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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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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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The MinXray HF100H+™ - is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays.

MinXray HF100H+1M is a portable unit which operates from 120 V 50-60~ AC. The unit utilizes a newly designed high frequency inverter and can be mounted to a tripod or support arm. The usual safety precautions regarding the use of xrays must be observed by the operator.

Here's an analysis of the provided text regarding the MinXray HF100H+™ High Frequency Diagnostic X-Ray Unit, structured to address your specific questions about acceptance criteria and study details:

The provided documentation details a 510(k) premarket notification for an X-ray unit, which is a hardware device. The "acceptance criteria" and "study" described are focused on demonstrating substantial equivalence to existing predicate devices, rather than establishing clinical performance metrics in the way AI/software devices typically would for diagnostic accuracy. Therefore, many of your requested points regarding AI device studies (like expert consensus, MRMC studies, training sets, etc.) are not applicable to this submission.

I will answer the questions based on the information available in the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

The "acceptance criteria" for this submission are primarily focused on demonstrating that the new device, MinXray HF100H+™, performs as safely and effectively as its predicate devices and meets relevant technical standards. The "reported device performance" is a comparison of its technical specifications to those predicates.

Study Description:
The study proving the device meets the acceptance criteria is a "bench and user testing" comparison to predicate devices, focusing on demonstrating substantial equivalence in safety and effectiveness. The conclusion states "the results of bench and user testing indicates that the new device is as safe and effective as the predicate device."

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

• Sample size for the test set: Not explicitly stated in the document. "Bench and user testing" is mentioned, implying internal testing and perhaps observation of performance. There is no information regarding a specific dataset of X-ray images or clinical cases used for testing.
• Data provenance: Not applicable in the context of an X-ray hardware device. The "testing" refers to the device itself, not patient data. "Bench testing" implies laboratory conditions, and "user testing" would likely involve qualified personnel operating the device.

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

• This question is not applicable to this submission. This is a hardware device focusing on general X-ray production, not a diagnostic AI algorithm that interprets images or requires expert ground truth for image interpretation. The "testing" here assesses technical performance and adherence to safety and function standards.

4. Adjudication method for the test set

• This question is not applicable to this submission. Adjudication methods are typically used for assessing disagreements in image interpretation or clinical outcomes, which is not the subject of this hardware device submission.

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 question is not applicable to this submission. An MRMC study is relevant for AI-powered diagnostic tools designed to assist human readers. This device is a general-purpose diagnostic X-ray unit.

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

• This question is not applicable to this submission. This is a standalone hardware X-ray machine. There is no algorithm for image interpretation described or evaluated.

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

• This question is not applicable to this submission in the context of diagnostic accuracy. "Ground truth" for this device would refer to its technical specifications matching design parameters and fulfilling performance standards (e.g., producing X-rays at specified kV and mA settings, meeting safety requirements). The "bench testing" would verify these physical and electrical performance points.

8. The sample size for the training set

• This question is not applicable to this submission. This device is an X-ray hardware unit, not an AI model that requires a training set.

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

• This question is not applicable to this submission, as there is no training set for an AI model.

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