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510(k) Data Aggregation
(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.
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(51 days)
CombiDiagnost R90 is a multi-functional general RF 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 lying positions. The CombiDiagnost R90 retrieves images by means of a Cesium Iodide flat panel detector.
Philips fluoroscopy systems (standard configuration) consist of the Basic unit ("geometry" or "table unit"). Workstation Eleva Workspot (with integrated generator control, hand switch, keyboard, mouse, touch screen and PC), dual screen-monitor, Spot film device (digital camera or flat panel detector), Dynamic detector, Fixed detector, X-ray Generator Velara, X-ray tube assembly, Receptor (Flat panel detector). The optional component like 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", are also available.
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. As part of the radiographic system, the Eleva software is intended to acquire, process, store, display and export digital Fluoroscopy and radiographic 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).
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The Front-end Software is intended to acquire images.
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The Back-end Software is intended to query patient data from Radiology Information System (RIS), store, display and export digital radiographic images to Picture Archiving and Communication System (PACS)
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The Image Processing Software is intended to perform the pre and post processing on the acquired raw images.
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 (K202564) along with functional clusters like Digital Subtraction Imaging and stitching on the table
- updates to improve usability and serviceability. -
The provided text does not contain detailed acceptance criteria or a study that directly proves the device meets specific performance metrics in a way that would typically be described for an AI/CADe device. The document is a 510(k) summary for a general radiography/fluoroscopy system (CombiDiagnost R90) and focuses on demonstrating substantial equivalence to a predicate device.
However, based on the information provided, I can infer some aspects related to acceptance and testing.
Here's an attempt to structure the information according to your request, acknowledging the limitations from the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a table of explicit, quantitative acceptance criteria for the new features (like UNIQUE 2 image processing or Bone Suppression) or their specific performance against those criteria. Instead, it relies on demonstrating that these features, which are either identical to or upgrades from previously cleared devices, maintain or improve safety and effectiveness.
The closest to "acceptance criteria" are the standards and guidance documents followed:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compliance with FDA recognized standards and guidance documents (e.g., ISO, IEC safety and performance standards for X-ray equipment, FDA guidance for solid-state X-ray imaging devices). | Non-clinical verification and validation tests, as well as image quality testing, were performed according to the listed standards and guidance documents. Test results demonstrate that the CombiDiagnost R90 meets the acceptance criteria and is adequate for its intended use. (Page 10) |
| Maintenance/Improvement of Image Quality (for new imaging features) | - UNIQUE 2 (radiography modality only): Intended to provide improved image processing, reduced noise, and improved contrast compared to UNIQUE for radiography only. It does not alter the clinical workflow, hence there is no change to the safety or effectiveness of the device. (Page 8) - The Eleva software is upgraded to incorporate new features for better imaging, and tests verified no impact on safety or effectiveness. (Page 7) - The Image Acquisition remains the same on a basic level, while incorporating new features. (Page 7) |
| Mitigation of risks associated with changes (software, optional components) | Safety risk assessment report conducted. Risks associated with changes are considered in the risk management report and activities, showing all risks are sufficiently mitigated and overall residual risks are acceptable. (Page 5, 10) |
| No negative impact on safety and effectiveness compared to predicate. | Comparisons in Table 1 and Table 2 demonstrate that minor differences in technological characteristics (like the OS upgrade, additional reference monitor, firmware tool) or the inclusion of features from a reference device (UNIQUE 2, Bone Suppression) do not affect the safety or effectiveness of the CombiDiagnost R90 when compared to the predicate device. (Pages 6-9) |
| Adequate Human Factors and Usability. | Human Factors and Usability Engineering Test performed. (Page 10) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in terms of patient data or image datasets for the non-clinical performance tests mentioned. The testing refers to conformance to standards and internal verification/validation processes for the device itself. Given it's a 510(k) for an X-ray system, not an AI diagnostic algorithm, the "test set" would typically refer to phantom images, system measurements, and functional tests rather than a patient image dataset.
- Sample Size: Not explicitly stated for any specific test. The phrase "non-clinical verification and validation tests as well as image quality testing" suggests a range of internal engineering and performance tests.
- Data Provenance: Not applicable in the context of patient data as this summary focuses on device substantial equivalence rather than a new diagnostic AI a diagnostic AI algorithm. The device manufacturer is Philips Medical Systems DMC GmbH, located in Hamburg, Germany.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not provided because the submission is not for an AI/CADe device requiring expert ground truth for interpretation of medical images. The "ground truth" for this type of device would be established by engineering specifications, physical measurements, and compliance with recognized standards.
4. Adjudication Method for the Test Set
Not applicable, as this is not an AI/CADe device requiring human interpretation adjudication.
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
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. This type of study is typically conducted for AI/CADe devices to evaluate their impact on human reader performance, which is not the primary focus of this 510(k) for an X-ray imaging system. The document explicitly states: "The CombiDiagnost R90 did not require a clinical study since substantial equivalence... was demonstrated..." (Page 11).
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is an X-ray system, not a standalone AI algorithm. It mentions "Image Processing Software" and features like "UNIQUE 2" and "Bone Suppression," but these are integrated functionalities within the imaging system to enhance image quality, not standalone diagnostic algorithms.
7. The Type of Ground Truth Used
For an X-ray imaging system, the "ground truth" for non-clinical testing would typically involve:
- Engineering Specifications: Conformance to design parameters and functional requirements.
- Physical Measurements: Using phantoms and test equipment to measure parameters like resolution, contrast, dose, noise, and geometric accuracy.
- Compliance with Standards: Meeting the requirements outlined in recognized national and international standards (e.g., AAMI ANSI ISO 14971, AAMI ES60601-1, IEC 60601-1-2/3, IEC 60601-2-54, IEC 62220-1-1).
The document mentions "image quality testing" (Page 10) and verifies that upgraded software features (like UNIQUE 2) aim to provide "improved image processing, reduced noise, and improved contrast" (Page 8), suggesting these metrics are part of the testing ground truth.
8. The Sample Size for the Training Set
Not applicable. This device is an X-ray system, not a machine learning model that requires a training set of data. The software components are developed and verified through traditional software engineering processes rather than machine learning training.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no machine learning "training set" for this device.
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