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The Radiography 7000 M is intended for diagnostic procedures on both adult and pediatric patients who are unable to be transferred to the stationary X-ray system. It enables radiographic imaging of various body parts, including the skull, chest, spine, shoulders, pelvis, extremities, abdomen, and other body regions. The system allows for applications in different positions, such as sitting, standing, and lying in either a prone or supine position. However, it should be noted that the system is not suitable for mammography applications.

The Radiography 7000 M digital mobile will be a new motorized mobile x-ray system that will employ integrated wireless flat panel detectors of two different sizes (large and small) to obtain digital images in mobile environments; the system will also be able to utilize CR or traditional film cassettes in a back-up scenario. The system will primarily use wireless technology for image acquisition and the transmission of images to archive systems like PACS, as well as for the retrieval of patient and exam information from the radiology information system (RIS) or hospital information system (HIS). The system is available in the following configurations: with 20 kW X-ray generator, with 40 kW X-ray generator. The Radiography 7000 M system is an integrated system consisting of the following subsystems: Base Unit (Sedecal Mobile X-ray system SM-IV, cleared under K232185 August 21, 2023), SkyPlate Family of detectors (Wireless Portable Detectors) and their accessories, Eleva WorkSpot 43.0.

The provided text describes the acceptance criteria and the study conducted for the Philips Radiography 7000 M, a mobile X-ray system. The document is a 510(k) summary of safety and effectiveness, and primarily demonstrates substantial equivalence to a predicate device.

Here's an analysis based on the provided information, addressing your specific questions:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a detailed table of specific quantitative acceptance criteria alongside corresponding quantitative device performance metrics for features like image quality (e.g., resolution, SNR) beyond stating compliance with general standards. Instead, it provides a summary that all tests passed, indicating that the device met its acceptance criteria. This is common in 510(k) summaries where detailed test reports are typically provided separately to the FDA.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a "test set sample size" in terms of patient data or clinical images. The testing conducted is primarily non-clinical performance testing and bench testing for compliance with various recognized standards (e.g., electrical safety, software validation, cybersecurity). The data provenance is implied to be from laboratory settings during these non-clinical tests. There is no mention of patient data being used for validating the device's performance in this specific 510(k) submission.

"There is no clinical data submitted in this 510(k) Premarket notification."

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

Since no clinical data or clinical "test set" was used (as stated in point 2), there is no information about experts establishing ground truth for such a set. The document focuses on showing substantial equivalence through engineering and regulatory compliance, not clinical performance evaluation with human readers.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set requiring ground truth adjudication is mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement with AI vs. Without AI Assistance

No MRMC study was done, nor is AI assistance a stated feature of this specific device's submission. The device is a mobile X-ray system, not an AI-powered diagnostic tool. The submission focuses on the safety and effectiveness of the hardware and integrated software for image acquisition, primarily demonstrating equivalence to a predicate device.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This is a medical device for X-ray imaging, inherently involving a human operator (technologist or physician) to acquire and interpret images. There's no "algorithm only" performance reported in the context of an AI-driven diagnostic algorithm.

7. The Type of Ground Truth Used

For the non-clinical testing, the "ground truth" is established by the specified requirements and standards themselves. For example, for electrical safety, the ground truth is adherence to the voltage limits defined in IEC 60601-1. For image quality, it's compliance with established metrics and guidelines from guidance documents. There is no ground truth based on expert consensus, pathology, or outcomes data mentioned, as no clinical study data was submitted.

8. The Sample Size for the Training Set

Not applicable. As this is not an AI/ML device requiring a training set, the concept of a training set sample size does not apply here. The device's functionality is based on established physics and engineering principles, not statistical learning from a dataset.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for an AI/ML model for this device.

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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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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

Image Quality Details (from document):

Modulation Transfer Function (MTF) (according to IEC 62220-1-3 standard)

Detective Quantum Efficiency (DQE) (according to IEC 62220-1-3 standard) at 2 µGy

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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Philips Radiology Smart Assistant is intended to provide patient positioning feedback using validated 2D X-Ray systems. Philips Radiology Smart Assistant is a software which informs Healthcare Professionals regarding patient positioning quality in accordance with clinical guidelines. Philips Radiology Smart Assistant is not intended for diagnostic purposes. It is not intended to be used as the basis for repeating an image.

Philips Radiology Smart Assistant is a software package intended to be used by qualified healthcare professionals. The software is used with general purpose computing hardware for the processing, display of images, and patient positioning feedback within a clinical environment. Philips Radiology Smart Assistant software supports receiving and displaying images from X-ray systems.

The system supports receiving, sending, storing, acceptance and displaying of medical images received from the following modality types via DICOM: DX as well as hospital/radiology information systems.

Philips Radiology Smart Assistant includes a post-processing patient positioning feedback function for posterior-anterior (PA) chest X-ray images. The patient positioning assessment is intended to provide a qualified healthcare professional with timely feedback on the quality of acquired X-ray images that do not suffice the positioning quality standards of clinical guidelines. The quality check comprises an assessment of the following parameters:

• Collimation
• Patient Rotation
• Patient Inhalation State

Here's a breakdown of the acceptance criteria and study details for the Philips Radiology Smart Assistant, based on the provided text:

Acceptance Criteria and Device Performance

The document states that the Philips Radiology Smart Assistant provides "patient positioning feedback using validated 2D X-Ray systems" and "informs Healthcare Professionals regarding patient positioning quality in accordance with clinical guidelines." The quality check specifically assesses:

• Collimation
• Patient Rotation
• Patient Inhalation State

However, the provided text does not contain a specific table of acceptance criteria with numerical targets or the reported device performance for these criteria. It generally states that the device "met the acceptance criteria" in the clinical performance study, but the criteria themselves are not quantified.

Table of Acceptance Criteria and Reported Device Performance (Based on available information):

Study Details:

2. Sample size used for the test set and the data provenance:

• Sample Size for Test Set: Not explicitly stated in terms of a specific number. The document mentions "previously acquired posteroanterior (PA) chest X-ray images."
• Data Provenance: Not explicitly stated. The images were "previously acquired," but the country of origin and whether it was retrospective or prospective are not mentioned. Given they are "previously acquired," it's highly likely to be retrospective.

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

• Number of Experts: Not explicitly stated. The document mentions "the positioning quality assessment of clinicians." It does not specify how many clinicians.
• Qualifications of Experts: Not explicitly stated beyond "clinicians." The qualifications (e.g., radiologist with X years of experience) are not provided.

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

• Adjudication Method: Not explicitly stated. The document refers to "the positioning quality assessment of clinicians," but it does not detail any consensus or adjudication process (e.g., 2+1, 3+1).

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:

• MRMC Study: No, an MRMC comparative effectiveness study was not specifically described in the provided text. The study compared the algorithm's assessment to "clinicians using standard diagnostic metrics," which suggests a comparison of the AI's output against human assessment, but not a study of human readers with vs. without AI assistance.
• Effect Size: Not applicable, as an MRMC comparative effectiveness study was not detailed.

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

• Standalone Performance: Yes, a standalone performance study was conducted. The "algorithm's assessment as to whether or not an image met quality criteria for aspects of patient positioning quality was compared to the positioning quality assessment of clinicians." This indicates the algorithm's decisions were evaluated independently against a human-defined ground truth.

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

• Type of Ground Truth: Expert assessment/consensus. The ground truth was established by "the positioning quality assessment of clinicians using standard diagnostic metrics."

8. The sample size for the training set:

• Sample Size for Training Set: Not mentioned in the provided text. The document refers only to the clinical performance study on "previously acquired posteroanterior (PA) chest X-ray images."

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

• Ground Truth Establishment for Training Set: Not mentioned in the provided text. The document focuses on the validation study and does not describe the training process or how its ground truth was established.

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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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The DigitalDiagnost is intended to acquire, process, store, display and export digital radiographic images. The DigitalDiagnost is suitable for all routine radiography examinations, including specialist areas like intensive care, trauma or pediatric work, excluding fluoroscopy, angiography and mammography.

The proposed DigitalDiagnost is a high-end digital radiography system consisting of a height adjustable patient support table and a ceiling suspension consisting of a tube including a control handle used to acquire images with a flat panel fixed RAD detector. Additionally, different vertical stands for the radiography examinations are available. The ceiling suspension can be moved in longitudinal and lateral directions and additionally the tube can be tilted and rotated as well. The system is configured with a Philips x-ray generator and a flat panel fixed RAD detector, Pixium 4343RCE. Together with the tube these components form the radiography Image Chain. The additional option of the portable wireless detector i.e. the SkyPlates family can be used for free exposures as well as in the patient support table or in the vertical stand.
The proposed DigitalDiagnost is a modification of the predicate device, DigitalDiagnost C90 (K202564). The modifications include change of colour of the table, stand and ceiling suspension; changes in ceiling suspension, service features and a software update. The changes related to the software updates and service features have been recently cleared in the reference device, CombiDiagnost R90 (K203087).

The provided text describes a 510(k) summary for the Philips Medical Systems DMC GmbH DigitalDiagnost, demonstrating its substantial equivalence to a predicate device. The information details the device, its intended use, and the non-clinical tests performed. It explicitly states that no clinical data was submitted for this 510(k) premarket notification.

Therefore, many of the requested details regarding acceptance criteria for device performance, expert ground truth, MRMC studies, or training/test set specifics cannot be directly extracted from the provided document as they pertain to clinical studies or AI/algorithm performance evaluations, which were not part of this submission. The provided text focuses on demonstrating the substantial equivalence of modifications (e.g., color changes, mechanical button changes, software updates for service features) to an existing cleared device through non-clinical testing.

Here's a breakdown based on the available information:

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

The acceptance criteria are implicitly met by "Pass" results for the listed non-clinical tests. The reported device performance is that it complies with the requirements for each test.

2. Sample size used for the test set and the data provenance

The document does not specify a "test set" in the context of clinical data, as it explicitly states that no clinical data was submitted. The tests conducted were non-clinical verification and validation tests, implying laboratory or engineering testing rather than a clinical study with patient samples. Therefore, information on sample size for a test set (meaning patient data) and data provenance (country of origin, retrospective/prospective) is not applicable or provided in this 510(k) summary.

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

Not applicable, as no clinical ground truth was established for a test set in this non-clinical submission.

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

Not applicable, as no clinical test set requiring adjudication was used.

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 reported, as no clinical data or AI assistance feature is mentioned in the context of this 510(k) for the DigitalDiagnost. The changes are related to physical components and underlying software infrastructure, not an AI-based interpretation aid.

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

Not applicable, as there is no mention of a standalone algorithm for diagnostic performance. The device is an X-ray system, and the software updates are described as related to service features (logging, remote export, etc.) and not image interpretation algorithms.

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

For the non-clinical tests, the "ground truth" would be the engineering specifications and performance standards against which the device was tested (e.g., system requirements, risk control measures, imaging performance requirements, usability requirements). These are established technical benchmarks, not clinical ground truth derived from expert consensus or pathology.

8. The sample size for the training set

Not applicable, as there is no mention of a training set, which is typically associated with machine learning or AI models. The software updates are for system functionality and service.

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

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

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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).

• The Front-end Software is intended to acquire images.

• 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)

• 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:

• 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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The DigitalDiagnost C90 is intended to acquire, process, store, display and export digital radiographic images. The DigitalDiagnost C90 is suitable for all routine radiography examinations, including specialist areas like intensive care, trauma or pediatric work, excluding fluoroscopy, angiography and mammography.

The proposed DigitalDiagnost C90 is same as the 510(K) approved predicate (K182973) as mentioned below. It is a high-end digital radiography system consisting of a height adjustable patient support table and a ceiling suspension consisting of a tube including a control handle used to acquire images with a flat panel fixed RAD detector. Additionally, different vertical stands for the radiography examinations are available. The ceiling suspension can be moved in longitudinal and lateral directions and additionally the tube can be tilted and rotated as well. The proposed DigitalDiagnost C90 is configured with a Philips x-ray generator and a flat panel fixed RAD detector, Pixium 4343RCE, together with the tube these components form the radiography Image Chain. The proposed DigitalDiagnost C90 introduces a new wireless portable detector, pixium 3543DR i.e. SkyPlate E (cleared in reference device 510(K) K191813) and their relevant grids, in addition to the family of SkyPlate detectors (pixium 3543EZ i.e. Large and pixium 2430EZ i.e. Small) that are already integrated in the currently marketed (predicate) DigitalDiagnost C90 (K182973).

The Philips DigitalDiagnost C90 is a stationary x-ray system, and the submission K202564 introduces the SkyPlate E detector and its relevant grids as a modification to the previously cleared DigitalDiagnost C90 (K182973). The acceptance criteria and the study proving the device meets these criteria are primarily based on demonstrating substantial equivalence to the predicate device through non-clinical performance testing. No clinical study was performed.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Philips DigitalDiagnost C90, specifically regarding the addition of the SkyPlate E detector, are based on demonstrating equivalence or non-inferiority to the predicate device (DigitalDiagnost C90 with existing SkyPlate detectors) in key technological characteristics and the maintenance of clinical image quality, safety, and effectiveness. The reported device performance indicates that the new SkyPlate E detector either meets or is equivalent to the performance of the existing detectors, or that any differences do not negatively impact clinical image quality or safety.

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 DigitalDiagnost C90 did not require 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; and Safety and effectiveness."

Therefore, there was no clinical test set with human subject data used for this specific 510(k) submission. The evaluation was based on non-clinical performance data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable, as no clinical test set was used for this submission. The ground truth, in this context, was established through adherence to recognized standards and technical measurements, not expert clinical assessment of a dataset.

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

Not applicable, as no clinical test set was used.

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

Not applicable. This submission is for an x-ray system with a new detector, not an AI-powered diagnostic tool. No MRMC study was performed.

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

Not applicable, as this is not an AI algorithm. The performance evaluation was for the imaging system itself.

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

The "ground truth" for this submission was established through:

• Adherence to international and FDA-recognized consensus standards: This includes technical specifications and performance metrics outlined in standards like IEC 60601 series, IEC 62220-1, and IEC 62304.
• Results of non-standard performance tests: These tests are designed to verify specific technical aspects of the device and confirm its functionality and safety. The report mentions "System Verification Test," "Image Quality Test," and "Human Factors and Usability Engineering Test."
• Comparison to the predicate device: The core of the substantial equivalence claim relies on demonstrating that the new detector either performs the same as, or does not negatively impact the performance of, the previously cleared predicate device based on its technical specifications.

8. The sample size for the training set

Not applicable, as this is not an AI algorithm requiring a training set.

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

Not applicable, as this is not an AI algorithm.

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The DigitalDiagnost C90 is intended to acquire, process, store, display and export digital radiographic images. The DigitalDiagnost C90 is suitable for all routine radiography examinations, including specialist areas like intensive care, trauma or pediatric work, excluding fluoroscopy, angiography and mammography.

The DigitalDiagnost C90 is a high-end digital radiography system consisting of a height adjustable patient support table and a ceiling suspension consisting of a tube including a control handle used to acquire images with a flat panel fixed RAD detector. Additionally, different vertical stands for the radiography examinations are available. The ceiling suspension can be moved in longitudinal and lateral directions and additionally the tube can be tilted and rotated as well. The DigitalDiagnost C90 is configured with a Philips x-ray generator and a flat panel fixed RAD detector, Pixium 4343RCE (K170113 - February 9, 2017), together with the tube these components form the radiography Image Chain. As additional options, a portable detector (K141736 - July 25, 2014) can be used for free exposures as well as in the patient support table or in the vertical stand.

The provided text describes the Philips DigitalDiagnost C90, a stationary X-ray system, and states that it did not require a clinical study. Instead, substantial equivalence was demonstrated through non-clinical performance testing and validation.

However, the document does not contain a table of acceptance criteria or details of a study that proves the device meets specific acceptance criteria related to its performance beyond general safety and equivalence to a predicate device. It confirms that the device meets "the acceptance criteria" in general, but does not quantify them or describe the study in detail.

Therefore, many of the requested elements cannot be extracted from the provided text.

Here's a breakdown of what can and cannot be provided based on the input:

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

• Cannot be provided. The document states "The test results demonstrate that the proposed DigitalDiagnost C90 meets the acceptance criteria," but does not specify what those criteria are or report detailed device performance against them. It focuses on demonstrating substantial equivalence to a predicate device based on similar technological characteristics and adherence to consensus standards.

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

• Cannot be provided. The document refers to "nonclinical verification and validation tests as well as image quality testing" but gives no details about the sample size of any test sets or the provenance of any data used in these non-clinical tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

• Cannot be provided. Since no specific clinical or performance study with a test set and ground truth is detailed, information about experts and their qualifications is absent.

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

• Cannot be provided. No details on adjudication methods for a test set are mentioned.

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:

• Cannot be provided. The document explicitly states: "The proposed DigitalDiagnost C90 did not require a clinical study". Therefore, no MRMC study with AI assistance was performed or described.

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

• Cannot be provided. The device is an X-ray system, not primarily an AI algorithm. Its performance is evaluated as an imaging system, and no standalone algorithm performance is discussed.

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

• Cannot be provided. As no specific performance study is detailed, the type of ground truth used is not mentioned.

8. The sample size for the training set:

• Cannot be provided. The document does not describe any machine learning or AI components that would require a "training set" in the context of X-ray image interpretation or diagnostics. The device is a radiographic image acquisition, processing, storage, display, and export system.

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

• Cannot be provided. As no training set is discussed, how its ground truth was established is not relevant or provided.

In summary, the provided document focuses on demonstrating substantial equivalence to a predicate device (Philips Eleva Workspot for DigitalDiagnost K141736) through comparisons of technological characteristics, adherence to recognized standards for safety and performance (e.g., ISO 14971, IEC 60601 series), and non-clinical testing for verification and validation. It explicitly states that a clinical study was not required. No specific "acceptance criteria" table or quantitative performance data from a dedicated study assessing diagnostic accuracy or similar metrics are present.

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