(37 days)
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:
| Acceptance Criteria (Standard Reference) | Device Performance as Reported |
|---|---|
| ASTM F2052: Measurement of magnetically induced displacement force on passive implants in the magnetic resonance environment. | Testing completed on the worst-case implants, determining the devices are MR Conditional. |
| ASTM F2213: Measurement of magnetically induced torque on medical devices in the magnetic resonance environment. | Testing completed on the worst-case implants, determining the devices are MR Conditional. |
| ASTM F2119: Evaluation of MR image artifacts from passive implants. | Testing completed on the worst-case implants, determining the devices are MR Conditional. |
| ASTM F2182: Measurement of radio frequency induced heating on or near passive implant during magnetic resonance imaging. | Testing completed on the worst-case implants, determining the devices are MR Conditional. |
| ASTM F2503: Standard practice for marking medical devices and other items for safety in the magnetic resonance environment. | Testing completed, and devices are labeled as MR Conditional in accordance with this standard. |
| Substantial Equivalence: No significant changes to overall design, material, or indications from predicate devices (K122037). | The subject devices have the "same fundamental technology," are "manufactured from the same PEEK and tantalum materials," have "no changes to the overall design, to the material or the indications," and are therefore considered substantially equivalent to their predicates for MRI safety labeling. |
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.
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.