(30 days)
The UNIPLATE Anterior Cervical Plate System is intended for anterior cervical intervertebral body fixation. This system is indicated for patients in which stability is desired following anterior cervical fusion for the indications listed below. The intended levels for treatment range from C2-T1.
Indications include symptomatic cervical spondylosis, trauma, fracture, posttraumatic kyphosis or lordosis, turnor, degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, re-operation for failed fusion, or instability following surgery for the above indications.
The UNIPLATE Anterior Cervical Plate System consists of an assortment of plates and screws. The UNIPLATE Anterior Cervical Plate System also contains Class I manual surgical instruments and cases that are considered exempt from premarket notification. Manufactured from ASTM F 136 implant grade titanium Materials: alloy.
The provided text describes a 510(k) submission for a medical device and does not contain information about a study proving the device meets acceptance criteria or details about AI/algorithm performance. It is a regulatory submission for a spinal implant, which typically relies on mechanical testing and comparison to predicate devices, rather than AI performance studies or human reader studies.
Therefore, I cannot fulfill the request as it asks for information not present in the provided context. The document focuses on regulatory approval based on substantial equivalence and mechanical performance data, not a study evaluating algorithm performance or human reader improvement with AI.
To directly answer the prompt based on the absence of information:
- Table of acceptance criteria and reported device performance: Not applicable. The document refers to "Performance data per ASTM F 1717" being submitted to characterize the device but does not provide specific acceptance criteria or detailed results of those tests.
- Sample size used for the test set and the data provenance: Not applicable. This document is for a spinal implant, not an AI/algorithm-based device. "Test set" in this context would refer to mechanical testing of the implant, not a data set for an algorithm. Data provenance is not mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically defined for AI/algorithm studies (e.g., expert consensus on medical images) is not relevant to the regulatory submission for this physical medical device.
- Adjudication method: Not applicable.
- 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: No, an MRMC study was not done, as this is a physical medical device (spinal plate) and not an AI or imaging diagnosis device.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No, a standalone algorithm performance study was not done, as this is a physical medical device.
- The type of ground truth used: Not applicable in the context of AI/algorithm ground truth. The "ground truth" for this device would be its mechanical properties, established through standardized ASTM testing.
- The sample size for the training set: Not applicable, as this is not an AI/algorithm device.
- How the ground truth for the training set was established: Not applicable, as this is not an AI/algorithm 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.