(110 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 nonoperative 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 PERIMETER® C Spinal System consists of spacers/cages of various widths and heights, which can be inserted between two cervical bodies to give support and correction during cervical interbody fusion procedures. Additionally, this implant has six degrees of lordosis and 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 purpose of this submission is to include additional interbody cages manufactured from medical grade titanium alloy (Ti-6A1-4V ELI) and designed with lateral windows. The lateral windows allow for visibility of bone graft placement. The subject device is offered in a non-sterile form.
The Medtronic PERIMETER® C Spinal System is a medical device for anterior cervical interbody fusion procedures. The study demonstrates substantial equivalence to existing predicate devices based on non-clinical mechanical testing and Finite Element Analysis (FEA), following FDA guidance document, "Class II Special Controls Guidance Document: Intervertebral Body Fusion Devices".
1. Acceptance Criteria and Device Performance:
| Test Performed | Applicable Standard | Acceptance Criteria (Implicitly: Meet/Exceed Predicate Performance) | Reported Device Performance |
|---|---|---|---|
| Static Torsion Testing | ASTM F2077 (Test Methods for Intervertebral Body Fusion Devices) | Met/Exceeded performance of predicate devices | Successfully met all predetermined acceptance criteria. |
| Static Compression Bending Testing | ASTM F2077 (Test Methods for Intervertebral Body Fusion Devices) | Met/Exceeded performance of predicate devices | Successfully met all predetermined acceptance criteria. |
| Static Compression Shear Testing | ASTM F2077 (Test Methods for Intervertebral Body Fusion Devices) | Met/Exceeded performance of predicate devices | Successfully met all predetermined acceptance criteria. |
| Dynamic Torsion Testing | ASTM F2077 (Test Methods for Intervertebral Body Fusion Devices) | Met/Exceeded performance of predicate devices | Successfully met all predetermined acceptance criteria. |
| Dynamic Compression Bending Testing | ASTM F2077 (Test Methods for Intervertebral Body Fusion Devices) | Met/Exceeded performance of predicate devices | Successfully met all predetermined acceptance criteria. |
| Dynamic Compression Shear Testing | ASTM F2077 (Test Methods for Intervertebral Body Fusion Devices) | Met/Exceeded performance of predicate devices | Successfully met all predetermined acceptance criteria. |
| Subsidence Testing | ASTM F2267 (Standard Test Method for Measuring Load Induced Subsidence of the Intervertebral Body Fusion Device under Static Axial Compression) | Met/Exceeded performance of predicate devices | Successfully met all predetermined acceptance criteria. |
| Expulsion Testing | DRAFT ASTM F-04.25.02.02 | Met/Exceeded performance of predicate devices | Successfully met all predetermined acceptance criteria. |
The study concludes that "Based on the results the subject intervertebral devices demonstrated that they are as safe and effective as the predicate device(s)."
2. Sample Size and Data Provenance for Test Set:
No specific sample sizes for mechanical testing are provided in the document. The testing was non-clinical (laboratory-based) and not based on patient data, so "data provenance" in terms of country of origin or retrospective/prospective is not applicable.
3. Number of Experts and Qualifications for Ground Truth (Test Set):
Not applicable. This was a non-clinical, mechanical engineering study, not involving human expert assessment for ground truth.
4. Adjudication Method for Test Set:
Not applicable. As this was a non-clinical mechanical test, there was no adjudication method involving human interpretation of results.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study was done, as this was a non-clinical mechanical engineering study and did not involve human readers or AI assistance.
6. Standalone Performance Study:
Yes, a standalone performance study was done for the device in the sense of mechanical testing of the device itself (algorithm only without human-in-the-loop performance). The tests listed above are all standalone tests of the device's mechanical properties.
7. Type of Ground Truth Used:
The "ground truth" for the non-clinical tests was based on the performance requirements specified in the FDA guidance document "Class II Special Controls Guidance Document: Intervertebral Body Fusion Devices" and the applicable ASTM standards (ASTM F2077, ASTM F2267, and DRAFT ASTM F-04.25.02.02). The device's performance was compared against these established engineering standards and implicitly, against the performance of predicate devices.
8. Sample Size for Training Set:
Not applicable, as this was a non-clinical mechanical engineering study, not involving machine learning or a "training set" of data in the conventional sense.
9. How Ground Truth for Training Set Was Established:
Not applicable, as there was no training set in the context of this non-clinical mechanical study.
§ 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.