(30 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 Philips DigitalDiagnost C50 Digital Radiography System (Philips 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 Philips DigitalDiagnost C50 consists 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.
Based on the provided text, the device in question, the Philips DigitalDiagnost C50, is a stationary x-ray system cleared through a 510(k) premarket notification. The document does not describe acceptance criteria or a study that proves the device meets acceptance criteria in the context of an AI/algorithm-driven diagnostic aid.
Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (Philips DuraDiagnost K141381) and a reference device for the wireless detector (Varian Nexus DR™ Digital X-ray Imaging System K161459).
Therefore, I cannot provide the requested information about acceptance criteria and a study proving the device meets acceptance criteria related to AI/algorithm performance, a multi-reader multi-case study, standalone algorithm performance, or the ground truth establishment for a training set. The device is a traditional x-ray system, not an AI-powered diagnostic tool as suggested by some of the detailed questions.
However, I can extract information regarding overall device compliance and performance from the text as it relates to demonstrating substantial equivalence for an X-ray system:
Acceptance Criteria and Device Performance for the Philips DigitalDiagnost C50
The provided text on the Philips DigitalDiagnost C50's 510(k) submission does not include acceptance criteria and a study in the context of an AI-driven diagnostic device. Instead, it focuses on demonstrating substantial equivalence to predicate and reference devices for a stationary X-ray system. The "acceptance criteria" mentioned refer to the device meeting the requirements set forth by international and FDA-recognized consensus standards and device-specific guidance documents, as well as the successful completion of non-clinical verification and validation tests.
1. Table of Acceptance Criteria and Reported Device Performance (as related to Substantial Equivalence and Safety/Effectiveness):
The document details a comparison of technological characteristics between the proposed device (DigitalDiagnost C50) and its predicate (Philips DuraDiagnost) and reference device (Varian Nexus DR™ Digital X-ray Imaging System for the wireless detector). The "acceptance criteria" here are implicitly that the proposed device's characteristics are either identical or that any minor differences do not affect the safety or effectiveness, thus demonstrating substantial equivalence (SE).
| Feature | Acceptance Criteria (based on Predicate/Reference Device Equivalence) | Reported Device Performance (Philips DigitalDiagnost C50) |
|---|---|---|
| X-ray Tube | Similar x-ray tubes, with identical specifications for nominal X-ray tube voltage, nominal focal spot values, maximum tube current, maximum anode heat content, total filtration, maximum and anode heat dissipation. Minor difference in tube housing should not affect performance, safety, and effectiveness. | Uses RO 1750 ROT 380 & SRO 33100 ROT 380, which are similar and have the same specifications as the predicate's tubes (RO 1750 ROT 360 & SRO 33100 ROT 360). The minor tube housing difference has no impact on safety and effectiveness, demonstrating SE. |
| Max Tube Voltage | Same as predicate (150kV). | Same (150kV). No difference; demonstrating SE. |
| Focal Spot Size | Same as predicate (0.6mm/1.2mm). | Same (0.6mm/1.2mm). No difference; demonstrating SE. |
| Tube Max Power | Same as predicate (50KW/100KW, 250W equivalent anode input power). | Same (50KW/100KW, 250W equivalent anode input power). No difference; demonstrating SE. |
| Anode Type | Same as predicate (Rotation). | Same (Rotation). No difference; demonstrating SE. |
| Generator | Equivalent to predicate (M-CABINET CXA Pro 50kW, M-CABINET CXA Pro 65kW, M-CABINET Pro CXA 80kW, particularly 50kW/65kW). Minor difference in max power (80kW not included) should not affect safety and effectiveness. | Uses M-CABINET CXA Pro 50kW, M-CABINET CXA Pro 65kW. Max Power 50KW/65KW. These are equivalent to the predicate's available generators, with no impact on safety and effectiveness, demonstrating SE. |
| kV range | Same as predicate (40-150). | Same (40-150). No difference; demonstrating SE. |
| Milliampere second (mAs) product | Same as predicate (0.4 mAs-600 mAs with AEC control). | Same (0.4 mAs-600 mAs with AEC control). No difference; demonstrating SE. |
| Collimator Operation Mode | Same as predicate (Manual collimation). | Same (Manual collimation). No difference; demonstrating SE. |
| Shape of Beam | Same as predicate (Rectangular). | Same (Rectangular). No difference; demonstrating SE. |
| Detector Type | Fixed: Identical to predicate (GdOS). Wireless: Identical to reference device (PaxScan 4336Wv4 in Varian Nexus DR™ Digital X-ray Imaging System). No impact on safety and effectiveness. | Fixed: GdOS (identical to predicate). Wireless: PaxScan 4336Wv4 (GdOS), identical to the reference device. No impact on safety and effectiveness, demonstrating SE. |
| X-ray Scintillator Material | Fixed: Identical to predicate (GdOS). Wireless: Identical to reference device (GdOS) which replaces the predicate's Cesium Iodide. No impact on safety and effectiveness. | Fixed: GdOS (identical to predicate). Wireless: GdOS (identical to the reference device). No impact on safety and effectiveness, demonstrating SE. |
| Image Area | Fixed: Identical to predicate (42.5cm x 42.5cm). Wireless: Functionally equivalent/identical to reference device (42.7 cm x 34.4 cm vs. reference 42.4cm x 34.8cm). Minor differences should not impact safety and effectiveness. | Fixed: 42.5cm x 42.5cm (identical to predicate). Wireless: 42.7 cm x 34.4 cm (functionally equivalent to reference device's 42.4cm x 34.8cm). No impact on safety and effectiveness, demonstrating SE. |
| Image Matrix | Fixed: Identical to predicate (2874 x 2869). Wireless: Functionally equivalent/identical to reference device (3072 x 2476 vs. reference 2866 x 2350). Minor differences should not impact safety and effectiveness. | Fixed: 2874 x 2869 (identical to predicate). Wireless: 3072 x 2476 (functionally equivalent to reference device's 2866 x 2350). No impact on safety and effectiveness, demonstrating SE. |
| Analog / Digital (A/D) conversion | Same as predicate (16 bits). | Same (16 bits). No difference; demonstrating SE. |
| Source to Image Distance (SID) | Minor differences are acceptable as long as they do not alter application usage and are supported by bench testing results. | SID depends on configurations (ceiling suspension system). Slight difference compared to predicate (Table: 40-115cm; Wallstand: 110-245cm) but bench testing (Section 17) proved no alteration to application usage; thus, no impact on safety and effectiveness, demonstrating SE. |
| External Connectivity | Same as predicate (DICOM 3.0 compatible). | Same (DICOM 3.0 compatible). No difference; demonstrating SE. |
| Software Platform | Same as predicate (Eleva workspot). | Same (Eleva workspot). No difference; demonstrating SE. |
| Compliance with Standards | Complies with specified international and FDA-recognized consensus standards and device-specific guidance documents (e.g., AAMI / ANSI ES60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-2-28, IEC 60601-2-54, IEC 62304, ISO 14971, IEC 62366, CFR 1020.30, CFR 1020.31, FDA guidance documents). | Compliance confirmed through non-clinical verification and validation tests. The device "Meets the acceptance criteria and is adequate for its intended use" based on these tests. |
2. Sample Size and Data Provenance for Test Set (for an AI/Algorithm):
- Not applicable. The submission is for a traditional X-ray system, not an AI/algorithm-driven diagnostic device. The performance data relies on comparing the technical specifications and non-clinical bench testing against established standards and predicate devices.
3. Number of Experts and Qualifications to Establish Ground Truth (for an AI/Algorithm):
- Not applicable. See point 2.
4. Adjudication Method for Test Set (for an AI/Algorithm):
- Not applicable. See point 2.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Not applicable. The document explicitly states: "The DigitalDiagnost C50 did not require a clinical study since substantial equivalence to the primary 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." There is no mention of an MRMC study or an effect size for human readers with or without AI assistance.
6. Standalone Algorithm Performance:
- Not applicable. The device is an X-ray system, not a standalone algorithm.
7. Type of Ground Truth Used (for an AI/Algorithm):
- Not applicable. For this X-ray system, "ground truth" for performance is established through adherence to recognized standards, technical specifications, and successful non-clinical performance (bench) testing, demonstrating that the images generated are of appropriate quality and the system functions safely and effectively as intended.
8. Sample Size for the Training Set (for an AI/Algorithm):
- Not applicable. See point 2.
9. How the Ground Truth for the Training Set Was Established (for an AI/Algorithm):
- Not applicable. See point 2.
In summary, the Philips DigitalDiagnost C50 is a conventional X-ray system whose acceptance criteria are fundamentally tied to demonstrating substantial equivalence to legally marketed predicate devices through comprehensive non-clinical performance (verification and validation) tests and adherence to established international and FDA-recognized consensus standards. The document does not describe the evaluation of an AI or 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.