(84 days)
The Pioneer Poise Anterior Cervical Plate System is intended for anterior cervical fixation for the following indications: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
The Pioneer Poise Anterior Cervical Plate System consists of an assortment of plates and screws. The screws are used to secure the plates to the vertebral bodies of the cervical spine through an anterior approach. The Poise system consists of static and dynamic plates in lengths that range from 10-84mm and include one, two, three and four level designs. The dynamic design provides for uni-directional axial movement for postoperative load sharing between the plate and graft. The plates have an integrated screw retention mechanism. Screws range from 10-20mm in length, 4.0 or 4.5mm in diameter, and are available in self tapping or self drilling. The plates and screws are manufactured from Titanium alloy (ASTM F136) and Nitinol (ASTM F2063). The system also contains Class 1 manual surgical instruments and cases that are considered exempt from premarket notification.
The provided text describes the Pioneer Poise Anterior Cervical Plate System, a medical device, and its 510(k) submission. However, it does not include information about a study proving the device meets acceptance criteria related to AI/algorithm performance. The documentation focuses on demonstrating substantial equivalence to predicate devices through traditional mechanical testing and material comparisons.
Therefore, many of the requested sections regarding acceptance criteria and a study proving algorithmic performance cannot be fulfilled from the given text. The device is a physical spinal implant, not an AI or software-as-a-medical-device (SaMD), so the questions about AI performance metrics, ground truth, and reader studies are not applicable.
Here's an analysis based on the provided text, focusing on the information that is available:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this type of device are primarily related to its mechanical strength, durability, and material properties, demonstrating that it is substantially equivalent to legally marketed predicate devices. The "performance" here refers to the outcomes of these mechanical tests.
| Acceptance Criteria Category | Specific Test/Property | Reported Device Performance |
|---|---|---|
| Mechanical Performance | Static and fatigue compression bending (ASTM F1717) | Tested. Results demonstrate substantial equivalence to predicate devices. (Specific numerical thresholds or values are not provided in the summary, but the conclusion is "substantially equivalent"). |
| Static torsion (ASTM F1717) | Tested. Results demonstrate substantial equivalence to predicate devices. | |
| Axial pullout screw strength (ASTM F543) | Tested. Results demonstrate substantial equivalence to predicate devices. | |
| Screw pull-through plate (internal protocol) | Tested. Results demonstrate substantial equivalence to predicate devices. | |
| Screw retention characteristics (internal protocol) | Tested. Results demonstrate substantial equivalence to predicate devices. | |
| Material Composition | Plates and Screws | Manufactured from Titanium alloy (Ti6Al4V ELI, according to ASTM F136). Identical to predicate devices. |
| Screw-retention mechanism ("spring") | Manufactured from Nitinol (ASTM F2063). | |
| Dimensional Equivalence | Screw lengths (10-20mm) | Identical to predicate devices. |
| Screw diameters (4.0/4.5mm) | Identical to predicate devices. | |
| Overall plate length (10-84mm) | Identical to predicate devices. | |
| Plate types (one, two, three, four level; static & dynamic) | Identical to predicate devices. | |
| Intended Use & Principle of Operation | Indications for Use | Identical to predicate devices (degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, deformities, tumor, pseudoarthrosis, failed previous fusion). |
| Principle of Operation | Employs the same principles of operation as predicate devices (anterior cervical fixation, securing plates to vertebral bodies for uni-directional axial movement in dynamic designs). |
Due to the nature of the device (a physical spinal implant) and the content of the provided document (a 510(k) summary focused on substantial equivalence through mechanical testing), the following questions are not applicable to the submitted information.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. The "test set" in this context would refer to the samples of the device components used for mechanical testing. The document states "Non-Clinical Mechanical testing was presented to characterize construct and component performance," but does not specify the number of samples tested for each mechanical test. Data provenance like country of origin or retrospective/prospective is not relevant for non-clinical mechanical testing of physical implants.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. Ground truth, in the context of expert review, is not relevant for pre-market clearance of a physical implant based on mechanical engineering testing. The "ground truth" for mechanical testing is established by recognized ASTM standards and the physical properties observed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods are typically for evaluating subjective interpretations, often in image analysis or clinical assessments, which is not the primary method for demonstrating equivalence of a spinal implant.
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 question pertains to AI/algorithm performance studies, which are not relevant for this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This question pertains to AI/algorithm performance studies, which are not relevant for this device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable. The "ground truth" for the mechanical testing of this device is adherence to established ASTM standards and comparable performance to predicate devices' mechanical properties. This is measured objectively, not through human consensus, pathology, or outcomes data in the traditional sense for an AI/diagnostic device.
8. The sample size for the training set
- Not applicable. This device is a physical implant, not an AI model, so there is no "training set."
9. How the ground truth for the training set was established
- Not applicable. As there is no training set for an AI model, this question is irrelevant.
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.