(28 days)
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.
§ 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.