(25 days)
Collaboration Live is indicated for remote console access of the Philips ultrasound system for image review, consultation, guidance, support, and education in real time. Access must be granted by the technologist operating the system. Images reviewed remotely are not for diagnostic use.
Collaboration Live is a new software feature integrated in Philips Epiq and Affiniti Diagnostic Ultrasound Systems (K182857). Collaboration Live enables two-way communication of text, voice, image, and video information between an ultrasound system operator and a remote user on a Windows desktop or laptop computer. Collaboration Live facilitates: 1) remote service support, 2) remote clinical training and education, and 3) remote peer-to-peer collaboration (non-diagnostic). Collaboration Live functionality includes a remote control feature in which the ultrasound system operator may grant a qualified remote user control of all ultrasound system parameters via a virtual control panel and virtual touch screen. The ultrasound system operator maintains the ability to take back system control at any time. The remote user interacts with the ultrasound system using the Collaboration Live remote application, which is called Reacts.
The provided text describes the "Collaboration Live" device, a software feature for Philips ultrasound systems, and its substantial equivalence to a predicate device (GE Customer Remote Console). However, the document does not contain specific acceptance criteria, a detailed study proving performance, or the specific data requested in the prompt.
Instead, it broadly states: "Software verification supported a determination of substantial equivalence with the predicate GE Customer Remote Console (K150193), and demonstrated that Collaboration Live meets the acceptance criteria and is adequate for its intended use."
Without explicit acceptance criteria and corresponding performance data, it's impossible to fill out the requested table and answer the specific questions about sample size, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details.
Therefore, the answer below reflects the absence of this detailed information in the provided document.
Acceptance Criteria and Device Performance Study
The provided 510(k) summary for Philips Healthcare's "Collaboration Live" device states that "Software verification supported a determination of substantial equivalence with the predicate GE Customer Remote Console (K150193), and demonstrated that Collaboration Live meets the acceptance criteria and is adequate for its intended use."
However, the document does not explicitly define the specific acceptance criteria or present a detailed study report with quantitative performance metrics for Collaboration Live. No tables showing acceptance criteria alongside reported device performance are included. The description focuses on demonstrating substantial equivalence based on technological similarities and software verification, rather than a quantifiable performance study against predefined criteria.
Therefore, the following information cannot be extracted from the provided text:
1. A table of acceptance criteria and the reported device performance:
- Not provided in the document. The document only states that the device "meets the acceptance criteria" without specifying what those criteria are or presenting detailed performance data.
2. Sample size used for the test set and the data provenance:
- Not provided in the document. The document mentions "Software verification" but does not detail the test set size, its composition, or its origin (e.g., country, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / Not provided. Since no specific performance study with a test set and ground truth establishment is detailed, this information is absent.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable / Not provided.
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 performed / Not stated. The document explicitly states, "Collaboration Live did not require clinical testing to support a determination of substantial equivalence." This implies no clinical comparative effectiveness study, including MRMC studies, was conducted or reported. "Collaboration Live" is described as a remote access and collaboration tool, not an AI diagnostic aid that would typically involve human reader performance improvement studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not performed / Not stated. The device is a collaboration tool, not an autonomous diagnostic algorithm, so standalone performance in the typical sense is not an applicable characteristic for this type of device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable / Not provided. As no specific performance study against a ground truth is reported.
8. The sample size for the training set:
- Not provided. The document does not describe any machine learning or AI model training, thus no training set information is available.
9. How the ground truth for the training set was established:
- Not applicable / Not provided.
§ 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).