(30 days)
The CombiDiagnost R90 is a multi-functional general R/F system. It is suitable for all routine radiography and fluoroscopy exams, including specialist areas like angiography or pediatric work, excluding mammography.
The CombiDiagnost R90 is a multi-functional general Radiography/Fluoroscopy (R/F) system. It is suitable for all routine radiography and fluoroscopy exams, including specialist areas like angiography or pediatric work, excluding mammography.
The CombiDiagnost R90 is a remote-controlled fluoroscopy system in combination with high-end digital radiography. The system is suitable for routine X-ray examinations and special examinations on patients in standing, seated or laying positions. The CombiDiagnost R90 retrieves images by means of a Cesum Iodide flat panel detector.
Philips fluoroscopy systems consist of the following components (standard configuration):
- Basic unit (also called "geometry" or "table unit")
- Workstation Eleva Workspot with integrated generator control, hand switch, keyboard, mouse, touch screen and PC
- Equipped with a dual screen-monitor as standard
- Spot film device (digital camera or flat panel detector)
- X-ray Generator Velara
- X-ray tube assembly mounted in above table mode to be remote controlled
- Receptor: Flat panel detector
Optional components:
- Skyplate wireless portable detectors small and large
- Ceiling Suspension (CSM3)
- Vertical Wall stand (VS2)
- Ceiling Suspension for monitors
- Monitor trolley
- Remote control for RF viewer
- Accessories for "Stitching on the Table"
The CombiDiagnost R90 uses the same workflow from the currently marketed and predicate device, CombiDiagnost R90 (K163210) with only the following modifications:
- additional optional components (like the reference monitor, remote control),
- Eleva Workspot updated to incorporate new imaging features mainly from the previously approved reference device, DigitalDiagnost C90 (K182973) along with functional clusters like Digital Subtraction Imaging and stitching on the table
- updates to improve usability and serviceability.
The Eleva software of the proposed CombiDiagnost R90 is based on a workstation i.e., Eleva Workspot (computer, keyboard, display, and mouse) that is used by an operator to preset examination data and to generate, process and handle digital x-ray images. The Eleva Software system is decomposed into software components. These components are clustered in three component collections like the image handling focused Back-end (BE), the acquisition focused Front-end (FE) and Image Processing (IP). The Eleva software is intended to acquire, process, store, display and export digital fluoroscopy and radiographic images.
The proposed CombiDiagnost R90 is same as the predicate device (K203087) with some modifications as described.
The proposed device complies to 'Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices, dated September 1, 2016'. The solid-state imaging components including the detector in the proposed device have the same physical, functional, and operational characteristics as the predicate device (K203087). Also, other image chain components like X-ray tube and generator, which are used for exposure characteristics and clinical performance evaluation remains the same. Hence all the features and characteristics potentially influencing image quality of the proposed are in accordance with FDA guidance document. Additionally, image quality testing has been performed on the proposed device for the changes that are affecting the image quality.
The provided text is a 510(k) Summary for the Philips Medical Systems DMC GmbH CombiDiagnost R90, which is an X-ray system. This document focuses on demonstrating that the proposed device is substantially equivalent to a previously cleared predicate device, rather than proving a new medical diagnosis or treatment effectiveness. Therefore, the traditional acceptance criteria and study designs typically associated with AI/ML diagnostic devices (e.g., sensitivity, specificity, clinical accuracy, MRMC studies) are not directly applicable or reported in this type of submission.
Instead, the acceptance criteria and studies here are aimed at demonstrating that the modified device maintains the safety and effectiveness of the predicate device and complies with relevant standards and regulations.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| System Performance | Conformance to system requirements | Pass (System verification test activities substantiate that the system conforms to the system requirements) |
| Software Performance | Conformance to software requirements | Pass (Software verification test activities substantiate that the software conforms to the requirements) |
| Risk Control | System meets defined risk control measures | Pass (System meets the defined risk control measures) |
| Cybersecurity | System meets defined security risk control measures | Pass (Verification test activities substantiate that the system meets the defined security risk control measures) |
| Image Quality - MTF | MTF values are similar to or better than the predicate device, with no decrease in performance, and no impact to safety and effectiveness. | Similar: At 1 lp/mm, predicate had 66%, proposed had 63%; at 2 lp/mm, both had 35%; at 3 lp/mm, both had 19%; at 3.4 lp/mm, both had 15%. (See detailed table below; stated "Similar, the MTF remained the same, with on decrease, thus, overall, there is no impact to safety and effectiveness."). |
| Image Quality - DQE | DQE values are similar to or better than the predicate device, with no negative impact to safety and effectiveness. | Similar: At 0.05 lp/mm, proposed had 69% (predicate not explicitly stated at this point, but context implies comparison); at 1 lp/mm, both had 51%; at 2 lp/mm, both had 41%; at 3 lp/mm, both had 27%; at 3.4 lp/mm, both had 18%. (Stated "Similar, the DQE has remained essentially the same, with one slight increase, thus, overall, there is no impact to safety and effectiveness."). |
| Substantial Equivalence | Device is substantially equivalent to the predicate device in terms of design features, technological characteristics, indications for use, and safety and effectiveness. | Concluded: The proposed device is substantially equivalent to the predicate device. |
| Compliance with Standards | Compliance with all relevant FDA recognized consensus standards and guidance documents (e.g., IEC 60601 series, ISO 14971, cybersecurity guidance, solicitation of 510k for solid state x-ray imaging devices). | Pass: The device complies with all referenced standards and guidance documents. |
Image Quality Details (from document):
Modulation Transfer Function (MTF) (according to IEC 62220-1-3 standard)
| lp/mm | Predicate Device (K203087) % | Proposed Device % |
|---|---|---|
| 1 | 66 | 63 |
| 2 | 35 | 35 |
| 3 | 19 | 19 |
| 3.4 | 15 | 15 |
Detective Quantum Efficiency (DQE) (according to IEC 62220-1-3 standard) at 2 µGy
| lp/mm | Predicate Device (K203087) % | Proposed Device % |
|---|---|---|
| 0.05 | N/A (not explicitly listed) | 69 |
| 1 | 51 | 51 |
| 2 | 41 | 41 |
| 3 | 27 | 27 |
| 3.4 | 18 | 18 |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of clinical images or patient data for evaluating a diagnostic algorithm. This submission is for an X-ray imaging system, not an AI diagnostic algorithm. The "tests" mentioned are non-clinical engineering and conformity tests.
- Test Set Sample Size: Not applicable/not specified in the context of clinical images. The testing refers to verification and validation of the system's hardware and software components.
- Data Provenance: Not applicable in the context of clinical images or patient data. The tests are focused on the device's technical specifications and compliance with standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. This is not a study requiring expert-established ground truth for diagnostic accuracy, as it's a submission for an imaging device, not an AI diagnostic tool. The "ground truth" for the engineering tests would be the established technical standards and specifications.
4. Adjudication Method for the Test Set
Not applicable. No clinical image test sets requiring adjudication are mentioned. The testing involves compliance with standards and internal system verification.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. This type of study is not mentioned as it is not relevant for demonstrating substantial equivalence of an X-ray imaging system through non-clinical performance testing.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The CombiDiagnost R90 is an X-ray imaging system, not a standalone AI algorithm. While it contains "Eleva software" with imaging features, the submission focuses on the system's overall safety and performance, not a new AI algorithm's standalone diagnostic capability.
7. The Type of Ground Truth Used
The "ground truth" for the evaluations performed in this submission are:
- Engineering Specifications: The defined technical parameters and performance metrics for the device components (e.g., MTF, DQE values, electrical safety, EMC).
- Regulatory Standards: The requirements outlined in FDA recognized consensus standards (e.g., IEC 60601 series) and FDA guidance documents.
- Predicate Device Performance: The established performance and safety characteristics of the legally marketed predicate device (CombiDiagnost R90, K203087), against which the proposed device's performance is compared for substantial equivalence.
8. The Sample Size for the Training Set
Not applicable. This is an X-ray imaging device, not an AI algorithm that requires a training set for machine learning.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an AI algorithm mentioned.
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. 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). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic 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. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.