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K Number
K212837
Device Name
ProxiDiagnost N90
Manufacturer
Philips Medical Systems DMC GmbH
Date Cleared
2021-09-21

(14 days)

Product Code
JAA,KPR
Regulation Number
892.1650
Type
Special
Panel
RA
Reference & Predicate Devices
K203087,K202564,K173433
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

ProxiDiagnost N90 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.

Device Description

The ProxiDiagnost N90 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 ProxiDiagnost N90 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 by -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. The ProxiDiagnost N90 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), 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.

The Eleva software of the proposed ProxiDiagnost N90 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 ProxiDiagnost N90 uses the same workflow from the currently marketed and predicate device, ProxiDiagnost N90 (K173433) with only the following modifications:

  • Inclusion of Extended reviewing options (like the optional reference monitor & remote control),
  • Inclusion of some image processing features
  • Updates to Operating system and Eleva application Software to include state-of-art operating system and incorporate the changes
  • Replacement of the ceiling suspension with that of reference device, DigitalDiagnost C90 (K202564)
  • Updates to improve serviceability
  • Option for upgradability of Predicate device (K173433) to include the above changes
AI/ML Overview

The provided text is a 510(k) summary for the Philips ProxiDiagnost N90, an X-ray system. It primarily focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study proving the device meets specific acceptance criteria through an AI/human comparative effectiveness study or a standalone algorithm performance study.

The document does not describe acceptance criteria for an AI algorithm or a study proving an AI algorithm meets those criteria. Instead, it outlines the changes from a predicate device (K173433) and refers to the performance of other reference devices (K203087 and K202564) as justification for the modifications. The "acceptance criteria" discussed are in the context of device safety and effectiveness testing for a conventional medical device (X-ray system), aligning with recognized standards and guidance documents (e.g., IEC 60601 series, ISO 14971).

Therefore, I cannot provide the requested information regarding AI acceptance criteria and performance study details from the given text.

However, I can extract information about the overall device acceptance criteria and testing methodology as described for this X-ray system:

Overall Device Acceptance Criteria (Implied by Testing):

The acceptance criteria for the ProxiDiagnost N90 are implicitly demonstrated through adherence to various international standards and FDA guidance documents related to X-ray systems, electrical safety, electromagnetic compatibility, radiation protection, usability, software lifecycle processes, risk management, and biological evaluation. The testing performed is aimed at ensuring the device's safety and effectiveness compared to its predicate and reference devices, despite the noted modifications.

Study Proving the Device Meets Acceptance Criteria (as described in the document):

The "study" described is a series of non-clinical performance tests and verifications rather than a comparative clinical study with human readers or standalone AI performance.

Information Extracted from the Document (to the extent possible given the context):

  1. A table of acceptance criteria and the reported device performance:

    The document does not present a table of specific quantitative performance acceptance criteria for an AI algorithm or human reading performance. Instead, it states that "Tests were performed on the proposed ProxiDiagnost N90 according to the following FDA recognized standards and guidance documents." The reported "performance" is that these tests support the device being "safe and effective" and "substantially equivalent" to the predicate.

    Acceptance Criterion Category (Implied)Reported Device Performance/Verification Method
    General Safety & Performance- Compliance with ANSI AAMI ES60601-1:2005/(R)2012 And A1:2012 (Medical electrical equipment - Part 1: General requirements for basic safety and essential performance).
  • Compliance with IEC 60601-1-2 Edition 4.0 2014-02 (Electromagnetic disturbances - Requirements and tests).
  • Compliance with IEC 60601-1-3 Edition 2.1 2013-04 (Radiation protection in diagnostic X-ray equipment).
  • Compliance with IEC 60601-1-6 Edition 3.1 2013-10 (Usability).
  • Compliance with IEC 60601-2-54 Edition 1.1 2015-04 (Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy).
  • Compliance with ANSI AAMI ISO 14971: 2007/(R)2010 (Medical devices-Application of risk management to medical devices).
  • Compliance with ISO 10993-1, Fifth edition 2018-08 (Biological evaluation of medical devices).
  • System and software verification testing was performed for all modifications to demonstrate safety and effectiveness. |
    | New Features Performance | - Extended Reviewing Options: System Verification for Bluetooth remote control and additional reference monitor (test protocol identical to CombiDiagnost R90 K203087).
  • Image Processing Features:
    • Digital Subtraction Angiography: Sub-system (Eleva software) & System Verification (test protocol identical to CombiDiagnost R90 K203087).
    • Predefined annotations: Sub-system (Eleva software) & System Verification (test protocol identical to CombiDiagnost R90 K203087).
    • Bone Suppression: Sub-system (Eleva software) & System Verification (test protocol identical to DigitalDiagnost C90 K202564).
    • UNIQUE 2 (radiography): Sub-system (Eleva software) & System Verification (test protocol identical to DigitalDiagnost C90 K202564).
    • Intuitive User Interface for Processing Parameters: Sub-system Verification (Eleva software) (test protocol identical to DigitalDiagnost C90 K202564).
    • Deviation and Target Exposure Indices: Sub-system (Eleva software) & System Verification (test protocol identical to DigitalDiagnost C90 K202564).
    • Update of optional Skyflow feature: Sub-system (Eleva software) & System Verification (test protocol identical to DigitalDiagnost C90 K202564).
    • Access to and Export of Original Image Data: System Verification.
    • Improved OBSA: Sub-system (Eleva software) & System Verification (test protocol identical to DigitalDiagnost C90 K202564).
    • View Selection for Changed X-Ray Generation Data Sets: Sub-system Verification (Eleva software) (test protocol identical to DigitalDiagnost C90 K202564).
    • Avoid Ghosting in Verification Images of Portable Detectors: System Verification (test protocol identical to DigitalDiagnost C90 K202564).
  • Software Updates:
    • Operating system upgrade to Microsoft Windows 10: Sub-system (Eleva software) & System Verification (test protocol identical to CombiDiagnost R90 K203087).
    • Upgrade of Eleva Application software to increment 42: All relevant software functions tested at system and subsystem level (referencing tests for change #1, 2, 4 and 5).
  • Ceiling Suspension & Service Features:
    • Tube head control: System Verification (test protocol identical to DigitalDiagnost C90 K202564).
    • Collimator: System Verification (test protocol identical to DigitalDiagnost C90 K202564).
    • Monitoring and Firmware Updates for Field Service: System Verification (test protocol identical to CombiDiagnost R90 K203087).
    • Remote access for the field service Engineer: Sub-system Verification (Eleva software).
    • Service Diagnostic: System Verification (test protocol identical to CombiDiagnost R90 K203087 & DigitalDiagnost C90 K202564).
    • Hardware upgrades (Alpha drive Upgradeability): System Verification (test protocol identical to DigitalDiagnost C90 K202564). |
      | Upgradeability of Predicate Device | All relevant Software functions are tested at system and subsystem level (referencing tests for change #1, 2, 3 and 5 a,b,c). |

  1. Sample sizes used for the test set and the data provenance:

    • Test Set Sample Size: Not specified in terms of number of patient cases or images. The testing appears to be primarily system-level, software-level, and component-level verification, rather than evaluation on a diagnostic image dataset.
    • Data Provenance: The document explicitly states "There is no clinical data submitted in this 510(k) premarket notification." Therefore, there is no information on country of origin or retrospective/prospective nature of data for clinical evaluation, as none was performed.

  2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

    Not applicable. No clinical data or expert-established ground truth for diagnostic image interpretation was used or provided in this 510(k) submission.

  3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

    Not applicable, as no clinical image evaluation requiring adjudication was described.

  4. 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:

    No MRMC study was performed or described. This submission is for an X-ray system, not an AI-powered diagnostic algorithm requiring such a study for its clearance.

  5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

    No standalone algorithm performance study was performed or described, as this submission is for an X-ray system, not a standalone AI diagnostic algorithm.

  6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

    Not applicable. No clinical ground truth (expert consensus, pathology, outcomes data) was used in this 510(k) submission, as it explicitly states "There is no clinical data submitted." The testing relies on engineering and regulatory compliance standards.

  7. The sample size for the training set:

    Not applicable. The document describes an X-ray imaging system, not an AI model that would require a training set.

  8. How the ground truth for the training set was established:

    Not applicable, as there is no training set for an AI model discussed.

§ 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.