(382 days)
The EponaTech Metron-CP/MD is a clinical imaging software application for use with DR and CR radiography systems, primarily focused on chiropractic and podiatry use. Metron-CP/MD standard processes images using state of the art filtering techniques from various imaging sources and then makes them available to display, annotate, calibrate, mark-up, analyze, store, print and distribute using standard PC hardware. Metron-CP/MD stores and organizes the images (radiographs, ultrasounds, photographs, etc), and provides many various tools and algorithms to produce the best image possible from the imaging hardware. The filters are customizable by the user and organized in Metron-CP/MD's searchable database for later review. Metron-CP/MD also supports adding notes, taking accurate physical measurements, and producing other mark-ups to aid in analysis over time.
Metron-CP/MD is currently intended for chiropractic, podiatry use, and general human radiography. It is not intended for mammography use.
Metron-CP/MD's features advance imaging algorithms, calibration and measurement tools, multi-imaging stitching, report generation, and full compliance with voluntary Digital Imaging and Communications in Medicine (DICOM) Standard. The filters are customizable by the users and organized in Metron-CP/MD's searchable database for later review. Users then have the ability to put together multi-page formatted reports that can be used in connection with other documents. (See 21 CFR 892.2050)
In accordance with 21 CFR 801 Subpart D, the software is intended for prescription use.
Metron-MD is a clinical software program that allows medical professionals to acquire, display, manipulate and archiving medical images. It offers features (e.g. annotation, zoom, calibration, mark-up, measurement, etc.) routinely used by medical professionals, such as radiologists and orthopedists. Metron-MD supports the DICOM standard and accepts file formats including JPEG, Bitmap, TIFF, avi, and DICOM. Metron-MD runs on Windows based PC-compatible computers, accepts existing image files, and captures images and videos from capture devices such as USB video cameras, CR and DR systems, Digital Camera Media, and TWAIN images sources, etc.
The provided text does not contain information about specific acceptance criteria or a study that evaluates the device's performance against such criteria. The document is a 510(k) summary for Metron-MD, which is a Picture Archiving and Communications System (PACS) software.
The relevant sections state:
- "14. Testing Metron-MD is tested according to the specifications documented in this notification. Metron-MD is demonstrated to perform as intended." This is a general statement that does not provide details about specific tests, methodology, or results.
- "15. Conclusions Metron-MD is a medical device that is substantially equivalent to similar features in the Predicate Devices and has the same intended uses and technological characteristics. The different features included in the Metron-MD software do not affect the safety or effectiveness of the device. This premarket notification contains sufficient information to establish substantial equivalence to the Predicate Devices." This indicates that the device's approval is based on substantial equivalence to predicate devices, rather than meeting novel performance acceptance criteria from a specific study.
Therefore, I cannot extract the requested information as it is not present in the provided text. The document focuses on demonstrating substantial equivalence to predicate devices (K070618 and K003607) for its intended use as a PACS, rather than presenting a performance study with defined acceptance criteria and detailed findings.
§ 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).