(111 days)
to allow standard Web Browsers or DICOM devices, connected via LAN or WAN, to access and view DICOM images stored on a central DICOM 3.0 archive
The FreePix/PixPACS ('FreePix') is a standalone gateway/server system, connected to a The I roll in I m Free masparent online protocol and format conversion between the DICOM 3.0 protocol/format and the HTTP/HTML protocol/format. The FreePix enables any HTTP/HTML compliant Web Browser, running on any computer platform (e.g. PC, Macintosh, UNIX), to access and display image and archive data obtained from DICOM 3.0 compliant systems connected on the same network.
The provided text describes a DICOM/HTTP Gateway device called "FreePix" and its 510(k) summary. However, it does not contain any information regarding clinical acceptance criteria or a study proving that the device meets such criteria.
The document focuses on:
- Device Description: What the FreePix DICOM/HTTP Gateway is, its intended use, and its technical components.
- Predicate Device Comparison: A comparison between the FreePix and a predicate device (GE CT HiLight with independent remote viewing station) to establish substantial equivalence.
- System Testing: A brief mention of internal system testing ("utilizing a standard set of test data, i.e. DICOM images from multiple modalities obtained from various medical imaging manufacturers") to ensure proper performance during development, manufacturing, installation, and maintenance. This is a technical system test, not a clinical study to prove acceptance criteria related to diagnostic accuracy or human performance.
Therefore, I cannot provide the requested information. The document explicitly states that the FreePix is a gateway/server for viewing and does not perform any processing. It focuses on the technical functionality of converting and displaying DICOM images via a web browser.
Here's why each requested point cannot be answered from the provided text:
- A table of acceptance criteria and the reported device performance: No acceptance criteria or performance metrics (like sensitivity, specificity, accuracy) are defined or reported. The comparison table is for technical features with a predicate device, not performance against clinical criteria.
- Sample size used for the test set and the data provenance: The document mentions "a standard set of test data, i.e. DICOM images from multiple modalities obtained from various medical imaging manufacturers" for internal system testing, but provides no details on sample size, country of origin, or retrospective/prospective nature. This is not a clinical test set.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no mention of experts or ground truth establishment in the context of a clinical test set.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No clinical test set or adjudication is described.
- 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 applicable. The FreePix device is a gateway for viewing, not an AI or diagnostic assistance tool.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: The FreePix is a "standalone gateway/server system" in terms of its technical function, but the context of "standalone performance" typically refers to the diagnostic performance of an algorithm without human intervention. Since this device is for viewing and not diagnosis, this question doesn't apply in the common sense it's asked for medical devices with AI.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. No clinical ground truth is established as there is no clinical performance study described.
- The sample size for the training set: Not applicable. The FreePix is not an AI/machine learning device that requires a training set in the diagnostic performance sense.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided document describes a technical infrastructure device for image viewing and transfer, not a diagnostic or AI-powered medical device that would have clinical acceptance criteria or human performance studies.
§ 892.2020 Medical image communications device.
(a)
Identification. A medical image communications device provides electronic transfer of medical image data between medical devices. It may include a physical communications medium, modems, and interfaces. It may provide simple image review software functionality for medical image processing and manipulation, such as grayscale window and level, zoom and pan, user delineated geometric measurements, compression, or user added image annotations. The device does not perform advanced image processing or complex quantitative functions. This does not include electronic transfer of medical image software functions.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.