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Intended for digital image capture use in general radiographic examinations, wherever conventional screen-film systems may be used, excluding fluoroscopy, angiography and mammography. The kit allows imaging of the skull, chest, shoulders, spine, abdomen, pelvis, and extremities.

PRIMO S is an image acquisition and processing software application, in radiography mode for Flat Panel detectors. The software is specifically designed for integration with production equipment of the SEDECAL group. The PRIMO S application will be used on different types of Sedecal equipment / systems:

• mobile units
• fixed installations.

The PRIMO S VP application provides the following functions:

• User login: the device is usable only by authenticated users
• Management of the operator interface GUIs and setup of the application itself
• The operator interface GUI must reserve a space on the monitor for the Sedecal equipment/system GUI (choice of examination (APR), X-ray generator commands, collimator, stand, etc.)
• Management of patient data through manual entry and reception from the DICOM WORKLIST service
• Management of image processing algorithms for each type of examination
• Management of the automatic advancement procedures of the operations during the study.
• Image acquisition and processing
• Saving in Hard Disk of the acquired images
• Automatic and manual image stitching procedure
• Off-line image editing and optimization using process and graphic functions
• Documentation of images and study data using DICOM services of STORE, PRINT, CDROM, MPPS, RDSR, STORAGE COMMITMENT
• Application configuration setup
• Export and automatic saving of images on external support (USB key)

The application communicates with the Sedecal equipment through software modules (DLL) for:

• The choice of the examination, made by the operator through a GUI defined by Sedecal (APR)
• Send the exposure parameters foreseen by the selected exam (kV, mA, mAs, ms, collimator aperture, stand position, ...)
• Receive the system status parameters and the exposure result

While the provided text describes the PRIMO S device and its 510(k) submission, it explicitly states:

"6. Clinical testing. Not required for a determination of substantial equivalence."

This indicates that a clinical study with detailed acceptance criteria and performance metrics, as requested in your prompt, was not performed or required for the FDA clearance of this specific device. The clearance was based on substantial equivalence to a predicate device, supported by non-clinical testing and adherence to various standards.

Therefore, I cannot provide the specific information you requested regarding validation studies, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for a clinical test set, as such a study was not conducted or reported in this document.

The document primarily focuses on:

• Device Description: What PRIMO S is and what it does.
• Indications for Use: The medical conditions and body parts it's intended for.
• Technological Characteristics Comparison: How it compares to its predicate device (Sedecal SA K130883) in terms of X-ray generator, digital detectors, panel sizes, operating system, etc.
• Non-Clinical Testing: A list of standards (IEC 62304, EN/IEC 62366-1, ISO 14971, NEMA DICOM, ISO 15223-1) that were employed in development, and mention of software validation based on FDA guidance and cybersecurity considerations.

Since there's no clinical trial data, I cannot populate the table or answer the specific questions about the study design that would prove the device meets acceptance criteria based on clinical performance.

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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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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 not intended for mammography applications. This device is intended for use by qualified medical personnel and is contraindicated when, in the physician, procedures would be contrary to the best interest of the patient.

Intended for digital image capture use in general radiographic examinations, wherever conventional screen-film systems may be used, excluding fluoroscopy, angiography and mammography. The kit allows imaging of the skull, chest, shoulders, spine, abdomen, pelvis, and extremities.

This is a Windows 10 based software to be used in conjunction with an FDA cleared digital x-ray receptor panel. It can be used to upgrade film-based systems. This upgrade allows to acquire digital medical diagnostic X-ray images and transfer the images to hardcopy, softcopy, and archive devices on the same network. Some functions allowed with the E-COM DR-2000 DR software:
a. Add new patients to the system, enter information about the patient and physician that will be associated with the digital radiographic images.
b. Edit existing patient information.
c. Emergency registration and edit Emergency settings.
d. Pick from a selection of procedures, which defines the series of images to be taken.
e. Adjust technique settings before capturing the X-ray image.
f. 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.
g. Save an incomplete procedure, for which the rest of the exposures will be made at a later time.
h. Close a procedure when all images have been captured.
i. Review History images, resend and reprint images.
j. Re-exam a completed patient.
k. Protect patient records from being deleted by the system.
l. Delete an examined Study with all images being captured.
m. Edit user accounts.
n. Check statistical information.
o. Image QC.
p. Image stitching.

This document describes the FDA 510(k) premarket notification for the E-COM DR-2000 DR, a stationary x-ray system. However, it does not provide details regarding specific acceptance criteria, a study proving the device meets those criteria, or information on AI/standalone performance, expert adjudication, or ground truth establishment typically associated with such studies.

Here's a breakdown of the requested information based only on the provided text, highlighting what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document. The submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting specific quantitative performance metrics against acceptance criteria.

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

This information is not provided in the document. No specific test set for performance evaluation is mentioned. The submission states "Clinical Testing: Not required for a showing of substantial equivalence," implying a lack of a dedicated clinical test set for new performance evaluation.

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

This information is not provided in the document. Since no clinical testing or performance study is detailed, there's no mention of experts establishing ground truth for a test set.

4. Adjudication Method for the Test Set

This information is not provided in the document. As no test set is described, no adjudication method is mentioned.

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

This information is not provided in the document. The device is a "Stationary X-ray System" with software for image acquisition and management. There is no indication that it includes AI for interpreting images or assisting human readers. Therefore, an MRMC study related to AI assistance is not applicable and not mentioned.

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

This information is not provided in the document. As there is no mention of an algorithm for image interpretation or analysis, a standalone performance study is not applicable and not mentioned. The device's software functions are primarily for image acquisition, processing, and management.

7. The Type of Ground Truth Used

This information is not provided in the document. Since no clinical performance study is described, there's no mention of the type of ground truth used (e.g., expert consensus, pathology, outcomes data).

8. The Sample Size for the Training Set

This information is not provided in the document. The submission pertains to a conventional x-ray system and its control software. There is no discussion of machine learning or AI components that would require a "training set."

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

This information is not provided in the document. As no training set is discussed (see point 8), the establishment of its ground truth is also not mentioned.

Summary of the Document's Content Regarding Testing:

The K193644 submission's primary focus is on demonstrating substantial equivalence to a predicate device (K130883, Sedecal Digital Radiographic Upgrade Model SDRU-T). This is achieved by comparing the new device's indications for use and technological characteristics to the predicate.

The document states:

• "Bench/Performance Testing: The results of bench testing (software validation and risk analysis for a moderate level of concern device) shows that this new device poses no new issues of safety or effectiveness, has essentially the same technological characteristics as the predicate, and is therefore substantially equivalent to the predicate device."
• "Clinical Testing: Not required for a showing of substantial equivalence."

This indicates that the FDA clearance for E-COM DR-2000 DR was based on demonstrating similar technical specifications and safety/effectiveness profiles to an already cleared device, along with adherence to relevant software development and risk management guidance documents. It does not involve a new performance study with specific quantitative acceptance criteria or extensive clinical data as would be required for a novel device or one incorporating advanced AI algorithms.

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