(83 days)
The Pioneer Aspect 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 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 10-84mm and include one, two, three and four level designs. 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 fixed/variable self-tapping and self-drilling.
The provided text describes a 510(k) summary for the Pioneer Aspect Anterior Cervical Plate System. This is a medical device submission, and the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the mechanical testing performed to demonstrate substantial equivalence to a predicate device, rather than a clinical study evaluating AI performance.
Here's the breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (What was measured) | Reported Device Performance (How it compared to predicate) |
|---|---|
| Mechanical Performance: | |
| Static and Fatigue Compression Bending (per ASTM F1717) | "The test results of verification testing demonstrate that the mechanical performance of the Pioneer Aspect Anterior Cervical Plate System is substantially equivalent to the predicate device." (Implies meeting or exceeding predicate's performance or falling within acceptable variations) |
| Static Torsion Testing (per ASTM F1717) | "The test results of verification testing demonstrate that the mechanical performance of the Pioneer Aspect Anterior Cervical Plate System is substantially equivalent to the predicate device." |
| Axial Pullout Screw Strength (per ASTM F543) | "The test results of verification testing demonstrate that the mechanical performance of the Pioneer Aspect Anterior Cervical Plate System is substantially equivalent to the predicate device." |
| Screw Pull Through / Retention Characteristics (internal protocols) | "The test results of verification testing demonstrate that the mechanical performance of the Pioneer Aspect Anterior Cervical Plate System is substantially equivalent to the predicate device." |
| Material Composition | Identical materials used for both subject and predicate plates and screws (Ti6Al4V ELI for plates/screws, Nitinol for screw-retention mechanism). |
| Dimensions | Available screw lengths (10-20mm), screw diameters (4.0, 4.5mm), overall plate length (10-84mm), and plate types (one, two, three and four level; static) are identical to predicate. |
| Indications for Use | Identical to those of the predicate Pioneer Poise system. |
| Principles of Operation | Employs the same principles of operation as the predicate device. |
2. Sample size used for the test set and the data provenance
- Sample Size: The document does not explicitly state the number of physical samples (devices or constructs) tested for each mechanical test. ASTM standards for medical device testing often specify minimum sample sizes, but these details are not provided in this summary.
- Data Provenance: The testing was "performed per recognized ASTM F1717, axial pullout screw strength per ASTM F543, and additional testing performed per internal protocols." This indicates the tests were conducted by the manufacturer, Pioneer Surgical Technology, following established scientific and engineering standards. The data is prospective, generated specifically for this submission. The country of origin of the data is implicitly the USA, where Pioneer Surgical Technology is located.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable in the context of this device. This is a submission for an implantable mechanical device, not an AI or diagnostic device that requires expert-established ground truth from clinical images or data. The "ground truth" for this device's performance is objective mechanical measurements against engineering standards and comparison to a predicate device.
4. Adjudication method for the test set
Not applicable. There's no "adjudication" in the sense of expert review of subjective data. The performance is objectively measured by mechanical testing.
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 an implantable surgical plate, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI device. "Standalone performance" for this device refers to its mechanical properties as a physical implant, which were evaluated.
7. The type of ground truth used
The "ground truth" for this submission is based on:
- Objective Mechanical Measurements: Data derived from standardized mechanical testing (ASTM F1717, ASTM F543, and internal protocols) providing quantitative performance metrics.
- Comparison to Predicate Device: The performance of the Pioneer Aspect Anterior Cervical Plate System was compared directly to that of the legally marketed predicate device (Pioneer Poise Anterior Cervical Plate System) to demonstrate substantial equivalence. The predicate device's established performance serves as a benchmark for equivalence.
- Material Specifications: Adherence to material standards (ASTM F136 for Ti6Al4V ELI, ASTM F2063 for Nitinol).
8. The sample size for the training set
Not applicable. There is no "training set" in the context of mechanical device testing for substantial equivalence.
9. How the ground truth for the training set was established
Not applicable, as there is no training set.
§ 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.