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The Definium Pace Select ET is intended to generate digital radiographic images of the skull, spinal column, chest, abdomen, extremities, and other body parts in patients of all ages. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position and the system is intended for use in all routine radiography exams. Optional image pasting function enables the operator to stitch sequentially acquired radiographs into a single image. This device is not intended for mammographic applications.

The Definium Pace Select ET Radiography X-ray System is designed as a modular system with components that include a 2-axis motorized tube stand with tube and auto collimator assembled on an elevating table, a motorized wall stand, a cabinet with X-ray high voltage generator, a wireless access point, wireless detectors, an acquisition workstation including a monitor and control box with hand-switch. The system generates diagnostic radiographic images which can be reviewed or managed locally and sent through a DICOM network for reviewing, storage and printing.

By leveraging platform components / design, Definium Pace Select ET is similar to the predicate Definium Pace Select (K231892) and the reference Discovery XR656 HD (K191699) with regards to the user interface layout, patient worklist refresh and selection, protocol selection, image acquisition, and image processing based on the raw image. This product introduces motorized tube stand (vertical and tube angulation) instead of manual tube stand of the predicate. The high voltage generator is new and is backwards compatible to the predicates high voltage generator. This product also introduced Image Pasting on Table and Wall Stand Mode, Auto tracking for Wall Stand, Auto Angulation, Camera Workflow, DAP software calculation, Siemens LED collimator and LCD touch screen console. The other minor changes include updates to components due to obsolescence.

The provided document is a 510(k) premarket notification for a medical device called "Definium Pace Select ET." It describes the device, its intended use, and compares its technological characteristics to a predicate device ("Definium Pace Select") and a reference device ("Discovery XR656 HD").

However, this document does not contain any performance data or details of a clinical study that proves the device meets specific acceptance criteria based on AI or human reading performance.

The "PERFORMANCE DATA" section explicitly states: "The Definium Pace Select ET does not contain clinical testing data." Instead, it lists non-clinical tests performed, such as Risk Analysis, Requirements Reviews, Design Reviews, and various levels of verification testing (unit, integration, performance, safety, simulated use). These non-clinical tests are aimed at confirming the safety and effectiveness of the device as it relates to changes from the predicate, rather than evaluating specific clinical diagnostic performance metrics with a test set, ground truth, and human readers.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as the provided input does not contain this information.

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This product is intended to generate digital radiographic images of the skull, spinal column, extremities, and other body parts in patients of all ages. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position and the system is intended for use in all routine radiography exams. This device is not intended for mammographic applications.

The Definium Pace Select is a Digital Radiographic System designed as a modular system with components that includes fixed table with tube-stand, wallstand, cleared wireless digital detector, X-ray tube, collimator, high kV generator and acquisition workstation in control room. The system generates diagnostic radiographic images which can be sent through a DICOM network for applications including printing, viewing, and storage. The components may be grouped into different configurations to meet specific customer needs.

The FDA 510(k) summary for the Definium Pace Select, a Digital Radiographic System, indicates that clinical studies were not required to support substantial equivalence for this device. Therefore, a study proving the device meets specific acceptance criteria in terms of clinical performance (like sensitivity, specificity, or reader improvement with AI assistance) or a detailed clinical acceptance criteria table for such measures is not provided in this document.

The submission focuses primarily on demonstrating substantial equivalence to its predicate device (Discovery XR656 HD) based on non-clinical tests, technological characteristics, and safety/effectiveness data. The device's safety and effectiveness were confirmed through design verification and validation testing.

Here's a breakdown of the relevant information from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Since clinical studies were not deemed necessary for this 510(k) submission, there isn't a table presenting clinical acceptance criteria (e.g., sensitivity, specificity) and corresponding device performance metrics in the document. The acceptance criteria focused on compliance with voluntary standards and successful completion of verification and validation testing.

• ES 60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012
• IEC 60601-1-2:2014[Including AMD 1:2021]
• IEC 60601-1-3: 2021
• IEC 60601-1-6: 2020
• IEC 60601-2-54: 2018
• IEC 62366: 2015 + AMD1:2020
• ISO 10993-1: 2018
• ISO 10993-5: 2009/(R)2014
• ISO 10993-10: 2010/(R)2014
• ISO 10993-18 Second edition 2020-01
• PS 3.1 - 3.20: 2022d (DICOM set) |
  | Quality Assurance Measures | Applied: Risk Analysis, Requirements Reviews, Design Reviews, Unit level testing (Module verification), Integration testing (System verification), Performance testing (Verification), Safety testing (Verification), Simulated use testing (Validation). |
  | Risk Mitigation | Risks for new floor mounted positioners and image chain were evaluated, mitigated with design controls and labeling. Mitigations were verified and validated with acceptable results. |
  | Design Verification & Validation | Performed to confirm safety and effectiveness; test plans and results were executed with acceptable results. |

2. Sample Size for Test Set and Data Provenance:

No distinct "test set" in the context of clinical performance evaluation (e.g., images for diagnostic accuracy assessment) is mentioned because clinical studies were not required. The "testing" referred to in the document pertains to design verification and validation, which would involve hardware and software testing, rather than a clinical image dataset.

3. Number of Experts for Ground Truth and Qualifications:

Not applicable, as no clinical study requiring expert ground truth establishment for diagnostic accuracy was conducted for this submission.

4. Adjudication Method:

Not applicable, as no clinical study requiring adjudication of expert interpretations was conducted.

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

No MRMC study was conducted. The device is a digital radiographic system, and the submission emphasizes its substantial equivalence based on technological characteristics and safety, not on AI assistance to human readers.

6. Standalone (Algorithm Only) Performance:

Not explicitly detailed in terms of a standalone diagnostic performance study, as the device itself is an imaging system, not a standalone diagnostic algorithm. The "image processing with same algorithm" as the predicate device suggests the algorithms are part of the overall system functionality, not a separate AI diagnostic tool.

7. Type of Ground Truth Used:

For the non-clinical tests and design verification/validation, the "ground truth" would be established through engineering specifications, regulatory compliance standards, and functional requirements. For example, for radiation output, the ground truth would be the expected range defined by standards and the device's design. There is no mention of clinical ground truth (e.g., pathology, outcomes data) being used for this 510(k) submission.

8. Sample Size for Training Set:

Not applicable, as this device submission is for a digital radiographic system, not an AI/ML algorithm that typically requires a training set of data for development. The reference to "same algorithm" for image processing as the predicate implies existing, validated algorithms rather than newly trained ones.

9. How Ground Truth for Training Set Was Established:

Not applicable, as this device is not presented as an AI/ML system requiring a training set with established ground truth.

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