(86 days)
The Pioneer Release Laminoplasty Plating System is intended for use in the lower cervical and upper thoracic spine (C3 to T3) in laminoplasty procedures. The Pioneer Release Laminoplasty Plating System is used to hold the graft material in place in order to prevent the graft material from expulsion, or impinging the spinal cord.
The Pioneer Release Laminoplasty Plating System consists of implantable plates and screws that will act as a buttress to maintain decompression after a laminoplasty procedure. The system also contains Class 1 manual surgical instruments and cases that are considered exempt from premarket notification.
This document describes the acceptance criteria and the study that proves the Pioneer Release Laminoplasty Plating System meets those criteria.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Performance Standard) | Reported Device Performance |
|---|---|
| Static Four-Point Bend per ASTM F2193 | Functioned as intended |
| Fatigue Four-Point Bend per ASTM F2193 | Functioned as intended |
| Axial Screw Pull-Out per ASTM F543 | Functioned as intended |
| Substantial Equivalence to Predicate System | Achieved |
2. Sample Size and Data Provenance for Test Set
- Sample Size: Not explicitly stated in the provided document. The document mentions "standard testing" per ASTM F2193 and ASTM F543, implying that the number of samples would conform to the requirements of these standards.
- Data Provenance: The study appears to be a laboratory-based performance test conducted by the manufacturer, Pioneer Surgical Technology. There is no information regarding the country of origin of the data or whether it was retrospective or prospective in a clinical setting. The tests were performed on the device components themselves.
3. Number and Qualifications of Experts for Ground Truth (Test Set)
Not applicable. This device is a medical implant, and its performance was evaluated through mechanical testing, not by expert review of imaging or clinical data to establish ground truth.
4. Adjudication Method for the Test Set
Not applicable. As described above, the evaluation was based on mechanical test results against established ASTM standards, not on expert adjudication of clinical or imaging data.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not performed. This study focuses on the mechanical performance of a spinal implant system. MRMC studies are typically used for diagnostic or screening devices where human readers interpret data, often with and without AI assistance.
6. Standalone (Algorithm Only) Performance Study
Not applicable. This device is a physical medical implant, not an algorithm or AI system.
7. Type of Ground Truth Used
The "ground truth" for this study was established by recognized ASTM standards (F2193 and F543) for the mechanical performance of spinal implants. The device's ability to maintain its structural integrity and mechanical properties under specified loads, as defined by these standards, constituted the success criteria.
8. Sample Size for the Training Set
Not applicable. This device is a physical medical implant, not a machine learning model that requires a training set.
9. How Ground Truth for Training Set was Established
Not applicable, as no training set was used.
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.