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This Digital Mobile Diagnostic X-Ray System is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic 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.

These are modified versions of the predicate mobile digital diagnostic x-ray systems. They feature motorized movement and full battery operation. Various Canon digital X-ray panels are supplied with the system. The Mobile X-Ray Unit MOVIX DReamy has a Basic configuration or Advanced configuration. The Mobile X-Ray unit MOVIX DReamy is provided with touch screen to operate as a control console. The Digital Imaging System is composed by image receptors and application for image acquisition (control console & image processing controller). The Image acquisition software "CANON CXDI Control Software NE" runs on MOVIX DReamy and it is displayed on touch screen. The MOVIX DReamy Mobile X-Ray Unit is provided with separate battery packs for X-Ray generation and motorized movements of the unit can operate connected to mains or in stand-alone mode. New X-ray generator (model SHFM) is mounted on Battery Mobile X-Ray unit MOVIX DReamy. This X-Ray generator for MOVIX DReamy Mobile X-Ray Unit has a radiogenic unit mounted on head-assembly and comprising an X-ray tube with rotating anode and its circuit for high voltage. The electronic and associated software to control the X-ray generation are placed on mobile cart. The Battery Mobile X-Ray Unit MOVIX DReamy is provided with different output powers: 20 kW, 32 kW, 40 kW and 50 kW. There are available two X-ray tube inserts with rotating anode manufactured by CANON ELECTRON TUBES & DEVICES: XRR-3331 insert and E7886 insert. The Manual Beam Limiting Device is from Ralco, model: R108 F. External interface (controls) and covers are provided by Sedecal. There are two versions of collimator assembly, Basic and Advanced.

Based on the provided text, the MOVIX DReamy device is a mobile X-ray system. The document does not describe acceptance criteria for an AI/ML device or a study proving that the device meets such criteria. Instead, it is a 510(k) premarket notification for a mobile X-ray system, establishing substantial equivalence to a predicate device.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving an AI/ML device meets them based on the given document. The document describes the device, its intended use, comparison to a predicate device, and compliance with various international standards, but it explicitly states that no clinical testing was required to establish substantial equivalence.

The relevant sections for this request (AI/ML acceptance criteria and performance study) are not present in this document because it pertains to a different type of medical device clearance.

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Intended for use by a qualified/trained doctor or technician on both adult and pediatic 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

These are redesigned versions of our predicate mobile digital diagnostic xray systems. They feature motorized movement and full battery operation. Various Canon digital Xray panels are supplied with the system. (See list above.) The Mobile X-Ray Unit PhoeniX has a Basic configuration or Advanced configuration. Advanced configurations include:

• Second screen on head assembly.
• Smooth movements of head assembly.
• Telescopic arm in four steps instead three steps for basic configuration.

The Mobile X-Ray unit is provided with touch screen to operate as a control console. The Digital Imaging System is composed by image receptors and application for image acquisition (control console & image processing controller). The Image acquisition software "CANON CXDI Control Software NE" runs on Mobile X-ray unit and it is displayed on touch screen. It is the user interface and compatible digital detectors are listed above. All have FDA Clearance. The Advanced configuration has a second Touch Screen Monitor located on head-assembly.

The PhoeniX Mobile X-Ray Unit is provided with separate battery packs for X-Ray generation and motorized movements of the unit can operate connected to mains or in stand-alone mode, that is, operating without mains being present or unplugged from mains. The unit is connected to mains to charge the batteries; New rating: the input voltage range goes from 100 V~ to 240 V~, 1 phase, 1.1 kVA. New X-ray generator (model SHFM) is mounted on Battery Mobile X-Ray unit PhoeniX. This new X-Ray generator for PhoeniX Mobile X-Ray Unit has a radiogenic unit mounted on headassembly and comprising an X-ray tube with rotating anode and its circuit for high voltage. The electronic and associated software to control the X-ray generation are placed on mobile cart. The Battery Mobile X-Ray Unit PhoeniX is provided with different output powers: 20 kW, 32 kW, 40 kW and 50 kW. There are available two X-ray tube inserts with rotating anode manufactured by CANON ELECTRON TUBES & DEVICES:

• New: XRR-3331 insert.
• New: E7886 insert.
  New: Manual Beam Limiting Device from Ralco, model: R108 F. External interface (controls) and covers are provided by Sedecal. There are two versions of collimator assembly, Basic and Advanced.

The provided text describes a 510(k) premarket notification for a mobile X-ray system named PhoeniX. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study for novel acceptance criteria.

Therefore, many of the requested items (acceptance criteria, specific study details with sample sizes, expert involvement, and ground truth information) are not directly addressed in the provided FDA submission as they would be for a de novo marketing authorization or a more extensive clinical study. The submission relies heavily on non-clinical testing and the prior clearance of its components and predicate devices.

However, I can extract information related to the device's technical specifications and the basis for its substantial equivalence, which implicitly acts as its "acceptance criteria" for regulatory clearance.

Here's an analysis based on the provided text, addressing the points where information is available:

1. Table of Acceptance Criteria (Implicit) and Reported Device Performance

The device is considered acceptable if its performance and specifications are substantially equivalent to the predicate device and meet relevant international standards. The "reported device performance" in this context refers to its technical specifications and compliance with safety standards, rather than clinical performance metrics like sensitivity or specificity.

Regarding the Study Proving Acceptance Criteria:

The "study" in this submission is primarily a non-clinical bench testing and comparative analysis to establish substantial equivalence to a legally marketed predicate device (K161345 RadPRO® Mobile 40kW; RadPRO® Mobile 40kW FLEXPLUS).

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: Not specified in terms of number of images or patients. The non-clinical testing involved "Systems covering all generator/panel combinations were assembled and tested." This suggests testing of device configurations rather than a "test set" of medical images or patient data in the typical sense of an AI/CAD device.
• Data Provenance: Not applicable in the context of clinical data for a "test set." The testing是在实验室环境中，使用设备进行物理和功能验证。

3. Number of Experts and Qualifications to Establish Ground Truth:

• Not applicable as this was a non-clinical submission for substantial equivalence based on technical specifications and functionality. Clinical trials requiring expert reads for ground truth were not performed.

4. Adjudication Method:

• Not applicable as there was no clinical reading study or consensus required for ground truth determination.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No, an MRMC comparative effectiveness study was not done. The document states: "Summary of clinical testing: Clinical testing was not required to establish substantial equivalence because all digital x-ray receptor panels have had previous FDA clearance." This device is a mobile X-ray system, not an AI or CAD software that assists human readers.

6. Standalone (Algorithm Only Without Human-in-the-loop) Performance:

• Not applicable. This device is an X-ray imaging system, not an algorithm that performs a diagnostic task independently. Its performance is related to image quality, radiation output, mechanical safety, and electrical safety.

7. Type of Ground Truth Used:

• Technical Specifications and Compliance with Standards: The "ground truth" for this submission are the established performance characteristics of the predicate device and the specified requirements of relevant international safety and performance standards (e.g., IEC 60601 series, 21 CFR 1020.30). The "truth" is that the device meets these engineering and regulatory benchmarks.
• The document mentions that the modified combination of components "produced diagnostic quality images as good as our predicate generator/panel combination," implying an internal assessment of image quality, but no explicit detailed ground truth generation method is described for clinical image interpretation.

8. Sample Size for the Training Set:

• Not applicable. This is not an AI/ML device that requires a training set of data. The device's components (X-ray generator, panels, software) are either updates to existing technology or previously cleared devices.

9. How the Ground Truth for the Training Set Was Established:

• Not applicable, as there is no training set for an AI/ML algorithm.

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