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Picture Archiving and Communications for presenting images and information from the modalities to radiologists or others for reading. Includes standard viewing tools made to help the radiologist or cardiologist or others organize the images and read them in an efficient and easy manner.

The PACS product provides a system where images and accompanying data are sent from the modalities to the radiologists and technologists in digital format. The images are then viewed on a computer with such available tools a window, level, zoom, pan, roi, digital subtraction, ejection fraction, cross localize, and many other similar tools and with the ability to make notes and dictate a report. The images and report are then stored long term on a digital archive with multiple redundancy. All the information is also made available as a web based product where referring physicians or radiologists can access the information from anywhere using a secure system. The software is provided by NovaRad along with some 3 party software, principally from windows, and resides on off-the-shelf hardware hooked up to the radiology department local area network.

The provided text is a 510(k) summary for the NovaRad Corporation's PACS product (NovaPACS). It explicitly states that "There are no clinical tests to compare the two as they are merely software products that send and store images and information. Since the images are not changed or analyzed by the product there is no safety issue, except possible related to the safety of the archived images."

Therefore, based on the provided document, the following answers apply:

1. A table of acceptance criteria and the reported device performance
No acceptance criteria or reported device performance from a study are provided in the document. The device is a Picture Archiving and Communication System (PACS) and is not intended to change or analyze medical images, but rather to present and store them. Substantial equivalence was claimed based on functional similarity to a predicate device, not clinical performance metrics.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. No clinical or performance studies using a test set were conducted or mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. No clinical or performance studies using a test set were conducted or mentioned, hence no ground truth was established by experts for such a purpose.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical or performance studies using a test set were conducted or mentioned.

5. 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. No MRMC study was conducted. The device is a PACS for image viewing and storage, not an AI-powered diagnostic or assistance tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a PACS for image viewing and storage and does not involve a standalone algorithm for diagnostic performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. No clinical or performance studies requiring ground truth were conducted or mentioned.

8. The sample size for the training set
Not applicable. No machine learning or AI components requiring a training set are described for this PACS device.

9. How the ground truth for the training set was established
Not applicable. No machine learning or AI components requiring a training set are described for this PACS device, therefore no ground truth for a training set was established.

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