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INNOVISION-DXII is a stationery X-ray system intended for obtaining radiographic images of various anatomical parts of the human body, both pediatrics and adults, in a clinical environment. INNOVISION-DXII is not intended for mammography, angiography, interventional, or fluoroscopy use.

INNOVISION-DXII is a stationary X-ray system using single and three phase power and consists of Tube, HVG(High voltage generator), Ceiling suspended X-ray tube support, Floor to Ceiling X-ray tube support, patient table, detector stand, and X-ray control console. The X-ray control console is a window-based software that can view X-ray images and a mobile console mounted on an Android-based board that only controls X-rays without viewer function.

After turning on the control unit, it irradiates the set X-ray on the exposure position properly generating X-ray in the inverter generator using IGBT. The compositions like supporters for X-ray tube and tables are used to supply power from the High Voltage generator. When inverter type of Generator creates X-ray irradiation by certain exposure conditions, and X-ray penetrates the patient's body. X-ray information is transferred to a visible ray by a sensor's scintillator, and it turns to an electric signal through A-Si after transmitting photodiode to a TFT Array. This X-ray system is used with FDA cleared X-ray detectors. The electric signal is magnified and turned into a digital signal to create image data. The image is transferred to the PC display by an Ethernet Interface, and it can be adjusted.

The FDA 510(k) clearance letter for INNOVISION-DXII explicitly states that clinical testing was not performed for this device. Therefore, there is no study described within this document that proves the device meets acceptance criteria related to clinical performance or human reader studies.

The provided document focuses on non-clinical performance tests to demonstrate substantial equivalence to the predicate device.

Here's an analysis based on the information provided, outlining what is and isn't available regarding acceptance criteria and studies:

Acceptance Criteria and Device Performance (Non-Clinical)

The acceptance criteria for the INNOVISION-DXII are implicitly the successful completion of the bench tests according to recognized international standards and demonstration that the differences from the predicate device do not raise new safety or effectiveness concerns. The "reported device performance" is the successful passing of these tests, indicating the device is safe and effective in its essential functions.

Table 1: Acceptance Criteria and Reported Device Performance (Non-Clinical Bench Testing)

Study Details for Demonstrating Substantial Equivalence (Non-Clinical)

The study described is a series of bench tests (functional tests) conducted to ensure the safety and essential performance effectiveness of the INNOVISION-DXII X-ray system.

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

   • Sample Size: Not applicable. These are functional tests of the device itself rather than tests on a dataset. The "sample" refers to the physical device components and the system as a whole.
   • Data Provenance: Not applicable in the context of image data. The tests are performed on the device in a laboratory setting. The standards referenced are international (IEC).

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

   • Not applicable. Ground truth in this context refers to the expected functional performance of the device according to engineering specifications and regulatory standards (IEC 60601 series). These standards define the "ground truth" for electrical safety, mechanical performance, and radiation emission/accuracy. Experts are involved in conducting and interpreting these standardized tests, but there isn't a "ground truth" established by a panel of medical experts as there would be for image interpretation.

3. Adjudication method for the test set:

   • Not applicable. The tests are typically pass/fail based on objective measurements against predefined thresholds specified in the IEC standards. There is no subjective adjudication process mentioned.

4. 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 explicitly NOT done. The document states: "Clinical testing is not performed for the subject device as the detectors were already 510(k) cleared and the imaging software (Elui) is the same as the predicate device. There were no significant changes." This device is a stationary X-ray system, not an AI-assisted diagnostic tool for image interpretation.

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

   • No, a standalone algorithm performance study was not done. This device is an X-ray imaging system; it does not feature a standalone diagnostic algorithm. While it includes an imaging software (Elui), its performance is assessed as part of the overall system's image acquisition and processing capabilities, not as an independent diagnostic algorithm.

6. The type of ground truth used:

   • For the non-clinical bench tests, the "ground truth" is defined by the engineering specifications and the requirements of the referenced international standards (IEC 60601-1-3, IEC 60601-2-28, IEC 60601-2-54). These standards specify acceptable ranges for parameters like tube voltage accuracy, radiation output linearity, image resolution, and system stability.

7. The sample size for the training set:

   • Not applicable. This device is an X-ray system, not a machine learning algorithm that requires a training set of data.

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

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

Summary of Clinical/AI-related information:
The FDA 510(k) clearance for INNOVISION-DXII does not include any clinical studies or evaluations of AI performance, human reader performance, or diagnostic accuracy. The clearance is based purely on the non-clinical bench testing demonstrating that the device meets safety and essential performance standards and is substantially equivalent to its predicate device for obtaining radiographic images.

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The portable x-ray system may be used for diagnostic imaging of body extremities.

• Not for mammography use
• This device is not intended to replace a stationary radiographic system, which may be required for full optimization of image quality and radiation exposure for different exam types.

This portable X-ray system (Model: INNOVISION-P5) consists of an LCD display with up and down soft keys for controlling the kV settings. It includes a line-powered X-ray generator (transformer), an X-ray tube assembly, a collimator, a support stand, imaging processing software, and a digital flat-panel detector. The INNOVISION-P5 is a battery-operated, portable X-ray system designed for use with a flat-panel detector.

The major components of the X-ray main unit include handle, enclosure, main control panel, system control board, high-voltage tank, inverter, collimator (beam limiter), system control software running on the system control board, imaging processing software, and detector. The system control software is for real-time interaction and control with various circuit modules inside the X-ray generator. The software responds to user operations on the control panel. The user can adjust and control the kV and mAs parameters, and the software displays the parameters or directly load the APR parameters. The software loads the control data from X-ray output into the high-voltage generation control circuit of the system control board, and control the high-voltage tank to generate high-voltage to excite the X-ray tube inside to emit X-rays, control the switch of the collimator, and monitor the working status of the device, and control the display of the status indicators.

The system is for X-ray imaging and diagnosis in facilities with portable or fixing sites.

This INNOVISION-P5 is not intended for mammography.

The device can be used with an X-ray flat panel detector, a computer for receiving and detecting signal results and an image processing software. Under certain exposure conditions, the inverter generator irradiates X-rays and the X-rays penetrate the patient's body. The Software (Elui-P) and portable x-ray unit communicate via Bluetooth to send/receive data to operate the product. The X-ray information is turned into electrical signals by a detector. The electrical signals are magnified and converted into digital signals to create image data. The image is sent to the image processing software (Elui-P) via Wifi. This portable X-ray System is designed for handheld or stand-mounted imaging. Model INNOVISION-P5 can be configured to an optional portable stand that complies with IEC 60601- 1 safety standard. The recommended maximum load that the stand can safely carry is 6kgs to ensure the mechanical stability and effectiveness of the device.

The provided FDA 510(k) clearance letter and summary for the INNOVISION-P5 Mobile X-Ray System details the device's technical specifications and a comparison to a predicate device. However, it does not provide specific acceptance criteria or a detailed study that proves the device meets such criteria in a quantitative manner, nor does it include information about sample sizes for test/training sets, expert qualifications, or adjudication methods for quantitative performance metrics. The document primarily focuses on demonstrating substantial equivalence through technical comparisons and compliance with recognized safety and performance standards.

The information closest to "acceptance criteria" and "device performance" is presented in a qualitative statement about clinical image evaluation.

Here's an attempt to answer your questions based only on the provided text, highlighting what is present and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not explicitly state quantitative acceptance criteria for diagnostic performance (e.g., sensitivity, specificity, or specific image quality metrics) in a table format. The "reported device performance" related to image quality is a qualitative statement.

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

• Sample Size for Test Set: Not specified. The document mentions "X-ray images acquired using the subject device were evaluated," but no number of images or cases is provided.
• Data Provenance: Not specified. The country of origin of the data (patients, images) or whether the study was retrospective or prospective is not mentioned.

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

• Number of Experts: The document states "evaluated for image quality by a clinical expert." This implies one clinical expert.
• Qualifications of Experts: The expert is described as a "clinical expert" and "qualified expert." Further specific qualifications (e.g., "radiologist with 10 years of experience") are not provided.

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified. Given that only "a clinical expert" is mentioned, it's highly probable that no formal adjudication method was used (e.g., 2+1 or 3+1 consensus). The evaluation appears to be a single expert's assessment.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• MRMC Study Done: No. The document does not describe a multi-reader multi-case study, nor any comparative effectiveness study involving human readers with and without AI assistance. The device is a mobile X-ray system, not an AI-powered diagnostic tool, so such a study would not typically be required for this type of submission.
• Effect Size of Human Readers Improvement with AI: Not applicable, as no such study was performed or needed for this device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Standalone Study Done: Not applicable/Not explicitly separate. The device itself is an X-ray imaging system. Its fundamental "performance" is the generation of diagnostic images. The software (Elui-P) mentioned is for image processing, acquisition, transmission, and display, as well as parameter control for the X-ray unit. While the software underwent Verification and Validation, its "performance" is integrated into the overall device's ability to produce diagnostically acceptable images. There is no mention of a separate "algorithm-only" diagnostic performance study in the way one might evaluate an AI detection algorithm.

7. Type of Ground Truth Used

• Type of Ground Truth: The "ground truth" for the image quality evaluation appears to be expert consensus on diagnostic adequacy. The expert determined if the images met "diagnostic radiography standards" and "effectively support diagnostic purposes." There is no mention of pathology, long-term outcomes data, or other objective measures for establishing ground truth regarding specific findings or diseases.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable/Not specified. The document describes an X-ray imaging system, not a device incorporating a machine learning or AI algorithm that would require a "training set" in the conventional sense for diagnostic performance.

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

• How Ground Truth for Training Set Was Established: Not applicable. See reason above.

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INNOVISION-EXII is a stationery X-ray system intended for obtaining radiographic images of various anatomical parts of the human body, both pediatrics and adults, in a clinical environment. INNOVISION-EXII is not intended for mammography, angiography, interventional, or fluoroscopy use.

INNOVISION-EXII can receive X-ray signals from X-ray irradiation and digitize them into X-ray images by converting digital images to DICOM image format using Elui imaging software. INNOVISION-EXII is a general radiography X-ray system and not for mammography nor fluoroscopy. In addition, the system must be operated by a user who is trained and licensed to handle a general radiography X-ray system to meet the regulatory requirements of a Radiologic Technologist. Target areas for examinations include the head, spine, chest, and abdomen for diagnostic screening of orthopedic, respiratory, or vertebral discs. The system can capture a patient's postures, such as sitting, standing, or lying. This system can be used for patients of all ages, but it should be used with care for pregnant women and infants. The INNOVISION-EXII system has no part directly touching the patient's body.

The provided text describes a 510(k) summary for the INNOVISION-EXII stationary X-ray system, asserting its substantial equivalence to a predicate device (GXR-Series Diagnostic X-Ray System). However, the document does not contain information about acceptance criteria or a detailed study proving the device meets specific acceptance criteria related to its performance metrics for diagnostic imaging or AI assistance.

The "Clinical testing" section on page 9 merely states: "Clinical image evaluation of INNOVISION-EXII has been performed. The evaluation results demonstrated that INNOVISION-EXII generated images are adequate and suitable for expressing contour and outlines. The image quality including contrast and density are appropriate and acceptable for diagnostic exams." This is a very general statement and does not provide specific acceptance criteria or detailed study results.

Similarly, there are no details regarding AI performance (standalone or human-in-the-loop), sample sizes, ground truth establishment, or expert qualifications for such studies. The document focuses on establishing substantial equivalence based on intended use, technological characteristics, and compliance with various safety and performance standards (electrical safety, EMC, software validation, risk analysis).

Therefore, based solely on the provided text, the requested information about acceptance criteria and a study proving the device meets these criteria cannot be extracted or inferred. The document is a 510(k) summary focused on demonstrating substantial equivalence, not a detailed clinical performance study report.

Here is a breakdown of why each requested point cannot be addressed from the given text:

1. A table of acceptance criteria and the reported device performance: Not present. The "clinical testing" section is too vague.
2. Sample sized used for the test set and the data provenance: Not present. No specific test set for clinical performance is detailed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present. No ground truth establishment process is described beyond a general "clinical image evaluation."
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not present.
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 present. The document does not mention any AI component or MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not present. No mention of an algorithm or standalone performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not detailed. Only a general "clinical image evaluation" is mentioned.
8. The sample size for the training set: Not present. The document describes a medical imaging device, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established: Not applicable, as there's no mention of a training set or machine learning components.

In summary, the provided FDA 510(k) summary largely focuses on engineering and regulatory compliance (electrical safety, EMC, software validation, comparison of technical specifications to a predicate device) to establish substantial equivalence, rather than detailed clinical performance metrics derived from a study with specific acceptance criteria and ground truth for diagnostic accuracy.

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