(29 days)
As a part of a radiographic system, the Philips Eleva Workspot is intended to acquire, process, store, display, and export digital radiographic images. The Philips Eleva Workspot 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 is a workstation (computer, keyboard, display, mouse), combined with a flat solid state X-ray detector. It is designed to be used with the following set of flat solid state X-ray detectors: Philips Pixium 4600, Philips Wireless Portable Detector FD-W17, Philips Pixium 4343RC. It is used by the operator to preset examination data and to generate process and handle digital X-ray images. The Philips Eleva Workspot will be used as a common software platform in the following currently marketed Philips X-ray systems: Philips Digital Diagnost (K131483 October 7, 2013), 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 is intended to acquire, process, store, display, and export digital radiographic images. The Philips Eleva Workspot is also intended for clinical situations where physicians decide not to use an anti-scatter grid in situations where patients require bedside chest AP digital radiographs. There is a standalone version with minimal integration into the X-ray system. This standalone version does not connect to a solid state X-ray detector. Instead, it is intended to connect to a Philips PCR x-ray cassette reader. 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 device modification employs an additional software algorithm (referred to as "SkyFlow" in this premarket notification) to post-process digital radiographs that are generated in clinical situations where physicians decide not to use an anti-scatter grid in critical care departments of hospitals such as ICU and Emergency, where patients require bedside chest AP digital radiographs. The software modifications enhance image contrast, producing images that have similar detail contrast as images acquired with an anti-scatter grid. Image quality and detail detectability improvements depend on the clinical task, patient size, anatomical location, and clinical practice. The additional SkyFlow software feature is an optional and reversible image processing option that is not required by the Philips Eleva Workspot to reach its intended use.
The Philips Eleva Workspot is a workstation that acquires, processes, stores, displays, and exports digital radiographic images. The device was cleared under K140771. The 510(k) Summary does not contain a specific section outlining a clinical study to prove the device met acceptance criteria, nor does it present device performance metrics against defined acceptance criteria in a table.
Instead, the submission states that no clinical studies were required. The claim of substantial equivalence to the predicate device (Philips XD-S Direct Radiography Workstation/Package, K063781) was demonstrated through non-clinical performance testing (verification and validation) and compliance with international and FDA-recognized consensus standards (IEC 62304, IEC 62366, and ISO 14971).
The relevant sections from the 510(k) Summary state:
- "The Philips Eleva Workspot did not require clinical studies since Summary of substantial equivalence to the currently marketed and predicate device Clinical Data: was demonstrated with the following attributes: Design features; Indication for use; Fundamental scientific technology; Nonclinical performance testing including validation; and Safety and effectiveness."
- "The results of these tests demonstrate that Philips Eleva Workspot met the acceptance criteria and is adequate for this intended use."
Without a conducted clinical study providing specific performance metrics, the following requested information cannot be directly extracted from the provided text:
- A table of acceptance criteria and the reported device performance: Not available. The document states non-clinical tests "met the acceptance criteria" but does not detail these criteria or performance specifics.
- Sample size used for the test set and the data provenance: Not applicable, as no clinical test set was described.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method for the test set: Not applicable.
- 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.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The document describes a "standalone version with minimal integration into the X-ray system" but does not provide performance data for it. The primary evaluation focused on software verification and validation, implying an algorithm-only assessment of functionality without human interaction metrics.
- The type of ground truth used: Not applicable, as no clinical ground truth was established for performance evaluation.
- The sample size for the training set: Not applicable, as no details about machine learning model training or a training set are provided. The "SkyFlow" algorithm is mentioned as an additional software algorithm for post-processing, but no specifics on its development or training data are given.
- How the ground truth for the training set was established: Not applicable.
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.