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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 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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