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The ddrCruze™ is 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}

This represents the combination of the two of the predicate devices: K101517, Sedecal Mobile Digital Diagnostic X-Ray Systems (various models), manufactured by Sedecal SA (Spain), Software: PrestoDR Portable, K100400, CMT Medical Technologies LTD. (Used UNMODIFIED ). ddRCruze™ features a fully motorized mobile DR system, wireless connectivity, diagnostic image quality, viewing monitor for image review and system setup which can be positioned on any side of the system for added convenience. The system has a front-view camera for safe maneuverability.

Here's an analysis of the acceptance criteria and study information for the ddRCruze™ device, based on the provided 510(k) summary:

Acceptance Criteria and Device Performance

This 510(k) summary does not delineate specific, quantifiable acceptance criteria in the traditional sense, such as specific sensitivity or specificity targets. Instead, the acceptance is based on demonstrating substantial equivalence to predicate devices through a comparison of technical characteristics and intended use. The device's performance is reported by stating its characteristics alongside those of the predicate devices.

Table of Acceptance Criteria (Implicit) and Reported Device Performance

Study Information

Based on the provided 510(k) summary, the following information can be extracted regarding the studies conducted:

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

   • Not Applicable. The submission explicitly states "Description of clinical tests: Not applicable." This indicates that no new clinical test set with patient data was used to demonstrate the device's performance. The basis for clearance is substantial equivalence to previously cleared devices.

2. 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. As no clinical test set was used, no ground truth needed to be established by experts for this specific device clearance.

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

   • Not Applicable. No clinical test set was used.

4. 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 study was not conducted as this is a traditional X-ray system, not an AI-assisted diagnostic tool. The submission is for a mobile digital X-ray system comprising hardware (mobile unit, digital panel) and software, all of which had prior clearances or are components of previously cleared systems.

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

   • No. This device is an imaging system, not a standalone AI algorithm. It requires a human operator and interpretation.

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

   • Not Applicable. No new ground truth was established for this device's clearance. The clearance relies on the established safety and effectiveness of its predicate components and the equivalence of its technical characteristics.

7. The sample size for the training set:

   • Not Applicable. This submission is for a conventional medical imaging device (X-ray system), not an AI algorithm that requires a training set. The "software" mentioned (PrestoDR Portable) was used unmodified and had prior clearance.

8. How the ground truth for the training set was established:

   • Not Applicable. No training set was used for this device's clearance.

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