(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.
§ 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.