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CT Collaboration Live is indicated for remote communication with CT console (via chat, call, video call, screen sharing and remote access) by a qualified remote clinical user for consultation, guidance, support, and training in real time. Remote access must be granted by the CT technologist operating the system. Remote access is only available for Philips CT systems supporting CT Collaboration Live connectivity capabilities. Images reviewed remotely are not for diagnostic use.

The proposed CT Collaboration Live is a software application integrated in Philips Computed Tomography (CT) X-Ray CT 5300 Systems. CT Collaboration Live enables two-way communication of text, voice, image, and video information between a CT system operator and a remote user on a Windows device. CT Collaboration Live facilitates: 1) peer-to-peer consultation and training, 2) system-level remote sharing & operation, 3) access to live image feed and 4) remote expert user(s) and physician consultation. CT Collaboration Live functionality includes a remote-control feature in which the CT system operator may grant a qualified remote user control of the CT system parameters via a virtual control panel and virtual touch screen.

I am sorry, but the provided text does not contain the detailed information necessary to answer your request regarding acceptance criteria and a study proving device performance.

The document is a 510(k) summary for Philips Healthcare's "CT Collaboration Live" device. It primarily focuses on demonstrating substantial equivalence to a predicate device (Collaboration Live, K200179) rather than detailing specific acceptance criteria and the results of a primary study to prove those criteria were met for the new device.

Here's a breakdown of what is and is not in the document, relating to your request:

What is mentioned (but not in enough detail for your request):

• Acceptance Criteria: The text states, "All tests were used to support substantial equivalence of the proposed CT Collaboration Live and to demonstrate that CT Collaboration Live: ... Meets the acceptance criteria and is adequate for its intended use." However, it does not provide a table of these acceptance criteria or the specific performance metrics achieved against them.
• Study (Non-Clinical Performance Data): The document mentions "Non-clinical performance software verification testing has been performed" and that "Software verification activities demonstrate that the CT Collaboration Live software application meets the design input requirements." It also states, "The summary and conclusion of results are provided in the System Verification Test Report." However, the actual results of this testing that would prove the device met acceptance criteria are not included in this document.
• No Clinical Study: It explicitly states, "The proposed CT Collaboration Live did not require a clinical study since substantial equivalence to the predicate device Collaboration Live (K200179) was demonstrated."

What is NOT mentioned (which are required for your request):

• A table of acceptance criteria and reported device performance.
• Sample size used for the test set and data provenance.
• Number of experts used to establish ground truth and their qualifications.
• Adjudication method for the test set.
• Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of human readers with/without AI assistance.
• Whether a standalone performance study was done.
• The type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

This document serves as a regulatory submission demonstrating substantial equivalence, not a detailed technical report on specific performance metrics or clinical study results.

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