(15 days)
Smart Breath respiratory compensation option is a non-invasive software / hardware options that can be used to improve clinical images by reducing organ and tissue motion related to respiratory motion from patient breathing during a CT acquisition. The software will allow the user to retrospectively define the best respiratory phase from an image quality standpoint, and then will group images by the phase selected.
Retrospective Respiratory Gating enables a patient to be scanned on a CT with normal breathing. CT data are acquired and images are reconstructed without image artifacts due to organ and tissue motion. CT Images are synchronized with respiratory signal coming from external device and organ/tissue motion within the CT data reflecting both the organ motions and the chest motion. The user can then visually determine the optimum phase to perform volume imaging and post processing -quantification, contouring, segmentation. The respiratory phase identification is also provided.
The provided text does not contain information about specific acceptance criteria or a study demonstrating that the device meets such criteria. It primarily focuses on the device's description, indications for use, comparison with a predicate device, and the FDA's 510(k) clearance process.
Therefore, I cannot provide a table of acceptance criteria and reported device performance based on the input document.
Here's an explanation of why the requested information is absent and what details are present:
Missing Information:
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Acceptance Criteria Table and Reported Device Performance: This document does not specify any quantitative or qualitative acceptance criteria for the Smart Breath Respiratory compensation option. There is no performance data or metrics reported to demonstrate the device's efficacy, such as a percentage reduction in motion artifacts, improvement in image quality scores, or accuracy in respiratory phase identification.
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Sample Size and Data Provenance (for test set): No study is described, therefore no sample size for a test set or information about data provenance (e.g., country of origin, retrospective/prospective nature) is available.
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Number and Qualifications of Experts (for ground truth): Since no study establishing ground truth is mentioned, there's no information about experts or their qualifications.
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Adjudication Method: No study, no adjudication method described.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: The document does not mention any MRMC study, nor does it discuss comparative effectiveness with or without AI assistance, or any effect size.
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Standalone Performance Study: There is no description of a standalone algorithm performance study for this device.
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Type of Ground Truth: No study is described that would establish a ground truth (e.g., expert consensus, pathology, outcomes data).
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Sample Size for Training Set: The document makes no mention of a training set or its size.
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Ground Truth for Training Set: Since no training set is discussed, the method for establishing its ground truth is also not mentioned.
Information Present in the Document:
- Device Name: Smart Breath Respiratory compensation option
- Manufacturer: General Electric Medical Systems
- Indications for Use: To improve clinical images by reducing organ and tissue motion related to respiratory motion during a CT acquisition. The software allows users to retrospectively define the best respiratory phase for image quality and group images by the selected phase.
- Predicate Device: SmartScore 3.5 (K020929)
- Basis for Substantial Equivalence: Similar technology and phase selection process to the predicate device (SmartScore 3.5), which groups images based on cardiac phase. Smart Breath will use this grouping for respiratory phases to remove tissue motion.
- Risk Control: Software Development, Validation and Verification Process, adherence to industry and international standards.
- Conclusion (from manufacturer): "Smart Breath Respiratory Compensation Option does not result in any new potential safety risks and performs as well as devices currently on the market." This is a general statement of equivalency, not a report of specific performance metrics against acceptance criteria.
- FDA Clearance: The device received 510(k) clearance, indicating it was found substantially equivalent to a legally marketed predicate device. This process primarily evaluates safety and effectiveness relative to a predicate, rather than requiring the submission of specific performance metric studies against pre-defined acceptance criteria in the summary provided.
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.