(105 days)
The Sapphire Anterior Cervical Plate System is intended for anterior cervical fixation ( C2 - C7) in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (including fracture or dislocation), spinal stenosis, deformities or curvatures (kyphosis, lordosis or scoliosis), tumor, pseudoarthrosis, and failed previous fusion.
The Sapphire Anterior Cervical Plate System is comprised of plates and screws that are used for attachment to the anterior cervical spine. Both plates and screws are available in a variety of sizes to suit the individual pathology and anatomic condition of the patient. Plates are pre-shaped with radial and lordotic curvature and have large windows for graff and end plate visualization. Plates range in length to accommodate one to four levels of fusion.
Screws are available in both fixed and variable angle designs. Fixed angle screws have a predetermined trajectory relative to the plate. Variable angle screws provide freedom in traiectory of the screws into the vertebral body. All screws are equipped with an internal locking mechanism.
Plates and screws are manufactured from titanium alloy (Ti-6A1-4V) conforming to ASTM F 136 or ISO 5832-3, with certain subcomponents manufactured from nitinol conforming to ASTM F 2063.
The provided text describes a medical device, the Sapphire™ Anterior Cervical Plate System, and its clearance process through a 510(k) submission. This type of submission relies on demonstrating substantial equivalence to previously cleared devices, rather than conducting a de novo clinical study with specific acceptance criteria in the manner of an AI/ML device.
Therefore, many of the requested points are not applicable to this documentation.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Mechanical Performance | Dynamic Compression (ASTM F 1717) | "Mechanical testing indicates that the Sapphire™ Anterior Cervical Plate System is capable of performing in accordance with its intended use and is substantially equivalent to predicate devices." |
| Static Compression (ASTM F 1717) | (Same as above) | |
| Static Tension (ASTM F 1717) | (Same as above) | |
| Static Torsion (ASTM F 1717) | (Same as above) | |
| Material Conformance | Titanium alloy (Ti-6A1-4V) conforming to ASTM F 136 or ISO 5832-3 | "Plates and screws are manufactured from titanium alloy (Ti-6A1-4V) conforming to ASTM F 136 or ISO 5832-3..." |
| Nitinol conforming to ASTM F 2063 (for subcomponents) | "...with certain subcomponents manufactured from nitinol conforming to ASTM F 2063." | |
| Substantial Equivalence | To demonstrate equivalence in indications for use, design, function, and materials to predicate devices. | The device was "shown to be substantially equivalent previously cleared devices in indications for use, design, function, and materials used." Predicate devices listed are Atomic® Anterior Cervical Plate System (K060491), Synthes Anterior Cervical Vertebrae Plate (K926453), Amendia, LLC. Diamond Anterior Cervical Plate System (K100265), and Medtronic, Orion Anterior Cervical Plate System (K042499). |
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable. For mechanical testing, samples are typically physical units of the device and testing is done on a sufficient number of units to demonstrate statistical confidence in the mechanical properties. The text does not specify the number of units tested.
- Data Provenance: Not applicable in the context of clinical data. The data provenance is from laboratory mechanical testing of the device itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This is not a study involving human experts establishing ground truth for evaluating an AI/ML diagnostic or prognostic device. The "ground truth" for the mechanical tests would be the established ASTM F 1717 standards.
4. Adjudication method for the test set
- Not applicable. No human adjudication for a test set of clinical data was performed.
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 physical implant, not an AI/ML software device intended to assist human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. There is no algorithm for this physical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For mechanical testing, the "ground truth" is defined by the performance specifications outlined in ASTM F 1717. The device's performance is compared against these engineering standards as well as the documented performance of the predicate devices.
- For substantial equivalence, the "ground truth" is the established regulatory status and performance characteristics of the predicate devices (Atomic® Anterior Cervical Plate System, Synthes Anterior Cervical Vertebrae Plate, Amendia, LLC. Diamond Anterior Cervical Plate System, Medtronic, Orion Anterior Cervical Plate System).
8. The sample size for the training set
- Not applicable. There is no training set as this is not an AI/ML device.
9. How the ground truth for the training set was established
- Not applicable.
§ 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.