(90 days)
Indications for Use: It is intended that this device, in any system configuration, be removed after development of solid fusion mass. Hook components are indicated for use at C1-C7. Polyaxial screws are limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. These screws are not intended for placement in the cervical spine.
- Degenerative disk disease (DDD), defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.
- Spondylolisthesis
- Spinal stenosis
- Fracture/Dislocation
- Atlanto/Axial fracture with instability
- Revision of previous cervical spine surgery
- Tumors
The SOLANAS™ Posterior Stabilization System is a spinal fixation system intended to improve stability of the cervical and upper thoracic spine, C1-T3. There are a variety of implants that can be used for this procedure including cervical hooks, polyaxial pedicle screws and rods. All components are made from titanium alloy (ASTM F136).
The provided text describes a medical device submission (K052201) for the SOLANAS™ Posterior Stabilization System, focusing on its substantial equivalence to a predicate device and its indications for use. It outlines the product description, classification, and regulatory disposition. However, it does not contain information related to specific acceptance criteria, device performance metrics (like sensitivity, specificity, accuracy), or any study results validating such performance in the context of an AI/ML device.
The document primarily focuses on:
- Product Description: SOLANAS™ Posterior Stabilization System, made from titanium alloy, intended for cervical and upper thoracic spine stabilization.
- Indications for Use: Degenerative disk disease, spondylolisthesis, spinal stenosis, fracture/dislocation, atlanto/axial fracture with instability, revision of previous cervical spine surgery, and tumors.
- Substantial Equivalence: To the Summit™ system (K002733).
- Performance Data: Mentions "Mechanical testing... was performed and submitted," but provides no details on the tests, criteria, or results. This is typical for mechanical devices where structural integrity and biocompatibility are key, not diagnostic accuracy.
- Regulatory Approval: A 510(k) clearance based on substantial equivalence.
Therefore, I cannot provide the requested table or detailed information about acceptance criteria and study designs (sample sizes, ground truth, expert qualifications, MRMC studies, standalone performance, training set details) because this document pertains to a mechanical spinal fixation system, not a device with performance metrics related to diagnostic accuracy, which is usually the context for the questions you've asked (e.g., sensitivity, specificity, comparison to human readers, ground truth establishment).
In summary, none of the requested information regarding acceptance criteria for device performance (e.g., accuracy, sensitivity, specificity) and detailed study methodologies for validating such performance are present in the provided text. The "Performance Data" mentioned refers to mechanical testing, not a clinical study assessing diagnostic or prognostic accuracy.
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.