(123 days)
Indications for use vary depending on the specific product and its intended application. These products are designed for use in medical or laboratory settings by trained professionals. Depending on the device, intended uses may include:
- Diagnostic purposes: Analyzing biological samples (e.g., blood, urine, tissue) to identify diseases, conditions, or other health markers. This can include detecting infections, monitoring chronic illnesses, or screening for genetic predispositions.
- Therapeutic procedures: Assisting in or performing medical interventions, such as administering medications, delivering fluids, or providing respiratory support.
- Research and development: Used in laboratory experiments and studies to investigate biological processes, test new drugs, or develop new medical technologies.
- Monitoring physiological parameters: Measuring heart rate, blood pressure, oxygen saturation, or other vital signs.
- Sample collection and preparation: Gathering, processing, and storing biological samples for further analysis.
Specific indications for use are provided in the product's labeling, instructions for use (IFU), or accompanying documentation. Users should always refer to the manufacturer's provided information for the most accurate and complete indications.
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The FDA Clearance Letter for the Swoop® Portable MR Imaging® System (V2) provides details on the acceptance criteria and the studies conducted to demonstrate the device meets these criteria, particularly focusing on the "Advanced Reconstruction" feature which likely incorporates deep learning for image quality optimization.
Here's a breakdown of the requested information:
1. Acceptance Criteria and Reported Device Performance
The core performance of the device's "Advanced Reconstruction" was evaluated through three studies: Performance Analysis, Contrast-to-Noise Ratio (CNR) Validation, and Advanced Reconstruction Image Validation.
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Performance Analysis (Robustness, Stability, Generalizability) | Quantitative: Reduced Normalized Mean Squared Error (NMSE) and improved Structural Similarity Index (SSIM) for Advanced Reconstruction compared to Linear Reconstruction. | |
| Qualitative: Preservation of motion and zipper artifacts, and no unexpected output. | Quantitative: "For all models and all test datasets NMSE was reduced and SSIM was improved for Advanced Reconstruction test images compared to Linear Reconstruction test images." | |
| Qualitative: "Advanced Reconstruction preserved the presentation of motion and zipper artifacts, and no unexpected output was observed." | ||
| Contrast-to-Noise Ratio (CNR) Validation | Mean CNR of Advanced Reconstruction required to be greater than the mean CNR of baseline Linear Reconstruction at a statistical significance level of 0.05 for each sequence type. | "In all cases, CNR of Advanced Reconstruction was greater than or equal to Linear Reconstruction for both hyper- and hypo-intense pathologies. The study result demonstrates that Advanced Reconstruction does not unexpectedly modify, remove, or reduce the contrast of pathology features." |
| Advanced Reconstruction Image Validation (Human Reader Study) | Advanced Reconstruction required to perform at least as well as Linear Reconstruction in all categories (median score ≥0 on Likert scale) and perform better (≥1 on Likert scale) in at least one of the quality-based categories (noise, sharpness, contrast, geometric fidelity, artifact, overall image quality). | "Advanced Reconstruction achieved a median score of 2 (the most positive rating scale value) in all categories. This scoring indicates reviewers found Advanced Reconstruction improved image quality while maintaining diagnostic consistency relative to Linear Reconstruction." |
2. Sample Size Used for the Test Set and Data Provenance
The document describes three distinct test sets for different validation studies.
- Performance Analysis (Robustness, Stability, Generalizability):
- Sample Size:
- T1, T2, FLAIR group: 40 patients, 111 images.
- DWI group: 29 patients, 94 images.
- Data Provenance: Not explicitly stated regarding country of origin. The test set was "entirely independent from the dataset used for model training." The "Equipment Type" is listed as "Swoop v2" (with
- Sample Size:
§ 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.