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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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