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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.

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As a part of a radiographic system, the Philips Eleva Workspot with SkyPlate Detectors is intended to acquire, process, store, display, and export digital radiographic images. The Philips Eleva Workspot with SkyPlate Detectors 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 SkyPlate Detectors is a workstation (computer, keyboard, display, mouse), introducing the new flat solid state X-ray detectors "SkyPlate". It is used by the operator to generate, process and handle digital X-ray images. There are two different product configurations of the Philips Eleva Workspot with SkyFlow Detectors: Philips ProGrade, and Philips Eleva Workspot for DigitalDiagnost. The Philips ProGrade is used as a retrofit upgrade for the Philips BuckyDiagnost (K945278), whereas the Philips Eleva Workspot for DigitalDiagnost integrates a new generation of wireless portable x-ray detectors (SkyPlate) to replace the x-ray detector WPD FD-W17 (K090625) within the Philips DigitalDiagnost radiography system.

I am sorry, but the provided text does not contain the detailed information necessary to fully answer your request regarding acceptance criteria and the study that proves the device meets them. The document is a 510(k) summary for the Philips Eleva Workspot with SkyPlate Detectors, focusing on demonstrating substantial equivalence to predicate devices. While it mentions that a study was conducted, it lacks specific details on the acceptance criteria and the study design parameters you've requested.

Here's what I can extract and what's missing:

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

• Acceptance Criteria: The document mentions that "the non-clinical performance data demonstrate substantial equivalence" and that "the results of these tests demonstrate that Philips Eleva Workspot with SkyPlate Detectors the acceptance criteria and are adequate for this intended use." However, it does not explicitly list the quantitative acceptance criteria. It mentions that main physical values like DQE and MTF are "basically equal or better than the predicate device."
• Reported Device Performance:
  • MTF: Ranging from 61% to 14% (predicate 60% to 15%)
  • DQE: Ranging from 66% to 24% (predicate 66% to 22%)
  • In both cases, the device's performance is stated as "equal or better" than the predicate.

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

• Sample Size (Test Set): Not specified in the provided text.
• Data Provenance: Not specified, but the study was a "single-blinded concurrence study." Given the manufacturer is German, it's possible at least part of the data is from Germany or other European countries, but this is not confirmed. The document only mentions the study was conducted "according to CDRH's Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices."

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

• Not specified. The document states it was a "concurrence study" but does not detail the number or qualifications of experts.

4. Adjudication method for the test set:

• Not specified. The study is referred to as a "single-blinded concurrence study," which implies some form of comparison or agreement, but the specific adjudication method (e.g., 2+1, 3+1) is not provided.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:

• The document describes a "single-blinded concurrence study" comparing the new x-ray detectors to a predicate device. This is a direct comparison of imaging capabilities, not an MRMC study assessing the improvement of human readers with AI assistance. The device itself is an X-ray detector and workstation, not an AI-driven interpretive tool. Therefore, an effect size of human improvement with AI is not relevant or reported here.

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

• The study described is a "concurrence study" to confirm "images of equivalent diagnostic capability." This implies comparing the diagnostic utility of images produced by the new device against the predicate, which inherently involves human interpretation. It is not an algorithm-only standalone performance evaluation in the context of an AI device.

7. The type of ground truth used:

• The study aimed to confirm "images of equivalent diagnostic capability." This suggests the ground truth was based on diagnostic interpretations, likely clinical diagnoses made by experts from the images, but the exact nature (e.g., expert consensus, pathology, outcomes data) is not explicitly stated.

8. The sample size for the training set:

• Not applicable. This device is an X-ray detector and workstation, not an AI model that requires a training set. The "study" refers to a comparison of image quality and diagnostic capability for regulatory purposes.

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

• Not applicable, as there is no training set for an AI model.

In summary, the provided document focuses on demonstrating the substantial equivalence of the Philips Eleva Workspot with SkyPlate Detectors to existing predicate devices based on non-clinical performance data (like DQE and MTF) and a clinical "concurrence study" to confirm equivalent diagnostic capability. It does not provide the detailed study design, sample sizes, expert qualifications, or adjudication methods typically required for the more in-depth analyses you are requesting, especially concerning AI device evaluation.

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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:

1. 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.
2. Sample size used for the test set and the data provenance: Not applicable, as no clinical test set was described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
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.
6. 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.
7. The type of ground truth used: Not applicable, as no clinical ground truth was established for performance evaluation.
8. 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.
9. How the ground truth for the training set was established: Not applicable.

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