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The Sedecal URS LP/Millennium/RadPro Xray Units with Detector 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.

URS LP/Millennium/RadPro X-ray Units with Detector are stationery units which operate from 120 or 220 V 50-60~ AC. The units utilize high frequency inverters. The usual safety precautions regarding the use of x-rays must be observed by the operator. This modified device combines two FDA cleared devices by way of a common user interface, a color LCD touch panel. The X-Ray generator is controlled by a serial port on the CANON CXDI-50G. The new units offer additional mounting options for the tube head and other components.

The provided text describes a 510(k) summary for the SEDECAL URS LP/Millennium/RadPro X-ray Units with Detector. This submission appears to be for a combination device, integrating two previously cleared devices.

Based on the provided information, the 510(k) summary does not contain details about specific acceptance criteria or a study designed to prove the device meets those criteria in terms of clinical performance or detection accuracy. Instead, the summary focuses on demonstrating substantial equivalence to existing predicate devices.

Here's an analysis based on the information available:

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

No specific acceptance criteria related to a performance study (e.g., sensitivity, specificity, accuracy) are mentioned. The "Performance Standard" in the Substantial Equivalence Chart refers to 21 CFR 1020.30, which is a regulatory performance standard for diagnostic X-ray systems and their major components, not a clinical performance metric. This standard typically covers aspects like radiation safety, image quality characteristics (e.g., resolution, contrast, noise), and operational parameters.

The reported device performance is implicitly covered by the "SAME" statements in the Substantial Equivalence Chart, indicating that the new device's characteristics are the same as the predicate devices in terms of energy source, digital resolution (160 x 160 microns pixel pitch, approximately 6 million pixels and 4,096 gray scale contrast), and relevant safety/performance standards.

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

Not applicable. No clinical or performance test set data is provided. The evaluation was based on "bench, user, and standards testing" and a comparison of technical characteristics to predicate devices.

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)

Not applicable. No ground truth establishment by experts is mentioned, as there was no study involving medical image interpretation.

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

Not applicable. 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 such study was conducted or reported. This device is an X-ray unit, not an AI-powered diagnostic tool. The focus is on the hardware and its integration.

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

Not applicable. This is not an algorithmic diagnostic device.

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

Not applicable. No clinical ground truth was established, as the submission relies on demonstrating substantial equivalence of the hardware's technical characteristics and adherence to regulatory standards.

8. The sample size for the training set

Not applicable. No training set is mentioned as this is not a machine learning model.

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

Not applicable.

Summary of Acceptance Criteria and Performance (Based on provided text):

Since the submission is a 510(k) for a combination device based on substantial equivalence, the "acceptance criteria" are implied by the characteristics of the predicate devices and adherence to relevant regulatory standards.

In essence, the "study" demonstrating that the device meets acceptance criteria is the comparison to predicate devices and the assertion that "The results of bench, user, and standards testing indicates that the new device is as safe and effective as the predicate devices." No specific details of these "bench, user, and standards testing" are provided in the 510(k) summary itself, but they would collectively serve to confirm that the combined device meets the functional and safety requirements established by regulatory standards and the performance of its cleared components.

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