(90 days)
CS Imaging software is intended to be used with Carestream's dental digital imaging systems by healthcare professionals to display, adjust, measure, print and store 2D digital images of the dento-maxillofacial region of the human anatomy to support image diagnosis.
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This document is a 510(k) clearance letter for the CS Imaging software. It clears the device for marketing and states its intended use. However, it does not contain the acceptance criteria or a study proving the device meets those criteria, nor does it provide any performance metrics as typically found in clinical studies.
A 510(k) submission primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel performance against specific acceptance criteria with detailed study results as requested in the prompt. While a substantial equivalence determination often relies on comparing technical characteristics and showing that the new device performs as intended and is as safe and effective as a predicate device, the detailed study data you've requested regarding acceptance criteria and performance metrics are not typically presented in the FDA's 510(k) clearance letter itself. These details would usually be found in the manufacturer's 510(k) submission summary or detailed study reports.
Therefore, I cannot provide the requested information based solely on the provided text. The document confirms that the CS Imaging software is cleared for marketing with the indications for use described, but it does not detail:
- A table of acceptance criteria and reported device performance.
- Sample sizes, data provenance, number/qualifications of experts, or adjudication methods for test sets.
- Results from multi-reader multi-case (MRMC) comparative effectiveness studies.
- Results from standalone performance studies.
- The type of ground truth used.
- Sample size for the training set or how its ground truth was established.
The provided text only includes:
- Device Name: CS Imaging
- Indications for Use: "CS Imaging software is intended to be used with Carestream's dental digital imaging systems by healthcare professionals to display, adjust, measure, print and store 2D digital images of the dento-maxillofacial region of the human anatomy to support image diagnosis."
- Regulatory Class: II
- Product Code: LLZ
- Regulation Number: 21 CFR 892.2050
- Regulation Name: Picture archiving and communications system
§ 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).