(105 days)
The Pioneer Aspect Anterior Cervical Plate System is intended for anterior cervical fixation (C2-C7) 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 Aspect 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 system consists of static plates in lengths that range from 10-105mm and include one, two, three, four, and five level designs. The plates have an integrated screw retention mechanism. The system includes fixed/variable self-tapping and self-drilling screws in 04.0 or 04.5mm, ranging from 10-20mm in length.
The provided text is a 510(k) summary for the Pioneer Aspect Anterior Cervical Plate System. This document focuses on demonstrating substantial equivalence to existing predicate devices through mechanical performance testing, rather than establishing efficacy or safety through clinical trials with specific acceptance criteria in the manner often seen for diagnostic AI/ML devices. As such, many of the requested categories are not applicable to this type of submission.
Here's a breakdown of the available information in relation to your request:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Strength (General) | "Performance testing showed that the mechanical strength of the subject system is equivalent to or better than predicate devices and is therefore sufficient for the intended use." |
| ASTM F1717 (Dynamic and Static Compression Bending) | Completed. (Implicitly met standards, as the device was cleared) |
| Torsion Static Testing | Completed. (Implicitly met standards, as the device was cleared) |
| ASTM F543 (Screw Pull-Out Testing) | Completed. (Implicitly met standards, as the device was cleared) |
| Internal Protocols (Screw Pull-Through and Retention) | Completed. (Implicitly met standards, as the device was cleared) |
| Design Equivalence | "Available screw lengths, screw diameters, plate prominence and width, and plate types (one, two, three, four and five-level; static) fall within the range of predicate devices." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified in terms of number of devices or tests. The document mentions "non-clinical mechanical tests" and "testing per internal protocols."
- Data Provenance: The tests are non-clinical mechanical tests, not human data. Therefore, country of origin or retrospective/prospective is not applicable. The tests were performed by the manufacturer, Pioneer Surgical Technology, Inc.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This is not applicable. The "ground truth" for mechanical testing is established by industry standards like ASTM and internal engineering specifications, not by human expert consensus on clinical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This is a non-clinical mechanical test report.
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 device is a surgical implant, not an AI/ML diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This device is a surgical implant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" or reference for the performance evaluation was established by:
- ASTM (American Society for Testing and Materials) standards: Specifically ASTM F1717 for dynamic and static compression bending, and ASTM F543 for screw pull-out.
- Internal protocols: For assessing screw pull-through and retention characteristics.
- Performance of predicate devices: The "equivalent to or better than predicate devices" is the comparative benchmark for the mechanical strength.
8. The sample size for the training set
- Not applicable. This is a medical device for surgical implantation, not an AI/ML system requiring a training set.
9. How the ground truth for the training set was established
- Not applicable, as there is no training set for this type of device.
Summary of the Study (Mechanical Performance Testing):
The study primarily consisted of non-clinical mechanical tests to demonstrate that the Pioneer Aspect Anterior Cervical Plate System's mechanical performance is equivalent or superior to its legally marketed predicate devices.
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Tests performed included:
- ASTM F1717 dynamic and static compression bending.
- Torsion static testing.
- ASTM F543 screw pull-out testing.
- Internal protocols for screw pull-through and retention characteristics.
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Conclusion: The performance testing indicated that the mechanical strength of the subject system is equivalent to or better than predicate devices and is sufficient for its intended use. This demonstrated substantial equivalence, leading to the device's clearance.
§ 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.