Search Results

As a part of a radiographic system, the Philips Eleva Workspot with SkyFlow is intended to acquire, process, store, display, and export digital radiographic images. The Philips Eleva Workspot with SkyFlow is suitable for all routine radiography exams, including specialist areas like intensive care, trauma, or pediatric work, excluding fluoroscopy, angiography and mammography.

The Philips Eleva Workspot with SkyFlow is a workstation (computer keyboard, display, mouse), combined with a flat solid state X-ray detector. It is used by the operator to preset examination data and to generate process and handle digital X-ray images. The Philips Eleva Workspot with SkyFlow will be used as a common software platform in the following currently marketed Philips X-ray systems: Philips Digital Diagnost (K131483 – October 7, 2013), Philips MobileDiagnost (K111725 – July 19, 2011), Philips PCR Eleva (K093355– October 28, 2009), Philips EasyDiagnost Eleva (K031535 – September 6, 2006), and Philips BuckyDiagnost (K945278 – December 29, 1994). As a part of a radiographic system, the Philips Eleva Workspot with SkyFlow is intended to acquire, process, store, display, and export digital radiographic images. The Philips Eleva Workspot with SkyFlow is intended for clinical situations where practitioners deem necessary to remove the anti-scatter grid in critical care departments of hospitals (such as ICU and Emergency), where patients require portable radiographs. Whereas the Pre-Market Notification K140771 of the predicate device limited the indications for use of the SkyFlow option to bedside chest exams only, this Pre-Market Notification covers also other anatomical regions where scattered radiation might have an impact on image quality. There is a standalone version with minimal integration into the X-ray system. With the fully integrated version, the workstation screen also provides displays area and controls for X-ray generator control. The workstation computer can also host parts of the system control software.

The provided text does not contain acceptance criteria or a detailed study of device performance for the Philips Eleva Workspot with SkyFlow.

Instead, the document is a 510(k) summary for the Philips Eleva Workspot with SkyFlow, seeking substantial equivalence to a predicate device (Philips Eleva Workspot, K140771). This type of submission relies heavily on demonstrating that the new device is as safe and effective as an already cleared device, without necessarily requiring new, extensive clinical performance studies.

Here's what can be extracted and why the requested information is largely absent:

1. A table of acceptance criteria and the reported device performance

• Not present. The document states: "The image quality test results were equivalent or better with the modified SkyFlow function turned on than with this function turned off." This is a qualitative statement about an internal test, not quantitative acceptance criteria with reported performance metrics.

2. Sample size used for the test set and the data provenance

• Not present. The document mentions "non-clinical software verification and validation tests" and "image quality test results," but does not specify the sample size of images or the data provenance for these tests. The focus is on the device's technical specifications and adherence to standards rather than diagnostic performance on a patient dataset.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not present. Since there's no detailed diagnostic performance study described, there's no mention of experts or ground truth establishment in this context.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not present. As above, no diagnostic performance study details are 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

• No. The document explicitly states: "The Philips Eleva Workspot with SkyFlow did not require clinical studies since substantial equivalence to the currently marketed and predicate device was demonstrated with the following attributes: Design features; Indication for use; Fundamental scientific technology; Non-clinical performance testing including validation; and Safety and effectiveness." This indicates that a clinical study, including an MRMC study, was not performed or deemed necessary for this 510(k) clearance.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

• Not explicitly detailed as a diagnostic performance study. The "image quality test results" are a form of standalone testing, but no specific metrics or comparison against a diagnostic ground truth are provided. The device itself is an "Eleva Workspot with SkyFlow," which is a workstation with an image processing function (SkyFlow). It's essentially a standalone image processing system, but its performance is described in terms of image quality rather than diagnostic accuracy.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not present. For a device focused on image acquisition and processing rather than diagnostic interpretation, the "ground truth" for image quality might involve physical phantoms and objective image metrics rather than clinical diagnoses. However, these specifics are not provided.

8. The sample size for the training set

• Not applicable. The document describes "non-clinical software verification and validation tests." There's no mention of an "AI" or machine learning component that would require a "training set" in the conventional sense. The "SkyFlow" is described as a "modified" function, implying a fixed algorithm rather than a learning one.

9. How the ground truth for the training set was established

• Not applicable. See point 8.

In summary: The provided document is a 510(k) summary focused on demonstrating substantial equivalence through technical specifications, compliance with standards, and non-clinical performance testing. It does not contain the details of a clinical performance study with acceptance criteria, human reader studies, or ground truth establishment that would typically be associated with AI-powered diagnostic devices. The "SkyFlow" functionality seems to be an image processing algorithm (likely for scatter correction) that improves image quality, rather than a diagnostic AI that requires a training set and extensive clinical validation against a diagnostic ground truth.

Ask a specific question about this device