(41 days)
The DEL-IMS has application wherever the transmission of radiographic images and associated patient text data is desired to take place from an input, such as radiographic equipment which employs a digital image capture device, to an output device such as hardcopy, softcopy, or archive device.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.
The DEL-IMS is intended to provide a network connection via DICOM protocol to various output (e.g. hardcopy, softcopy and archive) devices from a radiographic system which uses a digital image capture device. It synchronizes the ready states of the digital image capture device and the radiographic equipment when a single x-ray console is desired, to provide the x-ray console features (e.g. technique selection) of the radiographic equipment.
The provided text describes a 510(k) summary for the DEL-IMS device, which is an operator console and imaging workstation for stationary digital X-ray systems. It outlines the device's function, its intended use, and its claim of substantial equivalence to a predicate device.
However, the document does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria. Instead, it focuses on the administrative aspects of the 510(k) submission, such as:
- Submitter and Contact Information: Del Medical Imaging, Bill Engel.
- Date Prepared: October 17, 2006.
- Trade Name & Common Name: DEL-IMS, Operator Console and Imaging Workstation for Stationary Digital X-Ray Systems.
- Classification: 21 CFR 892.2050 Picture Archiving and Communications Device, Class II.
- Predicate Device: Sterling DROC (K980970).
- Product Description: Provides network connection via DICOM protocol for image output, synchronizes digital image capture device and radiographic equipment.
- Indication for Use: Transmission of radiographic images and patient text data from digital image capture devices to output devices (hardcopy, softcopy, archive). Important caveat: Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary interpretations, and mammographic images require an FDA-approved monitor with specific resolution.
- Rationale for Substantial Equivalence: Same indication for use, same technological characteristics as the predicate. Minor technological differences do not raise new questions on safety or effectiveness.
- Safety and Effectiveness Information: Mentions operating instructions, software development processes (design, verification, validation), final device validation, and risk assessment prior to marketing. Also states compliance testing to IEC 60601-1-2.
- Conclusion: Performs same functions, equal safety and effectiveness, introduces no new safety risks, substantially equivalent to predicate.
Because the document is a 510(k) summary focused on substantial equivalence (comparing to a predicate device) rather than a de novo clinical validation study against specific performance criteria, the requested information about acceptance criteria and a study proving their fulfillment is not present in the provided text.
Therefore, I cannot populate the table or answer the specific questions related to acceptance criteria, sample sizes, expert involvement, or adjudication methods from this document. The document confirms the device's regulatory approval based on substantial equivalence to an existing device, which is a different type of assessment than proving performance against defined acceptance criteria through a specific study.
§ 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).