instrumentation and is to be implanted via an open, anterior approach.
The PEEK PREVAIL™ Cervical Interbody Device is an intervertebral body fusion device with internal screw fixation. The screws protrude through the interbody portion of the device and stabilize the vertebral body while preventing expulsion of the implant. The implant is "I-Beam" shaped with a 2 screw midline configuration. This device is intended to be radiolucent and the interior space of the product is to be used with autograft. The PEEK PREVAIL™ Cervical Interbody device implant is manufactured from PEEK and contains tantalum radiopaque markers and a Nitinol screw locking mechanism. The screws used with this device (ZEPHIR® Anterior Cervical Screws) are manufactured from Titanium Alloy.
The CAPSTONE CONTROL™ Spinal System Implants consist of PEEK cages of various widths and heights which include Tantalum markers. These implants can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autogenous bone graft. The CAPSTONE CONTROL™ Spinal System Implants are to be used with supplemental instrumentation and are to be implanted via an open or minimally invasive, posterior or transforaminal approach.
The CLYDESDALE® Spinal System Implants consist of PEEK cages of various widths and heights, which include Tantalum markers. These devices can be inserted via a lateral approach between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autogenous bone graft. The CLYDESDALE® Spinal System Implants are to be used with supplemental instrumentation.
The CRESCENT® Spinal System (PEEK) Implants consist of PEEK cages of various widths and heights which include Tantalum markers. These implants can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autogenous bone graft. The implants may be implanted via a posterior, transforaminal or lateral approach and the procedure may be open or minimally invasive. The CRESCENT® Spinal System Implants are to be used with supplemental instrumentation.
The SOVEREIGN® Spinal System Implants are an intervertebral body fusion devices with internal screw fixation. The screws protrude through the interbody portion of the device and stabilize the vertebral body while preventing expulsion of the implant. The implant is lens-shaped with three holes for placement of titanium screws. The SOVEREIGN® Spinal System contains both a fixed and a variable angle screw option. The fixed angle screw option provides an interference fit with the PEEK interbody implant. The variable angle screw option provides a slight clearance between the PEEK interbody implant and the screw which allows for a small amount of variable screw angulation. This system is intended to be radiolucent and the interior space of the product is to be used with autogenous bone graft. The accompanying cover plate is designed to resist screw backout and must be used when the variable angle screws are implanted. The SOVEREIGN® Spinal System interbody device is manufactured from PEEK and contains tantalum radiopaque markers. The screws used with this device are manufactured from titanium alloy.
The TELAMON® PEEK Spinal System Implants consist 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. The hollow geometry of the implants allows them to be packed with autogenous bone graft. These implants may be implanted via an open or a minimally invasive posterior approach. The TELAMON® PEEK Spinal System Implants are to be used with supplemental instrumentation.
The provided document is a 510(k) summary for Medtronic Sofamor Danek MRI Update for PEEK Interbody Fusion Devices. The purpose of this submission is to provide appropriate MRI safety labeling for the devices and information on how to perform an MRI scan on patients with these implants. The submission determines that the devices are "MR Conditional" as per ASTM F2503.
Here's an analysis of the acceptance criteria and the study that proves the device meets the acceptance criteria, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Set by ASTM Standards for MR Conditional) | Reported Device Performance (as tested) |
|---|---|
| Magnetically Induced Displacement Force (ASTM F2052): Devices should not pose a hazard due to magnetic field gradient. | Testing completed on worst-case implants provided a determination that devices are MR Conditional. (Specific forces/values not provided, but implies within acceptable limits.) |
| Magnetically Induced Torque (ASTM F2213): Devices should not pose a hazard due to magnetic field-induced torque. | Testing completed on worst-case implants provided a determination that devices are MR Conditional. (Specific torque values not provided, but implies within acceptable limits.) |
| MR Image Artifacts (ASTM F2119): Artifacts caused by the implant should not obscure critical diagnostic information. | Testing completed on worst-case implants provided a determination that devices are MR Conditional. (Specific artifact characteristics not provided, but implies acceptable for diagnostic use.) |
| Radiofrequency (RF) Induced Heating (ASTM F2182): Devices should not cause excessive heating during MRI. | Testing completed on worst-case implants provided a determination that devices are MR Conditional. (Specific temperature increases not provided, but implies within safe limits.) |
| MR Safety Labeling (ASTM F2503): Devices must be appropriately labeled for safety in the MR environment. | The devices in this submission have been determined to be MR conditional per ASTM F2503 and appropriate MRI safety labeling is being proposed. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document states that "testing has been completed on the worst case implants." It does not specify a numerical sample size for the test set (number of individual implants tested).
- Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It describes non-clinical testing performed in accordance with ASTM guidance. This implies laboratory testing rather than human subject data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to this submission. The "ground truth" here is established by the specified ASTM standards for MRI safety of implants, not by expert interpretation of data generated by the device. The testing involved physical measurements and evaluations according to these standards.
4. Adjudication Method for the Test Set
This information is not applicable. As the testing is non-clinical and based on physical measurements and adherence to ASTM standards, there is no need for adjudication by multiple readers or a consensus process.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This submission focuses on the MRI safety of the implanted devices themselves, not on an AI system assisting human readers in interpreting medical images.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone algorithm performance study was not done. This submission is for physical medical devices—interbody fusion implants—and their safety in an MRI environment, not for an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this assessment is defined by the ASTM International Standards for evaluating the safety and compatibility of passive implants in the Magnetic Resonance (MR) Environment:
- ASTM F2052
- ASTM F2213
- ASTM F2119
- ASTM F2182
- ASTM F2503
These standards outline the methodologies and acceptable limits for magnetic displacement, torque, RF heating, and image artifacts.
8. The Sample Size for the Training Set
This information is not applicable. This submission is not about an AI/ML algorithm that requires training data. It is about the physical properties of medical implants.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as point 8.
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