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The PROMO is intended for use in obtaining human anatomical images of patients who cannot be moved to the radiology department for medical diagnosis.

The PROMO is based on predicate device TOPAZ and the x-ray detectors are the same as the predicate system. The PROMO is moved smoothly with manual by user. The core part of x-ray source adopts high quality tube assembly, x-ray collimator, HV cable assembly and High Voltage x-ray Generator with excellent performance, lifetime and stability. Digital flat panel detector with CsI screen provides excellent spatial resolution, MTF, DQE and stability based on fine pixel pitch. The core part of x-ray source adopts high quality tube assembly, x-ray collimator, HV cable assembly and High Voltage x-ray Generator which have worldwide reputation on excellent performance, lifetime and stability. Touch screen LCD based x-ray control console provides user-friendly interface and easy technique selection. Collimator supports high accuracy for selected x-ray field size over any SID. The PROMO include imaging software that is the RADMAX. The RADMAX software can perform processing the radiological image acquired from solid state x-ray imaging device. The RADMAX software is based on predicate device TOPAZ. The CTR function is a manual quantitative imaging feature that allows users to measure the cardiothoracic ratio by manually selecting points using a mouse. The software function has been verified and validated as safe and effective.

The provided FDA 510(k) clearance letter and summary for the PROMO Mobile X-ray System do not contain information about specific acceptance criteria, reported device performance metrics in relation to those criteria, or details of a clinical study that proves the device meets acceptance criteria.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (TOPAZ) through non-clinical performance testing and compliance with various recognized standards and guidance documents. It confirms that the device's image performance was evaluated through bench testing.

Therefore, for the specific questions asked, most of the information is not available in the provided text.

Here's an breakdown of what can and cannot be answered based on the provided document:

Information that CANNOT be provided from the document:

• 1. A table of acceptance criteria and the reported device performance: The document mentions "bench testing was conducted to evaluate the image performance of the detector" and that "PROMO meets or exceeds TOPAZ in key image quality metrics such as uniformity, SNR, linearity, spatial resolution, and low contrast resolution." However, it does not provide specific numerical acceptance criteria for these metrics nor the quantitative reported performance of the device against them.
• 2. Sample size used for the test set and the data provenance: Since no clinical study or specific test set with patient data is described, this information is not available. The "test set" mentioned refers to non-clinical bench testing.
• 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 study involving expert interpretation is detailed.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable as no clinical study involving expert interpretation is detailed.
• 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. The PROMO is a mobile X-ray system, not an AI diagnostic tool, and the document does not describe any MRMC studies. The "CTR function" mentioned is a manual measurement tool, not an AI feature for diagnostic assistance.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this device itself is the imaging hardware, not an AI algorithm.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the non-clinical bench testing mentioned, the "ground truth" would be objective physical measurements of image quality parameters (e.g., standard phantoms for linearity, resolution, etc.). The document does not describe clinical ground truths.
• 8. The sample size for the training set: The document does not describe any machine learning or AI models with a "training set."
• 9. How the ground truth for the training set was established: Not applicable, as no training set is mentioned.

Information that CAN be inferred or directly stated from the document (regarding non-clinical testing and general acceptance):

The document implicitly defines "acceptance criteria" by stating compliance with recognized national and international standards for medical electrical equipment, radiation protection, usability, software life cycle, risk management, and cybersecurity. The "study" that proves the device meets these (non-clinical) acceptance criteria is the bench testing and verification/validation processes conducted according to these standards.

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

Summary regarding the device performance study:

The PROMO Mobile X-ray System's substantial equivalence to its predicate (TOPAZ) and its safety and effectiveness are established through non-clinical performance testing (bench testing). This testing focused on comparing technical specifications and image quality metrics against the predicate and ensuring compliance with a comprehensive set of international and FDA-recognized standards and guidance documents. The document explicitly states: "Bench testing was conducted to evaluate the image performance of the detector. The results showed that PROMO meets or exceeds TOPAZ in key image quality metrics such as uniformity, SNR, linearity, spatial resolution, and low contrast resolution. Therefore, the substantial equivalence in image quality performance is supported by objective bench testing data."

Type of ground truth used (for bench testing):

For the non-clinical bench testing, the ground truth would be established by objective physical measurements using standardized phantoms and test objects to assess imaging characteristics (e.g., bar patterns for spatial resolution, step wedges for linearity, uniform fields for uniformity).

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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 device is a battery-powered portable X-ray System, designed and manufactured by H&abyz. This portable radiographic system (Model: HnX-P1, HnX-PB) consists of an LCD display with up and down soft-keys for controlling kV, an X-ray generator (line-powered transformer), an X-ray tube assembly, a collimator and a cart. It can also use a stand instead of a cart. The HnX-P1 is used with a film-cassette or flat-panel detector. (The film-cassette or flat-panel detector, cart, and stand are not included in the basic components of the product.)

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), and system control software running on the system control board. 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 will display 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. 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. This portable X-ray System is designed for handheld or stand-mounted imaging.

It appears there may be a misunderstanding or a gap in the provided document regarding acceptance criteria and the study proving the device meets them. The document is an FDA 510(k) clearance letter for a portable X-ray system (HnX-P1, HnX-PB), and it does not contain information about acceptance criteria for AI/software performance or a study proving the device meets such criteria.

The document explicitly states several times that "Clinical studies were not performed." (Page 10, Section 8 on "Clinical studies"). This means there was no clinical evaluation of diagnostic accuracy or comparative effectiveness with human readers using this specific device.

The "Non-Clinical Test summary" (Page 9, Section 7) mentions:

• "A total of 30 clinical image samples, including elbows, hands, knees, ankles, and feet, were reviewed by qualified clinicians and determined to be of good quality and clinically useful." This sounds like an image quality assessment, not a performance study of an AI algorithm.
• "Software validation and risk analysis was performed." This refers to internal software quality assurance processes.

Therefore, many of the requested points related to AI performance, ground truth, expert adjudication, and MRMC studies cannot be answered from the provided text, as the device described is a hardware X-ray system, not an AI diagnostic algorithm.

However, I can still extract information based on the typical requirements for a 510(k) clearance for a hardware device like an X-ray system. The "acceptance criteria" here would typically relate to meeting performance standards for X-ray output, safety, electrical compatibility, and image quality demonstrations, rather than diagnostic accuracy of an AI algorithm.

Based on the provided FDA 510(k) clearance letter, here's an analysis tailored to what is present and what is absent:

Summary of Device Performance and Acceptance Criteria (as implied for a hardware X-ray system)

The acceptance criteria for a portable X-ray system like the HnX-P1/HnX-PB are primarily focused on safety, technical performance, and image quality adequacy for diagnostic use, rather than the diagnostic accuracy of an AI. The studies proving the device meets these criteria are primarily non-clinical tests and demonstrations of substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set (for "Image Quality" evaluation): 30 clinical image samples.
• Data Provenance: Not explicitly stated regarding country of origin or whether retrospective/prospective. However, the use of "clinical image samples" suggests real patient data, likely retrospective given the lack of a formal clinical study.

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

• For the "image quality" assessment of the 30 samples: "qualified clinicians" reviewed the images. The exact number of clinicians or their specific qualifications (e.g., "Radiologist with 10 years of experience") are not specified in this document.

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

• Not applicable/Not specified for this type of hardware evaluation. The document implies a qualitative assessment ("determined to be of good quality and clinically useful") rather than a diagnostic performance 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:

• No MRMC study was performed or required. The device is a portable X-ray system, not an AI diagnostic aid for human readers.
• The document explicitly states: "Clinical studies were not performed." (Page 10, Section 8).

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

• Not applicable. This device is a hardware X-ray imager, not a standalone AI algorithm. It produces images, but does not autonomously interpret them.

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

• For the "image quality" assessment, the "ground truth" was effectively the qualitative judgment of "qualified clinicians" that the images were "good quality and clinically useful." This isn't diagnostic "ground truth" (e.g., presence/absence of a disease).

8. The sample size for the training set:

• Not applicable. This document describes a hardware device, not an AI algorithm that requires a training set.

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

• Not applicable. As above, no AI training set is described or relevant to this hardware device clearance.

In conclusion, the provided FDA 510(k) clearance letter details the regulatory review for a medical device hardware (portable X-ray system), not an AI or software as a medical device (SaMD) with diagnostic capabilities that underwent a performance study against specific diagnostic acceptance criteria. The "acceptance criteria" discussed are largely compliance with electrical, safety, and performance standards, and a qualitative assessment of image utility.

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Portable X-ray Equipment REMEX Xcam6 is intended to be used in a hospital or clinic setting under the supervision of a qualified and trained clinician. This product is used as an x-ray source to produce diagnostic x-ray images of patient's extremities using an X-ray detector. It may be used in handheld or stand-mounted configurations for acquiring diagnostic radiographic images of extremities.

The device is not intended for mammography.

The REMEX Xcam6 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.

The REMEX Xcam6 is a handheld and portable general-purpose X-ray system intended for use by qualified and trained clinicians to obtain diagnostic radiographic images of patient's extremities.

The REMEX Xcam6 serves as an X-ray source and is designed to be used in conjunction with a Flat Panel Detector (FPD), which is not included as part of the system. The FPD is connected to a computer equipped with imaging software that enables image acquisition, display, manipulation, storage, and transmission.

The X-ray source is securely enclosed within the housing of the handheld unit, and the device does not come into direct contact with the patient during use.

During imaging procedures, the patient is positioned appropriately—either sitting or lying down—and the X-ray receptor is aligned accordingly. The patient is instructed to remain still while the operator sets the exposure parameters and initiates the radiographic exposure.

The operator has control over the following exposure parameters:

1. Tube Voltage (kVp): Adjustable from 40 to 90 kVp, in 1 kV increments.
2. Tube Current (mA): Adjustable from 2 to 6 mA, in 1 mA increments.
3. Exposure Time: Adjustable from 0.06 to 2.00 seconds, in 0.01-second increments.

The provided document outlines the FDA 510(k) clearance for the REMEX Xcam6, a portable X-ray equipment. While it confirms the device meets safety and performance standards for substantial equivalence to a predicate device, it does not provide explicit acceptance criteria in the form of specific performance metrics (e.g., sensitivity, specificity, accuracy) or detailed clinical study results typical for an AI/CADe device.

The document primarily focuses on technical characteristics, electrical safety, image quality (bench testing), and software validation. The "Clinical Performance Testing" section is very limited and only states that a board-certified radiologist verified the images were suitable for diagnostic interpretation, without quantifiable results.

Therefore, many of the requested details, especially those pertaining to a comparative effectiveness study involving AI assistance, multi-reader multi-case studies, or detailed AI performance metrics, are not available in the provided text as this is a traditional X-ray device clearance, not an AI/CADe device clearance.

Below is an attempt to address the questions based only on the information available in the provided FDA 510(k) clearance letter. Missing information will be explicitly stated as "Not provided."

Acceptance Criteria and Device Performance Study for REMEX Xcam6

The REMEX Xcam6 is a mobile X-ray system, not an AI or CADe (Computer-Aided Detection/Diagnosis) device, as indicated by the product code "IZL" (Mobile x-ray system) and the lack of AI-specific claims. Therefore, the acceptance criteria and study detailed in the document focus on demonstrating substantial equivalence to a predicate conventional X-ray system through technical specifications, safety, and image quality for diagnostic interpretation by a human clinician, rather than on AI-driven performance metrics like sensitivity, specificity, or reader improvement.

1. Table of Acceptance Criteria and Reported Device Performance

The document describes several non-clinical tests (electrical safety, EMC, image quality, dosimetry, software V&V) and a limited clinical test. The "acceptance criteria" for these tests are implicitly that the device performs "as intended" and is "as safe and effective as the predicate device," and that "all predefined acceptance criteria established in the test protocol" were met for bench testing. Specific, quantitative acceptance criteria for image quality beyond "suitable for diagnostic interpretation" are not explicitly stated for the clinical review.

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

• Test Set Sample Size: Not explicitly provided. The documentation states "A limited clinical test was conducted." It does not specify the number of images or patients included in this test.
• Data Provenance: Not provided (e.g., country of origin, retrospective or prospective).

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Number of Experts: "A board-certified radiologist" (singular) was stated to have reviewed and assessed the images.
• Qualifications of Experts: "Board-certified radiologist." No specific experience level (e.g., years of experience) is mentioned.

4. Adjudication Method for the Test Set

• Adjudication Method: Not provided. Given only one radiologist was mentioned for clinical review, a formal multi-reader adjudication method (e.g., 2+1, 3+1) is unlikely to have been performed for this specific clinical assessment. The radiologist's assessment served as the verification.

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

• MRMC Study: No. The provided information is for a traditional X-ray system, not an AI-assisted device. The clinical performance testing focused on verifying the image suitability for diagnostic interpretation by a single radiologist, not on human reader performance improvement with AI assistance.
• Effect Size of Human Readers Improvement: Not applicable, as no AI assistance is mentioned or evaluated.

6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) was Done

• Standalone Study: Not applicable. This device is a hardware X-ray system; it does not feature an AI algorithm that would have standalone performance. Its software controls the X-ray system's operation, not image interpretation.

7. The Type of Ground Truth Used

• Ground Truth Type: For the "limited clinical test," the "ground truth" for verifying image quality appears to be the subjective assessment and verification by a single "board-certified radiologist" that the images were "suitable for diagnostic interpretation."
• For bench testing, phantoms were used, with "predefined acceptance criteria" as the ground truth.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This product is a physical X-ray machine. It does not utilize an AI model that requires a training set in the conventional sense. The software mentioned (IEC 62304 Class B) relates to the operational control of the device, not image analysis or AI interpretation.

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

• Ground Truth Establishment for Training Set: Not applicable, as there is no AI model or training set specified for this device.

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The PRORAD ATLAS ULTRAPORTABLE Digital X-ray system is intended to deliver high-quality, diagnostic radiographic images of the body extremities. It utilizes a portable X-ray unit, flat-panel detector and image acquisition software to produce clear digital images, enabling fast and accurate diagnosis. The portable X-ray unit is intended to be used only when stand/tripod mounted.

The PRORAD ATLAS ULTRAPORTABLE X-ray digital system is predominantly employed in various settings, including health-care centres, temporary and emergency health centres (established, especially in pandemic circumstances), outreach and field interventions (such as mobile clinics/vans, screening campaigns, and home care), and tele-radiology solutions in remote areas.

The primary users anticipated for the system include radiographers, radiological technologists, and medical professionals who are trained in safety, radiation protection, and image management.

The PRORAD ATLAS ULTRAPORTABLE PLUS Digital X-ray system is intended to deliver high-quality, diagnostic radiographic images of the body extremities. It utilizes a portable X-ray Unit, flat-panel detector and real-time image processing using software to produce clear digital images, enabling fast and accurate diagnosis. The portable X-ray unit is intended to be used only when stand/tripod mounted.

The PRORAD ATLAS ULTRAPORTABLE PLUS X-ray digital system is predominantly employed in various settings, including health-care centres, temporary and emergency health centres (established, especially in pandemic circumstances), outreach and field interventions (such as mobile clinics/vans, screening campaigns, and home care), and tele-radiology solutions in remote areas.

The primary users anticipated for the system include radiographers, radiological technologists, and medical professionals who are trained in safety, radiation protection, and image management.

The PRORAD ATLAS X-Ray system includes the ULTRAPORTABLE and ULTRAPORTABLE PLUS, which are portable diagnostic X-ray systems with fixed 70kV and 2mA tube current. These systems are intended to produce anatomical X-rays of the body extremities in both pediatric and adult patients. The PRORAD ATLAS X-Ray system was designed, developed, and manufactured by Prognosys Medical Systems Private Limited. The model numbers are listed below.

The PRORAD ATLAS X-ray system is a sophisticated, battery-powered X-ray generator offered in two versions: PRORAD ATLAS ULTRAPORTABLE and ULTRAPORTABLE PLUS. The main distinction between these models lies in their exposure time ranges and target anatomical areas. The ULTRAPORTABLE model provides exposure times ranging from 0.01 to 1.30 seconds, while the ULTRAPORTABLE PLUS model offers an extended exposure range of 0.01 to 2.5 seconds. Both models share identical internal components, software, algorithms, and operational features and are intended for imaging body extremities. The system includes a high-voltage tank with an X-ray tube mounted on an adjustable tripod stand, allowing users to adjust the height to the specific imaging area. Exposure parameters are configured through the X-ray generator's graphical user interface (GUI). After setting the parameters and positioning the patient on the detector, the X-ray is activated via an exposure switch. The detector captures the radiation, converts it into a digital signal, and transmits the data wirelessly to a computer equipped with compatible software. The images are processed and displayed on the computer for diagnostic review. The PRORAD ATLAS system is compatible with several 510(k)-cleared detectors and their associated software, listed below in Table 1. Prognosys includes one detector and its pre-configured software in the package, depending on availability. Fully battery-operated, the system does not support direct power connection but can seamlessly integrate with multiple detectors and compatible software as part of the package.

The provided FDA 510(k) clearance letter and supporting documentation for the PRORAD ATLAS ULTRAPORTABLE X-Ray Systems do not include acceptance criteria or a detailed study that proves the device meets specific performance criteria beyond general safety and effectiveness.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (Remex KA6, K212144) rather than presenting a performance study with defined acceptance criteria. The "Summary of non-clinical testing" lists a series of international standards (IEC, ISO) and FDA guidance documents that were followed for design control, risk management, verification, and validation. The "Summary of clinical testing" mentions that clinical images were collected and reviewed by a qualified radiologist, confirming they are "clinically acceptable." However, specific quantitative acceptance criteria for image quality, diagnostic accuracy, or other performance metrics, along with the study design and results against those criteria, are not detailed in this document.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor can I provide information about sample size, expert details, adjudication methods, MRMC studies, standalone performance, or training set specifics, as this information is not present in the provided text.

Based on the available text, here's what can be extracted:

• Overall Conclusion: The device is deemed "safe and effective when the device is used as labelled and is substantially equivalent to the predicate device."

Here's a breakdown of why the requested information cannot be fully provided based on the input:

1. A table of acceptance criteria and the reported device performance: This information is not explicitly stated in the document. The document confirms that "Validation of PRORAD ATLAS X-Ray System has demonstrated that the system enables optimal and quality imaging of anatomical structures" and that clinical images are "clinically acceptable," but no specific quantitative criteria or performance metrics are given.

2. Sample size used for the test set and the data provenance: The document states that "Clinical images of body extremities were collected from patients of varying ages, weights, and BMIs." However, the exact sample size and the provenance (e.g., country of origin, retrospective/prospective nature) of this clinical image test set are not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: The document mentions that images were "reviewed by a qualified radiologist." It does not specify the number of radiologists or their specific qualifications (e.g., years of experience, board certification).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: No adjudication method for the clinical image review is 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: An MRMC study is not mentioned. The device described is an X-ray system, not an AI software to assist human readers.

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 an algorithm, and it's intended to be used by trained medical professionals.

7. The type of ground truth used: The ground truth for the clinical images appears to be "clinical acceptability" as determined by a "qualified radiologist." This aligns with "expert consensus" in a general sense, but no more objective ground truth (e.g., pathology, outcomes data) is mentioned for the image quality assessment.

8. The sample size for the training set: The document does not mention a training set, as it describes an X-ray hardware system, not an AI-driven software that requires a training set.

9. How the ground truth for the training set was established: Not applicable, as no training set is mentioned.

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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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Europa (Alternative: AiRTouch) portable X-ray system is intended for use by trained or qualified doctors to produce diagnostic X-ray images of extremities in adult and pediatric(over 12 years old) patients. These images are obtained using anatomical structures captured by film or image processing systems (workstation) after an examination involving radiation exposure with cassette IP, CR, or DR (portable flat panel). Only intended for stand-mounted use.

EUROPA(Alternative: AiRTouch) portable X-ray System generates X-ray with variable tube current and voltage (kVp) to take diagnostic X-rays of extremities for adult and pediatric patients. It operates on 22.2VDC supplied by a rechargeable Lithium-Ion Polymer battery pack. The X-ray tube head, X-ray controls and power source are assembled into a single portable X-ray enclosure. EUROPA(Alternative: AiRTouch) portable X-ray System includes high voltage generator, X-ray tube, a control board (PCB), rechargeable battery, LCD user interface, X-ray beam limiting device, and a remote-control switch (hand switch). Operating principle is that x-ray generated by high voltage electricity into x-ray tube, which penetrates patients' extremities and makes x-ray images on receptor. EUROPA(Alternative: AiRTouch) Portable X-ray System is intended to be used by trained clinicians or technicians for both adult and pediatric(over 12 years old) patients.

EUROPA(Alternative: AiRTouch) portable X-ray is intended to be mounted on a tripod stand.

The provided FDA 510(k) clearance letter for the Europa Portable X-ray System is primarily a regulatory document affirming substantial equivalence to a predicate device. It details the device's technical specifications and how they compare to the predicate, as well as the non-clinical testing performed to meet electrical safety and radiation protection standards.

However, the document does NOT contain the information typically found in a study proving a device meets acceptance criteria related to its diagnostic performance (e.g., accuracy, sensitivity, specificity, or human perception improvement with AI assistance). The "clinical images" mentioned appear to be for general image quality assessment, not a structured clinical study with quantifiable metrics against defined acceptance criteria.

Therefore, I cannot extract the detailed information requested regarding acceptance criteria and a study proving the device meets performance acceptance criteria. The document focuses on showing the device is substantially equivalent to a predicate device based on its technical specifications and adherence to safety and performance standards for X-ray equipment.

The relevant section related to "performance" in this document refers to:

• Non-clinical testing: Adherence to various IEC and CFR standards related to electrical safety, electromagnetic disturbances, radiation protection, and X-ray tube assemblies.
• "Clinical images" assessment: A qualitative statement that "Clinical images taken with EUROPA 85 and EUROPA 90 have presented overall appropriate image quality of the anatomical structures, both bony and soft tissues of the upper and lower extremities." This is not a quantitative performance study.

To answer your request based solely on the provided text, the following points are all "Not Provided" or "Not Applicable" because the document is a regulatory clearance letter focused on substantial equivalence rather than a detailed performance study report.

Summary of Device Acceptance Criteria and Performance (Based on the provided K244049 document):

The provided document, an FDA 510(k) clearance letter, primarily serves to demonstrate that the Europa (Alternative: AiRTouch) Portable X-ray System is substantially equivalent to a predicate device (EZER Portable X-ray System, K193535). The "acceptance criteria" discussed are largely related to technical specifications, electrical safety, radiation performance, and adherence to recognized standards, rather than a specific clinical performance study measuring diagnostic accuracy or reader improvement.

No clinical study details regarding diagnostic performance metrics (e.g., sensitivity, specificity, AUC) are provided in this document. The "clinical images" mentioned appear to have been part of a qualitative assessment of overall image quality for regulatory submission, not a formal quantitative performance study.

Detailed Breakdown of Requested Information:

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The device is designed to perform general radiography x-ray examinations on all pediatric and all adult patients, in all patient treatment areas.

Treatment areas are defined as professional health care facility environments where operators with medical training are continually present during patients' examinations.

The !M1 mobile X-ray system is a diagnostic mobile x-ray system utilizing digital radiography (DR) technology. The device consists of a self-contained x-ray generator, image receptor(s), imaging display and software for acquiring medical diagnostic images both inside and outside of a standard stationary x-ray room. The !M1 system incorporates a flat-panel detector(s) that can be used wirelessly for exams such as in-bed projections. The system can also be used to expose CR phosphor screens or film.

The provided FDA 510(k) clearance letter and documentation describe a submission for an updated mobile X-ray system, !M1. However, the document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific performance acceptance criteria for an AI/algorithm-based medical device.

The clearance is for a mobile X-ray system and its components (generators, X-ray tubes, collimators, and new lines of digital detectors and associated imaging software), not an AI algorithm for diagnostic interpretation that would typically have specific performance metrics like sensitivity, specificity, or AUC against a ground truth.

Therefore, many of the requested items related to AI/algorithm performance (e.g., sample size for test set, number of experts, adjudication method, MRMC studies, standalone performance, ground truth for training/test sets, training set sample size) are not applicable or not provided in this type of 510(k) submission for an imaging device itself. The "performance" being improved here refers to the image acquisition capabilities (DQE, MTF, pixel size, kV, mAs, kW) of the new hardware components, not the output of a diagnostic AI algorithm.

Based on the provided document, here's what can be extracted:

Acceptance Criteria and Reported Device Performance

The "acceptance criteria" for this device are largely implied by demonstrating that the new components (collimator, generator, X-ray tube, software, and detectors) either maintain or improve upon the technical specifications and image quality parameters of the predicate device, while maintaining the same Indications for Use. The "study" proving this largely relies on non-clinical testing and compliance with relevant performance standards for X-ray equipment and image quality.

Study Details (As applicable to an X-ray System 510(k))

1. Sample size used for the test set and the data provenance:
   This 510(k) is for an X-ray imaging system and its components, not a diagnostic AI algorithm. Therefore, there isn't a "test set" of patient cases in the context of an AI study.

   • Test Data: The testing involves non-clinical verification and validation of hardware performance (e.g., kV, mAs, kW measurements, image quality metrics like DQE, MTF, and spatial resolution using phantoms or test targets) and software functionality.
   • Provenance: Not explicitly stated, implied to be internal testing by the manufacturers (Solutions for tomorrow AB, Konica Minolta, Canon Inc., Vieworks Co., Ltd) in their development and quality assurance processes. This is typical for device component integration.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   Not applicable (N/A). Ground truth in this context refers to the measured physical properties and image quality metrics of the X-ray system components, not clinical diagnoses made by experts. For example, DQE and MTF are measured using standardized methods and phantoms, not adjudicated by clinical experts.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
   N/A. This is relevant for clinical studies where human readers establish ground truth for diagnostic AI. Here, performance is verified through engineering and physics measurements.

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:
   N/A. This is not an AI diagnostic assistance device. It's an X-ray imaging system.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
   N/A. Not an AI diagnostic algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   For the components of the X-ray system, the "ground truth" consists of physical measurements and standardized tests of parameters such as:

   • Output of the X-ray generator (kV, mAs, kW).
   • Image quality metrics of the detectors (DQE, MTF, pixel size, spatial resolution) measured using phantoms and established procedures (e.g., IEC standards).
   • Functionality of the collimator.
   • Compliance with electrical and radiation safety standards (EN 60601 series).

7. The sample size for the training set:
   N/A. The document does not describe an AI algorithm that requires a "training set" of patient data in the conventional sense. The "software" mentioned is operational imaging software, not a deep learning model for image interpretation.

8. How the ground truth for the training set was established:
   N/A. See point 7.

In summary, the provided document details a 510(k) submission for an updated mobile X-ray system and its components. The "acceptance criteria" and "proof" relate to meeting the performance specifications for hardware and integrated software functionality, and compliance with medical device standards, rather than the diagnostic performance of an AI algorithm.

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The ULTRA 1040 Portable X-ray Unit is a portable X-ray device, intended for use by a qualified/trained physician or technician for the purpose of acquiring X-ray images of the patient's extremities.

This device is not intended for mammography.

This Portable X-ray Unit (Model: ULTRA 1040) consists of the following major components: an X-ray main unit, an X-ray exposure hand switch and a battery charger and other components. The X-ray main unit is mainly for emitting X-rays required for X-ray exams; the hand switch is for output control of X-ray emitting, and the battery charger is for charging the built-in battery in the X-ray main unit. The device can be used with an X-ray detector, a computer for receiving and detecting signal results and image processing software. The major components of the X-ray main unit include: handle, enclosure, control panel, system control board, high-voltage tank, collimator (beam limiter), lithium-ion battery and system control software running on the system control board.

The system control software is for real-time interaction and control with various circuit modules inside the portable X-ray unit. The software responds to user operations on the control panel. The user can adjust and control the kV and mAs parameters, and the software will display 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 ray tube inside to emit X-rays, control the switch of the collimator indicator, and monitor the working status of the device, the battery power status, and control the display of the status indicators.

The provided FDA 510(k) clearance letter for the ECORAY Ultra 1040 is a regulatory document and does not contain the detailed clinical study results, particularly regarding acceptance criteria for AI-related performance, MRMC studies, or the specifics of training and test set ground truth establishment. The document focuses on showing substantial equivalence to a predicate device through non-clinical testing (electrical safety, EMC, software, bench performance) and a general statement about a "task-based image quality study" for clinical adequacy.

Therefore, I cannot provide a table of acceptance criteria and reported device performance related to AI, nor can I fully answer questions about AI-specific study design, ground truth, or MRMC studies, as this information is not present in the provided text.

The document does mention:

• A "comprehensive, task-based image quality study" to assess clinical adequacy (Section 8).
• Radiologic technologists acquired images, and radiologists clinically evaluated image quality (Section 8). This implies human evaluation, but not necessarily a comparative effectiveness study with AI.
• Software testing in accordance with IEC 62304:2006/A1:2015 (Section 7.3). This standard governs software life cycle processes for medical devices, but doesn't specify AI performance metrics.

Based only on the provided text, here's what can be extracted and what cannot:

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

Cannot be provided for AI-related performance. The document states:

• "The Ultra 1040 Portable X-ray Unit met bench testing acceptance criteria as defined in the test protocols." (Section 7.2)
• "All test results were satisfying with the standards." (Section 7.1 regarding electrical, mechanical, environmental safety, and EMC).
• For the clinical study: "radiologist clinically evaluated the image quality" to assess "clinical adequacy of the device's imaging performance." (Section 8)

However, the specific quantitative acceptance criteria and their corresponding reported values for image quality performance or any AI-assisted diagnostic criteria are not detailed in this document. The document primarily focuses on regulatory compliance and substantial equivalence to a predicate, not detailed clinical performance metrics for an AI component.

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

• Test Set Size: Not specified for any clinical study.
• Data Provenance: Not specified (e.g., country of origin). The study "collected radiographic images for relevant anatomical indications stated in the Indications for Use." (Section 8). There is no mention of retrospective or prospective.

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

• Number of Experts: Not specified.
• Qualifications of Experts: "radiologist" (Section 8). Specific experience (e.g., "10 years of experience") is not mentioned.

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

• Adjudication Method: Not specified. It only states "radiologist clinically evaluated the image quality."

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: The document does not describe an MRMC comparative effectiveness study involving AI assistance. The clinical study mentioned is for "assessing the clinical adequacy of the device's imaging performance" (Section 8), implying the performance of the X-ray unit itself, not an AI component integrated into a diagnostic workflow with human readers.
• Effect Size of Human Improvement with AI: Not applicable, as no MRMC study with AI assistance is described.

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

• Standalone Performance: The document describes the "ULTRA 1040 Portable X-ray Unit" and its "system control software" which manages device parameters and operations (Section 4). It is a mobile X-ray system, not an AI algorithm for image analysis. The "bench test for the Ultra 1040 Portable X-ray Unit assessed radiation performance, collimator accuracy, battery performance, imaging quality, and safety" (Section 7.2). This is testing of the X-ray hardware and its basic software functions, not an AI algorithm assessing images.

It seems this device is an X-ray imaging machine, and the "software" mentioned (Section 4) refers to the control software for the X-ray unit itself, not an AI for image interpretation or diagnosis. Therefore, a standalone performance study for an AI algorithm is not relevant based on the information provided.

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

• Type of Ground Truth: For the "task-based image quality study," the ground truth for image quality appears to be established by clinical evaluation by "radiologist" (Section 8). This is a form of expert consensus or expert reading, but specifically for image quality, not for diagnostic findings like disease presence/absence.

8. The sample size for the training set

• Training Set Size: Not applicable. This document does not describe the development or training of an AI algorithm for image analysis. The "software" mentioned is operational control software for the X-ray machine.

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

• Ground Truth Establishment for Training Set: Not applicable, as no AI algorithm training is described.

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The 'TOPAZ Mobile X-ray System' is intended for use in obtaining human anatomical images of patients who cannot be moved to the radiology department for medical diagnosis.

"TOPAZ" system is a system providing state-of-the-art image quality, user interface. "TOPAZ" system may be moved quietly and smoothly with motor drive mechanism "TOPAZ" system has a basic type column, and a collapsible type column option with a trendy design that allows driving without disturbing the front view. The core part of x-ray source adopts high quality tube assembly, motorized x-ray collimator. HV cable assembly and High Voltage X-Ray Generator. Touch screen LCD based x-ray control console provides user-friendly interface and easy technique selection. Collimator supports high accuracy for selected x-ray field size over any SID. Direct radiography via flat panel detector improves-exam speed and comfort with efficiency. Digital flat panel detector with Csl screen provides spatial resolution, MTF, DQE and stability based on fine pixel pitch. Selection of an anatomical study on the Digital Imaging Software automatically sets up the x-ray generator's preprogrammed exposure technique. The types of "TOPAZ" system are divided into TOPAZ-32D, and TOPAZ-40D according to maximum power and mA. The higher the maximum output, the wider the mA range to choose from, giving the user more technical options to choose from. The "TOPAZ Mobile X-ray System" consists of a tube assembly. x-ray collimator. High Voltage X-Rav Generator, detector and mechanical parts for mobility.

The provided text is a 510(k) Summary for the TOPAZ Mobile X-ray System, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria in the format typically used for AI/CADe devices. This document describes the device, its intended use, technological characteristics, and differences from the predicate, along with non-clinical testing for safety and EMC standards.

Therefore, the specific information about "acceptance criteria and the study that proves the device meets the acceptance criteria" as requested for AI/CADe devices (including details like sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth, and training set details) is not present in this 510(k) Summary.

This document primarily asserts that the "TOPAZ Mobile X-ray System" is substantially equivalent to the predicate device "TOPAZ Mobile DR System (K201124)" based on:

• Identical intended use.
• Similar technological characteristics, with modifications thoroughly tested for safety and effectiveness against international standards.
• Nonclinical testing results provided in the 510(k) demonstrating that predetermined acceptance criteria were met for safety (electrical safety, EMC, radiation protection) and software validation.

The "study that proves the device meets the acceptance criteria" in this context refers to the nonclinical testing against various recognized international and FDA standards, not a clinical performance study with human readers or pathology, as would be expected for AI/CADe systems.

Here's a summary of the available information regarding acceptance criteria and testing, tailored to what is provided in the document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly present a table of acceptance criteria and reported device performance in the typical format for clinical accuracy for AI/CADe. Instead, it states that the device was assessed, tested, and passed predetermined testing criteria during validation testing, aligning with the risk analysis. It also confirms that the device meets "all the requirements listed in the Standards" (see the Standards table below). The "device performance" reported is its conformance to these standards and its substantial equivalence to the predicate.

Nonclinical Standards Met (acting as acceptance criteria for safety and effectiveness):

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

• Not Applicable/Not Provided. The document describes non-clinical engineering and software validation testing against standards, not a clinical study involving a "test set" of patient data for diagnostic performance. The focus is on the device's hardware, software (RADMAX), and new flat panel detectors meeting safety and electrical standards.

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. Ground truth establishment by experts is relevant for clinical performance studies, which this document does not describe.

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

• Not Applicable/Not Provided. This is relevant for clinical performance studies.

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. This document describes a 510(k) for an X-ray system, not an AI/CADe system. No MRMC study was performed or is mentioned.

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

• Not Applicable/No. The device itself is an X-ray system, not an algorithm, and its performance is assessed in terms of meeting engineering and regulatory standards, not standalone diagnostic performance. The imaging software (RADMAX) is mentioned as identical to the predicate and has a "Basic Documentation Level" of concern, implying human interpretation of images.

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

• Not Applicable/Not Provided. For the non-clinical testing described, "ground truth" would relate to the correct functioning of the hardware and software according to specifications and standards, not clinical diagnostic accuracy.

8. The sample size for the training set:

• Not Applicable/Not Provided. This is relevant for AI/ML models. While the device contains software, it is not described as an AI/ML diagnostic algorithm needing a training set. The software changes are primarily GUI and image processing module updates, verified for impact on safety and effectiveness (not AI training).

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

• Not Applicable/Not Provided. As above, this is not an AI/ML submission requiring a training set.

In summary, the provided 510(k) document is for a mobile X-ray system and demonstrates substantial equivalence through nonclinical testing against recognized performance, safety, and EMC standards, rather than a clinical performance study with acceptance criteria related to diagnostic accuracy, which would be typical for AI-powered diagnostic devices.

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