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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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