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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 MC2 Portable X-ray System is indicated for use by qualified/trained medical professionals on adult patients for orthopedic radiographic, orthopedic serial radiographic, orthopedic fluoroscopic, and orthopedic interventional procedures of extremities distal to the shoulders and distal to the knees. The device is not intended for use during surgery. The device is not intended to replace a stationary radiographic system.

The device is to be used in healthcare facilities where qualified operators are present (e.g., outpatient clinics, urgent cares, imaging centers, sports medicine facilities, occupational medicine clinics).

The device is not intended to be used in environments with the following characteristics:

• Aseptic or sterile fields, such as in surgery
• Home or residential settings or other settings where qualified operators are not present ●
• Vehicular and moving environments ●
• Environments under direct sunlight ●
• Oxygen-rich environments, such as near an operating oxygenation concentrator ●

The MC2 Portable X-ray System ("MC2 System" or "MC2") is a portable and handheld X-ray system designed to aid clinicians with point-of-care visualization through diagnostic X-rays of extremities distal to the shoulders and distal to the knees. The device allows clinicians to select desired technique factors best suited for their patient's anatomy. The MC2 consists of two major system components: the emitter and the cassette. The MC2 emitter and cassette are battery-powered and are charged via a wired charger. The system is intended to interface wirelessly to an external tablet when used with the OXOS Device App or to a monitor with an off-the-shelf ELO Backpack and the OXOS Device App. The MC2 utilizes an Infrared Tracking System to allow the emitter to be positioned above the patient's anatomy and aligned to the cassette by the operator. The MC2 also utilizes a LIDAR system to ensure patient safety by maintaining a safe source-to-skin distance.

The MC2 is capable of three X-ray imaging modes: single radiography, serial radiography, and fluoroscopy. In single and serial radiography modes, the user can utilize the entire range of kV values (40-80kV), while fluoroscopy mode is limited to 40-64kV. In single radiography mode, the user can utilize the entire range of mAs values, while serial radiography and fluoroscopy are limited to 0.04-0.08 mAs. Single radiography acquisitions may be performed handheld, while serial radiography and fluoroscopy require the emitter to be in a stand-mounted configuration.

The MC2 contains various safety features to ensure patient and operator safety. The primary interlocks that ensure system geometry is maintained include a source-to-image distance interlock, an active area interlock, a source-to-skin distance interlock, and a stand-mounted interlock.

The source-to-image distance interlock uses the Tracking System to disallow X-ray acquisition when the device is outside the bounds of source-to-image distance (SID). This acts concurrently with the source-to-skin distance (SSD) interlock which uses the LIDAR system to disallow X-ray acquisition below 30cm source-to-skin distance. Both conditions must be met for X-ray acquisition to be allowed. The active area interlock uses the Tracking System to prevent the X-ray field from extending beyond the bounds of the active area. The stand-mounted interlock prevents handheld X-ray acquisition in serial radiography and fluoroscopy modes.

In addition to the components listed above, the MC2 includes accessories, such as a clinical cart and a wireless foot pedal should be used for stand-mounted imaging when initiating single, serial or fluoroscopic acquisitions remotely. The clinical cart supports the MC2 for stand-mounted operation and allows the user to position anatomy easily. An accessory stand such as the clinical cart is required to facilitate stand-mounted imaging modes. Radiography and Photo modes may be used without a stand.

The provided text details the regulatory approval of the OXOS Medical, Inc. MC2 Portable X-ray System (K241567) but does not contain specific acceptance criteria or the detailed results of a study proving the device meets those criteria. The document states that a comprehensive, task-based image quality study was conducted and that five radiologists clinically evaluated the image quality, but it does not provide the quantitative results, acceptance thresholds, or statistical analyses from this study.

Therefore, much of the requested information cannot be extracted from the given text.

Based on the provided document, here's what can be inferred or explicitly stated:

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

This information is not provided in the document. The document states:

• "All components of the MC2, including software, were verified and validated to demonstrate compliance with the appropriate regulations and in accordance with the risk profile analysis." (Page 10)
• "All forms of testing showed the MC2 to be compliant with the relevant standards and safe and effective in the procedures and scenarios outlined in the Indications for Use." (Page 10)
• "The MC2 Portable X-ray System met bench testing acceptance criteria as defined in the test protocols." (Page 10)

However, the specific "acceptance criteria as defined in the test protocols" and the actual "reported device performance" against these criteria are not detailed.

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

• Sample Size for Test Set: Not specified. The document only mentions that "a comprehensive, task-based image quality study was conducted to assess the clinical adequacy of the device's imaging performance" and "Radiologic technologists acquired images in all acquisition modes." (Page 11)
• Data Provenance (country of origin, retrospective/prospective): Not specified.

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

• Number of Experts: "five radiologists clinically evaluated the image quality." (Page 11)
• Qualifications of Experts: Only "radiologists" are mentioned; specific qualifications such as years of experience are not provided.

4. Adjudication method for the test set

• Adjudication Method: Not specified. It is mentioned that "five radiologists clinically evaluated the image quality," but there is no description of how their evaluations were combined or adjudicated (e.g., 2+1, 3+1, none).

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

• MRMC Study Done: Yes, a "comprehensive, task-based image quality study" was performed with "five radiologists clinically evaluated the image quality." However, this study appears to be an assessment of the device's imaging performance itself for clinical adequacy, not a direct comparative effectiveness study of human readers with vs. without AI assistance.
• Effect Size of Human Readers Improvement: Not discussed or measured, as the study described is not focused on AI assistance to human readers. The MC2 appears to be an X-ray system, not an AI diagnostic tool.

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

• The MC2 is an X-ray system, not an algorithm. Therefore, "standalone (algorithm only)" performance metrics are not applicable in the typical sense for an AI model. The performance testing section refers to the system's overall compliance and image quality.

7. The type of ground truth used

• Type of Ground Truth: The "clinical evaluation of image quality" by radiologists suggests that the ground truth for image quality assessment was based on expert consensus/evaluation of the images themselves for their "clinical adequacy." It doesn't explicitly state if pathology or outcomes data were used in establishing this ground truth.

8. The sample size for the training set

• The document describes the MC2 Portable X-ray System as a medical device, specifically an X-ray system, not an AI/ML algorithm that requires a "training set" in the common sense. Therefore, information about a "training set sample size" is not applicable to this device's description.

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

• As mentioned above, the device is an X-ray system, not a machine learning model. Thus, the concept of a "training set" and its "ground truth establishment" is not relevant to the information provided about this particular device.

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ERI Portable X-ray System is a portable x-ray source with a fixed tube current and voltage for producing x-ray images of extremities using computed radiography (CR) detection plate or digital radiography (DR) detector, and the applicable objects are adults. This product is for use by qualified personnel.

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.

ERI Portable X-ray System generates and controls X-ray with a fixed tube current and voltage (kV). It uses X light source to produce X-ray images of human anatomical structures for diagnosis, and the applicable objects are adults. It operates on 14.4VDC supplied by a rechargeable Lithium-Ion Polymer battery pack.

The ERI Portable X-ray System, is a portable x-ray device that comes in three models: CVX-air, CVX-lite and CVX-E. The differences is as follows:
X-ray tube voltage: CVX-air 70kV, CVX-lite 67 kV, CVX-E 60 kV
X-ray tube current: CVX-air 1mA, CVX-lite 0.8mA, CVX-E 0.6mA
Power Consumption: CVX-air 70 W, CVX-lite 53.6 W, CVX-E 36W
Others are the same as CVX-air
The main model and series models have the same internal and external appearance, only the X-ray irradiation parameter settings are different

The X-ray tube head, X-ray controls and power source are assembled in a portable case. The ERI Portable X-ray System is comprised of the following components:

• (1) X-ray module
• (2) Oscillating circuit board
• (3) Control board
• (4) Beam limiting device
• (5) LCD screen
• (6) Extension wire control
• (7) rechargeable battery.

The provided text details the FDA 510(k) clearance for the ERI Portable X-ray System and includes information about non-clinical testing and comparison to a predicate device. However, it does not contain the specific acceptance criteria for a study or a detailed description of a study that explicitly proves the device meets those criteria with quantitative outcomes like sensitivity, specificity, or improvement effect sizes. The document focuses on demonstrating substantial equivalence to a predicate device through technological comparisons and adherence to relevant standards.

Here's a breakdown of the information that is present and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Not explicitly provided in the document. The document states "The results confirm that the device's design is appropriate and effective for its intended use" and "clinical trials were conducted to compare the imaging results of the ERI Portable X-ray System with those obtained from commercially available X-ray devices. These trials demonstrated that the image quality produced by the ERI system is on par with that of the comparison devices, supporting its substantial equivalence as a portable X-ray system."

However, neither specific numerical acceptance criteria (e.g., minimum diagnostic accuracy, image quality scores) nor quantifiable performance metrics (e.g., sensitivity, specificity, observer agreement, SNR, CNR values) are reported in the text for the subject device or the predicate.

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

Not explicitly provided. The document vaguely states "clinical trials were conducted" but does not give the sample size (number of images, number of patients) of the test set, nor the country of origin of the data, or whether it was retrospective or prospective.

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

Not explicitly provided. The document refers to "clinical trials" and "image quality produced by the ERI system is on par with that of the comparison devices," which implies some form of assessment, likely by experts. However, the number and qualifications of these experts are not specified.

4. Adjudication Method for the Test Set

Not explicitly provided. Due to the lack of detail on how the "clinical trials" and "image quality" assessments were performed, the adjudication method (e.g., 2+1, 3+1 consensus, or independent review) is not mentioned.

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

Not explicitly mentioned as an MRMC study. The document states "clinical trials were conducted to compare the imaging results of the ERI Portable X-ray System with those obtained from commercially available X-ray devices." While this implies a comparison, it doesn't specify if it was a formal MRMC study or if it measured an effect size of human readers improving with AI vs. without AI assistance. The device described is an X-ray source and system, not an AI-assisted diagnostic tool, so an MRMC study related to AI might not be applicable here.

6. Standalone (Algorithm Only) Performance Study

Not applicable/Not provided. The ERI Portable X-ray System is an X-ray hardware system, not a software algorithm that performs standalone diagnostic tasks without human interaction. Therefore, a standalone algorithm performance study, as typically done for AI/CAD devices, is not relevant to this submission and is not described.

7. Type of Ground Truth Used for the Test Set

Not explicitly provided with specifics. The statement "image quality produced by the ERI system is on par with that of the comparison devices" suggests that the ground truth for image quality was likely established by expert assessment or comparison against an accepted standard for diagnostic image quality. However, the exact nature (e.g., expert consensus on diagnostic usability, specific phantoms, or clinical outcomes) is not detailed.

8. Sample Size for the Training Set

Not applicable/Not provided. As this is a hardware device for X-ray imaging, there isn't a "training set" in the context of machine learning. The device's performance is validated through engineering tests and clinical evaluations, not by training a model on a dataset.

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

Not applicable/Not provided. See the explanation for point 8.

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The device is a diagnostic X-ray system which is intended to be used by trained dentists and dental technicians as an extra-oral X-ray source for producing diagnostic x-ray images using intra-oral receptors. Its use is intended for both adults and pediatric subjects.

Intended as extraoral x-ray source to be used with intraoral image receptors for diagnostic imaging by dentists or dental technicians.

The Ray98(P) by Ningbo Runyes Medical Instrument Co., Ltd., is a portable x-ray device. The technology of this device was originally developed in Korea more than a decade ago and global production is still concentrated in that country.

The subject device is designed for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structure by exposing an x-ray image receptor to ionizing radiation. The x-ray source, a tube, is located inside the portable device. All three conventional types of intraoral receptors can be used with this device-analog x-ray film, digital phosphorous plates, and digital x-ray sensors.

This device is used in general dentistry and is supplied with an internal timer to control the duration of the x-ray source to the patient. The portable x-ray device is a choice model to assist doctors with special need patients, nursing home patients in the office that cannot be easily moved, as well as other special situations. The choice of an x-ray generator is a matter of functional utility in the dental operatory and personal preference by the medical professional.

This document describes the 510(k) premarket notification for the Portable X-ray System Model Ray98(P). However, the information provided does not contain details about a study evaluating the device's performance against specific acceptance criteria for an AI/CAD system, nor does it detail a multi-reader multi-case (MRMC) comparative effectiveness study.

The document primarily focuses on establishing substantial equivalence to a predicate device (MobileX Portable X-ray System, K180561) based on similar indications for use, intended use, technological characteristics, and conformity to relevant safety and performance standards for X-ray systems.

Therefore, I cannot provide the requested information regarding acceptance criteria, reported device performance, sample sizes, expert involvement, adjudication methods, or MRMC study details because this information is not present in the provided text.

The document states that:

• Non-Clinical Performance Data was collected for electrical safety and EMC, software validation, usability, clinical evaluation, and risk assessment.
• All tests were performed in accordance with IEC and ISO standards.
• Conformity with all standards was determined by the device manufacturer, Ningbo Runyes Ltd., Korea.
• Electrical tests were performed by KCTL, Inc. Laboratories, Inc., Korea.
• The Guidance document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" applies to this device, and details are provided within the Software Validation Report (which is not included here).

Based on the provided text, the device is a portable X-ray system, not an AI/CAD system, and the clearance is for the hardware device itself, not for an AI algorithm's diagnostic performance. Hence, the request for details on AI-specific performance criteria, MRMC studies, ground truth establishment for AI models, etc., is not applicable to the content of this document.

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The Portable X-ray System is used as a portable, extra oral x-ray source for producing diagnostic x-ray images using conventional film, PSP (phosphor plates) or digital sensors. It is intended for adult and pediatric patients. This equipment is available only to trained and qualified dentist or dental technician.

The portable X-Ray system, Canis014D07, is intended to be used by trained dentists and dental technicians as an extra-oral x-ray source for producing diagnostic x-ray images using intraoral image receptors. The images presented in the product screen are for preview purposes only, not for imaging diagnosis. It also includes accessories, which are battery, recharging unit and hand switch.

The provided text describes a 510(k) premarket notification for a Portable X-ray System (Canis014D07). It outlines the device's indications for use, its technological characteristics compared to predicate and reference devices, and a summary of non-clinical testing conducted to demonstrate safety and effectiveness.

However, the document does not contain information related to specific acceptance criteria for diagnostic performance, a study evaluating device performance against such criteria, sample sizes for test or training sets, data provenance, number or qualifications of experts for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance.

The "Summary of Performance Testing" section states that the performance test for the device and predicate are "identical in the indications for use, patient population, intended operation environment, and electrical safety." It also mentions "Validation was performed for overall operation by taking and reviewing test images" and that "the test images were reviewed by a professional with adequate qualifications, and that the images were of diagnostic quality." This suggests a qualitative assessment of image quality rather than a quantitative study with pre-defined diagnostic performance metrics.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance, or details about the study that proves acceptance criteria are met, as this information is not present in the provided text.

Based on the available text, here's what can be extracted with respect to your request, noting the missing information:

Acceptance Criteria and Study Details (Based on Available Information)

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not specified. The document mentions "test images were reviewed," but the number of images is not provided.
• Data Provenance: Not specified.

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

• Number of Experts: "a professional" (singular)
• Qualifications of Experts: "a professional with adequate qualifications" (No specific details like "radiologist with 10 years of experience" are provided).

4. Adjudication method for the test set:

• Adjudication Method: Not specified. It appears a single professional reviewed the images for diagnostic 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: No, an MRMC study was not described. The device is an X-ray system, not an AI algorithm for image interpretation.

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

• Standalone Performance: Not applicable. This device is an X-ray imaging system, not an AI algorithm. Its performance refers to its ability to produce diagnostic images, not to interpret them. The document explicitly states, "The images presented in the product screen are for preview purposes only, not for imaging diagnosis."

7. The type of ground truth used:

• Type of Ground Truth: Expert opinion on "diagnostic quality" of the images produced by the device.

8. The sample size for the training set:

• Sample Size for Training Set: Not applicable/not specified. The device is a hardware X-ray system, not an AI algorithm that requires a training set.

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

• Ground Truth for Training Set: Not applicable.

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The APX-24 Portable X-ray is intended for use by a qualified/trained physician on both adult and pediatric subjects for taking diagnostic X-rays.

The APX-24 Portable X-ray is a portable unit that operates from120 V / 220-240V, 50 / 60 Hz. The unit utilizes a newly designed high-frequency inverter and can bemounted to a tripod or support arm. The operator must observe the usual safety precautions regarding the use of x- rays.

The provided FDA 510(k) summary for the APX-24 Portable X-ray System does not contain the specific details required to answer all aspects of your request regarding acceptance criteria and a study proving the device meets those criteria. The document primarily focuses on demonstrating substantial equivalence to a predicate device through technical specifications and adherence to general safety and performance standards.

Here's a breakdown of what can be extracted and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" for the device's performance in terms of diagnostic accuracy or image quality compared to a clinical gold standard. Instead, it relies on demonstrating that the device meets general performance standards for X-ray systems and exhibits similar technical specifications to its predicate device.

The table below summarizes the technical characteristics, but it's not an acceptance criteria table related to diagnostic performance.

2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
4. Adjudication method for the 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
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
8. The sample size for the training set
9. How the ground truth for the training set was established

Missing Information:

The provided document describes a portable X-ray system, not an AI-powered diagnostic device or software. Therefore, the concepts of "test set," "training set," "ground truth," "experts for ground truth," "adjudication methods," "MRMC studies," "AI improvement," and "standalone algorithm performance" are not applicable to this submission.

The 510(k) summary focuses on demonstrating that the APX-24 Portable X-ray System is substantially equivalent to a predicate device (MinXray HF100H+) based on its intended use, technological characteristics, and compliance with recognized safety and performance standards for X-ray equipment. It does not involve a clinical study to assess its diagnostic accuracy or the performance of an AI algorithm.

Nonclinical Testing:

The document lists several nonclinical performance standards that the device successfully met (Section VII). These standards cover aspects like:

• IEC 60601-1-3:2008+A1:2013: General requirements for basic safety and essential performance — Collateral Standard: Radiation protection in diagnostic X-ray equipment.
• IEC 60601-2-65:2012 / EN 60601-2-65:2013: Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment (though this seems somewhat misplaced if the device is general-purpose X-ray).
• EN 60601-1-2:2015: General requirements for basic safety and essential performance — Collateral Standard: Electromagnetic disturbances — Requirements and tests.
• EN 61000-3-2:2014, EN 61000-3-3:2013: Electromagnetic compatibility (EMC) standards.
• IEC 62133:2012 / EN 62133:2013: Secondary cells and batteries containing alkaline or other non-acid electrolytes – Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications. (Suggests internal battery component).
• EN 60601-1:2006/A1:2013: General requirements for basic safety and essential performance.
• IEC 60601-2-54:2009+A1:2014: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy. (This is a more direct standard for such a device).
• 21CFR 1020.30 & 1020.31: Federal regulations for ionizing radiation emitting products, specifically related to diagnostic X-ray systems and their components.

These nonclinical tests are the "study" demonstrating the device meets the "acceptance criteria" inherent in these international and national standards. The acceptance criteria for these tests are the pass/fail limits defined within each standard, and the report states that "Testing was performed successfully" and "Performance evaluation (test) reports and the device inspection report confirmed that the APX-24 Portable X-ray System is suitable for the device's intended use."

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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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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 device is a diagnostic x-ray system, which is intended to be used by trained dentists and dental technicians as an extra-oral x-ray source for producing diagnostic x-ray images using intra-oral image receptors. its use is intended for both adults and pediatric subjects.

The portable x-ray system (Models: MiniX-V, MiniX-S) is an x-ray generating device which is mainly designed for dental examination. The device has an x-ray tube for generating x-rays, a high voltage transformer for generating high voltages, a high voltage rectification circuit for transforming and boosting AC voltage to mixed pulse voltage, a high voltage divide circuit for lowering high voltage to measure and calibrate high voltages, as well as a high voltage tube tank, a high frequency inverter circuit for generating high voltages, a control P.C.B for controlling, saving and displaying the data, a power P.C.B for supplying power to the circuit and apparatus in housing, user interface (LCD screen) and beam limiting part (x-ray emitting cone). The apparatuses above can be embedded in one or several cases, and except for the radiation opening in the x-ray system, all units are completely shielded by lead or high-density materials, protecting patients and users from unnecessary exposure of radiation. The package includes a remote control switch, a battery charger, and a backscatter shield. And the remote control switch can be used when the device is mounted on fixable stands as optional arms in user manual or digital camera tripods. Operating principle is that the high voltage electricity is getting into the x-ray tube and generates x-ray source. This x-ray source comes out from the emitting cone and goes through teeth and jaw of patient, and makes x-ray images onto image receptors as a chemical film or a digital sensor. Once the user enters the desired tube voltage data in the numerical value (%) by means of the user interface and press the x-ray exposure button, the system generates mixed pulse voltage (MiniX-V: 70kV max, MiniX-S: 60kV max) from the transformed and boosted AC voltage through high voltage generator. So the user is able to obtain x-ray images of patients' teeth and jaws from the image receptors, and diagnose about the images.

The provided FDA 510(k) summary for the DIGIMED Portable X-ray System (Models: MiniX-V, MiniX-S) states that "Clinical images were provided however they were not necessary in order to establish substantial equivalence with the predicate devices." and therefore, no acceptance criteria based on clinical performance or a study demonstrating the device meets such criteria is described.

Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (DIGIMED Portable X-Ray System, K152859) primarily through technical specifications and compliance with safety and performance standards. The only difference noted between the new device and the predicate is the "X-ray waveform" (mixed pulse versus constant potential (DC)).

However, based on the information provided, here's a breakdown of what can be inferred about the safety and performance evaluation:

1. Table of Acceptance Criteria and Reported Device Performance

Since clinical performance acceptance criteria are not mentioned as necessary for substantial equivalence, the "acceptance criteria" presented below are for technical and safety aspects, which are implied to be met for FDA clearance.

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

The document does not describe a clinical "test set" in the sense of patient data used for diagnostic performance evaluation. The "test reports" mentioned are for compliance with technical, electrical, and safety standards (e.g., IEC standards, EMI standards). These typically involve laboratory testing of the device itself, not human subjects. Therefore, no sample size for a clinical test set or data provenance is provided.

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

As no clinical test set is described, this information is not applicable and therefore not provided.

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

As no clinical test set is described, 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

No MRMC comparative effectiveness study was mentioned or performed. This submission is for an X-ray imaging device, not an AI-powered diagnostic tool. The document explicitly states: "Clinical images were provided however they were not necessary in order to establish substantial equivalence with the predicate devices." This implies that the review was focused on the device's technical specifications and safety profile, not its diagnostic efficacy compared to a predicate or with AI assistance.

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

No standalone algorithm performance study was mentioned or performed, as this is a hardware device (X-ray system), not a software algorithm or AI.

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

Since the primary evaluation was for technical/safety compliance and substantial equivalence to a predicate device, the "ground truth" would be established by validated testing equipment and adherence to recognized international standards (e.g., IEC, CISPR) and FDA guidance documents. For example, an oscillometer would measure the kVp output, and its reading would be the ground truth for that specification.

8. The sample size for the training set

Not applicable. This device is a portable X-ray system, not an AI model requiring a training set of images.

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

Not applicable. This device is a portable X-ray system, not an AI model requiring a training set.

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The MobileX Portable X-ray System is a diagnostic X-ray system which is intended to be used by trained dentists and dental technicians as an extra-oral X-ray source for producing diagnostic x-ray images using intra-oral receptors. Its use is intended for both adults and pediatric subjects.

Intended as extraoral x-ray sources to be used with intraoral image receptors for diagnostic imaging by dentists or dental technicians.

MobileX Portable X-ray System of Denterprise International, Inc., is a handheld xray device. The technology of this device was originally developed in Korea more than a decade ago and global production is still concentrated in that country.

The subject device is designed for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structure by exposing an x-ray image receptor to ionizing radiation. The x-ray source, a tube, is located inside the handheld device. All three conventional types of intraoral receptors can be used with this device-analog x-ray film, digital phosphorous plates, and digital x-ray sensors.

This device is used in general dentistry and is supplied with an internal timer to control the duration of the x-ray source to the patient.

The software is designed for a button operated device to be used by a user and a display window to be observed by the user. The software is for controlling the operation of the hardware according to the user operation that is required for this device. This software is new but this type of software is common for use in the handheld x-ray systems.

The provided document is a 510(k) summary for the MobileX Portable X-ray System, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving the device meets specific acceptance criteria in terms of clinical performance or diagnostic accuracy.

Therefore, the requested information regarding acceptance criteria and a study proving their fulfillment, especially concerning diagnostic performance (e.g., sensitivity, specificity), cannot be fully extracted from this document. The document describes non-clinical performance data confirming safety and effectiveness compared to the predicate, primarily through engineering and regulatory standards rather than a clinical multi-reader, multi-case study or standalone algorithm performance.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in terms of clinical performance metrics (e.g., sensitivity, specificity, accuracy for a diagnostic task). Instead, it focuses on adherence to engineering and regulatory standards, and technological equivalence to a predicate device.

2. Sample Size for Test Set and Data Provenance

The document explicitly states "Clinical data was not needed to support substantial equivalence."
The "Non-Clinical Performance Data" section lists various engineering and regulatory tests. These tests are generally performed on a small number of engineering samples or prototypes of the device itself rather than a "test set" of patient data.

• Sample Size for Test Set: Not applicable in the context of clinical or diagnostic performance on patient data, as no such study was conducted or reported. For engineering tests (e.g., electrical safety, radiation leakage), the "sample size" typically refers to the number of devices tested, which would be very small (e.g., 1-several units).
• Data Provenance: Not applicable for patient data. Engineering tests were performed in Korea (manufacturer: Remedi Co., Ltd., Korea; electrical test: KCTL, Inc. Laboratories, Inc., Korea). These are non-patient, non-clinical tests.

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

This information is not applicable as no clinical "test set" of patient data requiring expert-established ground truth for diagnostic performance evaluation was used. The evaluation focused on engineering compliance and equivalence.

4. Adjudication Method for the Test Set

This information is not applicable as no clinical "test set" requiring adjudication of ground truth was used.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is an X-ray source (hardware), not an AI-powered diagnostic software. Therefore, the concept of human readers improving with AI assistance is not relevant to this submission.

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

No, a standalone algorithm-only performance study was not done. This is an X-ray device, not a diagnostic algorithm.

7. The type of ground truth used

This information is not applicable in the context of diagnostic performance (e.g., expert consensus, pathology, outcomes data), as no such study was performed. The "ground truth" for the device's performance was its adherence to established engineering standards (e.g., IEC, ISO, CFR) and demonstration of equivalent physical and technical characteristics to the predicate device.

8. The sample size for the training set

This information is not applicable. This is a hardware device submission, not an AI/Machine Learning algorithm that requires a "training set" of data.

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

This information is not applicable as there was no training set.

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