(23 days)
The DIGITAL RADIOGRAPHY CXDI-Elite / E1 provides digital image capture for conventional film/screen radiographic examinations. This device is intended to capture, for display, radiographic images of human anatomy, and to replace radiographic film/screen systems in all general purpose diagnostic procedures. This device is not intended for mammography applications.
The DIGITAL RADIOGRAPHY CXDI-Elite, also called the DIGITAL RADIOGRAPHY E1, (hereinafter referred to as CXDI-Elite) is a solid-state x-ray imager. The CXDI-Elite is a series of detectors, and in the predicate device consists of the CXDI-720C Wireless detector (also called the AR-E3543W detector), the CXDI- 420C Wireless detector (also called the AR-E4343W detector), and the CXDI-420C Fixed detector (also called the AR-E4343S detector). The detector intercepts x-ray photons, and the scintillator emits visible spectrum photons that illuminate an array of photodetectors that create electrical signals. After the electrical signals are generated, the signals are converted to digital values. The digital values are sent to the PC via a wired or wireless connection, converted to images with the CXDI Control Software, and then displayed on the PC/monitors. The PC/monitors used with the CXDI-Elite are not a part of this submission. The proposed changes to the predicate device, DIGITAL RADIOGRAPHY CXDI-Elite (K221620), include the addition of a new detector, the CXDI-820C Wireless (also called the AR-E2735W), to the CXDI-Elite series; the standardization of the thickness of CXDI-720C Wireless and CXDI-420C Wireless; the firmware update from F2.00.03.00 to 02.01.04.00; the CXDI Control Software version update from 3.10.2.2 to 3.10.2.6; and the addition of a 25 m of the CXDI-420C Fixed detector cable and a 10 m of Wiring Cable (WC-01). Together, these changes make up the CXDI-Elite.
Here's a breakdown of the acceptance criteria and study information for the Digital Radiography CXDI-Elite / E1, based on the provided text:
Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than a comprehensive performance study of a novel device. Therefore, a traditional "study that proves the device meets the acceptance criteria" in terms of clinical outcomes or diagnostic accuracy with human-in-the-loop is expressly stated as not necessary for this submission. The "acceptance criteria" here are primarily about conformance to safety and performance standards after design changes, and the "study" is the verification/validation activities.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Conformance with U.S. Performance Standard for radiographic equipment | The evaluation confirmed that the changes (addition of new detector, firmware, software updates) did not impact CXDI-Elite conformance with the U.S. Performance Standard for radiographic equipment. |
| Conformance with relevant voluntary safety standards for Electrical safety | The evaluation confirmed that the changes did not impact CXDI-Elite conformance with relevant voluntary safety standards for Electrical safety, specifically IEC 60601-1, 60601-1-3, and 60601-2-54. |
| Conformance with relevant voluntary safety standards for Electromagnetic Compatibility (EMC) | The evaluation confirmed that the changes did not impact CXDI-Elite conformance with relevant voluntary safety standards for Electromagnetic Compatibility, specifically IEC 60601-1-2. |
| Conformance with relevant voluntary safety standards for Usability | The evaluation confirmed that the changes did not impact CXDI-Elite conformance with relevant voluntary safety standards for Usability, specifically IEC 60601-1-6. |
| Device works as intended | Adequate detector bench testing successfully demonstrated that the subject detector CXDI-Elite / E1 works as intended. The verification/validation activities conducted support a determination of substantial equivalence, indicating the device performs as expected for its intended use (digital image capture for conventional film/screen radiographic examinations, replacing film/screen systems in general purpose diagnostic procedures, not for mammography). No new questions regarding safety or effectiveness were raised compared to the predicate device. |
| Substantial Equivalence to Predicate Device (K221620) | Achieved, based on similarities in primary intended use, principles of operation, functional design, and established medical use. |
Study Details:
This submission describes verification/validation activities rather than a clinical study.
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Sample size used for the test set and the data provenance: Not applicable in the context of a clinical test set. The submission refers to "adequate detector bench testing" and "verification/validation activities" which would involve testing the device itself against various parameters and standards. No specific number of images or patient data is mentioned for testing in the summary provided. The focus is on the device's technical performance and safety, not diagnostic accuracy based on a dataset.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for diagnostic decision-making from expert interpretation is not relevant for this type of submission, as it's not a diagnostic AI device requiring human reader comparison. The "ground truth" here is compliance with engineering specifications and regulatory standards, established through technical testing.
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Adjudication method for the test set: Not applicable. As there were no human readers establishing ground truth for diagnostic accuracy, no adjudication method was used.
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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: Not applicable. This device is a general-purpose digital radiography system, not an AI-assisted diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Yes, in terms of product performance and safety, the device itself was evaluated in a standalone manner (through bench testing and compliance checks). The "device works as intended" conclusion stems from this.
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The type of ground truth used:
- Engineering specifications and performance standards: For parameters like pixel pitch, scintillator type, spatial resolution, IP level, wireless communication, and physical dimensions.
- Regulatory standards: IEC 60601-1, 60601-1-2, 60601-1-3, 60601-2-54, 60601-1-6, and the U.S. Performance Standard for radiographic equipment.
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The sample size for the training set: Not applicable. This document does not describe the development of an AI algorithm, so there is no "training set."
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How the ground truth for the training set was established: Not applicable, as there is no training set for an AI algorithm mentioned.
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.