(484 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 PERIMETER® C Spinal System consists of spacers 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, 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. This device is offered in PEEK-OPTIMA® (i.e., POLYETHERETHERKETONE) with tantalum markers. Medical grade titanium implants and medical grade PEEK implants may be used together. Never use titanium or titanium alloy implants with stainless steel in the same construct.
Here's a breakdown of the acceptance criteria and the study information for the PERIMETER® C Spinal System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Mechanical Test Standards: | Met: |
| Static Torsion (per ASTM F2077-03) | Results indicate acceptance criteria were met. |
| Static Compression (per ASTM F2077-03) | Results indicate acceptance criteria were met. |
| Dynamic Compression (per ASTM F2077-03) | Results indicate acceptance criteria were met. |
| Dynamic Torsion (per ASTM F2077-03) | Results indicate acceptance criteria were met. |
| Static Compression-Shear (per ASTM F2077-03) | Results indicate acceptance criteria were met. |
| Subsidence (per ASTM F2267-04) | Results indicate acceptance criteria were met. |
| Expulsion Testing | Results indicate acceptance criteria were met. |
| Overall Goal: | Met: |
| Demonstrate substantial equivalence to predicate devices | Substantial equivalence demonstrated through mechanical tests and engineering rationale. |
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary focuses on non-clinical mechanical testing for the PERIMETER® C Spinal System. Therefore, there is no "test set" in the context of patient data (e.g., medical images, clinical outcomes).
- Sample Size for Test Set: Not applicable, as this refers to mechanical test specimens, not patient data. The document does not specify the number of individual test articles (implants) used for each mechanical test.
- Data Provenance: Not applicable. The data comes from in-vitro mechanical testing, not a country of origin for patient data. This is a retrospective analysis of device performance against established ASTM standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. For mechanical testing, the "ground truth" is defined by the established ASTM standards and engineering principles. The results are compared against these predetermined criteria, not against expert human interpretations of patient data.
4. Adjudication Method for the Test Set
Not applicable. Mechanical test results are measured and directly compared to quantitative acceptance criteria defined by the ASTM standards. There is no need for adjudication as you would have for subjective interpretations of clinical findings.
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 submission is for a medical implant (spinal system), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study comparing human reader performance with and without AI is not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is not an algorithm-based device.
7. The Type of Ground Truth Used
The ground truth used for demonstrating the device's performance against its acceptance criteria is:
- Standardized Mechanical Test Criteria: Specifically, the requirements outlined in ASTM F2077-03 (Standard Test Methods for Intervertebral Body Fusion Devices) and ASTM F2267-04 (Standard Test Method for Evaluating the Subsidence of an Intervertebral Body Fusion Device Under Static Axial Compression).
- Engineering Rationale: Complementary engineering analysis to support the mechanical test results.
8. The Sample Size for the Training Set
Not applicable. There is no "training set" as this is not a machine learning or AI-driven device requiring data for model training.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set, there is no ground truth to be established for it.
§ 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.