(16 days)
The DuraDiagnost 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 DuraDiagnost Digital Diagnostic Radiographic System (DuraDiagnost) 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 DuraDiagnost consist of the following components: Tube column with X-ray assembly, wall stand with detector carrier, patient table with detector carrier and floating table top, high voltage generator, and 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 the study information for the Philips DuraDiagnost, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than setting specific performance acceptance criteria for the new device as would be found in a clinical trial protocol. Instead, the "acceptance criteria" here relate to the device meeting recognized standards and exhibiting technical characteristics similar to its predicates.
| Feature / Standard | Acceptance Criteria (Implied) | Reported Device Performance (Philips DuraDiagnost) |
|---|---|---|
| Technical Design Characteristics | (Demonstrated similar construction and fundamental scientific technology to predicate devices for components like X-ray tube, generator, wall stand, patient table, detector, and workstation. See comparison features below.) | |
| Tube Design | Identical to Philips BuckyVision (RO 1750 & SRO 33100) | RO 1750 & SRO 33100 |
| Max Tube Voltage | Identical to predicate devices (150kV) | 150kV |
| Focal Spot Size | Identical to predicate devices (0.6mm/1.2mm) | 0.6mm/1.2mm |
| Tube Max Power | Identical to Philips BuckyVision (50KW/100KW) | 50KW/100KW |
| Anode Type | Identical to predicate devices (Rotation) | Rotation |
| Generator Max Power | Identical to Philips BuckyVision (50KW/65KW/80KW) | Identical to Philips BuckyVision (50KW/65KW/80KW) |
| Generator kV Range | Identical to predicate devices (40-150) | 40-150 |
| Generator mAs Product | Identical to Philips BuckyVision (0.5 mAs-600 mAs with AEC control) | 0.5 mAs-600 mAs (with AEC control) |
| Collimator Operation | Manual collimation, same as GE Brivo XR385; also motorized automatic collimation option. | Manual collimation with motorized automatic collimation option |
| Shape of Beam | Rectangular | Rectangular |
| Detector Type | Digital Detector (Fixed & Wireless), identical to predicate devices (GE Brivo XR385, Philips BuckyVision, Swissray ddRVersa™ Motion) | Digital Detector (Fixed & Wireless) |
| X-ray Scintillator Material | Fixed: GdOS, Wireless: Cesium Iodide; identical to predicate devices (GE Brivo XR385, Swissray ddRVersa™ Motion) | Fixed: GdOS, Wireless: Cesium Iodide |
| Image Area | Wireless: 42.4cm x 34.8cm (identical to Swissray ddRVersa™ Motion); Fixed: 43cm x 43cm; slight differences with other predicates not expected to alter diagnostic image quality. | Wireless: 42.4cm x 34.8cm; Fixed: 43cm x 43cm |
| Image Matrix Size | Wireless: 2866 x 2350 (identical to Swissray ddRVersa™ Motion); Fixed: 2874 x 2869; slight differences with other predicates not expected to alter diagnostic image resolution. | Wireless: 2866 x 2350; Fixed: 2874 x 2869 |
| A/D Conversion | Identical to Philips BuckyVision and Swissray ddRVersa™ Motion (16 bits). | 16 bits |
| SID | Table: 50-110cm; Wallstand: 100-180cm (slight differences with GE Brivo XR385 not expected to significantly alter application usage). | Table: 50-110cm; Wallstand: 100-180cm |
| DICOM | DICOM 3.0 compatible (same as all predicate devices). | DICOM 3.0 compatible |
| Software Platform | Eleva workspot (same as Philips BuckyVision). | Eleva workspot |
| Compliance with Standards & Guidance | Compliance with all listed international and FDA-recognized consensus standards and FDA Guidance documents. | Complies with AAMI / ANSI ES60601-1, IEC 60601-1-2, 60601-1-3, 60601-2-28, 60601-2-54, IEC 62304, ISO 14971, IEC 62366, CFR 1020.30, CFR 1020.31, and FDA guidance documents related to solid state X-ray imaging, software, wireless technology, and pediatric information. |
| Diagnostic Image Quality | Similar diagnostic image quality when compared with the predicate devices. | Demonstrated similar diagnostic image quality to predicate devices. |
| Safety and Effectiveness | Equivalent to predicate devices in terms of safety and effectiveness for its intended use. Overall device is adequate for its intended use. | Demonstrated substantial equivalence in safety and effectiveness compared to predicate devices through design features, fundamental scientific technology, indications for use, and non-clinical performance (verification/validation) tests. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not applicable. This 510(k) relies on non-clinical performance testing and comparison to predicate devices, not a clinical test set of patient images.
- Data Provenance: The data provenance is primarily from bench testing, engineering verification, and validation activities against recognized standards and guidance documents. This is not patient-level data. The manufacturer is Philips Healthcare (Suzhou) Co., Ltd in China.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- Number of Experts: Not applicable. Since there was no clinical test set of patient images, no experts were used to establish ground truth in this context. The "ground truth" for this submission is related to engineering specifications and compliance with regulatory standards.
- Qualifications of Experts: N/A
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. No test set of patient images requiring adjudication was used.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- MRMC Study: No, an MRMC comparative effectiveness study was not done. The submission explicitly states: "Clinical study was not warranted to support this 510(k) submission, since substantial equivalence to the currently marketed and predicate devices was demonstrated with the following attributes: Design features; Indication for use; Fundamental scientific technology; and Safety and effectiveness."
- Effect Size: Not applicable, as no MRMC study was performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- This device is a hardware digital radiographic system with integral software for image acquisition, processing, storage, and viewing. It is not an AI algorithm in the context of standalone performance. Therefore, a "standalone algorithm only" performance study is not applicable. The performance evaluation focuses on the entire system's compliance with standards and equivalence to predicate systems.
7. The Type of Ground Truth Used
- The "ground truth" for this submission is based on:
- Engineering Specifications and Design Features: Comparing the technical characteristics of the DuraDiagnost to those of the predicate devices.
- International and FDA-recognized Consensus Standards: Compliance with electrical safety, EMC, radiation protection, software lifecycle, risk management, and usability standards (e.g., IEC 60601 series, IEC 62304, ISO 14971).
- FDA Guidance Documents: Adherence to specific guidance for solid-state X-ray imaging, software, wireless technology, and pediatric information.
- Predicate Device Performance: The established safety and effectiveness of the legally marketed predicate devices (GE Brivo XR385, Philips BuckyVision, Swissray ddRVersa™ Motion) serves as a benchmark for substantial equivalence.
8. The Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This submission is for a conventional digital radiographic system and does not involve an AI algorithm with a training set of images. The "training" for such a system would involve engineering design and software development, not machine learning from a dataset.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable, as there is no AI algorithm training set involved.
§ 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.