(258 days)
The Signature Orthopaedics Pinehurst Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine (C2-C7). The System is in the immobilisation and stabilisation of the spine as an adjunct to fusions in patients with:
· Degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies);
- · Spondylolisthesis;
- · Trauma (I.e fracture or dislocations);
- Tumors:
- · Deformity (defined as kyphosis, lordosis, or scoliosis);
- · Pseudoarthrosis:
- · Failed previous fusion;
- · Spinal stenosis
The Signature Orthopaedics' Pinehurst Anterior Cervical Plate System's components are manufactured from Ti6Al4V alloy per ISO 5832-3 and ASTM-F136.
The Pinehurst Anterior Cervical Plate Systemis temporary supplemental fixation device consisting of variety of shapes and sizes of plates and screws. The plates attach to the anterior cervical spine with a minimum four screw per plate. The plates are offered in one-level, two-level, three-level and four-level fusion configurations. The plates have an integrated locking mechanism that prevents screw-backout. The Pinehurst plates and screws are supplied sterile.
The document describes the Pinehurst Anterior Cervical Plate System, a medical device, and its successful 510(k) premarket notification to the FDA. The submission demonstrates substantial equivalence to legally marketed predicate devices.
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
The acceptance criteria for this type of device are primarily based on non-clinical performance standards to ensure safety and mechanical integrity. The document details the types of tests performed. While specific numerical acceptance thresholds are not provided in this summary, the statement "Non-clinical testing and engineering evaluations were conducted to verify that the performance of Pinehurst Anterior Cervical Plate System is adequate for anticipated invivo use" confirms that the device met these implicit performance criteria.
| Acceptance Criteria Category | Specific Test/Evaluation | Reported Device Performance |
|---|---|---|
| Mechanical System Integrity | Static and dynamic compression bending testing | Performance adequate for anticipated in vivo use (successful) |
| Static torsion testing | Performance adequate for anticipated in vivo use (successful) | |
| Screw Fixation Strength | Screw insertion testing | Performance adequate for anticipated in vivo use (successful) |
| Screw pull-out testing | Performance adequate for anticipated in vivo use (successful) | |
| Screw torque to failure testing | Performance adequate for anticipated in vivo use (successful) | |
| Biocompatibility | Material composition (Ti6Al4V alloy per ISO 5832-3 and ASTM-F136) | Same material as most predicates, slight difference from two predicates (Ti6Al4V ELI vs Ti6Al4V) which was deemed equivalent and not raising new safety/effectiveness questions. |
| Design Characteristics | Plate configurations (1, 2, 3, 4 levels) | Meets specified configurations |
| Integrated locking mechanism | Present and prevents screw back-out | |
| Dimensional Equivalence | Profile thickness | Within the profile thickness of predicates |
| Size range | Within the size range of predicates | |
| Functional Equivalence | Number of supplemental fixation points | Accommodates same number as predicates |
| Contouring to vertebral body | Contoured to match vertebral body (like predicates) | |
| Implantation method (manual, hand-tightened screws) | Same as predicates |
2. Sample Size Used for the Test Set and Data Provenance
The document states that "Non-clinical testing ... were carried out on the worst case sizes of the plates and screws." This indicates a focused testing approach on the configurations most likely to experience mechanical stress.
- Test Set Sample Size: Not explicitly stated as a number of devices, but rather as "worst case sizes" for both plates and screws. This implies a representative selection from the product range.
- Data Provenance: The testing was non-clinical, meaning it focused on laboratory and engineering evaluations. This type of data is typically generated in a controlled environment by the manufacturer or contracted testing facilities, not directly from human patients. The country of origin for the testing would likely be Australia, given the manufacturer's location. The data is prospective in the sense that the tests were conducted specifically for this submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
For non-clinical performance testing of a physical medical device like an anterior cervical plate system, the "ground truth" is established through adherence to recognized engineering standards and validated testing protocols.
- Number of Experts: Not applicable in the same way as for diagnostic AI. The "experts" would be the engineers, test technicians, and quality assurance personnel responsible for conducting the tests and interpreting the results according to established biomechanical testing standards.
- Qualifications of Experts: These individuals would typically hold engineering degrees (e.g., biomedical, mechanical) and possess expertise in medical device testing, biomechanics, and ISO/ASTM standards relevant to spinal implants.
4. Adjudication Method for the Test Set
Adjudication methods (e.g., 2+1) are typically used for clinical studies involving human readers or expert consensus on clinical data (e.g., imaging interpretation). For non-clinical, objective performance testing, an adjudication method for test results is generally not applicable. Test failures/passes are determined by predefined engineering criteria and measurement systems. Quality control and review processes by qualified engineers would ensure the validity of the results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. MRMC studies are typically used to assess the performance of diagnostic imaging devices or AI algorithms when interpreted by human readers, often comparing performance with and without AI assistance. This document describes the non-clinical performance testing of a physical implantable device, not a diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone algorithm performance study was not done. This device is a physical implant, not an algorithm or AI software. Therefore, this type of study is not relevant.
7. The Type of Ground Truth Used
For the non-clinical performance testing, the ground truth is based on:
- Engineering Standards and Biomechanical Principles: The "ground truth" for the device's performance in static and dynamic loading, screw pull-out, etc., is derived from industry-accepted and regulatory-recognized biomechanical testing standards (e.g., ASTM F1717 for spinal implants). These standards define how the device should behave under specific conditions to meet safety and effectiveness requirements.
- Material Specifications: Adherence to material standards (e.g., ISO 5832-3 and ASTM-F136 for Ti6Al4V alloy) constitutes a form of ground truth for material composition and properties.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device that requires training data. The "training set" concept is relevant to machine learning algorithms, not for the physical attributes and mechanical performance testing of an implantable medical device.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
§ 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.