(43 days)
The Pioneer BacFuse Device is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); and/or tumor. The Pioneer BacFuse Device is intended for use with bone graft material (i.e. allograft or autograft), not intended for stand-alone use.
The Pioneer Spinous Process Fusion Plate is a plate with spacer system designed to provide posterior fixation by physically linking adjacent spinous processes. The system also contains Class 1 manual surgical instruments and cases that are considered exempt from premarket notification. The Pioneer Spinous Process Fusion Plate is composed of Ti Alloy per ASTM F136.
The Pioneer Spinous Process Fusion Plate is a medical device designed for posterior, non-pedicle supplemental fixation in the non-cervical spine (T1-S1). It aims to achieve supplemental fusion by linking adjacent spinous processes, intended for use with bone graft material.
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 Criterion | Reported Device Performance |
|---|---|
| Static Torsion | Equivalent or superior to predicate devices. |
| Static Tension | Equivalent or superior to predicate devices. |
| Static Compression | Equivalent or superior to predicate devices. |
| Static Locking Mechanism | Equivalent or superior to predicate devices. |
| Dynamic Flexion-Extension | Equivalent or superior to predicate devices. |
| Dynamic Locking Mechanism | Equivalent or superior to predicate devices. |
| Intended Use | Identical to predicate devices. |
| Material Composition | Identical to predicate devices (Ti Alloy per ASTM F136). |
| Design Characteristics | Identical to predicate systems. |
| Mechanism of Action | Identical to predicate systems. |
2. Sample Size Used for the Test Set and Data Provenance
The document states that "representative worst case constructs" were used for each test mode. However, it does not specify the exact sample size for these tests.
The data provenance is not explicitly mentioned (e.g., country of origin). The testing described is in vitro performance testing rather than human clinical trial 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 as the study described is a series of mechanical performance tests, not a clinical study involving expert assessment of patient outcomes or imaging. The "ground truth" for these tests would be the established engineering standards and specifications for spinal implants.
4. Adjudication Method for the Test Set
This information is not applicable as it pertains to expert disagreement in clinical evaluations, not mechanical testing.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A multi-reader multi-case (MRMC) comparative effectiveness study was not performed. The presented data focuses on mechanical performance testing of the device itself, not on human reader performance with or without AI assistance.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
This information is not applicable as the device is a mechanical medical implant, not an AI algorithm.
7. Type of Ground Truth Used
The ground truth used for these performance tests is based on established engineering standards and specifications suitable for spinal interlaminal fixation devices, as demonstrated by comparison to predicate devices, which are already legally marketed and have met equivalent standards. These standards would dictate acceptable ranges for static and dynamic mechanical properties.
8. Sample Size for the Training Set
This information is not applicable as the device is a mechanical implant, not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as above.
§ 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.