(83 days)
MyoStrain® software is an image processing device that post-processes strain-encoded (SENC) images, which are acquired by MRI systems equipped with a SENC pulse sequence. MyoStrain software receives SENC images from MRI storage and archives, and performs extraction of time-resolved, quantitative strain information per voxel and other cardiac measurements, viewing, image manipulations, communications, and printing. Available measurements include longitudinal and circumferential strain to quantitatively describe the wall motion of the heart. Tools are provided to display regional motion properties of the heart. A report interface is provided. Measurement tools provide information that can be output in standardized or specialized report formats. This interface makes it possible to quickly and reliably fill out a complete clinical report of a cardiac imaging exam with strain. The results of the measurement tools are interpreted by the physician and can be communicated to referring physicians to support the determination of a diagnosis.
The Myocardial Solutions Myostrain is software that runs on Windows-based operating systems to view and analyze SENC MR images of the heart in DICOM format. MyoStrain quantifies regional and global cardiac from SENC images by implementing the SENC processing methods. With a friendly graphic user interface, users are able to analyze SENC MR images and obtain fast and reproducible measurements of myocardial strain, ejection fraction, and volumes. Measurements are collected and presented on screen as a report showing values as colors and numbers, and this report can be printed or exported in digital format.
The provided text does not contain the acceptance criteria or details of a study that proves MyoStrain (6.0) meets specific performance criteria.
The document is a 510(k) summary for the device MyoStrain (6.0). In such submissions, the primary goal is to demonstrate substantial equivalence to a legally marketed predicate device, not necessarily to provide a detailed clinical or performance study report with specific acceptance criteria and results.
While the document mentions "PERFORMANCE TESTING" and "Software Verification and Validation Testing," it states that these were "conducted, and documentation was provided as recommended by FDA's Guidance..." It does not present the actual results, acceptance criteria, or study details within this summary.
Therefore, I cannot provide the requested information from the given text.
To confirm, none of the specific details requested below are present in the provided text:
- A table of acceptance criteria and the reported device performance: Not provided.
- Sample size used for the test set and the data provenance: Not provided.
- Number of experts used to establish the ground truth for the test set and the qualifications: Not provided.
- Adjudication method: Not provided.
- Multi Reader Multi Case (MRMC) comparative effectiveness study details: Not provided.
- Standalone (algorithm-only) performance details: Not provided.
- Type of ground truth used: Not provided.
- Sample size for the training set: Not provided.
- How the ground truth for the training set was established: Not provided.
§ 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.