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This is a portable X-ray system with following limitations of use: The device may be used for handheld diagnostic imaging of body extremities. The device may be used for stand mounted diagnostic imaging of head, abdomen, or extremities. The device may be used for stand mounted imaging of the chest when used without a grid. - Not to be used on bariatric patients, unless imaging 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 is a complete portable battery operated digital x-ray system with the indications for use stated above. It consists of the battery operator described in K182207 paired with the wireless battery operated digital x-ray acquisition components described in K191451. This is therefore a new combination of all previously cleared components. The digital x-ray receptor system uses a wireless panel and a Dell laptop computer fitted with a 300Mbps Mini Wireless N USB Adapter. The generator can be hand held (within the limitations of the indications), tripod mounted, or mobile stand mounted. Two models are proposed: IMPACT and X-RANGER. The two models differ in their targeted markets and in the type of computer supplied. The IMPACT uses a DELL PRECISION 3550 Laptop whereas the X-RANGER uses a DELL LATITUDE 7424 RUGGED LAPTOP. The IMPACT is aimed at the commercial market whereas the X-RANGER is aimed at the military market. The software is unmodified from that employed in our reference device (K191451) and it remains at a moderate level of concern. The image receptor (cleared under K191451) is wireless and measures 14x17 inches.

The provided text describes a 510(k) premarket notification for the MinXray IMPACT and X-Ranger portable X-ray systems, establishing substantial equivalence to a predicate device (TR90BH K182207) and referencing an imaging system (CMDR 2CW K191451).

However, the document does not contain acceptance criteria for device performance or a study demonstrating that the device meets such criteria. Instead, it focuses on demonstrating substantial equivalence based on the device's intended use, technological characteristics, and compliance with various safety and performance standards for medical electrical equipment.

The relevant information regarding performance is limited to:

• Panel Performance: Panel MTF ~63% (@ 1lp/mm) and Panel DQE ~62% (@ 0lp/mm), which are properties of the digital image capture panel (from reference device K191451), not acceptance criteria for the overall X-ray system.
• Safety and Effectiveness: Stated that "The results of bench testing indicates that the new device is as safe and effective as the predicate device. Proper system operation is fully verified upon installation." This is a general statement, not a specific performance metric against acceptance criteria.

Therefore, many parts of your request for acceptance criteria and a study proving their fulfillment cannot be answered from the provided text.

Here's an attempt to answer the questions based on the available information, noting where data is missing:

1. Table of acceptance criteria and the reported device performance

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

• The document primarily describes non-clinical bench testing and compliance with standards. It does not refer to a test set in the context of image data for diagnostic performance evaluation.
• No information on data provenance (country of origin, retrospective/prospective) is provided, as no such image-based test set is detailed.

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

• Not applicable. No image-based test set with ground truth established by experts is mentioned. The software for image acquisition is described as "unmodified" and "remains at a moderate level of concern." "Overall operation" was verified by "reviewing test images," but the reviewers' qualifications are not stated.

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

• Not applicable. No image-based test set requiring an adjudication method 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

• No MRMC or comparative effectiveness study involving human readers or AI assistance was performed or mentioned. The device is purely an X-ray system, not an AI-assisted diagnostic tool.

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

• Not applicable. This is an X-ray imaging device, not a standalone algorithm.

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

• Not applicable. No diagnostic ground truth was established as part of this submission, which focused on the safety and performance of the X-ray system itself.

8. The sample size for the training set

• Not applicable. No training set for an algorithm is mentioned as this is a hardware device submission.

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

• Not applicable.

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Intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammography.

This represents the straightforward combination of three devices: One of three cleared MinXray Portable HF X-ray generators: a) HF120/60H PowerPlus cleared in K040046, (and in K141885) OR b) HF100H+ cleared in K052721 OR C) HF1202 PowerPlus cleared in K153059. d) Plus: A 510(k) cleared (K153058) Digital X-Ray Receptor Panel CareView 1500C X-ray Flat Panel Detector. PLUS: the dicomPACS® software package (Same as our predicate). e) The x-ray generators are portable units which operate from 120/240V 50-60° AC. The generator unit utilizes a high frequency inverter and can be mounted to a tripod or support arm. The usual safety precautions regarding the use of x-rays must be observed by the operator. The digital panel features the Careray flat panel technology in a sleek and compact unit. The portable panel provides digital X-ray image capture for a wide range of applications. The lightweight design, generous imaging area, and fast processing times of the detector make it easy to capture high quality diagnostic images for routine diagnosis, as well as challenging trauma and bedside exams. It's a portable solution for a faster, more streamlined approach to digital radiography. The only difference between this modified device and our predicate devices is the model number of the digital x-ray receptor panel. The predicate panel can communicate either by wireless or wired connection. The subject device communicates by Ethernet only.

The provided text describes a 510(k) premarket notification for a mobile X-ray system (CMDR 2C) seeking substantial equivalence to a predicate device. This submission primarily focuses on hardware equivalence and non-clinical testing, rather than an AI/ML-based diagnostic device requiring extensive performance metrics against a clinical ground truth.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/ML device (e.g., sample sizes for test/training sets, expert adjudication methods, MRMC studies, specific ground truth types for disease detection) are not applicable or not present in this document.

However, I can extract the information related to the device's performance through bench testing and the rationale for claiming substantial equivalence.

Here's an analysis based on the provided document:

1. Table of acceptance criteria and the reported device performance:

Since this FDA submission is for a medical device (mobile X-ray system) and not an AI/ML diagnostic tool, the "acceptance criteria" are related to established performance standards for X-ray imaging devices and demonstrating equivalence to a predicate device. The "reported device performance" is primarily about image quality and compliance with relevant safety and electrical standards.

• UL 60601-1 (2005) (Electrical medical device safety)
• IEC 60601-1-2 (2007) (Electromagnetic Compatibility)
• Additionally, the HF1202H PowerPlus generator meets IEC 60601-2-54: Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy (not applicable to older generators).
• Risks and hazardous impacts of the device modification were analyzed by FMEA methodology. Risk control and protective measures were reviewed and implemented. "The overall assessment concluded that all identified risks and hazardous conditions were successfully mitigated and accepted." |
  | Software Compatibility: New panel compatible with existing software. | "We verified software compatibility with the new CareView Cw digital panel." The dicomPACS® software was installed on a Dell Inspiron laptop, and proper installation was verified by running the software. A Wi-Fi connection (for the predicate panel) was confirmed, and the X-ray generator was used to take test exposures with a radiographic phantom. "No modifications were necessary to any of the hardware or software other than changing the digital panel." |
  | Substantial Equivalence: Performance is as safe and effective as predicate. | "The results of bench testing indicate that the new devices are as safe and effective as the predicate devices."
  The primary difference is the digital X-ray receptor panel, with the new panel communicating via Ethernet only, while the predicate panel could communicate via wireless or wired. However, the panel's core performance characteristics (Pixel Pitch, pixels, Size, Scintillator, Spatial Resolution, A/D Resolution, MTF, DQE) are identical to the predicate panel (which was cited as the predicate in the K150929 submission). |

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

• Sample Size: Not explicitly stated as a numerical sample size of "cases" or "patients" in the context of clinical images. The testing involved "Prototype systems covering all generator/panel combinations" and "Several test exposures" with "a radiographic phantom." This suggests a limited number of phantom images rather than a large clinical test set.
• Data Provenance: The data used for testing (phantom images) would have been generated in-house during the bench testing. The document does not specify country of origin for this testing data. The testing was non-clinical for this specific submission ("Summary of clinical testing: Clinical testing was not required to establish substantial equivalence.").

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

• Not applicable / Not specified. Given that this is a non-clinical bench study focused on physical performance and image quality of an X-ray machine rather than a diagnostic AI algorithm, there was no "ground truth" derived from expert clinical reads of patient images. The evaluation of "diagnostic quality" for phantom images would likely be performed by engineers or physicists familiar with imaging standards, but specific numbers or qualifications are not provided.

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

• Not applicable. No adjudication method for expert reads was used as no clinical images or expert reads were part of this substantiation.

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

• No. An MRMC study was not done. This device is a standard X-ray imaging system, not an AI-assisted diagnostic tool.

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

• Not applicable. This device is an X-ray machine; there is no standalone AI algorithm whose performance is being evaluated in this submission.

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

• The "ground truth" for this submission was based on physical phantom measurements and engineering standards compliance (e.g., compliance with UL, IEC standards, and the ability to produce images "of diagnostic quality" using standard test phantoms like the i.b.a. Test Device DIGI-13). There was no clinical ground truth (expert consensus, pathology, or outcomes data) used in this particular substantial equivalence determination.

8. The sample size for the training set:

• Not applicable. This submission is for an X-ray imaging device, not an AI/ML algorithm that requires a training set.

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

• Not applicable. No AI/ML training set was used.

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Intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammography.

This represents the straightforward combination of three devices: One of three cleared MinXray Portable HF X-ray generators: a) HF120/60H PowerPlus cleared in K040046, (and in K141885) OR b) HF100H+ cleared in K052721 OR c) HF1202 PowerPlus cleared in K153059. Plus: A 510(k) cleared (K150929) Digital X-Ray Receptor Panel CareView 1500Cw X-ray Flat Panel Detector. d) e) PLUS: the dicomPACS® software package (Same as our predicate). The x-ray generators are portable units which operate from 120/240V 50-60° AC. The generator unit utilizes a high frequency inverter and can be mounted to a tripod or support arm. The usual safety precautions regarding the use of x-rays must be observed by the operator. The digital panel features the Careray flat panel technology in a sleek and compact unit. The portable panel provides digital X-ray image capture for a wide range of applications. The lightweight design, generous imaging area, and fast processing times of the detector make it easy to capture high quality diagnostic images for routine diagnosis, as well as challenging trauma and bedside exams. It's a portable solution for a faster, more streamlined approach to digital radiography. The only difference between this modified device and our predicate devices is the supplier of the digital x-ray receptor panel.

The provided text describes a 510(k) premarket notification for the MinXray CMDR 2CW (Multiple Models) mobile x-ray system. The submission aims to demonstrate substantial equivalence to a predicate device, the CMDR 2ST/CMDR 2SPE (Multiple Models).

Here's an analysis of the acceptance criteria and study information:

Acceptance Criteria and Reported Device Performance

The core of the acceptance criteria revolves around demonstrating substantial equivalence to the predicate device. This is primarily assessed by comparing the technological characteristics and showing that the new device is as safe and effective as the predicate, with the same indications for use.

The device performance is demonstrated through non-clinical testing, specifically focused on confirming proper system operation and diagnostic image quality.

The primary difference and therefore the key point of evaluation for substantial equivalence was the Digital X-ray Panel.

Study Information

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

   • The test set consisted of "several test exposures" using a radiographic phantom.
   • The data provenance is not explicitly stated in terms of country of origin, but it was generated during non-clinical bench testing by MinXray, Inc. This was a prospective test conducted for the purpose of this submission.

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

   • The text does not specify the number or qualifications of experts who evaluated the images during the bench testing. It only states that "The images were evaluated and found to be of diagnostic quality."

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

   • An adjudication method is not described. The evaluation was likely performed internally as part of the bench testing.

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

   • No MRMC or AI-assisted study was performed. The device is a mobile x-ray system, not an AI diagnostic tool.

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

   • Not applicable, as this is an x-ray imaging system, not a diagnostic algorithm.

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

   • The ground truth for the non-clinical testing was based on the expected diagnostic quality of images produced from a radiographic phantom, as assessed by comparison to images from the predicate device and general standards of diagnostic quality for x-ray imaging.

7. The sample size for the training set:

   • Not applicable, as this is not a machine learning device. The "training" here refers to the development and testing of the x-ray system components and their integration.

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

   • Not applicable in the context of a machine learning training set. For the development and verification of the x-ray system, the "ground truth" was established through engineering specifications, regulatory standards (e.g., UL, IEC, DHHS radiation safety), and the performance characteristics of previously cleared predicate/reference devices (generators, panels, software).

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The TR90BH is a portable X-ray system with following limitations of use:
The device may be used for handheld diagnostic imaging of body extremities
The device may be used for stand mounted diagnostic imaging of head, abdomen, or extremities.
The device may be used for stand mounted imaging of the chest when used without a grid.

• Not to be used on bariatric patients, unless imaging body extremities
• Not for mammography use
• The TR90BH 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.

We have developed compact, lightweight, battery powered easy-carry TR90BH based on the technology of HF1202H. This device can be used with a stand or hand-held. A detailed comparison table with an equivalent device is provided below. The MinXray TR90BH consists of a battery powered X-ray generator (tubehead/control), continuously adjustable light beam collimator, mounting trunnion, exposure cord with 2-stage exposure switch, battery charger, AC adaptor and AC power cord, and those are provided in a portable carry case with wheels. If a stand is purchased with the TR90BH, such as the MinXray XGS series of gas spring portable mobile stands, instructions for assembly of the stand and the attachment of the TR90BH are included with the stand. The device works with a dedicated secondary Lithiumion battery, therefore it can be operated at no power supply places such as disaster sites. A few number of shots can be taken in short chanks to the newly designed and superior patent licensed battery. The x-ray tube is Toshiba Electron Tubes & Devices D-0814 0.8mm, 9.86kHU which is designed for diagnostic x-ray applications. 2-stage exposure switch: The exposure switch has 2-stage button. The first stage preheats the filament of the x-ray tube and lights collimator enabling operator to confirm exposure area. After keeping the button position at the first stage end for approximately 1 second, exposure preparation will be done and the STAND BY indicator will light. The second stage initiates the x-ray exposure for the sec display in advance. When the second stage is fully pressed, x-ray will be emitted, the X-RAY indicator will light, and an audible signal will be heard. One must PRESS AND HOLD THE SECOND STAGE END POSITION UNTIL THE EXPOSURE HAS TERMINATED. The switch operates in a "dead man" mode in that x-ray exposure will terminate immediately as a safety feature when the button is released.

The provided text does not contain detailed acceptance criteria or a study proving the device meets specific performance metrics in the way a diagnostic imaging AI would. Instead, this document is a 510(k) summary for an X-ray system (TR90BH), focusing on demonstrating substantial equivalence to a predicate device based on technical specifications, safety standards compliance, and intended use.

However, I can extract the information that is present concerning testing and validation.

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

The document does not specify quantitative acceptance criteria in terms of diagnostic accuracy (e.g., sensitivity, specificity, AUC) or image quality metrics. Instead, it relies on demonstrating compliance with recognized safety and performance standards for X-ray equipment and a general assessment of its functionality and image output.

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

• Sample size for clinical test: The document states "A limited clinical test was performed." No specific number of patients or images is provided.
• Data provenance: Not specified. It's likely an internal test conducted by MinXray Inc. or a contracted entity, given the nature of a 510(k) submission for an X-ray system rather than a diagnostic AI. The test was clinical in nature, implying prospective data collection, but details are absent.

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)

• Number of experts: One expert.
• Qualifications of experts: "A Board Certified Radiologist performed a successful review." No details on years of experience or specialization beyond being Board Certified.

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

• Adjudication method: Not applicable. Only one expert was involved in the review.

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 comparative effectiveness study was not done. This device is an X-ray system, not an AI-powered diagnostic tool for interpretation. Its evaluation focuses on hardware performance, safety, and image generation, not reader assistance.

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

• Standalone performance: Not applicable in the context of diagnostic AI. This device is an X-ray machine. The "clinical test" assessed its ability to image anatomy, not its performance as a standalone diagnostic algorithm.

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

• Ground truth for clinical test: The "successful review" by a Board Certified Radiologist served as the ground truth, confirming the device's ability to image anatomy. This is essentially expert review/opinion on imaging capability rather than a ground truth for a specific disease diagnosis.

8. The sample size for the training set

• Training set sample size: Not applicable. This document describes an X-ray hardware system, not a machine learning algorithm that requires a training set.

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

• Ground truth for training set: Not applicable, as there is no training set for this type of device.

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Intended for use by a qualified trained physician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammography.

This represents the straightforward combination of three devices: One of three cleared MinXray Portable HF X-ray generators: HF120/60H PowerPlus cleared in K040046, (and in K141885) OR HF100H+ cleared in K052721 OR HF1202 PowerPlus cleared in K153059. One of three cleared digital X-ray receptor panels: Toshiba FDX3543RP OR the Toshiba FDX3543RPW cleared in K162687 (and others) OR the PerkinElmer Solid State Imager, (K140551) PLUS: the dicomPACS® software package (K141885) (Same as our predicate). The X-ray generators are portable units which operate from 120 V 50-60° AC. The generator unit utilizes a high frequency inverter and can be mounted to a tripod or support arm. The usual safety precautions regarding the use of x-rays must be observed by the operator. The digital panel features the formerly used Toshiba panels or PerkinElmer flat panel technology in a sleek and compact unit. The portable panels provide digital X-ray image capture for a wide range of applications. The lightweight design, generous imaging area, and fast processing times of the detector make it easy to capture high quality diagnostic images for routine diagnosis, as well as challenging trauma and bedside exams. It's a portable solution for a faster, more streamlined approach to digital radiography. The only difference between this modified device and our predicate device is the digital x-ray receptor panel.

The provided text does not contain information about acceptance criteria and a study proving a device meets these criteria in the typical sense of a diagnostic medical device evaluating patient data for specific clinical endpoints.

Instead, the document is a 510(k) premarket notification for a mobile X-ray system, which is a piece of medical imaging equipment. The "acceptance criteria" and "study" described herein relate to demonstrating substantial equivalence to a previously cleared predicate device, rather than proving the performance of a diagnostic algorithm against a clinical ground truth.

Here's an analysis based on the provided text, addressing the points where information is available:

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

The document doesn't present a formal table of acceptance criteria for a diagnostic performance study. Instead, it focuses on demonstrating that the new devices have similar technological characteristics and performance to the predicate device, and that they produce images of "diagnostic quality."

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

• Test Set Description: The "test set" in this context refers to prototype systems and phantom images, not a clinical image dataset with patient outcomes.
• Sample Size: "Prototype systems covering all generator/panel combinations were assembled and tested." "Several test exposures showed that the system was operating properly." "All panel/generator combinations were tested" with the DIGI-13 device. The exact number of exposures or phantom images is not specified beyond "several" and "all combinations."
• Data Provenance: This was bench testing performed internally by MinXray, Inc. The data is entirely synthetic (phantom images) and technical system performance data, not patient data from a specific country or for retrospective/prospective analysis.

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. The evaluation of "diagnostic quality" from the phantom images was an internal assessment.
• Qualifications of Experts: Not specified. It's implied that the evaluation was done by the manufacturer's personnel, likely engineers or qualified technicians, as part of the system testing. There is no mention of external radiologists or clinicians establishing ground truth for these technical images.

4. Adjudication method for the test set:

• Adjudication Method: Not applicable. There was no multi-reader or consensus-based adjudication in a clinical diagnostic sense. The evaluation was a technical assessment of image quality and functionality against established safety and performance standards for X-ray equipment.

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 comparative effectiveness study was not done. This device is a mobile X-ray system, not an AI-powered diagnostic tool.
• Effect Size of AI Assistance: Not applicable, as no AI component or human-in-the-loop diagnostic performance was evaluated.

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

• Standalone Performance: Not applicable. This device is a hardware system for acquiring X-ray images, not a standalone diagnostic algorithm.

7. The type of ground truth used:

• Type of Ground Truth: The "ground truth" here is fundamentally technical adherence to performance standards and comparison to a predicate device's established image quality using a phantom. It's not clinical diagnosis, pathology, or outcomes data. The i.b.a. Test Device DIGI-13 (a device for quality tests at CR and DR systems) served as a standard for image quality assessment.

8. The sample size for the training set:

• Training Set Sample Size: Not applicable. This is not an AI/machine learning device. There is no mention of a "training set" in the context of diagnostic algorithms.

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

• Ground Truth Establishment for Training Set: Not applicable. As there is no training set for a diagnostic algorithm, there's no ground truth established in that context.

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This radiographic system is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammographic use.

The MinXray HF1202 consists of an X-ray generator (tubehead/control), continuously adjustable light beam collimator, mounting trunnion, exposure cord with 2-stage exposure switch, and AC power cord. If a stand is purchased with the HF1202, such as the MinXray XGS series of gas spring portable mobile stands, instructions for assembly of the stand and the attachment of the HF1202 are included with the stand. This is a high-frequency generator of updated design. The unit has a serial port and a Bluetooth port for communication of technique factors to a PC. The PC cannot initiate an exposure. When used, the PC must employ FDA cleared software and digital receptor panels. Known compatible with Toshiba FDX4343RP and FDX4343RPW digital x-ray panels. The FDX4343RP was cleared in K130883 (and K131211) and the FDX4343RPW was cleared in K143257.

The provided text describes a 510(k) premarket notification for the MinXray HF1202H PowerPlus™ Portable X-ray Equipment, seeking substantial equivalence to a predicate device. This document does not describe a study that uses AI or machine learning, nor does it provide acceptance criteria and performance data in the typical sense for such devices (e.g., sensitivity, specificity, AUC).

Instead, this document describes a traditional medical device (an X-ray machine) and its comparison to a legally marketed predicate device. The core of the equivalence claim is based on bench testing and compliance with recognized standards, rather than performance metrics on a clinical image test set adjudicated by experts.

Therefore, for your requested information:

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

The "acceptance criteria" here are compliance with various IEC standards and demonstrating functional equivalence to the predicate device. The "reported device performance" is the conclusion of compliance with these standards and the comparison of specifications presented in the table on pages 3-4.

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

Not applicable. The "test set" was not a collection of clinical images or patient data but rather the physical device tested against engineering standards and specifications. The document mentions "test images" were reviewed for overall operation, but no specific sample size of these images or their provenance is provided, as they were not used to establish clinical performance metrics.

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

Not applicable. Ground truth, in the context of clinical performance evaluation by experts, was not established for this type of device submission. The evaluation was primarily based on engineering compliance and functional specifications.

4. Adjudication method for the test set

Not applicable, as there was no expert adjudication of a test set of clinical cases.

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. This device is a portable X-ray machine, not an AI or CAD system. No MRMC study was conducted.

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

Not applicable. This is not an AI/algorithm-based device.

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

The "ground truth" for this submission refers to the established engineering standards, regulatory requirements, and the specifications of the predicate device. It's based on technical compliance and functional equivalence rather than clinical outcomes or diagnostic accuracy.

8. The sample size for the training set

Not applicable. This device is not an AI/Machine Learning system, so there is no training set in the conventional sense.

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

Not applicable, as there is no training set.

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This digital radiographic system is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammographic use.

This represents the straightforward interconnection of three devices: The MinXray HF120/60H PowerPlus™ (K040046), the Toshiba Solid State Imager, and the dicomPACS® software package. MinXray HF120/60H PowerPlus™ is a portable unit which operates from 120 V 50-60° AC. The generator unit utilizes a high frequency inverter and can be mounted to a tripod or support arm. The usual safety precautions regarding the use of x-rays must be observed by the operator. The digital panel features the Toshiba flat panel technology in a sleek and compact unit. The portable panel provides digital X-ray image capture for a wide range of applications. The lightweight design, generous imaging area, and fast processing times of the detector make it easy to capture high quality diagnostic images for routine diagnosis, as well as challenging trauma and bedside exams. It's a portable solution for a faster, more streamlined approach to digital radiography. The only difference between this modified device and our predicate device is the supplier of the digital x-ray receptor panel. The previous supplier was Varian. The two model numbers differ only in the configuration and weight of the mounting hardware.

The provided document is a 510(k) premarket notification for a digital portable X-ray system. The aim of the submission is to demonstrate substantial equivalence to a legally marketed predicate device, not to prove the device meets specific performance criteria through a study with acceptance criteria in the way a novel therapeutic or diagnostic device would.

Therefore, many of the requested details about acceptance criteria, sample sizes, expert qualifications, and ground truth establishment, which are typical for studies validating the performance of a new diagnostic algorithm or device feature, are not applicable here. This document focuses on demonstrating that a modified device (changing the digital panel supplier) performs equivalently to an already cleared device.

Here's an attempt to extract relevant information given the limitations:

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria: While specific numerical acceptance criteria for image quality aren't explicitly stated in a table format, the underlying criterion is that the diagnostic image quality of the new device (with the Toshiba panel) must be comparable to that of the predicate device (with the Varian panel).
• Reported Device Performance: "The images were evaluated by a board certified radiologist and found to be of comparable diagnostic quality."

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

• Sample Size for Test Set: "Several test exposures" were performed using "Supertech" lung/chest phantom and other phantoms. A precise number is not given.
• Data Provenance: Not applicable as phantom images were used, not patient data with specific country of origin. This was a prospective test in the sense that the new system was assembled and then tested with phantoms.

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

• Number of Experts: One
• Qualifications of Experts: "A board certified radiologist." Specific years of experience are not mentioned.

4. Adjudication Method for the Test Set

• Adjudication Method: "None" for comparison, as only one radiologist evaluated the images. The radiologist made a direct comparison to images from the predicate device.

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 done. This device is an X-ray system, not an AI-assisted diagnostic tool.

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

• Standalone Performance: Not applicable in the context of an X-ray imaging device. The device's "performance" is its ability to produce diagnostic images. The evaluation described involves a human (radiologist) interpreting these images.

7. The Type of Ground Truth Used

• Ground Truth: The "ground truth" for the comparison was the diagnostic quality of images produced by the predicate device (MinXray CMDR-2S with Varian 4336R panel). This is a comparison of diagnostic image quality as assessed by an expert, rather than reference to pathology, outcomes data, or a different "ground truth" standard. The phantoms represent known anatomical structures.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This document describes a 510(k) submission for a medical device (X-ray system), not an AI/machine learning algorithm that requires a training set.

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

• Ground Truth for Training Set: Not applicable, as this is not an AI/machine learning algorithm with a training set.

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This digital radiographic system is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammographic use.

This represents the straightforward interconnection of three devices: The MinXray HF120/60H PowerPlus™ (K040046), the Varian Solid State Imager, and the dicomPACS® software package. MinXray HF120/60H PowerPlus™ is a porable unit thich operates from 120 V 50-60~ AC. The generator unit utilizes a high frequency invester and can be mounted to a tripod or support arm. The usual safety precautions regarding the use of x-rays must be observed by the operator. The digital panel features the Varian flat panel technology in a sleek and compact unit. The portable panel provides digital X-ray image capture founovide range of applications. The lightweight design, generous imaging area, and fast processing times of the detector make it easy to capture high quality diagnostic images for routine diagnosis, as well as challenging trauma and bedside exams. It's a portable solution for a faster, more streamlined approach to digital radiography.

The provided text describes a 510(k) submission for the MinXray CMDR-2S Digital Diagnostic X-Ray System (Mobile). This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than conducting new clinical trials to establish device performance against specific acceptance criteria.

Therefore, many of the requested elements (acceptance criteria, specific study design, sample sizes, expert ground truth establishment, MRMC studies, standalone performance, and training set details) are not applicable or not explicitly detailed in the provided document for a de novo testing of the device's diagnostic performance. The document primarily relies on bench testing and comparison to a predicate device's existing performance.

Here's an analysis based on the provided information, noting where details are not available:

1. Table of Acceptance Criteria and Reported Device Performance

No specific performance acceptance criteria for diagnostic accuracy or specific metrics (like sensitivity, specificity) are defined or reported for the CMDR-2S device itself in the provided text. The submission focuses on substantial equivalence to a predicate device based on technical characteristics and intended use.

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

• Not applicable / Not provided. The document describes bench testing to compare the new device to a predicate, not a clinical study with a patient test set for diagnostic performance evaluation.

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

• Not applicable / Not provided. No patient test set with expert-established ground truth is described.

4. Adjudication method for the test set

• Not applicable / Not provided. No patient test set 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

• No. This is a medical device 510(k) for an X-ray system, not an AI-powered diagnostic tool. An MRMC study comparing human readers with and without 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. This is not an AI algorithm. It's a digital X-ray system.

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

• Not applicable / Not provided. For the purpose of this 510(k), the "ground truth" is implied by the predicate device's established safety and effectiveness, supported by bench testing of the new device's components and system functionality.

8. The sample size for the training set

• Not applicable / Not provided. This is not an AI/machine learning device that requires a training set.

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

• Not applicable / Not provided. This is not an AI/machine learning device.

Summary of the Study that Proves the Device Meets Acceptance Criteria (as per the 510(k) context):

The "study" that proves the device meets the acceptance criteria (which, in a 510(k), primarily means substantial equivalence to a legally marketed predicate device) is documented as "bench testing."

• Purpose: To demonstrate that the MinXray CMDR-2S Digital Diagnostic X-Ray System (Mobile) is as safe and effective as the predicate device (MinXray CMDR-1S, K082627) despite key component changes (Dell laptop instead of Panasonic, dicomPACS® software included, Varian 4336R digital panel instead of CANON CXDI 50G).
• Methodology (implied): Bench testing was performed to verify the proper system operation and ensure that the new components (computer, digital panel, software) function harmoniously and meet performance standards identical to those of the predicate device (21 CFR 1020.30). The submission states, "The results of bench testing indicates that the new device is as safe and effective as the predicate devices. Proper system operation is fully verified upon installation."
• Conclusion: Based on this bench testing, MinXray Inc. concluded that the CMDR-2S is "as safe and effective as the predicate device, have few technological differences, and has no new indications for use, thus rendering it substantially equivalent to the predicate device." The FDA concurred with this assessment, granting the 510(k) clearance.

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This digital radiographic system is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays.

This represents the straightforward interconnection of two FDA cleared devices: The MinXray HF120/60H PowerPlus™ (K040046) and the Canon CXDI-50G Solid State Imager (K031447). MinXray HF120/60H PowerPlus™ is a portable unit which operates from 120 V 50-60~ AC. The generator unit utilizes a high frequency inverter and can be mounted to a tripod or support arm. The usual safety precautions regarding the use of x-rays must be observed by the operator. The digital panel features Canon's large-area flat panel technology in a sleek and compact unit. The portable CXDI-50G provides digital X-ray image capture for a wide range of applications. The lightweight design, generous imaging area, and fast processing times of the detector make it easy to capture high quality diagnostic images for routine diagnosis, as well as challenging trauma and bedside exams. It's a portable solution for a faster, more streamlined approach to digital radiography.

The provided text describes a 510(k) submission for the MinXray CMDR-1S Digital Diagnostic X-Ray System (Mobile). This submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing a detailed study proving the device meets specific acceptance criteria through clinical performance metrics.

Therefore, the information required to fully answer your request regarding acceptance criteria and a study proving those criteria are met is not present in the provided text. The document primarily discusses the device's technical specifications and intended use in comparison to a predicate device, concluding substantial equivalence based on bench testing.

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

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

• Cannot be provided. The document does not define specific performance acceptance criteria for image quality, diagnostic accuracy, or clinical effectiveness. It focuses on demonstrating equivalence to predicate devices through technical characteristics and bench testing.

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

• Cannot be provided. The text only mentions "bench testing" and does not refer to any human or clinical test sets, their sample sizes, or data provenance.

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)

• Cannot be provided. No clinical test set involving expert review or ground truth establishment is mentioned.

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

• Cannot be provided. No clinical test set is described, so no adjudication method is mentioned.

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 done, and no AI component is described. The device is a digital X-ray system, not an AI-powered diagnostic tool. The document states it is "the straightforward interconnection of two FDA cleared devices."

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

• Not applicable. This device is a hardware system for acquiring X-ray images, not an algorithm.

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

• Cannot be provided. No clinical ground truth is established or referenced. The "ground truth" for the substantial equivalence claim is the performance and safety of the predicate device.

8. The sample size for the training set

• Not applicable, no training set for an algorithm is mentioned.

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

• Not applicable, no training set for an algorithm is mentioned.

Summary of what the document focuses on:

The MinXray CMDR-1S Digital Diagnostic X-Ray System (Mobile) achieved 510(k) clearance by demonstrating substantial equivalence to a previously cleared predicate device (K042361 DIGITAL PORTABLE X-RAY UNITS, MODEL SP-HF-4.0 D, SEDECAL USA, INC). This approach to regulatory clearance typically relies on technical comparisons and non-clinical testing rather than extensive clinical performance studies with specific acceptance criteria as you might see for a novel diagnostic algorithm.

The core of the "study" demonstrating this equivalence is:

• Bench testing: The document states, "The results of bench testing indicates that the new device is as safe and effective as the predicate devices. Proper system operation is fully verified upon installation."
• Comparison of Characteristics: A table comparing characteristics like intended use, configuration, generator type, and performance standard confirmed that the new device is largely "SAME" or has minor technological differences (e.g., generator made by a different company and different MHz).

The acceptance criteria for this type of submission would generally be that the new device does not raise different questions of safety and effectiveness and performs comparably to the predicate device in terms of its technical specifications and typical operation (as verified by bench testing). The document concludes that "the MinXray CMDR-1S Digital Diagnostic X-Ray System is as safe and effective as the predicate device, have few technological differences, and has no new indications for use, thus rendering it substantially equivalent to the predicate device."

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