(59 days)
Filmless Clinic is a device intended to provide capability for the acceptance, transfer, display, storage, digitization and digital processing of medical images via the DICOM standard protocol.
Options allow for additional capability, including transmission of images, digitization of film images, acceptance of digital images directly from different medical image modalities, and quality control review of images.
Filmless Clinic is intended for use by qualified physicians and radiologists and other personnel.
Filmless Clinic is a device intended to provide capability for the acceptance, transfer, display, storage, digitization and digital processing of medical images via the DICOM standard protocol.
Options allow for additional capability, including transmission of images, digitization of film images, acceptance of digital images directly from different medical image modalities, and quality control review of images.
This document is a 510(k) clearance letter from the FDA for a device named "Filmless Clinic." It states that the device is substantially equivalent to legally marketed predicate devices. However, this type of regulatory document does not contain the detailed study information, acceptance criteria, or performance data that you've requested.
The FDA 510(k) clearance process primarily focuses on demonstrating substantial equivalence to a predicate device, rather than requiring new, full-scale clinical trials with specific acceptance criteria and detailed performance metrics to prove safety and effectiveness in the same way a PMA (Premarket Approval) might.
Therefore, I cannot extract the following information from the provided text:
- A table of acceptance criteria and the reported device performance: This information is not found in a 510(k) clearance letter.
- Sample size used for the test set and the data provenance: Not available.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available.
- Adjudication method for the test set: Not available.
- 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: Not available. This device, being a Picture Archiving and Communication System (PACS), is not an AI-assisted diagnostic tool in the sense of image interpretation enhancement for human readers. It's a system for handling medical images.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not available.
- The type of ground truth used: Not available.
- The sample size for the training set: Not available.
- How the ground truth for the training set was established: Not available.
The document confirms the device's intended use and regulatory classification but does not provide the technical performance study details you are looking for.
§ 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).