(26 days)
The DigitalDiagnost C90 is intended to acquire, process, store, display and export digital radiographic images. The DigitalDiagnost C90 is suitable for all routine radiography examinations, including specialist areas like intensive care, trauma or pediatric work, excluding fluoroscopy, angiography and mammography.
The proposed DigitalDiagnost C90 is same as the 510(K) approved predicate (K182973) as mentioned below. It is a high-end digital radiography system consisting of a height adjustable patient support table and a ceiling suspension consisting of a tube including a control handle used to acquire images with a flat panel fixed RAD detector. Additionally, different vertical stands for the radiography examinations are available. The ceiling suspension can be moved in longitudinal and lateral directions and additionally the tube can be tilted and rotated as well. The proposed DigitalDiagnost C90 is configured with a Philips x-ray generator and a flat panel fixed RAD detector, Pixium 4343RCE, together with the tube these components form the radiography Image Chain. The proposed DigitalDiagnost C90 introduces a new wireless portable detector, pixium 3543DR i.e. SkyPlate E (cleared in reference device 510(K) K191813) and their relevant grids, in addition to the family of SkyPlate detectors (pixium 3543EZ i.e. Large and pixium 2430EZ i.e. Small) that are already integrated in the currently marketed (predicate) DigitalDiagnost C90 (K182973).
The Philips DigitalDiagnost C90 is a stationary x-ray system, and the submission K202564 introduces the SkyPlate E detector and its relevant grids as a modification to the previously cleared DigitalDiagnost C90 (K182973). The acceptance criteria and the study proving the device meets these criteria are primarily based on demonstrating substantial equivalence to the predicate device through non-clinical performance testing. No clinical study was performed.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Philips DigitalDiagnost C90, specifically regarding the addition of the SkyPlate E detector, are based on demonstrating equivalence or non-inferiority to the predicate device (DigitalDiagnost C90 with existing SkyPlate detectors) in key technological characteristics and the maintenance of clinical image quality, safety, and effectiveness. The reported device performance indicates that the new SkyPlate E detector either meets or is equivalent to the performance of the existing detectors, or that any differences do not negatively impact clinical image quality or safety.
| Feature | PREDICATE Device Performance (DigitalDiagnost C90 with SkyPlate Small & Large) | PROPOSED Device Performance (DigitalDiagnost C90 with SkyPlate E) | Acceptance Criteria (Implicit from "Discussion & Conclusion") | Reported Device Performance (Discussion & Conclusion) |
|---|---|---|---|---|
| Detector Type | Digital wireless flat detector | Digital wireless flat detector | Same | Equivalent; No impact to safety and effectiveness. |
| Detector Models | SkyPlate Large (3543EZ), SkyPlate Small (2430EZ) | SkyPlate Large (3543EZ), SkyPlate Small (2430EZ), SkyPlate E (3543DR) | Addition of SkyPlate E does not affect clinical workflow or image quality. | Addition of SkyPlate E detector does not affect the clinical workflow or clinical image quality so there is no impact to the safety and effectiveness of the device. |
| X-Ray Absorber | CsI Scintillator | CsI Scintillator | Same | Equivalent; No impact to safety and effectiveness. |
| Installation Type | Portable | Portable | Same | Equivalent; No impact to safety and effectiveness. |
| Readout Mechanism | Thin Film Transistor | Thin Film Transistor | Same | Equivalent; No impact to safety and effectiveness. |
| Detector Size | SkyPlate Small: 328mm x 268mm x 16mm | |||
| SkyPlate Large: 384mm x 460mm x 16mm | SkyPlate Small: Same | |||
| SkyPlate Large: Same | ||||
| SkyPlate E: 384.5mm x 460.5mm x 16.0mm | Equivalent size does not affect clinical workflow or image quality. | Equivalent size does not affect the clinical workflow or clinical image quality so there is no impact to the safety and effectiveness of the device. | ||
| Max X-ray Dose for Linear Response | 50 μGy | 50 μGy | Same | Equivalent; No impact to safety and effectiveness. |
| Maximum Usable Dose | SkyPlate Small: 75 μGy | |||
| SkyPlate Large: 75 μGy | SkyPlate Small: Same | |||
| SkyPlate Large: Same | ||||
| SkyPlate E: 80 μGy | Equivalent or better. | Equivalent or better; No impact to safety and effectiveness of the device. | ||
| Maximum Lifetime Dose | 100 Gy | 100 Gy | Same | Equivalent; No impact to safety and effectiveness. |
| Detector Weight | SkyPlate Small: 1.6 Kg (incl. battery) | |||
| SkyPlate Large: 2.8 Kg (incl. battery) | SkyPlate Small: Same | |||
| SkyPlate Large: Same | ||||
| SkyPlate E: 3.1 Kg (incl. battery) | No impact on clinical workflow. | It has no impact on clinical workflow. Therefore, no impact on safety and effectiveness of the device; thus, demonstrating SE. | ||
| Image Size (X-ray field) | SkyPlate Small: 284x222mm | |||
| SkyPlate Large: 344.8mm x 421.2mm | SkyPlate Small: Same | |||
| SkyPlate Large: Same | ||||
| SkyPlate E: 345mm x 426mm | Difference does not impact clinical Image Quality. | This difference in the Image Size (X-ray field) does not impact clinical Image Quality. Therefore, no impact on safety and effectiveness of the device; thus, demonstrating SE. | ||
| Pixel Size | SkyPlate Small & Large: 148 μm | SkyPlate Small & Large: Same | ||
| SkyPlate E: 160 μm | Difference of 12 μm does not impact image resolution to affect clinical image quality. | The difference of 12 μm pixel size does not impact the image resolution to an extent that can impact the clinical image quality. Therefore, no impact on safety and effectiveness of the device; thus, demonstrating SE. | ||
| Image Matrix Size (Number of pixels) | SkyPlate Small: 1500 X 1920 | |||
| SkyPlate Large: 2330 x 2846 | SkyPlate Small: Same | |||
| SkyPlate Large: Same | ||||
| SkyPlate E: 2156 x 2662 | Infinitesimal change and reduction does not impact clinical Image Quality. | Infinitesimal change in the image size (X-ray field) and reduction in number of pixels due to 160 μm pixel size does not impact clinical Image Quality. Therefore, no impact on safety and effectiveness of the device; thus, demonstrating SE. | ||
| Nyquist Frequency | SkyPlate Small & Large: 3.38 lp/mm | SkyPlate Small & Large: Same | ||
| SkyPlate E: 3.125 lp/mm | Difference does not impact clinical Image Quality. | This difference in the Nyquist Frequency does not impact clinical Image Quality. Therefore, no impact on safety and effectiveness of the device; thus, demonstrating SE. | ||
| Modulation Transfer Function (MTF) | SkyPlate Small & Large (e.g., 1 lp/mm 61%, 3.38 lp/mm 10%) | SkyPlate Small & Large: Same | ||
| SkyPlate E (e.g., 1 lp/mm 62%, 3.125 lp/mm 16%) | Difference does not impact clinical Image Quality. | This difference in the Modulation Transfer Function does not impact clinical Image Quality. Therefore, no impact on safety and effectiveness of the device; thus, demonstrating SE. | ||
| Detective Quantum Efficiency (DQE) | SkyPlate Small & Large (e.g., 0 lp/mm 70%, 3.38 lp/mm 19%) | SkyPlate Small & Large: Same | ||
| SkyPlate E (e.g., 0 lp/mm 70%, 3.125 lp/mm 18%) | Difference does not impact clinical Image Quality. | This difference in the Detective Quantum Efficiency does not impact clinical Image Quality. Therefore, no impact on safety and effectiveness of the device; thus, demonstrating SE. | ||
| ADC Digitisation | 16 Bit | 16 Bit | Same | Equivalent; No impact to safety and effectiveness. |
| Signal to Electronic Noise Ratio (SENR) | SkyPlate Small & Large: Min 38 dB – typical: 43 dB (@ 1 μGy) | SkyPlate Small & Large: Same | ||
| SkyPlate E: Min 37 dB - typical: 42.8 dB (@ 1 μGy) | Equivalent. | Equivalent; No impact to safety and effectiveness. | ||
| Data Interface to Workstation | AP to workspot: 1 GBit/s Ethernet, etc. | Same | Same | Equivalent; No impact to safety and effectiveness. |
| Grids | Large Grids for SkyPlate Large, Small Grid for SkyPlate Small | Large Grids for SkyPlate Large: Same | ||
| Small Grid for SkyPlate Small: Same | ||||
| Large Grids for SkyPlate E | Addition of new grids does not impact clinical workflow. | Addition of new grids for SkyPlate E introduction has no impact on clinical workflow. Therefore, no impact on safety and effectiveness of the device; thus, demonstrating SE. | ||
| Indications for Use | Acquire, process, store, display, export digital radiographic images, suitable for routine radiography. | Same | Same | Equivalent; No impact to safety and effectiveness. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document explicitly states: "The proposed DigitalDiagnost C90 did not require clinical study 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; and Safety and effectiveness."
Therefore, there was no clinical test set with human subject data used for this specific 510(k) submission. The evaluation was based on non-clinical performance data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable, as no clinical test set was used for this submission. The ground truth, in this context, was established through adherence to recognized standards and technical measurements, not expert clinical assessment of a dataset.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical test set was used.
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. This submission is for an x-ray system with a new detector, not an AI-powered diagnostic tool. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable, as this is not an AI algorithm. The performance evaluation was for the imaging system itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this submission was established through:
- Adherence to international and FDA-recognized consensus standards: This includes technical specifications and performance metrics outlined in standards like IEC 60601 series, IEC 62220-1, and IEC 62304.
- Results of non-standard performance tests: These tests are designed to verify specific technical aspects of the device and confirm its functionality and safety. The report mentions "System Verification Test," "Image Quality Test," and "Human Factors and Usability Engineering Test."
- Comparison to the predicate device: The core of the substantial equivalence claim relies on demonstrating that the new detector either performs the same as, or does not negatively impact the performance of, the previously cleared predicate device based on its technical specifications.
8. The sample size for the training set
Not applicable, as this is not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
Not applicable, as this is not an AI algorithm.
§ 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.