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This software is intended to generate digital radiographic images of the skull, spinal column, extremities, and other body parts in patients of all ages. Applications can be performed with the patient sitting, or lying in the prone or supine position and is intended for use in all routine radiography exams. The product is not intended for mammographic applications.

This software is not meant for mammography, fluoroscopy, or angiography.

The I-Q View is a software package to be used with FDA cleared solid-state imaging receptors. It functions as a diagnostic x-ray image acquisition platform and allows these images to be transferred to hard copy, softcopy, and archive devices via DICOM protocol. The flat panel detector is not part of this submission. In the I-Q View software, the Digital Radiography Operator Console (DROC) software allows the following functions:

• 1. Add new patients to the system; enter information about the patient and physician that will be associated with the digital radiographic images.
• 2. Edit existing patient information.
• 3. Emergency registration and edit Emergency settings.
• 4. Pick from a selection of procedures, which defines the series of images to be acquired.
• 5. Adiust technique settings before capturing the x-ray image.
• 6. Preview the image, accept or reject the image entering comments or rejection reasons to the image. Accepted images will be sent to the selected output destinations.
• 7. Save an incomplete procedure, for which the rest of the exposures will be made at a later time.
• 8. Close a procedure when all images have been captured.
• 9. Review History images, resend and reprint images.
• 10. Re-exam a completed patient.
• 11. Protect patient records from being deleted by the system.
• 12. Delete an examined Study with all images being captured.
• 13. Edit User accounts.
• 14. Check statistical information.
• 15. Image QC.
• 16. Image stitching.
• 17. Provides electronic transfer of medical image data between medical devices.

The provided document is a 510(k) summary for the I-Q View software. It focuses on demonstrating substantial equivalence to a predicate device through bench testing and comparison of technical characteristics. It explicitly states that clinical testing was not required or performed.

Therefore, I cannot provide details on clinical acceptance criteria or a study proving the device meets them, as such a study was not conducted for this submission. The document relies on bench testing and comparison to a predicate device to establish substantial equivalence.

Here's a breakdown of what can be extracted from the provided text regarding acceptance criteria and the "study" (bench testing) that supports the device:

1. Table of Acceptance Criteria and Reported Device Performance

Since no clinical acceptance criteria or performance metrics are provided, this table will reflect the general statements made about the device performing to specifications.

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

• Test Set Sample Size: Not applicable/not reported. The document describes bench testing, not a test set of patient data.
• Data Provenance: Not applicable. Bench testing generally involves internal testing environments rather than patient data from specific countries or retrospective/prospective studies.

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 test set was used, no experts were needed to establish ground truth for patient data. Bench testing typically relies on engineering specifications and verification.

4. Adjudication method for the test set

• Not applicable. No clinical test set or human interpretation was involved.

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, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical Testing: The bench testing is significant enough to demonstrate that the I-Q View software is as good as the predicate software. All features and functionality have been tested and all specifications have been met. Therefore, it is our conclusion that clinical testing is not required to show substantial equivalence." The device is software for image acquisition, not an AI-assisted diagnostic tool.

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

• Yes, in a sense. The "study" described is bench testing of the software's functionality and its integration with solid-state detectors. This is an evaluation of the algorithm/software itself.

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

• For bench testing, the "ground truth" would be the engineering specifications and expected functional behavior of the software and its interaction with hardware components. It's about verifying that the software performs according to its design requirements.

8. The sample size for the training set

• Not applicable. The I-Q View is described as an image acquisition and processing software, not an AI/machine learning model that typically requires a training set of data.

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

• Not applicable, as there is no mention of a training set or AI/machine learning component.

Summary of the "Study" (Bench Testing) for K203703:

The "study" conducted for the I-Q View software was bench testing. This involved:

• Verification and validation of the software.
• Demonstrating the intended functions and relative performance of the software.
• Integration testing to verify that compatible solid-state detectors performed within specification as intended when used with the I-Q View software.

The conclusion drawn from this bench testing was that the software performs to specification and is "as safe and as functionally effective as the predicate software." This was deemed sufficient to demonstrate substantial equivalence, and clinical testing was explicitly stated as not required.

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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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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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