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The RADspeed PRO is intended to generate digital or conventional radiographic images of the skull, spinal column, chest, abdomen, extremities, and other body parts of human anatomies in all routine radiography examinations. The RADspeed Pro enables radiographic or tomographic exposures of the whole body of all ages including pediatric patients. Exposures may be taken with the patient sitting, standing, or lying in the prone or supine position. The RADspeed PRO uses portable or integrated flat panel detectors to generate diagnostic images by converting x-rays into electronic signals. The device is also designed to be used with conventional film/screen or computed radiography (CR) cassettes. The Tomosynthesis option is intended to generate tomographic images of human anatomies. Tomosynthesis technique is used to produce a specific cross-sectional plane of the body by reconstruction. The device is intended to be used in hospitals, clinics, imaging centers, and/or other healthcare facilities by qualified/trained professionals. The device is not intended for mammographic applications.

The RADspeed PRO is an X-ray radiography system that is mainly used for the radiography of various regions of the patient's body in a standing or recumbent position. The RADspeed PRO can be used in a wide range of applications from general radiography using X-ray film or Computed Radiography (CR) cassettes, to digital radiography. The RADspeed PRO consists of an X-ray high voltage generator, X-ray tube unit, X-ray tube support and collimator. The system can be configured with radiographic table, radiographic stand and digital radiography system as well. Optionally, the device is also used to perform tomosynthesis radiography by three different reconstruction modes. Filtered Back-Projection (FBP) mode is used to obtain a tomosynthesis image by performing back-projection after correcting the projection data. Shift Addition (SA) mode is used to obtain a tomosynthesis image at an arbitrary slice plane height by shifting each image according to projection angle of the tube based on the reconstruction height, and by applying image addition processing to them. Iteration (IR) mode is used to reduce metal artifact in tomosynthesis image. FBP mode is generally recommended for all body parts. In case an artifact is observed at joints and other similar places, SA mode may remedy this artifact. In case metal artifact is obviously displayed, IR mode is recommended to reduce metal artifact.

The provided document is a 510(k) premarket notification for the Shimadzu Corporation's RADspeed PRO, referencing K233722. It primarily focuses on demonstrating substantial equivalence to a predicate device (K152244) rather than presenting a performance study against specific acceptance criteria for a new clinical indication or AI algorithm.

The modifications to the RADspeed PRO are described as mainly cosmetic and updates to hardware components (larger displays, updated imaging panels that are themselves cleared 510k devices) and software infrastructure (programming language, operating system) without changes to the underlying software functionality or core technological features. The device does not appear to incorporate a new AI algorithm for diagnostic purposes that would require a study with clinical performance metrics like sensitivity, specificity, or reader improvement.

Therefore, the requested information regarding acceptance criteria and performance study results for an AI algorithm (including sample sizes, ground truth establishment, expert adjudication, MRMC studies, or standalone performance) is not present in the provided text.

The document states:

• "The fundamental technological features are the same for the subject and the predicate systems. The modifications are mainly cosmetic in nature." (Page 4)
• "The software functionality remains unchanged." (Page 5, Page 6)
• "The imaging components were replaced by more recently cleared digital x-ray receptor panels made by FUJIFILM. ... All the imaging panels have 510(k) clearance... The integration software, although updated, has the identical functionality to the predicate." (Page 5)
• "The radiation safety aspects of the device have not changed. The device remains compliant with the FDA Radiation Safety Standards." (Page 9)
• "The non-clinical data supports the safety of the device and the hardware and software verification and validation demonstrate that new device should performs as intended in the specified use. Based on our risk analysis and bench testing, the differences do not affect its clinical safety or effectiveness." (Page 9)

The performance testing mentioned (Software Validation, EMC and Electrical Safety Testing) is related to regulatory compliance and safety for the modified device, not to the clinical performance of a new diagnostic algorithm.

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The RADspeed fit is intended to generate digital or conventional radiographic images of the skull, spinal column, chest, abdomen, extremities, and other body parts of human anatomies in all routine radiography examinations. The RADspeed fit enables radiographic exposure of the whole body of all ages including pediatric patients. Exposures may be taken with the patient sitting, standing, or lying in the prone or supine position. The RADspeed fit uses portable or integrated flat panel detectors to generate diagnostic images by converting x-rays into electronic signals. The device is also designed to be used with conventional film/screen or computed radiography (CR) cassettes. The device is not intended for mammographic techniques. The indications for use remain the same as those for the predicate, except for the removal of tomographic technique.

The RADspeed fit is an X-ray radiography system that is mainly used for the radiography of various regions of the patient's body in a standing or recumbent position. The RADspeed fit can be used in a wide range of applications from general radiography using X-ray film or Computed Radiography (CR) cassettes, to digital radiography. The RADspeed fit consists of an X-ray high voltage generator, X-ray tube unit, X-ray tube support and collimator. The system can be configured with radiographic table, radiographic stand and digital radiography system as well. The X-ray generator of RADspeed fit has the capability to communicate with the digital radiography system to synchronize exposure timing, receive a code to select an anatomical program and to send X-ray technique factors and dose information after exposure.

The provided document describes a 510(k) premarket notification for the "RADspeed fit" device, which is a stationary X-ray system. The core of the submission is to demonstrate substantial equivalence to a legally marketed predicate device (K152244 RADspeed Pro) and a digital radiography system (K170332 Digital Radiography CXDI-710C Wireless / CXDI-810C Wireless).

The document does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria through a clinical or non-clinical evaluation comparing the device's output to ground truth, as typically seen for AI/ML-based medical devices or devices where image quality itself is the primary novelty.

Instead, the submission focuses on demonstrating substantial equivalence through:

1. Comparison of Technological Characteristics: Showing that the new device shares fundamental technology with the predicate devices and that modifications (removed functions, added features like FPD rotation tray and calculated dose-area product display) do not affect safety or essential effectiveness.
2. Compliance with Standards: Stating that the new device conforms to relevant IEC standards (IEC60601-1, IEC60601-1-2, IEC60601-1-3) and CFR, which are general safety and performance standards for medical electrical equipment and X-ray systems.
3. Software Verification and Validation: Showing that these processes were conducted according to FDA guidance, assuring safety and effectiveness for the software modifications related to interface adaptation.
4. Claim of Substantial Equivalence for Image Quality: Since the digital radiography system (detectors) used in the new device is "exactly the same as the predicate device (K170332)," the submission argues that "the output image is substantially equivalent to the predicate device as long as the quality and profile of input X-ray are similar." The compliance of X-ray generators with IEC60601-1 is cited to ensure similar X-ray quality.

Therefore, many of the requested details regarding acceptance criteria, test set characteristics, expert involvement, and specific performance metrics (like sensitivity, specificity, or MRMC results) are not applicable or not present in this type of 510(k) submission, which relies on demonstrating equivalence through design similarity, functional comparison, and adherence to general safety standards rather than a de novo performance study against a specified ground truth for a novel function.

However, I can extract the information that is present and explain why other points are not detailed.

Summary of Device Acceptance Criteria and Performance Data (Based on provided document):

The acceptance criteria are not presented in a quantitative table with specific metrics (e.g., sensitivity, specificity, accuracy). Instead, the acceptance is based on demonstrating substantial equivalence to predicate devices by ensuring:

• Safety and Effectiveness: The device is as safe, as effective, and performs as well as the predicate device(s).
• Technological Equivalence: Key technological elements (energy emission, X-ray generation mechanism, image data acquisition/processing, hardware/software components) are the same or comparable.
• Compliance with Standards: Adherence to relevant IEC standards (IEC60601-1, 60601-1-2, 60601-1-3) and CFR for electrical, mechanical, chemical, thermal, and radiation safety, and electromagnetic compatibility.
• Software Verification and Validation: Software risks are analyzed, and V&V testing is conducted per FDA guidance to ensure its safety and effectiveness, despite modifications to adapt interfaces.
• Image Quality Equivalence: The digital radiography system (detector) is identical to a legally marketed predicate (K170332), thus ensuring "substantially equivalent" output image quality when combined with X-ray generators complying with relevant IEC standards.
• Non-introduction of New Safety/Effectiveness Concerns: Modifications (removed functions, added minor features) do not adversely impact safety or effectiveness.

The "study" proving this device meets its "acceptance criteria" is primarily the comparative analysis of its design, technology, and compliance with standards against established predicate devices, as documented in the 510(k) submission.

Breakdown of Requested Information based on the provided text:

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

   • Acceptance Criteria (Implicit - Substantial Equivalence):

     • Device is as safe, as effective, and performs as well as predicate device (K152244 RADspeed Pro).
     • Digital Radiography system (Canon CXDI-710C/810C) is identical to a legally marketed device (K170332).
     • Compliance with IEC 60601-1, 60601-1-2, 60601-1-3, and CFR (for radiation safety).
     • Software V&V conducted per FDA guidance, showing no new risks.
     • No new safety or effectiveness concerns due to modifications.

   • Reported Device Performance (as stated in the document):

     • Electromagnetic compatibility: In conformity with IEC60601-1-2.
     • Materials and Bio-compatibility: In conformity with IEC 10993-1. All materials in clinical use by other commercial products.
     • Sterility: Not sterilized (same as predicate).
     • Electrical, Mechanical, Chemical and Thermal safety: Substantially equivalent to predicate by conformed standards.
     • Software: Risk Analysis and V&V testing conducted; identified level of concern, documentation consistent. "Difference does not affect its safety and effectiveness."
     • Non-clinical Image Performance: "Substantially equivalent to the predicate device" because the Digital Radiography system is identical to K170332, and X-ray generators comply with IEC60601-1.
     • Clinical Performance: "Substantially equivalent to the predicate device" for the same reasons as non-clinical performance.
     • Radiation safety: Substantially equivalent by conformities of CFR and IEC60601-1-3.

   (Note: This is not a quantitative performance table but a qualitative statement of equivalence and compliance.)

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

   • Not applicable/Not provided in this document. This submission primarily relies on design comparison, compliance with general standards, and leveraging the prior clearance of the identical digital detector system. There is no specific test set of patient images with ground truth described for "proving" the device's image quality or diagnostic performance via a clinical trial.

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/Not provided. As there is no described test set with ground truth established, no experts for this purpose are mentioned.

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

   • Not applicable/Not provided.

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 done or mentioned. This device is a basic X-ray system, not an AI-assisted diagnostic tool.

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

   • Not applicable/Not done. This device is an X-ray imaging system, not an algorithm providing a standalone diagnostic output.

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

   • Not applicable/Not provided. No specific "ground truth" for diagnostic accuracy or image quality assessment (beyond compliance with technical standards) is detailed in this type of submission. The ground truth in this context is implicitly the "known good performance" of the predicate devices and the established performance of the identical digital detector.

8. The sample size for the training set

   • Not applicable/Not provided. This is a hardware device submission. While software V&V is mentioned, it's about system integration and safety, not an AI/ML algorithm that requires a "training set."

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

   • Not applicable/Not provided. (See point 8).

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The RADspeed Pro is intended to generate digital or conventional radiographic images of the skull, spinal column, chest, abdomen, extremities, and other body parts of human anatomies in all routine radiography examinations. The RADspeed Pro enables radiographic or tomographic exposures of the whole body of all ages including pediatric patients. Exposures may be taken with the patient sitting, standing, or lying in the prone or supine position.

The RADspeed Pro uses portable or integrated flat panel detectors to generate diagnostic images by converting x-rays into electronic signals. The device is also designed to be used with conventional film/screen or computed radiography (CR) cassettes. The Tomosynthesis option is intended to generate tomographic images of human anatomies. Tomosynthesis technique is used to produce a specific cross-sectional plane of the body by reconstruction of tomographic acquisition.

The device is intended to be used in hospitals, clinics, imaging centers, and/or other healthcare facilities by qualified/trained professionals.

The device is not intended for mammographic applications.

The RADspeed Pro is an X-ray radiography system that is mainly used for the radiography of various regions of the patient's body in a standing or recumbent position. The RADspeed Pro can be used in a wide range of applications from general radiography using X-ray film or Computed Radiography (CR) cassettes, to digital radiography. The RADspeed Pro consists of an X-ray high voltage generator, X-ray tube unit, X-ray tube support and collimator. The system can be configured with radiographic table, radiographic stand and digital radiography system as well.

Optionally, the device is also used to perform tomosynthesis radiography by three different reconstruction modes. Filtered Back-Projection (FBP) mode is used to obtain a tomosynthesis image by performing back-projection after correcting the projection data. Shift Addition (SA) mode is used to obtain a tomosynthesis image at an arbitrary slice plane height by shifting each image according to projection angle of the tube based on the reconstruction height, and by applying image addition processing to them. Iteration (IR) mode is used to reduce metal artifact in tomosynthesis image. FBP mode is generally recommended for all body parts. In case an artifact is observed at joints and other similar places, SA mode may remedy this artifact. In case metal artifact is obviously displayed. IR mode is recommended to reduce metal artifact.

The provided text describes a 510(k) summary for the RADspeed Pro X-ray system. Here's a breakdown of the acceptance criteria and study details based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with quantitative performance metrics for disease detection or diagnostic accuracy. Instead, the performance studies primarily aim to demonstrate "substantial equivalence" to predicate devices, focusing on image quality and artifact reduction.

The closest to "acceptance criteria" are the conformities to various standards and the stated goal of achieving image quality comparable to predicate devices.

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

• Test Set Sample Size: The document mentions "several different anatomical body phantoms" for phantom tests, and an unspecified number of "anthropomorphic phantom images" for the tomosynthesis reconstruction review. Specific numerical sample sizes (e.g., number of phantoms, number of images reviewed) are not provided.
• Data Provenance: The studies were non-clinical performance testing using phantoms. There is no mention of human patient data (retrospective or prospective) being used for the performance evaluation detailed in Section V.

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

• Number of Experts: "A U.S. board-certified radiologist" (singular) was used for the review of the tomosynthesis anthropomorphic phantom images.
• Qualifications: "U.S. board-certified radiologist." No information about years of experience or subspecialty is provided.

4. Adjudication Method for the Test Set

The document mentions "a U.S. board-certified radiologist review" for the tomosynthesis images. This single-reader review implies no adjudication method (like 2+1 or 3+1 consensus) was conducted, as there was only one expert involved in that specific review. For other non-clinical tests (bench tests, image quality evaluations), the method of evaluation and any expert involvement or adjudication is not specified.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. The document does not describe an MRMC comparative effectiveness study involving human readers with and without AI assistance. The radiologist review mentioned was for phantom images to assess image quality for substantial equivalence, not a comparative reader study to measure improvement from AI assistance.

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

Yes, implicitly. The "non-clinical performance bench test and image quality evaluate substantial equivalence of image processing technique" were conducted comparing the new device's output to predicate devices. This implies evaluating the algorithm's performance (specifically, its image processing and reconstruction capabilities) on phantom data. The metal artifact reduction function of the tomosynthesis option was also "conducted performance testing" which would be a standalone evaluation of the algorithm's output. The radiologist review of phantom images could be seen as an 'expert-in-the-loop' check on the standalone output.

7. The Type of Ground Truth Used

• Phantom Gold Standard: For the non-clinical performance testing (including general image quality, tomosynthesis reconstruction, and metal artifact reduction), the ground truth was established by the physical properties and known characteristics of the anatomical body phantoms used. The 'truth' is inherent in the phantom's design and the controlled testing environment. For Dual Energy Subtraction, it was related to the "distinction of lesion overlying bones to calcification or tubercle shade" within a phantom context.
• Expert Review of Phantom Images: For the tomosynthesis reconstruction review, a U.S. board-certified radiologist provided an evaluation, which serves as an expert opinion on the image quality rendered from the phantom data against the expected 'truth' from the phantom.

8. The Sample Size for the Training Set

The document does not provide any information about a training set or its sample size. This submission focuses on the performance testing of the modified device against predicate devices for substantial equivalence, not on the development or training of an AI algorithm from a dataset in the typical sense. While software processing is mentioned, details about machine learning training are absent.

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

As no training set is mentioned, there is no information on how its ground truth might have been established.

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RADSpa™ components are intended to be used in hospitals, imaging centers, radiologist reading practices and by any user who requires and is granted access to view patient's images, demographic and report information.

RADSpa™ PACS is a flexible, standards-compliant, web-based, workflow management solution designed for centralized and distributed imaging environments. This device consolidates all radiology exam information including images and reports from multiple systems into a centrally managed work list, which can be accessible using any browser. RADSpa™ PACS provides complete PACS functionality used to receive and manage DICOM images and make the data available across a network. RADSpa™ viewer is used for diagnosis and Primary Image Interpretation of DICOM compliant image data derived from all modalities. This component is not intended for mobile devices.

RADSpa™ MPR/MIP/3D components are used for post-processing and is designed to assist radiologists in the diagnostic analysis, visualization, and quantification of CT and MR images. This device supports enhanced visualization and analysis techniques such as multi-planar and oblique reformats, maximum intensity projections, image averaging, subtraction and blinking of images acquired at different time points.

RADSpa™ MPR/MIP/3D is also used to perform post-processing analysis digital images from CT and MR. The software analysis tools may be applied to image subtractions, reformatted images, multi-planar reformats and maximum intensity projections. The software package includes tools to allow the radiologist to manipulate and fly-through images for enhanced visualization.

RADSpa™ MPR/MIP/3D is not intended for mobile devices.

RADSpa™ is a software device that consists of RADSpa™ PACS and Viewer&RADSpa™ 2D/MPR/MIP/3D viewer.

RADSpa™ PACS components (server-side) enable receiving, storing and sending DICOM images and managing the workflow required for radiologists. The components are developed using .NET and runs on Windows OS. The images are stored in the file system and the workflow-related data in a RDBMS database

RADSpa MPR/MIP/3Dviewer components run on Windows OS and enable downloading of images from RADSpa™ server and viewing and manipulating of those images on the workstation

Overall features include:

• Centralized or Distributed Archive functionality
• Uses commercially available computers, servers, operating systems and network infrastructure, with expandable storage capability
• Single or Multi server options (i.e. Archive, Web Server and PACS application can reside on a single server computer)
• Pre-emptive downloading- perfecting of images in real time Web based solution
• Scalable from single practice to enterprise wide PACS
• High level of security
• DICOM, JPEG and JPEG 2000 compliant

The provided document is a 510(k) summary for the RADSpa™ system, a Picture Archiving Communication System (PACS) with viewing and post-processing capabilities. While it details the device description, intended use, and substantial equivalence to predicate devices, it does not contain information about specific acceptance criteria, performance study results, or validation methodology (e.g., sample size, expert qualifications, ground truth establishment, or multi-reader multi-case studies) for the RADSpa™ device itself.

The document primarily focuses on establishing substantial equivalence to existing PACS systems (ResolutionMDTM 2.1 and eRAD PACS) by comparing features and intended use. The conclusion states that the submission contains "adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate device" and mentions a "hazard analysis" and "Level of Concern for potential hazards has been classified as 'minor'". This indicates that the regulatory approval was based on demonstrating equivalence rather than the submission of a new clinical performance study with specific acceptance criteria and results.

Therefore, I cannot extract the requested information from the provided text. The document does not describe:

1. A table of acceptance criteria and reported device performance.
2. Sample size, data provenance, number of experts, qualifications, or adjudication methods for a test set.
3. Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or its effect size.
4. Standalone (algorithm only) performance.
5. The type of ground truth used.
6. The sample size for the training set.
7. How the ground truth for the training set was established.

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This single use sterile equipment cover is intended for use by professionals in a sterile clinical setting to cover and prevent contamination of non-patient contact equipment during various procedures.

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The provided text is a 510(k) premarket notification letter from the FDA regarding the "RadScan Equipment Slicker®". This type of document determines substantial equivalence to a predicate device and approves the device for market. It does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert reviews as requested in your prompt. These details would typically be found in the manufacturer's submission to the FDA, which is not included here.

Therefore, I cannot provide the requested information based on the given document.

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The RadStar DDR Digital Imaging System is intended for use in generating radiographic images of human anatomy. This device is intended to replace film/screen systems in all general purpose diagnostic procedures. This device is intended for incorporation into a complete x-ray system by qualified x-ray service personnel. This device is not intended for mammography applications. This device is intended for use by qualified medical personnel and is contraindicated when, in the judgment of the physician, procedures would be contrary to the best interest of the patient.

The RadStar Digital Imaging System consists of two components, a solid state x-ray imager and software for viewing the captured images on a Windows-based computer. The device is intended for incorporation into a complete x-ray system by qualified x-ray service personnel. The RadStar Digital Imaging System will display high quality images in less than 5 seconds over a wide range of X-Ray dose settings.

This document is a 510(k) summary for the RadStar Digital Imaging System, describing its substantial equivalence to previously marketed devices. It does not contain the typical elements of a study proving a device meets specific acceptance criteria as it would for an algorithm or AI-powered device.

For medical devices that generate images, "acceptance criteria" are usually related to image quality metrics, safety, and performance against predicate devices. The study involved in such a submission primarily aims to demonstrate substantial equivalence to a predicate device, rather than proving performance against pre-defined quantitative acceptance criteria for a new and innovative function.

Based on the provided text, here's an analysis:

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

The provided text does not define specific quantitative "acceptance criteria" for performance metrics like sensitivity, specificity, accuracy, or image quality scores. This submission is for a conventional digital X-ray detector, and its performance demonstration focuses on substantial equivalence rather than novel algorithm performance.

The submission states:

• "The RadStar Digital Imaging System will display high quality images in less than 5 seconds over a wide range of X-Ray dose settings."
• "The technological characteristics between the predicate and proposed devices are identical. There is no difference in fundamental scientific technology."
• "There are no significant differences between the RadStar Digital Imaging System and the predicate devices and therefore, the RadStar Digital Imaging System does not raise any questions regarding safety and effectiveness."
• "The RadStar Digital Imaging System, as designed, is as safe and effective as the predicate device, and the device is determined to be substantially equivalent to the referenced predicate device currently on the market."

These statements serve as the "performance" claim, but they are qualitative and comparative to existing technology, not quantitative against specific, pre-defined acceptance criteria for diagnostic efficacy.

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

Not applicable. This is a submission for a digital X-ray imager, not an AI or algorithm-based diagnostic tool requiring a test set of patient data with ground truth. The "test" for this device would involve engineering and physical performance evaluations (e.g., image resolution, DQE, MTF, dose response) rather than a clinical study with patient images to evaluate diagnostic accuracy.

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 there is no mention of a "test set" of medical images requiring expert ground truth establishment.

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

Not applicable, as there is no mention of a "test set" requiring 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

Not applicable. This is not an AI-assisted device. The submission focuses on the digital imaging system itself replacing film/screen systems.

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

Not applicable. This is not an algorithm, but a hardware imaging system with associated viewing software. Its performance is inherent to its image acquisition capabilities.

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

Not applicable. There is no "ground truth" in the clinical sense for this type of device submission. Performance is assessed through technical specifications and comparison to predicate devices.

8. The sample size for the training set

Not applicable. This device does not use machine learning or AI that requires a "training set."

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

Not applicable, as there is no training set for this device.

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