(28 days)
ProxiDiagnost N90 / Precision CRF 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.
Same as the legally marketed predicate device ProxiDiagnost N90 (K212837, Substantial Equivalent (SE) date on September 21, 2021), the proposed ProxiDiagnost N90 / Precision CRF 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.
Same as the legally marketed predicate device ProxiDiagnost N90 (K212837, SE date on September 21, 2021), the proposed ProxiDiagnost N90 / Precision CRF is a nearby controlled fluoroscopy system in combination with high-end digital radiography system consisting of a floor-mounted tilt adjustable patient support table and a scan unit consisting of a tube and a flat panel dynamic detector, Pixium FE4343F, for the fluoroscopy examinations. The tabletop can be moved by a motor in the lateral and longitudinal direction and can be tilted at -85° to +90° degrees. The scan unit tilts with the table and can be moved in the longitudinal and lateral direction, relative to the table and to the patient. The system is suitable for routine X-ray examinations and fluoroscopy examinations on patients in standing, seated, or lying positions. Same as the legally marketed predicate device ProxiDiagnost N90 (K212837, SE date on September 21, 2021), the proposed ProxiDiagnost N90 / Precision CRF retrieves images by means of a Cesium Iodide flat panel detector.
Same as the legally marketed predicate device ProxiDiagnost N90 (K212837, SE date on September 21, 2021), the proposed ProxiDiagnost N90 / Precision CRF consists 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). Fixed Detector (Fluoroscopy). X-ray Generator for R/F applications, X-ray tube assembly. The optional components like wireless portable detectors small and large, Bucky tray for wireless portable detectors SkyPlate detector, Ceiling Suspension, Fixed Vertical stand, Ceiling Suspension for monitors, monitor trolley, Remote control for R/F (Radiography-fluoroscopy) viewer, accessories for "Stitching Stand", are also available.
Same as the legally marketed predicate device ProxiDiagnost N90 (K212837, SE date on September 21, 2021), the Eleva software of the proposed ProxiDiagnost N90 / Precision CRF 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 Backend (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 accessories for the proposed ProxiDiagnost N90 / Precision CRF are the same as the predicate device ProxiDiagnost N90 (K212837).
The list of the accessories for the proposed ProxiDiagnost N90 / Precision CRF:
- Footrest ●
- Hand Grips 0
Radiation Protection Accessories
-
Flexible Radiation Protection Apron 0
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Front Radiation Protection Apron ●
Additional Accessories (Optional) -
Monitor Trolley ●
-
Monitor Ceiling Suspension
-
Parking Frame for Accessories ●
-
Shoulder Support ●
-
Side bar ●
-
Compression Belt ●
-
Adjustable Lateral Cassette Holder
-
Leg Supports
-
o Infusion Bottle Holder
-
Arm Support for Catheterization
-
Ankle Clamps
-
Overhead Hand Grip
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Adult Headrest
-
Mattress
-
Rotatable Stool for Footrest
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Pediatric Micturition Set
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Stretch Grip for Wall Stand
-
Bar Code Scanner o
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Patient Support ●
-
o Stitching Ruler
Accessories for the SkyPlate Detector (Optional)
- Mobile Detector Holder ●
- Detector Holder Patient Bed ●
- Portable Panel Protector ●
- Detector Handle ●
- WPD Bags ●
- o Grids for SkyPlate Detector large
The Components for the proposed ProxiDiagnost N90 / Precision CRF are the same as the predicate device ProxiDiagnost N90 (K212837).
The list of the Components for the proposed ProxiDiagnost N90 / Precision CRF:
- Eleva Workspot and RF Viewer ●
- UPS for Eleva Workspot (Optional) ●
- Table ●
- Indication Box ●
- Foot Switch
- Ceiling Suspension Motorized CSM3 (Optional) ●
- Wall Stand (Vertical Stand VS2) (Optional)
- SkyPlate / Portable Detector (Optional) 0
The proposed device complies to 'Guidance for the Submission of 510(k)'s for Solid State Xray 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 (K212837). Also, other image chain components like Xray 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 information provided is about a regulatory submission (510(k)) to the FDA for a medical device called ProxiDiagnost N90 / Precision CRF. This type of submission aims to demonstrate that a new device is "substantially equivalent" to an already legally marketed predicate device. Therefore, the "study" referred to is primarily focused on demonstrating this equivalence rather than a traditional clinical study proving novel efficacy.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes the acceptance criteria in terms of compliance with various FDA-recognized standards and guidance documents, and the reported device performance is that it "Passes" these criteria. The safety and effectiveness of the device are deemed "Equivalent" to the predicate device.
| Acceptance Criteria (What the device must meet) | Reported Device Performance (How the device performed) |
|---|---|
| Compliance with FDA-recognized consensus standards and guidance documents for medical electrical equipment, radiation protection, usability, software life cycle, risk management, and biological evaluation (e.g., ANSI AAMI ES60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-1-6, IEC 60601-2-54, IEC 62304, ISO 14971, ISO 10993-1, IEC 62366-1, IEC 60601-2-28, IEC 6220-1-3). | The proposed device ProxiDiagnost N90 / Precision CRF complies with these standards. Test results demonstrate that the device conforms to its specifications and is safe and effective for its intended use. |
| Compliance with specific FDA guidance documents for Solid State X-Ray Imaging Devices (Sept 1, 2016). | The proposed device complies. "The solid-state imaging components including the detector in the proposed device have the same physical, functional, and operational characteristics as the predicate device (K212837)." "Image quality testing has been performed on the proposed device for the changes that are affecting the image quality." |
| Compliance with FDA guidance for Content of Premarket Submissions for Software Contained in Medical Devices (May 11, 2005). | The proposed device complies. "The software for the proposed device ProxiDiagnost N90 / Precision CRF has the same 'Level of concern (Moderate)' as that of the predicate device (K212837). The software verification testing has been conducted as per the level of concern." |
| Compliance with FDA guidance for Pediatric Information for X-ray Imaging Device Premarket Notifications (Nov 2017). | The proposed device complies. "The changes made to the proposed device do not affect the pediatric application. The indication for use of the proposed device is the same as the predicate device (K212837)." |
| Compliance with FDA guidance for Radio Frequency Wireless Technology in Medical Devices (Aug 14, 2013). | The proposed device complies. "All the radiofrequency components of the predicate device (K212837) and proposed device are the same except for the replacement of Bluetooth remote control in the predicate device by infrared remote control in the proposed device. The verification testing has been conducted for the safety and efficacy of the remote control." |
| Compliance with FDA guidance for Management of Cybersecurity in Medical Devices (Oct 2, 2014, and updated Sep 2023). | The proposed device complies. "A set of cybersecurity controls to assure proposed device's cybersecurity and maintain medical device functionality and safety are in place. Cybersecurity plan and risk document are prepared..." "Results demonstrate that the test complies with the Cybersecurity requirements." |
| Specific Verification Tests | Results |
| System Verification testing (System conforms to system requirements) | Pass. System verification test activities substantiate that the system conforms to the system requirements. |
| Software verification testing (Software conforms to 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 testing | Pass. Results demonstrate that the test complies with the Cybersecurity requirements. |
2. Sample Size Used for the Test Set and Data Provenance:
The document describes non-clinical performance testing and mentions "non-clinical performance test data" and "tests performed on the proposed ProxiDiagnost N90 / Precision CRF". This type of submission relies on engineering and design verification/validation, not patient data in the sense of a clinical trial. Therefore, there is no information on a "test set" sample size in terms of patient data or data provenance (country of origin, retrospective/prospective). The testing was conducted on manufactured devices and their components.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Again, for this type of non-clinical submission, there is no mention of experts establishing a "ground truth" for a test set in the clinical image interpretation sense. The "ground truth" for non-clinical performance refers to the device's adherence to engineering specifications and regulatory standards, which are verified through various tests and reports.
4. Adjudication Method:
Given that this is not a study involving human reader interpretation of images for diagnosis, there is no adjudication method described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, a MRMC comparative effectiveness study was not done. The submission explicitly states: "There is no clinical data submitted in this 510(k) premarket notification." The purpose is to demonstrate substantial equivalence to a predicate device, primarily through non-clinical performance and a comparison of technological characteristics.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
Based on the information, this is an X-ray system, not an AI algorithm for image interpretation. The "Eleva software" is described as used by an operator to "preset examination data and to generate, process and handle digital x-ray images." While software verification testing was done, it pertains to the functionality of the system's control and image processing, not a standalone diagnostic algorithm. Therefore, a standalone AI algorithm study was not performed.
7. Type of Ground Truth Used:
For the non-clinical performance testing, the "ground truth" is effectively the engineering specifications and the requirements outlined in the FDA-recognized consensus standards and guidance documents. For example, the "System Verification testing" aims to confirm that the "system conforms to the system requirements," which serve as the ground truth for that specific test.
8. Sample Size for the Training Set:
Not applicable. As this is not an AI diagnostic algorithm, there is no "training set" in the context of machine learning. The device is a traditional X-ray imaging system with integrated software for image acquisition and processing.
9. How the Ground Truth for the Training Set Was Established:
Not applicable for the same reasons as point 8.
§ 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.