(53 days)
SAGE 7 is a package of software tools for MR spectroscopic data processing and display. SAGE 7 is indicated for use for a wide variety of MR spectroscopic data management tasks, including file handling, display, processing/modeling, analysis, storage and hard copy output. The resultant spectroscopic presentations, when interpreted by a trained physician, can provide physiological / chemical information that can be useful in determining a diagnosis.
The GE SAGE 7 Spectroscopy Analysis Software is designed to operate on GE Signa Horizon Systems and GE Advantage Windows workstations. It provides a toolkit of software applications to handle a wide variety of tasks associated with spectroscopy data management. The SAGE (Spectroscopy Analysis GE) package provides the capability for the trained clinical spectroscopist to reconstruct, analyze, and display spectra and spectroscopic images to provide information to support a diagnosis. SAGE 7 provides a tool for the spectroscopist to process raw spectroscopy data into spectra or spectroscopic images, view them, and optionally perform numerical analyses to obtain spectroscopic parameters (ex. peak positions, widths, heights, areas, etc.).
The provided text does not contain specific acceptance criteria or a detailed study proving the device meets particular performance metrics beyond a general equivalence claim. The document is a 510(k) summary for a software enhancement (SAGE 7 Spectroscopy Analysis option) and primarily focuses on demonstrating substantial equivalence to a predicate device (SA/GE Analysis option).
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states that the SAGE 7 Spectroscopy Analysis option was evaluated against the International medical equipment safety standard IEC 601-2-33 ("Particular requirements for the safety of magnetic resonance equipment for medical diagnosis"). It concludes that the device is "comparable to the SA/GE Spectroscopy option."
However, no specific performance metrics (e.g., accuracy, sensitivity, specificity, processing speed, output consistency) or acceptance criteria (e.g., "must achieve X% accuracy," "processing time must be less than Y seconds") are mentioned or reported for either the SAGE 7 or the predicate device in this document. The "performance" is implicitly tied to safety and substantial equivalence to an already marketed device.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Compliance with International medical equipment safety standard IEC 601-2-33 | Evaluated against IEC 601-2-33. |
| Comparability to predicate device (SA/GE Analysis option) regarding basic operations and indications for use. | Determined to be comparable. Basic operations (Fourier transform, phasing, peak-picking, integration, fitting) are not significantly changed. No new indications for use or potential hazards. |
| Functionality in processing, analysis, and display of MR spectroscopic data. | Provides a toolkit for reconstruction, analysis, and display of spectra and spectroscopic images. Allows for numerical analyses (peak positions, widths, heights, areas, etc.). |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify a test set, sample size, or data provenance (e.g., country of origin, retrospective/prospective clinical data). The evaluation appears to be based on a comparison of features and capabilities rather than a performance study on a specific dataset.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
The document does not mention any experts being used to establish ground truth for a test set.
4. Adjudication Method:
Given that no test set or ground truth establishment is described, there is no mention of an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
The document does not mention an MRMC comparative effectiveness study, nor does it discuss human reader improvement with or without AI assistance. The focus is on the software tool itself, not its impact on human interpretation.
6. Standalone Performance Study:
A standalone performance study (algorithm only) as typically understood (e.g., reporting metrics like accuracy, sensitivity, specificity on a dataset) is not described. The "Summary of Studies" section refers to evaluation against a safety standard and comparison to a predicate device, not a performance study using a defined algorithm output and ground truth. The device is described as "a toolkit of software applications," and its output (spectroscopic presentations) is intended to be "interpreted by a trained physician."
7. Type of Ground Truth Used:
Since no specific performance study is detailed, no specific ground truth type (e.g., expert consensus, pathology, outcomes data) is mentioned as being used for evaluation.
8. Sample Size for the Training Set:
The document does not mention a training set size. The device is described as "software tools" and "spectroscopy analysis option," implying it's an analytical tool rather than a machine learning model that typically undergoes a training phase with a specific dataset.
9. How Ground Truth for the Training Set Was Established:
As no training set is mentioned, there is no information on how ground truth for a training set was established.
§ 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.