(62 days)
The Sapphire X3 Anterior Cervical Plate System is intended fixation (C2-T1) 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
- · Failed previous fusion
The purpose of this submission is to seek clearance for additional implant sizes in the Sapphire X3 Anterior Cervical Plate System. The Spinal Elements' Sapphire X3 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 conditions of the patient. Plates are pre-shaped with radial and lordotic curvature and have large windows for graft and end plate visualization. Plates range in length to accommodate one to five levels of fusion. Sapphire X3 plates accommodate larger angles for the distal screws in order to minimize plate overhang on the vertebral bodies.
All screws are equipped with an internal locking mechanism that is actuated by rotating a preassembled inset screw. Upon rotation, the insert screw interfaces with a clip in the head of the screw causing the clip to expand. The expansion of the clip prevents the screw from disassociating from the plate.
Screws are available in both fixed and variable angle designs. Fixed angle screws have a predetermined trajectory relative to the plate. The fixed angle screws have a neck diameter similar in size to the screw hole diameter of the plate.
Variable angle screws provide freedom in trajectory of the screws into the vertebral body. They allow 8° of angulation in any direction relative to the plate. The variable angle screws have a neck diameter that is smaller than the screw hole diameter of the plate. This difference in diameter allows the variable angle screws to be inserted at various angles relative to the plate.
The materials used for the system remain unchanged. The plates and screws are manufactured from titanium alloy (Ti-6Al-4V) conforming to ASTM F136 or ISO 5832-3. The locking clips on the screws are manufactured from Nitinol conforming to ASTM F2063.
This document, K231593, describes the 510(k) premarket notification for the "Sapphire X3 Anterior Cervical Plate System". However, it does not contain any information about acceptance criteria or a study proving the device meets those criteria for software or AI/ML-driven performance.
The document primarily focuses on:
- Regulatory Clearance: Announcing the FDA's decision to clear the device for market.
- Device Description: Details about the physical components, materials, and design of the Sapphire X3 Anterior Cervical Plate System (plates and screws for spinal fixation).
- Indications for Use: The medical conditions for which the device is intended (e.g., Degenerative Disc Disease, Trauma, Spinal Stenosis).
- Predicate Devices: Identifying previously cleared devices that are similar and establish substantial equivalence.
- Performance Data (Mechanical Testing): Mentioning that mechanical performance testing (static compression bending, static torsion, dynamic compression bending) was performed according to ASTM F1717, which is a standard for spinal implant constructs.
There is no mention of any AI/ML component, software performance, or a study involving human readers or ground truth for diagnostic purposes. The device is a physical spinal implant system, not a diagnostic AI tool.
Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth establishment because this information is not present in the provided document. The questions posed are relevant for AI/ML medical devices, which this product is not.
§ 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.