(272 days)
The Ivy MR Wireless Gating System's intended use is to acquire physiologic signals, comprising ECG, PP, and RESP, to provide reference outputs to trigger the acquisition of gated images during MRI scanning in systems operating at 3.0 Tesla in strength.
The MR Wireless Gating System is intended for use on adult and pediatric patients.
This product is limited to use by trained and qualified medical professionals. This product is not intended for the diagnosis, treatment, or prevention of any disease nor is it intended as life support equipment. The product is restricted for use on one patient at a time and is not in home care monitoring. This product not intended to provide diagnostic clinical information with regard to patient cardiac, peripheral pulse, or respiratory monitoring.
The Ivy MR Wireless Gating System is to be used in conjunction with GE Healthcare Signa Premier 3T Magnetic Resonance Scanners.
Not Found
I am sorry, but the provided text from the FDA 510(k) K171778 letter for the "Ivy MR Wireless Gating System, Model WGS-100" does not contain any information about acceptance criteria or a study that proves the device meets those criteria.
The document is an FDA clearance letter, which states that the device is substantially equivalent to legally marketed predicate devices. It covers:
- Device Name: MR Wireless Gating System, Model WGS-100
- Regulation Number and Name: 21 CFR 892.1000, Magnetic Resonance Diagnostic Device
- Regulatory Class: Class II
- Product Code: LNH
- Indications for Use: To acquire physiologic signals (ECG, PP, RESP) to provide reference outputs to trigger gated MRI acquisition at 3.0 Tesla, for adult and pediatric patients, in conjunction with GE Healthcare Signa Premier 3T Magnetic Resonance Scanners. It also specifies limitations (e.g., not for diagnosis, treatment, life support, one patient at a time, not for home care monitoring, not for providing diagnostic clinical information).
- General Controls: Details requirements such as registration, listing, good manufacturing practice, labeling, etc.
The document does NOT include:
- A table of acceptance criteria or reported device performance data.
- Information on sample sizes, data provenance, number of experts, adjudication methods for test sets.
- Details about MRMC comparative effectiveness studies or standalone performance.
- Type of ground truth used.
- Sample size for training sets or how ground truth for training was established.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based solely on the provided text. To get this information, you would typically need to refer to the full 510(k) submission summary or associated testing reports, which are not included in this FDA clearance letter.
§ 892.1000 Magnetic resonance diagnostic device.
(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.