(142 days)
The Pioneer Spinous Process Fusion Plate 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 discogenic back pain with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis, trauma and/or tumor. The Pioneer Spinous Process Fusion System is intended for use with bone graft material (i.e. allograph or autograph), 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. All components of the Pioneer Spinous Process Fusion Plate are comprised of Titanium Alloy Ti6Al4V per ASTM F136. 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 a posterior, non-pedicle supplemental fixation device.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Material Composition | All components composed of Titanium Alloy Ti6Al4V per ASTM F136. The predicate device is composed of the same material. |
| Mechanical Performance (Static and Fatigue) | Static and fatigue disassociation testing at the locking interface between the screw and barrel was conducted. The device was found to be equivalent to the predicate device. |
| Dimensional Equivalence | A dimensional comparison between the subject and predicate Spinous Process Fusion Plate devices demonstrated no significant differences exist that would impact strength or function. |
| Intended Use Equivalence | The indication for use of the Pioneer Spinous Process Fusion Plate is the same as the predicate device. |
| Mechanism of Action Equivalence | Mechanism of action is identical to that of predicate systems. |
| Available Sizes Equivalence | Available sizes are identical to that of predicate systems. |
| Safety and Effectiveness (Overall Conclusion) | Based on dimensional comparison, static and fatigue testing, and similarities in intended use, design, and physical characteristics with predicate devices, the device is considered equivalent in terms of safety and effectiveness, and substantially equivalent to existing legally marketed devices. |
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary does not specify a "test set" in the context of clinical data or a patient study. The performance data presented focuses on bench testing for mechanical properties and dimensional comparisons to a predicate device.
- Sample Size for Bench Testing (Static and Fatigue): Not explicitly stated in terms of number of units tested, but described as "testing at the locking interface between the screw and barrel."
- Data Provenance: The data is generated from in vitro (bench) testing and engineering comparisons, not from human or animal subjects. Therefore, there is no country of origin or retrospective/prospective classification.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. The "test set" is not clinical data requiring expert review for ground truth establishment. The evaluation relies on engineering principles and performance testing.
4. Adjudication Method for the Test Set
Not applicable. There is no clinical test set requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission focuses on device equivalence through material, design, and mechanical testing against a predicate device, not on assessing human reader performance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This device is a physical medical implant (a fusion plate), not an algorithm or AI software. Therefore, the concept of "standalone performance" for an algorithm is not relevant.
7. Type of Ground Truth Used
The "ground truth" for this device, in the context of proving its equivalence, is established through:
- Engineering Specifications and Standards: Adherence to ASTM F136 for material composition.
- Mechanical Performance Standards: Successful completion of static and fatigue disassociation testing to demonstrate equivalence to a predicate device.
- Dimensional Comparison: Direct physical measurement and comparison to an existing predicate device.
- Predicate Device Performance: The safety and effectiveness of the existing predicate device serves as the benchmark against which the new device is compared.
8. Sample Size for the Training Set
Not applicable. This is not an AI/ML device where a "training set" would be used. The evaluation is based on engineering design and testing.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set, there is no establishment of ground truth for it.
§ 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.