(89 days)
SmartPreo IA option enables breath hold studies and trigger acquisition based on timing related to the arrival of a user injected exogenous contrast agent bolus.
The SmartPrep IA Option is an optional imaging technique that results in a scan acquisition being triggered off of the arrival of a user injected bolus of contrast agent at a prescribed volume of interest.
This document, a 510(k) summary for the GE Medical Systems SmartPrep IA, primarily focuses on demonstrating substantial equivalence to a predicate device and outlining safety standards. It does not contain the detailed information necessary to fully answer your request regarding acceptance criteria and a study proving those criteria are met for a device that involves performance metrics like sensitivity, specificity, or human reader improvement.
Here's a breakdown of why and what information is available:
Missing Information and Why:
The provided text describes a modification to an existing MR system (SmartPrep IA Option) that optimizes the timing of scan acquisition based on contrast agent arrival. This is a functional and safety-centric submission for a medical imaging technique, not a diagnostic AI device requiring performance metrics like sensitivity, specificity, or human reader studies.
Therefore, the following cannot be extracted from the provided text:
- A table of acceptance criteria and the reported device performance: This document confirms functionality and safety, not diagnostic performance metrics.
- Sample sized used for the test set and the data provenance: Not applicable to a functional/safety evaluation of this nature.
- Number of experts used to establish the ground truth... and their qualifications: Not applicable.
- Adjudication method: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. This is not an AI diagnostic assistant.
- Standalone (algorithm-only) performance: Not applicable. While it's an "option" (software), its performance is in optimizing image acquisition, not interpreting images.
- Type of ground truth used: Not applicable.
- Sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
Information Available from the Document:
- Device Description: The SmartPrep IA Option is an optional imaging technique that triggers scan acquisition based on the arrival of a user-injected bolus of contrast agent at a prescribed volume of interest.
- Indications for Use: Enables breath-hold studies and triggers acquisition based on timing related to the arrival of a user-injected exogenous contrast agent bolus.
- Summary of Studies: The SmartPrep IA Option was evaluated to the IEC 601-2-33 International medical equipment safety standard for Magnetic Resonance Systems.
- Conclusions: Evaluation testing confirmed the functionality of the software. The option does not result in any new potential hazards.
In summary, this document is a regulatory submission for a software feature improving MR scan acquisition, not a diagnostic AI device requiring performance validation against clinical endpoints or human reader studies.
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NOV 27 1996
GE Medical Systems
P.O. Box 414, W-709 Milwaukee, WI 53201 USA
SUMMARY OF SAFETY AND EFFECTIVENESS
- This 510(k) summary of safety and effectiveness information is submitted in accordance o with the requirements of 21 CFR Part 807.87(h).
- o ldentification of Submitter Larry A. Kroger, Ph.D., 414-544-3894, August 16, 1996
- 0 Identification of the Product SmartPrep IA
Manufactured by:
GE Medical Systems 3200 N. Grandview Blvd. Waukesha, Wi 53188
-
o Marketed Device
The SmartPreo IA Option is a modification to the currently marketed Signa Horizon MR Systems. -
o Device Description
The SmartPrep IA Option is an optional imaging technique that results in a scan acquisition being triggered off of the arrival of a user injected bolus of contrast agent at a prescribed volume of interest.
o Indications for Use
SmartPreo IA option enables breath hold studies and trigger acquisition based on timing related to the arrival of a user injected exogenous contrast agent bolus.
o Comparison with Predicate
The SmartPrep IA Option is substantially equivalent to the currently marketed Signa Horizon HiSpeed MR System. The Fast Gradient Echo pulse sequence is modified by the insertion of an Infusion Advisor scan.
0 Summary of Studies
The SmartPrep IA Option was evaluated to the IEC 601-2-33 International medical equipment safety standard for Magnetic Resonance Systems. Evaluation testing confirmed the functionality of the software.
- 0 Conclusions
It is the opinion of GE that the SmartPrep IA Option is substantially equivalent to the currently marketed Signa Horizon Fast Gradient Echo pulse sequence. The option does not result in any new potential hazards.
§ 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.