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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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