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These Portable Diagnostic Radiographic Systems are 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, chest, abdomen, 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).

The AMADEO M-DR mini Portable X-Ray is a fully digital X-ray system for use for first aid services, intensive care units, emergency departments, as well as ships and mobile hospitals (e.g. container solutions) in inaccessible areas, in laboratories and scientific stations in remote parts of the world. The AMADEO M-DR mini is used for wireless digital X-ray imaging. The device represents the straightforward combination of 510(k) exempt devices (x-ray generator, code IZO and collimator, code IZX) and already cleared digital panels and imaging software. Two different models of digital image acquisition panels are offered: PerkinElmer XRpad2 4336 or CareView 1500CW. Both of the panels and the associated software have been previously cleared by FDA (K161966 or K150929). Integration with the portable system was straightforward.

The provided text is a 510(k) summary for the AMADEO M-DR mini and AMADEO M-AX mini mobile X-ray systems. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific device performance or clinical studies.

Therefore, many of the requested details about acceptance criteria, performance studies, sample sizes, expert qualifications, and ground truth establishment are not present in this document.

Here's a breakdown of what can be extracted and what is missing:

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

The document doesn't provide a table of formal acceptance criteria with numerical performance targets for the device. Instead, it asserts equivalence to the predicate device based on meeting recognized standards and similar characteristics.

2. Sample size used for the test set and the data provenance:

• Sample Size: Not specified. The document mentions "test images" were obtained, but no specific number of images or patients is provided.
• Data Provenance: Not specified. As clinical testing was not required, there is no mention of country of origin or whether data was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided. Since the submission states clinical testing was "Not required because the proposed digital panels have prior FDA clearance," it implies that new ground truth establishment by experts for image interpretation was not part of this specific submission.

4. Adjudication method for the test set:

Not applicable, as no formal clinical test set or adjudication by experts 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:

Not applicable. This submission is for a mobile X-ray system, not an AI-powered diagnostic device, and therefore, an MRMC study comparing human readers with and without AI assistance was not performed or mentioned.

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

Not applicable. This device is an imaging system, not a standalone algorithm.

7. The type of ground truth used:

The concept of "ground truth" in the context of diagnostic accuracy from expert consensus or pathology is not directly applicable to this submission. The "ground truth" for this device's performance relies on its ability to produce diagnostic radiographic exposures that are comparable to those of the predicate device and meet established safety and performance standards. This is evaluated through:

• Compliance with DHHS Radiation Safety Performance Standard.
• Compliance with electrical safety and EMC standards (IEC-60601 series).
• Test images demonstrating total system functionality.

8. The sample size for the training set:

Not applicable. 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.

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