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510(k) Data Aggregation
(210 days)
DIGITAL RADIOGRAPHY CXDI-401C WIRELESS
The DIGITAL RADIOGRAPHY CXDI-401C Wireless provides digital image capture for conventional film/screen radiographic examinations. This device is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures. This device is not intended for mammography applications.
The model of detector included in this submission is a solid state x-ray imager. Model CXDI-401C Wireless has an approximate imaging area of 41.5 x 42.6 cm. For this model, the detector intercepts x-ray photons and the scintillator emits visible spectrum photons that illuminate an array of photo-detectors that create electrical signals. After the electrical signals are generated, the signals are converted to digital values and the images will be displayed on monitors. The digital value can be communicated to the operator console via wiring connection or wireless. The proposed model includes the Non-Generator Connection Mode, allowing this model to detect x-ray irradiation without direct electrical connection to the x-ray generator.
The Canon DIGITAL RADIOGRAPHY CXDI-401C Wireless device is a flat panel digital imager intended to replace conventional film/screen radiographic systems for general diagnostic procedures, excluding mammography. The provided document details its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or specific studies proving device performance against such criteria in the way a clinical performance study would.
Instead, the document focuses on demonstrating substantial equivalence to existing FDA-cleared predicate devices (K131106 MQB DIGITAL RADIOGRAPHY CXDI-701C Wireless and K103591 MQB DIGITAL RADIOGRAPHY CXDI-401C COMPACT). The performance claim is that the device is "safe and effective, performs comparably to the predicate device(s), and is substantially equivalent."
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly present a table of quantitative acceptance criteria for clinical performance (e.g., sensitivity, specificity, accuracy, or image quality metrics for specific disease detection) or compare the device's performance against such criteria. The "performance" described is largely comparative to predicate devices for technological characteristics and compliance with safety and established standards.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety and Effectiveness | "device is safe and effective" |
| Comparable performance to predicate devices | "performs comparably to the predicate device(s)" |
| Substantial equivalence to predicate devices | "is substantially equivalent to the predicate device(s)" |
| Compliance with internal functional specifications (including software) | "verification/validation testing to internal functional specifications (including software)" |
| Non-clinical image comparisons | "non-clinical image comparisons involving flat panel display images taken with the new device and the predicate devices" |
| Compliance with FDA Guidance for Software in Medical Devices | "compliance of the CXDI-401C Wireless to all FDA requirements stated in Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" |
| Compliance with FDA Guidance for RF Wireless Technology | "CXDI-401C Wireless RF technology is in accordance with the FDA Guidance Radio Frequency Wireless Technology in Medical Devices" |
| Compliance with FDA Guidance for Solid State X-ray Imaging Devices | "CXDI-401C Wireless complies with the FDA requirements stated in Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices" |
| Equivalence in image quality to CXDI-701C Wireless | "evaluations of the Non-clinical and Clinical Considerations... including the image quality evaluation, show the CXDI-401C Wireless to be equivalent to the CXDI-701C Wireless" |
| Compliance with U.S. Performance Standard for radiographic equipment | "complies with the U.S. Performance Standard for radiographic equipment" |
| Compliance with relevant voluntary safety standards (IEC) | "complies with... IEC standards 60601-1, 60601-1-2, 60601-1-3, and 60601-2-32" |
| Compliance with FCC test standards (SAR, EMI) | "complies with the FCC test standard for SAR... and for EMI test regulations FCC Part 15 Subpart B:2012 Class A and ICES-003 Issue 5:2012 Class A" |
2. Sample size used for the test set and the data provenance:
The document mentions "non-clinical image comparisons involving flat panel display images taken with the new device and the predicate devices" and "image quality evaluation." However, it does not specify the sample size for any test set (number of images, patients, or types of cases) nor the data provenance (e.g., country of origin, retrospective/prospective). These appear to be internal verification and validation tests rather than a formal clinical trial with a defined test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
The document does not provide information on the number or qualifications of experts used to establish ground truth for any image comparisons or evaluations.
4. Adjudication method for the test set:
The document does not specify any adjudication method for a test set.
5. 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 MRMC comparative effectiveness study is mentioned. The device described is a digital radiography system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
The device is a hardware component (flat panel detector) for digital radiography. It is not an algorithm that performs image analysis in a "standalone" fashion as would be discussed for AI. The performance is related to its image capture capabilities, implying a human-in-the-loop for interpretation.
7. The type of ground truth used:
The document implies "image quality evaluation" and "non-clinical image comparisons." The nature of the "ground truth" for these evaluations is not explicitly stated. For "image quality," it could refer to objective metrics, visual assessment against a reference, or comparison to known image characteristics. For "non-clinical image comparisons," it likely refers to direct comparison of images from the new device versus predicate devices. This is not a clinical ground truth derived from pathology or patient outcomes.
8. The sample size for the training set:
The document describes a hardware device. There is no mention of a training set in the context of an algorithm or AI model.
9. How the ground truth for the training set was established:
As there is no training set mentioned for an algorithm, this information is not applicable.
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