(63 days)
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CliniscanSM MRI is intended for automatic labeling, visualization and volumetric quantification of segmented brain structures from a set of MRI images. This software is intended to automate the current manual process of identifying, labeling and quantifying the volume of segmental brain structures identified on MR images.
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This software is intended for use on adult patients only (18+ years).
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CliniscanSM MRI is NOT intended to diagnose, treat, cure or prevent any disease. All results must be reviewed by a qualified healthcare professional prior to any diagnosis.
Not Found
The provided document (K153593) is an FDA 510(k) clearance letter for the CliniscanSM MRI device. This document primarily focuses on the substantial equivalence determination and regulatory aspects. It does not contain specific information about the acceptance criteria, the study that proves the device meets the acceptance criteria, or most of the detailed technical study information requested in your prompt.
The FDA clearance letter confirms that the device is "substantially equivalent" to legally marketed predicate devices, but it does not include the detailed performance study results that would typically be part of a 510(k) submission.
Therefore, I cannot provide much of the requested information based solely on the text you provided.
Here's what I can extract or infer, and what cannot be provided:
What can be extracted/inferred:
- Device Name: CliniscanSM MRI
- Intended Use: Automatic labeling, visualization, and volumetric quantification of segmented brain structures from MRI images in adult patients (18+ years). It automates the current manual process.
- Regulatory Class: II
- Product Code: LLZ (Picture archiving and communications system)
What cannot be provided from the given document:
- A table of acceptance criteria and the reported device performance: This detailed performance data is not in the clearance letter.
- Sample size used for the test set and the data provenance: Not mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
- Adjudication method for the test set: Not mentioned.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: This typically applies to AI-assisted diagnostic devices, and while this device performs segmentation and quantification, the clearance letter does not describe such a study.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: While the device automates a process, specific standalone performance metrics are not provided.
- The type of ground truth used: Not mentioned.
- The sample size for the training set: Not mentioned.
- How the ground truth for the training set was established: Not mentioned.
To obtain this information, you would typically need to refer to the full 510(k) submission documentation, which is not included in the provided text. The FDA clearance letter only summarizes the outcome of the review process.
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).