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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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EZER Portable X-Ray system is a portable x-ray source with a fixed tube current and voltage for producing diagnostic x-ray images of extremities using digital or film image receptors. Its use is intended to be used by trained clinician or technicians for both adult and pediatric subjects age 2 and above.

It is not intended to replace a radiographic system with variable tube current and voltage (KVp) which may be required for full optimization of image quality and radiation exposure for different exam types.

EZER Portable X-ray System generates and controls X-ray with a fixed tube current and voltage (kVp) in order to take diagnostic X-rays of extremities for adult and pediatric patients. It operates on 22.2VDC supplied by a rechargeable Lithum-Ion Polymer battery pack. The X-ray tube head. X-ray controls and power source are assembled into a single hand-held enclosure. EZER Portable X-ray System includes high voltage generator, X-ray tube, a control board (PCB), rechargeable battery, LCD user interface, X-ray beam limiting cone, and a remote control switch (hand switch). Operating principle is that x-ray generated by high voltage electricity into x-ray tube, which penetrates extremities and makes x-ray images on receptor. INTEL stick PC is integrated with EZER so the user can see X-ray image from LCD display without a computer. EZER Portable X-ray System is intended to be used by trained clinicians or technicians for both adult and pediatric patients.

The embedded 7" TFT display in EZER Portable X-ray is not intended to be used for diagnosis.

Here's a breakdown of the acceptance criteria and study information for the EZER Portable X-ray System, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" with specific numerical thresholds for performance metrics. Instead, it describes a subjective comparison study against a predicate device. The primary "acceptance criterion" appears to be demonstrating similar overall quality to the predicate device.

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

• Sample Size: Not explicitly stated in terms of number of images or cases. The document mentions "Images taken from the predicate and subject devices were reviewed." This implies a set of images was used, but the quantity is not specified.
• Data Provenance: Not explicitly stated. The study details do not mention the country of origin of the data or whether it was retrospective or prospective.

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

• Number of Experts: One (1) expert.
• Qualifications: An American board-certified radiologist. No specific number of years of experience is provided.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. Only a single expert reviewed and rated the images, so there was no multi-reader consensus or adjudication process described. The expert directly compared and rated the images.

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

• MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. Only a single radiologist performed the image comparison.
• Effect Size: Not applicable, as no MRMC study was conducted.

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

• Standalone Performance: Not applicable. The EZER Portable X-ray System is an X-ray imaging device, not an AI algorithm. The study described is an evaluation of the image output generated by the device, which is then interpreted by a human expert. The device does include an embedded display for reference, but it's explicitly stated "not intended to be used for diagnosis."

7. The Type of Ground Truth Used

• Type of Ground Truth: "Expert comparison/rating." The ground truth was established by a single American board-certified radiologist who reviewed and rated images from both the subject device and the predicate device. This is a form of subjective expert evaluation.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. The EZER Portable X-ray System is a hardware device (X-ray system) and not an AI or machine learning algorithm that requires a training set in the typical sense.

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

• Training Set Ground Truth: Not applicable, as the device is not an AI/ML system requiring a training set with established ground truth.

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The FLUSION-9001 fluoroscopic C-arm Mobile X-ray System is intended to provide fluoroscopic and radiographic imaging of the patient during diagnostic, surgical and interventional procedures. Clinical applications may include but are not limited to digital subtraction angiography, orthopedical, abdominal, vascular, cardias, critical care and emergency room procedures.

The FLUSION-9001 fluoroscopic C-arm Mobile X-ray System consists of a high voltage (HV) inverter generator, a tube support unit, an X-ray beam limiting device, mobile cart, a detector, operating software, and a tube, and is primarily used in a hospital for diagnosis of diseases in skeletal. respiratory and urinary systems such as the skull, spinal column, chest, abdomen, extremities, and other body parts. This device is not intended to be used for mammography applications.

FLUSION-9001 fluoroscopic C-arm Mobile X-ray System is a solution to produce radiological images of patient during medical operations. This inverter control X-ray unit visualizes the anatomical structure on screen, which is obtained by X-ray fluoroscopy and a flat panel detector. This system can be applied in emergency room, operation room, cast room or etc. of a hospital.

The provided document is a 510(k) summary for the FLUSION-9001 Fluoroscopic C-arm Mobile X-ray System. It focuses on demonstrating substantial equivalence to predicate devices based on technical specifications and adherence to recognized standards.

Therefore, the document does not contain information about acceptance criteria for device performance in a clinical study, or a study specifically designed to prove the device meets such criteria in terms of diagnostic accuracy or impact on human readers.

The information provided describes the device's technical specifications and compares them to predicate and reference devices, along with compliance with relevant industry standards and regulations for medical devices.

Here's a breakdown of what is available and what is not:

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

• Not Available: The document does not provide a table of acceptance criteria for diagnostic performance outcomes (e.g., sensitivity, specificity, accuracy) or reported performance metrics from a clinical study. The tables present technical specifications of the device and its comparators (e.g., X-ray tube heat capacity, detector DQE, pixel matrix).

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

• Not Available: There is no mention of a test set, sample size, or data provenance related to a clinical performance study. The testing performed focuses on non-clinical aspects like electrical, mechanical, software, and risk management.

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 Available: Since there is no mention of a clinical test set or ground truth establishment, this information is not provided.

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

• Not Available: There is no information on any adjudication method for a clinical test set.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not Available: The document describes a fluoroscopic C-arm Mobile X-ray system, which is an imaging device, not an AI-powered diagnostic tool. Therefore, an MRMC comparative effectiveness study involving AI assistance for human readers would not be applicable or expected for this device nor is it mentioned.

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

• Not Available: As noted above, this is an imaging acquisition device, not an algorithm, so standalone performance is not relevant in the context of diagnostic algorithms.

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

• Not Available: There is no mention of ground truth as it pertains to clinical diagnostic performance.

8. The sample size for the training set

• Not Available: This device is a hardware system, not a machine learning model, so there is no training set in the context of AI/ML.

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

• Not Available: See point 8.

What the document does describe (Non-clinical testing for substantial equivalence):

The document details the non-clinical testing performed to establish substantial equivalence (refer to section VIII. Non clinical testing and IX. Conclusion):

• Standards Adherence: The device successfully underwent testing according to various IEC and EN standards related to medical electrical equipment, including safety, electromagnetic compatibility, and specific requirements for X-ray equipment (e.g., EN 60601-1, EN 60601-1-2, IEC 60601-1-3, IEC 60601-2-43, IEC 60601-2-54).
• Guidance Document Utilization: The development informed by FDA guidance documents regarding software in medical devices, 510(k) submissions for solid-state X-ray imaging devices, cybersecurity, and pediatric information for X-ray imaging devices.
• Regulatory Compliance: Conformance to 21 CFR 1020 Subchapter J (Performance Standards for Ionizing Radiation Emitting Products), 21 CFR 1020.30 (Diagnostic x-ray system and their major components), and 21 CFR 1020.32 (Fluoroscopic Equipment).

The conclusion states that based on these tests and comparisons to predicate devices, the FLUSION-9001 system is considered substantially equivalent in its design, mechanical and electrical performance, making it suitable for its intended use.

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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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EZER Portable X-Ray system is intended to be used by trained dental technicians as an extraoral x-ray source for producing diagnostic x-ray intraoral image receptors. Its use is intended for both adult and pediatric subjects.

EZER Portable X-ray System generates and controls X-ray in order to diagnose of tooth and iaw. It operates on 22.2VDC supplied by a rechargeable Lithum-Ion Polymer battery pack. The X-ray tube head, X-ray controls and power source are assembled into a single hand-held enclosure. EZER Portable X-ray System includes high voltage generator, X-ray tube, a control board (PCB), rechargeable battery, LCD user interface, X-ray beam limiting cone, and a remote control switch (hand switch). Operating principle is that x-ray generated by high voltage electricity into x-ray tube, which penetrates tooth and makes x-ray images on receptor. INTEL stick PC is integrated with EZER so the user can see X-ray image from LCD display without a computer. EZER Portable X-ray System is intended to be used by trained dentists or dental technicians. Its use is intended for both adult and pediatric subjects.

The embedded 7' TFT display in EZER Portable X-ray is not intended to be used for diagnosis.

The provided text is a 510(k) Summary for the EZER Portable X-ray System, which is a device for producing diagnostic dental X-ray images. The document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a clinical study with detailed acceptance criteria and performance metrics for an AI/algorithm-based diagnostic device.

Therefore, the following information regarding acceptance criteria and a study proving device performance will be limited by the nature of the provided text, as it describes a hardware device (X-ray system) and not an AI-driven diagnostic tool that would typically have the requested performance metrics.

There is no information in the provided document about the acceptance criteria and study that proves the device meets specific performance criteria related to the diagnostic accuracy of an AI algorithm.

The document primarily focuses on:

• Safety and Efficacy of the X-ray Hardware: This is demonstrated through adherence to various IEC and EN standards for medical electrical equipment, radiation safety, and electromagnetic compatibility, as well as compliance with 21 CFR regulations for diagnostic X-ray systems.
• Substantial Equivalence: The primary goal of the 510(k) submission is to show that the EZER Portable X-ray System is substantially equivalent to a legally marketed predicate device (Dexcowin ADX 4000W; iRay D4) in terms of indications for use and technological characteristics.

Based on the provided text, I cannot complete the requested tables and sections with specific AI-related performance metrics. However, I can extract the relevant information regarding the device's technical specifications and the type of non-clinical testing performed.

Here's a breakdown of what can be extracted and what cannot be, based on your request and the provided text:

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

The document does not specify "acceptance criteria" in terms of diagnostic accuracy (e.g., sensitivity, specificity for detecting a condition) because EZER is an X-ray source, not a diagnostic interpretation algorithm. Instead, it confirms compliance with safety and performance standards for an X-ray device.

The performance metrics mentioned pertain to the X-ray output and electrical characteristics for the device itself.

Study Proving Device Meets Acceptance Criteria:

The document states: "Testing was performed successfully according to the following standards" and lists multiple IEC, EN, and CFR standards. This non-clinical testing demonstrates that the device itself (the X-ray system) meets the technical and safety performance criteria required for such a device. There is no mention of a diagnostic performance study in the context of disease detection or image interpretation, as the device is an X-ray source.

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

This information is not applicable and therefore not provided in the document. The testing described is non-clinical performance testing of the hardware device against engineering standards, not a clinical study on diagnostic accuracy involving a test set of patient data.

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)

This information is not applicable and therefore not provided. No clinical "ground truth" was established as this is not a diagnostic algorithm.

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

This information is not applicable and therefore not provided.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable and therefore not provided. The device is an X-ray source, not an AI assistance tool for image interpretation.

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

This information is not applicable and therefore not provided. The device is a standalone X-ray system; it does not perform algorithmic diagnosis. The embedded 7" TFT display is not intended to be used for diagnosis.

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

This information is not applicable and therefore not provided.

8. The sample size for the training set

This information is not applicable and therefore not provided. The device is not an AI algorithm that requires a training set.

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

This information is not applicable and therefore not provided.

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The LaVid FMTS System is a stationery X-ray system intended for obtaining radiographic images of various of the human body, both pediatrics and adults, in a clinical environment.

The LaVid FMTS System is not intended for mammography, interventional, or fluoroscopy use.

The LaVid FMTS System is a stationery X-ray system intended for obtaining radiographic images of various of the human body, both pediatrics and adults, in a clinical environment.

This document is an FDA 510(k) clearance letter for the LaVid FMTS DIAGNOSTIC X-RAY SYSTEM. It indicates that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory provisions. However, the provided text does not contain information regarding:

• Acceptance criteria for device performance.
• A study proving the device meets acceptance criteria.
• Reported device performance metrics.
• Sample sizes used for test or training sets.
• Data provenance.
• Number or qualifications of experts for ground truth establishment.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Effect size of human reader improvement with AI.
• Standalone algorithm performance studies.
• Type of ground truth used.
• How ground truth for the training set was established.

The document primarily focuses on the regulatory clearance for the device, its indications for use, and general regulatory compliance information. It does not delve into the technical performance evaluation that would typically include the requested details.

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