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To be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the cervical, lumbar, and thoracic regions of the spine that can be interpreted by a trained physician.

Models CTL-63 and CTL-128 Spine Array Coils

This document is an FDA 510(k) clearance letter for two spine array coils (Models CTL-63 and CTL-128). It primarily addresses the regulatory approval process and states that the devices are substantially equivalent to legally marketed predicate devices.

Crucially, this document does NOT contain a study that proves the device meets acceptance criteria, nor does it provide any of the detailed information requested in your prompt regarding performance metrics, sample sizes, ground truth establishment, or clinical study designs (MRMC, standalone).

The letter confirms that the devices are intended "to be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the cervical, lumbar, and thoracic regions of the spine that can be interpreted by a trained physician." However, it does not specify what "diagnostic images" means in terms of image quality metrics, clinical accuracy, or any performance benchmarks.

Therefore, I cannot populate the table or answer the specific questions based solely on the provided text. The FDA 510(k) clearance process often relies on demonstrating substantial equivalence to a predicate device, which may involve engineering comparisons and basic bench testing rather than extensive clinical efficacy studies with the type of detailed performance criteria you are asking for.

To answer your questions, you would need access to the actual 510(k) submission itself (which is not provided here) or a separate clinical study report for these devices.

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