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1. Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), 2) Spinal stenosis, 3) Spondylolisthesis, 4) Spinal deformities, 5) Fractures, 6) Pseudarthrosis,7) Tumor resection, 8) Failed previous Fusion. When used as Fixation system the multiaxial screw components are also indicated for skeletally mature patients: a. Having severe spondylolisthesis (grade 3 or 4) of the L5-S1 vertebral joint, b. Who are receiving fusion using authogeneous bone graft only, c. Who are having the device fixed or attached to the lumbar or sacral spine (L.3 and below), d. Who are having the device removed after the development of solid fusion mass.

The Vertelink KOBRA™ Spinal Fixation System is designed to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the acute and pationic instabilities or deformities of the lumbar spine, spinal tumor and failed previous fusions. It can be used in either percutaneous or open surgery procedures. The system is composed of titanium pedicle screws and rods that are implanted in posterior manner either during an open surgical procedure or percutaneously using minimally invasive techniques.

The provided text is a 510(k) premarket notification for a medical device called the "Vertelink KOBRA™ Fixation System". This type of document is used to demonstrate that a new medical device is substantially equivalent to a legally marketed predicate device, rather than proving it meets specific acceptance criteria through a study.

Therefore, the document does not contain the information requested regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, or MRMC comparative effectiveness studies. These are typically associated with performance studies for certain types of devices, especially those involving AI or diagnostic interpretations, which is not the case for this spinal fixation system.

The core of this submission is to show substantial equivalence to an existing device (CD HORIZON® Spinal System, K030932) based on similar technological characteristics and indications for use, rather than to present a de novo clinical performance study against pre-defined acceptance criteria.

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The Pathway™ Access Sheath Catheter is designed to facilitate the entry of interventional devices into the vessels of the cardiovascular system.

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The provided document is a 510(k) clearance letter from the FDA for the Vertelink Corporation's Pathway Access Sheath Catheter. This type of document declares that a medical device is substantially equivalent to a predicate device already on the market and does not contain the detailed information necessary to answer the questions about acceptance criteria and study design for an AI/CADe device.

Specifically, the document does not include:

• A table of acceptance criteria and reported device performance.
• Information about sample sizes for test sets or data provenance.
• Details about experts or ground truth establishment.
• Adjudication methods.
• Any mention of multi-reader multi-case (MRMC) comparative effectiveness studies or standalone performance.
• Information on training set size or how its ground truth was established.

This document is a regulatory approval, not a scientific study report.

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The expandable sheath is designed especially for formation of large nephrostomy tracts required for percutaneous removal of renal and ureteral calculi.

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This FDA Premarket Notification (510k) provides no information about acceptance criteria or a study proving that the device meets acceptance criteria. The document is generally about the FDA's decision to clear the device for market based on substantial equivalence to a predicate device, rather than providing detailed performance study results from the manufacturer.

Therefore, I cannot provide the requested information from the given text.

If this were a document that contained such a study, I would look for sections detailing:

• Performance Data: Tables or descriptions of metrics like sensitivity, specificity, accuracy, etc.
• Study Design: Information on how the study was conducted, including sample size, data collection methods (retrospective/prospective), and data origin.
• Ground Truth Establishment: Details on how the "correct" answers were determined, including the number and qualifications of experts, and adjudication methods.
• Comparative Studies: Mention of MRMC studies or other comparisons to human performance.
• Training Data: If an AI device, details on the training set size and ground truth establishment for training.

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