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Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography.

This is a motorized mobile diagnostic x-ray system. The MDR16 Mobile Direct Radiographic System facilitates X-ray examinations, in situations where it is not possible to transport the patient to a ward with fixed equipment. The unit is stable and precise, yet easy to maneuver due to smooth battery-powered motorization. Electric tube unit and wheel locks, 180º column rotation, and a simple user interface provide for add operator convenience and rapid patient positioning. The MDR17 System allows the acquisition of X-ray images on digital panel, CR, or film, by setting techniques based on anatomic area. Technique presets can be customized. Immediate image display after acquisition, and the possibility of immediate transmission to PACS, help minimize workflow time. Instructions for use are included within the device labeling, and the information provided will enable the user to operate the device in a safe and effective manner. Furthermore, the intended operators of the MDR17 Mobile Direct Radiographic System are health care professionals familiar with and responsible for the x-ray examinations being performed. To minimize electrical, mechanical, and radiation hazards, Del Medical, Inc. adheres to recognized and established industry practice, and all equipment is subject to final performance testing. The digital x-ray panel includes automatic exposure detection. Two different size panels are available: 35 x 43 cm or 24 x 30 cm. The software is compatible with either panel via menu setting.

The provided text does not contain information about acceptance criteria for device performance or a study demonstrating that the device meets such criteria in terms of diagnostic accuracy or clinical outcomes. The document is a 510(k) premarket notification for a mobile X-ray system (MDR17 Mobile Direct Radiographic System), focusing on proving substantial equivalence to a predicate device (RadPRO® Mobile 40kW).

The "Performance Testing" section primarily discusses bench testing for electrical safety, mechanical safety, EMC, and software, and clarifies that clinical testing was not required for a determination of substantial equivalence because the digital X-ray receptor panel had already received FDA clearance.

Therefore, I cannot fulfill the request to provide the acceptance criteria and study details related to device performance in the context of diagnostic accuracy, human reader improvement, or standalone algorithm performance, as this information is explicitly stated as not being required or performed in this submission.

However, I can extract the information provided about the testing that was conducted:

Here's the relevant information based on the provided text, focusing on the evaluations performed for K173018, even though it highlights the absence of clinical performance studies:

1. A table of acceptance criteria and the reported device performance

Since this is a substantial equivalence submission relying on bench testing for safety and electrical/mechanical performance, and not a clinical performance study measuring diagnostic accuracy, there are no specific "acceptance criteria" presented in terms of diagnostic metrics (e.g., sensitivity, specificity, AUC) for the device itself. Instead, the "acceptance criteria" are implied by adherence to recognized consensus standards for safety and electrical characteristics.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided as no clinical performance study or test set for diagnostic accuracy was conducted or required. The testing referred to is bench testing against engineering standards.

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)

This information is not provided as no clinical performance study requiring expert ground truth establishment was conducted or required.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided as no clinical performance study requiring adjudication was conducted or required.

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, an MRMC comparative effectiveness study was not done. The submission explicitly states, "Clinical testing is not required for a determination of substantial equivalence." This device is a mobile X-ray system, not an AI-powered diagnostic tool.

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

No, a standalone performance study was not done. This device is a hardware X-ray system, not an algorithm, and clinical testing was not required.

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

This information is not applicable as no clinical performance study requiring ground truth was conducted. For the bench testing, the "ground truth" was adherence to the specifications of the referenced international and national consensus standards.

8. The sample size for the training set

This information is not applicable as this submission is for a hardware medical device (X-ray system), not a machine learning or AI algorithm that requires a training set.

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

This information is not applicable as this submission is for a hardware medical device (X-ray system), not a machine learning or AI algorithm.

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