(59 days)
The PreView-III™ Anterior Cervical Plate System is intended for the cervical spine in skeletally mature patients receiving fusion by autogenous and/or allogenic bone graft. The implants are attached to the anterior cervical spine (C2-T1). PreView-III™ Anterior Cervical Plate System is intended for use under the following indications degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), spondylolisthesis, trauma (i.e., fracture), tumor, deformity (i.e., kyphosis, and scoliosis), spinal stenosis, pseudoarthrosis, and failed previous fusion.
The PreView III™ Anterior Cervical Plate System is composed of the following components: Plates with preassembled locking rings. Bone screws. These components can be assembled by associated instruments to provide immobilization of the cervical spine. All components made from Ti-6Al-4V ELI (ASTM F-136).
The provided text is a 510(k) summary for the Nexus Spine, LLC's PreView-III™ Anterior Cervical Plate System. This summary describes a medical device, specifically an orthopedic implant for spine fixation, and assesses its substantial equivalence to a predicate device based on mechanical performance testing.
The questions you've asked are typically relevant to the performance validation of AI/ML-driven medical devices, particularly those that might use imaging data to assist in diagnosis or treatment planning.
Based on the provided text, the questions regarding acceptance criteria and study proving an AI device meets those criteria cannot be fully answered because this submission is NOT for an AI/ML device.
The PreView-III™ Anterior Cervical Plate System is a physical implant, not a software device or an AI application that processes images or data. The "performance testing" described in the document refers to mechanical tests (Static Compression Bending, Static Torsion, Dynamic Compression Bending) performed on the physical plate system to demonstrate its structural integrity and safety/effectiveness compared to a predicate device, as per ASTM F1717.
Therefore, many of the specific points you've requested (such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, training set details, etc.) do not apply to this type of device submission.
Here's what can be extracted and inferred from the text, reframing it in the context of a traditional medical device submission:
- Device Type: Physical Spinal Intervertebral Body Fixation Orthosis (implant).
- Purpose of "Study": To demonstrate mechanical substantial equivalence to a legally marketed predicate device (Alphaspine, Inc, PreView Anterior Cervical Plate System (K062371)).
- "Acceptance Criteria" (Mechanical Performance): While not explicitly stated as numerical criteria in a table, the implied acceptance criterion is that the PreView-III™ Anterior Cervical Plate System's mechanical performance (in terms of Static Compression Bending, Static Torsion, and Dynamic Compression Bending) must be substantially equivalent to the predicate device per ASTM F1717 standards.
- "Reported Device Performance": "The results demonstrated that the subject device has substantially equivalent mechanical performance to predicate device."
- Sample Size: For mechanical testing of physical implants, a "sample size" refers to the number of physical devices or components tested. This is not specified in the summary but would be detailed in the full test report submitted to the FDA. It's not "data samples" in the way AI models use them.
- Data Provenance: Not applicable in the context of patient data. The "data" comes from laboratory mechanical tests.
- Experts/Ground Truth/Adjudication/MRMC/Standalone Performance/Training Set: None of these are applicable because the device is a physical implant, not an AI/software device that interprets data or images. Its "performance" is determined by physical stress tests, not by human interpretation of its outputs or by learning from data.
In summary, the provided document does not contain the information needed to answer your questions because it describes a mechanical implant, not an AI/ML-driven medical 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.