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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 multifunctional fixed X-ray equipment consisting of Examination Table, Bucky Stand, Tube/Bucky Stand, X-ray Source Assembly (Tube/Collimator), High Voltage Generator plus Operating Panel, Conventional Image Receivers and, in specific version, Image System with Flat panel detector and Workstation for image acquisition, processing and visualization. The equipment was developed to perform radiographic examinations of patients in reclining, standing or sitting positions. Six possible tube head configurations are available: FLOOR TO CELLING TUBE STAND, FLOOR MOUNTED TUBE STAND, ROTARY U-ARM mount with integrated film/digital cassette mount, MANUAL CEILING-MOUNTED TELESCOPIC TUBE STAND, MOTORIZED CEILING-MOUNTED TELESCOPIC TUBE STAND, ROTARY STRAIGHT ARM mount with integrated film/digital cassette mount. The Apolo provides a complete x-ray system with generator, tube head, and collimator. The generator is made by us, VMI, whereas the tube head, collimator, and digital x-ray receptor panels/software are made by other manufacturers. Tube heads are typically Toshiba and collimators are typically Ralco. The Apolo D comes with digital x-ray receptor panels (see the comparison table below) while the Apolo S comes without digital x-ray receptor panels. This system employs without modification software Econsole cleared in K152172. This software has a Moderate level of concern. The reference detectors made by DRTECH can be used with anti-scatter grids.

This document is a 510(k) premarket notification for the Apolo D / Apolo S stationary x-ray system. It does not contain information about an AI/ML-based device or a study involving acceptance criteria for such a device. The device described is a traditional x-ray system, and the clearance is based on substantial equivalence to a predicate device, not on AI-driven performance metrics.

Therefore, I cannot extract the requested information (acceptance criteria, details of a study proving device meets acceptance criteria, sample sizes, expert involvement, adjudication, MRMC, standalone performance, ground truth, training set specifics) from the provided text because these elements are related to the evaluation of AI/ML devices, which is not applicable here.

The document explicitly states regarding clinical testing:
"Clinical testing was not required to establish substantial equivalence because all digital x-ray receptor panels have had previous FDA clearance." This further confirms that no clinical performance study, particularly one measuring AI-driven diagnostic accuracy, was conducted for this submission.

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