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510(k) Data Aggregation
(26 days)
The Xenco Medical Pedicle Screw System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion. The Xenco Medical Screw System is intended for posterior, noncervical pedicle fixation or anterolateral fixation for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); curvatures (i.e., scoliosis, kyphosis); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; tumor; pseudoarthrosis; and failed previous fusion.
Not Found
I am sorry, but the provided text is a letter from the FDA to Xenco Medical, LLC regarding the 510(k) premarket notification for the Xenco Medical Pedicle Screw System. It confirms the device's substantial equivalence to legally marketed predicate devices and outlines regulatory requirements.
The document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or any of the other details requested in your prompt.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given text.
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(70 days)
The Xenco Medical Pedicle Screw System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion. The Xenco Medical Screw System is intended for posterior, noncervical pedicle fixation or anterolateral fixation for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); curvatures (i.e., scoliosis, kyphosis, or lordosis); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; tumor; pseudoarthrosis; and failed previous fusion.
Not Found
I am sorry, but the provided text does not contain any information about acceptance criteria or a study that proves a device meets those criteria. The document is an FDA 510(k) clearance letter for the Xenco Medical Pedicle Screw System, which primarily discusses the regulatory approval process and indications for use.
Therefore, I cannot fulfill your request for information regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment.
Ask a specific question about this device
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