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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

• 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

• Adult Headrest

• Mattress

• Rotatable Stool for Footrest

• Pediatric Micturition Set

• Stretch Grip for Wall Stand

• Bar Code Scanner o

• 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.

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.

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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.

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

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). |

2. 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.

3. 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.

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

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

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:

   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.

6. 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.

7. 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.

8. 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.

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

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

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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.

The ProxiDiagnost N90 is a multi-functional nearby controlled fluoroscopy system in combination with a high-end digital radiography system consisting of a floor-mounted tiltadjustable 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 -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 fully integrated system is provided with a x-ray tube(s) with collimator and high resolution displays. The ProxiDiagnost N90 is configured with a Philips x-ray generator and a flat panel dynamic detector, Pixium FE4343F, components of the Philips radiography/fluoroscopy Image Chain. As additional options, the ProxiDiagnost N90 can be used as a digital radiography system consisting of a mounted tube in a ceiling suspension together with the portable or fixed detector in the vertical stand.

Based on the provided text, the ProxiDiagnost N90 is evaluated for substantial equivalence to its predicate device, EasyDiagnost Eleva (K031535). The document outlines non-clinical data and makes a case against the need for a clinical study.

Here's an analysis of the requested information:

1. Table of acceptance criteria and the reported device performance:

The document broadly states that "The test results demonstrate that the proposed ProxiDiagnost N90 meets the acceptance criteria and is adequate for its intended use." However, specific numerical acceptance criteria or performance metrics for the ProxiDiagnost N90 are not detailed in a table. The comparison provided focuses on demonstrating technological similarities to the predicate device rather than presenting specific performance thresholds for the new device.

The "Discussion" column in the "Summary of technological characteristics" table implicitly suggests that if a characteristic is "Similar" or "Equivalent" to the predicate, it meets acceptance criteria for substantial equivalence.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

The document explicitly states: "The proposed ProxiDiagnost N90 did not require a clinical study since substantial equivalence to the currently marketed and predicate device was demonstrated with the following attributes: Design features, Indication for use, Fundamental scientific technology, Non-clinical performance testing including validation; and Safety and effectiveness."

Therefore, there is no test set sample size from a clinical study for the ProxiDiagnost N90 itself. The evaluation relied on non-clinical verification and validation tests against recognized consensus standards and a comparison to the predicate and reference devices.

No information on data provenance for a clinical test set is available, as no clinical study was conducted.

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

Since no clinical study was performed and no test set with clinical data was used for evaluation, there were no experts used to establish ground truth for a test set in this submission.

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

As no clinical test set was used for evaluation of the ProxiDiagnost N90, no adjudication method was applied for a test set.

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:

There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study being conducted for the ProxiDiagnost N90. The device is a general R/F system, not an AI-assisted diagnostic tool, so such a study would not be relevant in this context.

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

The device is an imaging system, not an algorithm in the AI sense. Its "performance" would relate to image quality and system functionality, which was assessed through non-clinical performance testing (verification and validation tests according to standards like IEC 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-2-54, IEC 62220-1). These tests are typically "standalone" in that they evaluate the device's technical specifications and functionality independent of direct human interpretation studies.

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

For the non-clinical performance and validation tests, the "ground truth" would be established by the specified engineering tolerances, recognized international standards (e.g., IEC standards for image quality, safety, and performance), and the performance characteristics of the predicate and reference devices. For instance, the MTF and DQE values for the detector are reported and implicitly "compared" to cleared components, meaning the "ground truth" for the acceptance of these values is their alignment with previously cleared and accepted digital imagers.

8. The sample size for the training set:

As no clinical study was performed and the device is an imaging system (not an AI model requiring a training set), there is no training set sample size.

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

Since no training set was used, ground truth for a training set was not established.

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