(17 days)
The DigitalDiagnost C50 system is intended for use in generating radiographic images of human anatomy by qualified/ trained doctor or technician. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. This device is not intended for mammographic applications.
The DigitalDiagnost C50 Digital Radiography System (DigitalDiagnost C50) is a flexible digital radiography (DR) system that is designed to provide fast and smooth radiography examinations of sitting, standing or lying patients. The DigitalDiagnost C50 consist of the following components: ceiling suspension with X-ray assembly, wall stand with detector carrier, patient table with detector carrier and floating table top, high voltage generator, and an acquisition and reviewing workstation for post-processing, storage and viewing of images. Images may be transferred via a DICOM network for printing, storage and detailed review.
Here's a breakdown of the acceptance criteria and study information for the DigitalDiagnost C50, based on the provided text.
1. Table of Acceptance Criteria & Reported Device Performance:
| Feature | Acceptance Criteria (Predicate) | Reported Device Performance (DigitalDiagnost C50) | Comment on Equivalence |
|---|---|---|---|
| Basic information | |||
| Product Code | KPR | Identical (KPR) | No difference; thus, demonstrating SE. |
| Regulation No. | 21 CFR 892.1680 | Identical (21 CFR 892.1680) | No difference; thus, demonstrating SE. |
| Device Class | II | Identical (Class II) | No difference; thus, demonstrating SE. |
| Electrical Requirement | Input voltage: 3-phase, 200/208/240/380/400/415/440/480/500Vac; Frequency:50/60Hz; Current: Short term: 112A (with generator M-CABINET CXA 50kW), 134A (M-CABINET CXA 65kW); Long term: 10A. | Identical | No difference; thus, demonstrating SE. |
| Design characteristic | |||
| X-ray Tube | RO 1750 ROT 380 & SRO 33100 ROT 380 | Identical | No difference; thus, demonstrating SE. |
| Max Tube Voltage | 150 kV | Identical | No difference; thus, demonstrating SE. |
| Focal Spot Size | 0.6mm/1.2mm | Identical | No difference; thus, demonstrating SE. |
| Tube Max power | 50KW/100KW (250W equivalent anode input power) | Identical | No difference; thus, demonstrating SE. |
| Anode Type | Rotation | Identical | No difference; thus, demonstrating SE. |
| Generator | Philips Healthcare (Suzhou), M-CABINET CXA Pro 50kW, M-CABINET CXA Pro 65kW | Identical | No difference; thus, demonstrating SE. |
| Max Power | 50KW/65KW | Identical | No difference; thus, demonstrating SE. |
| KV range | 40-150 | Identical | No difference; thus, demonstrating SE. |
| Milli ampere sec (mAs) product | 0.4 mAs-600 mAs (with AEC control) | Identical | No difference; thus, demonstrating SE. |
| Collimator | |||
| Operation Mode | Manual collimation | Identical | No difference; thus, demonstrating SE. |
| Shape of Beam | Rectangular | Identical | No difference; thus, demonstrating SE. |
| Detector | |||
| Type | Digital Detector, Fixed RAD Detector, Wireless Static Detector | Identical | No difference; thus, demonstrating SE. |
| Fixed RAD Detector | Pixium 4343RG | Pixium 4343RCE (identical to predicate DigitalDiagnost C90 K182973) | The difference between 4343RCE and 4343RG is scintillator material and other minor differences of image area and image matrix. The differences don't affect the safety or effectiveness. Thus, demonstrating SE. |
| Wireless Static Detector | Varian PaxScan4336W | SkyPlate E (Trixell 3543DR) (identical to reference MobileDiagnost WDR 2.2 K191813) | The Skyplate E Detector is identical to the Skyplate E Detector of the currently marketed and Reference Device 1, MobileDiagnost WDR 2.2 (K191813- August 2, 2019). Thus, demonstrating SE. |
| X-ray Scintillator Material (Fixed) | GdOS (Fixed: Pixium 4343RG) | Cesium Iodide (Fixed: Pixium 4343RCE) | The fixed RAD detector of the proposed DigitalDiagnost C50 and currently marketed and Reference Device 3, DigitalDiagnost C90(K182973- January 11, 2019, Philips Medical Systems DMC) are both fabricated from identical Cesium Iodide material, thus demonstrating SE. |
| X-ray Scintillator Material (Wireless) | GdOS (Wireless Varian PaxScan4336W) | Cesium Iodide (Wireless SkyPlate E) | The Wireless Detector of the proposed DigitalDiagnost C50 and the currently marketed and Reference Device 1, MobileDiagnost WDR 2.2 (K191813- August 2, 2019) are both fabricated from identical Cesium Iodide material, thus demonstrating SE. |
| Image Area (Fixed) | 42.5cm x 42.5cm (Fixed: Pixium 4343RG) | 42.03cm x 42.54cm (Fixed: Pixium 4343RCE) | The image area of the DigitalDiagnost C50, provided with fixed RAD detector is identical to the image area of the Fixed RAD Detector of the currently marketed and Reference Device 3, DigitalDiagnost C90(K182973- January 11, 2019, Philips Medical Systems DMC), thus demonstrating substantial equivalence. |
| Image Area (Wireless) | 42.7 cm x 34.4 cm (Wireless: Varian PaxScan4336W) | 34.5 cm x 42.5cm (Wireless: SkyPlate E) | The image area of the proposed Wireless Detector SkyPlate E is identical to the Wireless Detector SkyPlate E of the currently marketed and reference device 1, MobileDiagnost WDR 2.2 (K191813- August 2, 2019, Sedecal SA). thus demonstrating SE. |
| Image Matrix (Fixed) | 2,874 x 2,869 (Fixed: Pixium 4343RG) | 2,874 x 2840 (Fixed: Pixium 4343RCE) | The image matrix of the proposed DigitalDiagnost C50, provided with fixed RAD detector is similar to the image matrix of the currently marketed and Reference Device 3, DigitalDiagnost C90. Thus demonstrating substantial equivalence. Infinitesimal change in the image size (X-ray field) does not impact clinical Image Quality. Therefore, they are equivalent and there is no impact on the safety and effectiveness of the device; thus, demonstrating SE. |
| Image Matrix (Wireless) | 3,072 x 2,476 (Wireless: Varian PaxScan4336W) | 2,156 x 2,653 (Wireless-SkyPlate E) | The image matrix of the proposed DigtialDiagnost C50 provided with wireless detector SkyPlate E is similar to the currently marketed and Reference Device 1, MobileDiagnost WDR 2.2. Infinitesimal change in the image size (X-ray field) does not impact clinical Image Quality. Therefore, they are equivalent and there is no impact on the safety and effectiveness of the device; thus, demonstrating SE. |
| Pixel Size (Fixed) | 148 μm (Fixed: Pixium 4343RG) | 148 μm (Fixed: Pixium 4343RCE) | The pixel size of the proposed DigtialDiagnost C50 provided with fixed RAD detector is identical to the pixel size of the currently marketed and Reference Device 3, DigitalDiagnost C90. Thus demonstrating substantial equivalence. |
| Pixel Size (Wireless) | 139 μm (Wireless: Varian PaxScan4336W) | 160 μm (Wireless-SkyPlate E) | The pixel size of the proposed DigtialDiagnost C50 provided with wireless detector SkyPlate E is identical to the currently marketed and Reference Device 1, MobileDiagnost WDR 2.2. Thus demonstrating SE. |
| Analog / Digital (A/D) conversion | 16 bits | Identical | No difference; thus, demonstrating SE. |
| Table | |||
| Table type | Fixed and Height adjustment | Identical | No difference; thus, demonstrating SE. |
| Height adjustment | 51.5 cm to 91.5 cm above floor, motorized adjustment | Identical | No difference; thus, demonstrating SE. |
| Tabletop longitudinal travel range | +/- 550mm | Identical | No difference; thus, demonstrating SE. |
| Tabletop Lateral travel | +/- 130mm | Identical | No difference; thus, demonstrating SE. |
| Loading (patient weight) | 210 Kg | Identical | No difference; thus, demonstrating SE. |
| Wall Stand | |||
| Vertical movement range | 1500mm | Identical | No difference; thus, demonstrating SE. |
| Movement mode | Manual | Identical | No difference; thus, demonstrating SE. |
| Tube Stand | |||
| Type | Ceiling suspension | Identical | No difference; thus, demonstrating SE. |
| Tube rotation | +/- 135 degree | Identical | No difference; thus, demonstrating SE. |
| Longitudinal movement range | 1500 mm | Identical | No difference; thus, demonstrating SE. |
| Source to Image Distance (SID) | |||
| SID | SID depends on different configurations, because the DigitalDiagnost C50 is a ceiling suspension X-ray system. | Identical | No difference; thus, demonstrating SE. |
| External Connectivity | |||
| DICOM | DICOM 3.0 compatible | Identical | No difference; thus, demonstrating SE. |
| Software Platform | |||
| Software | Eleva WorkSpot | Identical | No difference; thus, demonstrating SE. |
| SkyFlow Software | No | Yes | The proposed Digital Diagnost C50 includes the SkyFlow software used in the currently marketed and reference device Eleva Workspot with SkyFlow, (K153318- December 22, 2015, Philips Medical Systems DMC), thus, demonstrating SE. |
| Image Processing Algorithm | UNIQUE | UNIQUE 2 | UNIQUE 2 image processing algorithm provided with DigitalDiagnost C50 was previously cleared with the currently marketed and Reference Device 3, DigitalDiagnost C90 (K182973- January 11, 2019, Philips Medical Systems DMC). Upgrading to UNIQUE2 image processing algorithm does not alter the clinical workflow, hence no impact on the safety or effectiveness of the device; thus, demonstrating SE. |
| Operating System | Windows 7 embedded | Windows 10 embedded | Introduction of operating system Windows 10 embedded does not impact clinical image quality. Therefore, there is no impact on the safety and effectiveness of the device; thus, demonstrating SE. |
Study Proving Acceptance Criteria:
The document states that a non-clinical verification/validation study was performed. The basis for substantial equivalence is that the DigitalDiagnost C50 is considered equivalent to the predicate DigitalDiagnost C50 (K163410) based on:
- Identical Indications for Use.
- Fundamental scientific technology (including largely identical components or components identical to other cleared reference devices).
- Non-clinical performance testing (demonstrating compliance with standards).
- Safety and effectiveness (as supported by the non-clinical testing).
The non-clinical verification and validation tests demonstrated that the DigitalDiagnost C50:
- Complies with the aforementioned international and FDA-recognized consensus standards and FDA guidance documents.
- Meets the acceptance criteria and is adequate for its intended use.
2. Sample size used for the test set and the data provenance:
The document explicitly states: "The DigitalDiagnost C50 does not require clinical study..." and "Summary of Clinical Data: Based on the information provided above, the DigitalDiagnost C50 is considered substantially equivalent to the currently marketed and predicate DigitalDiagnost C50 (K163410, January 4, 2017) in terms of fundamental scientific technology."
Therefore, there appears to be no clinical test set, sample size, or specific data provenance for a clinical study as part of this 510(k) submission. The evaluation relies on non-clinical performance data and equivalence to predicate/reference devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Since no clinical study with a test set was performed, this information is not applicable and not provided in the document.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Since no clinical study with a test set was performed, this information is not applicable and not provided in the document.
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 MRMC comparative effectiveness study was mentioned. The device described, DigitalDiagnost C50, is an X-ray system, not an AI-assisted diagnostic device. Therefore, this information is not applicable and not provided in the document.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
The DigitalDiagnost C50 is an X-ray imaging system. There is no mention of a standalone algorithm-only performance study, as it's not a standalone diagnostic algorithm. Therefore, this information is not applicable and not provided in the document.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the non-clinical verification and validation tests, the "acceptance criteria" were derived from international and FDA-recognized consensus standards and FDA guidance documents (listed on pages 11-12). These standards themselves implicitly define the "ground truth" or acceptable performance ranges for device characteristics, image quality, electrical safety, radiation protection, software lifecycle, usability, and risk management. No other forms of expert consensus, pathology, or outcomes data are mentioned for establishing ground truth for the device's technical specifications.
8. The sample size for the training set:
Since no clinical study or AI algorithm training is described for this device, this information is not applicable and not provided in the document.
9. How the ground truth for the training set was established:
Since no clinical study or AI algorithm training is described for this device, this information is not applicable and not provided in the document.
§ 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.