(30 days)
The CR25.0 is indicated for use to provide diagnostic quality images to aid in physician diagnosis. The CR25.0 is intended to be used mainly in chest, skeletal, and gastro-intestinal x-ray imaging applications.
The ADC Compact Plus, the predicate device, is a computed radiology imaging system. Instead of screens and photographic film for producing the diagnostic image, the ADC Compact Plus system utilizes an "imaging plate." a plate coated with photo-stimulatable storage phosphors that are sensitive to X-rays and capable of retaining a latent image. This imaging plate is inserted into a device that scans it with a laser and releases the latent image in the form of light which is converted into a digital bit stream. The bit stream of image data is stored locally and can also be stored in a PACS network in DICOM format.
The CR25.0 is very similar to the ADC Compact Plus and the ADC Solo. The electronics are being reorganized and made smaller, which will result in lower power requirements. However, the basic principles of operation are unchanged. Instead of upgrading the currently marketed economy system called the ADC Solo, components of the high-end ADC Compact Plus were reintegrated into a compact lower-cost system, resulting is no loss of resolution or other measures of image quality.
This 510(k) summary for the Agfa CR25.0 doesn't contain detailed acceptance criteria or performance data from a specific study. Instead, it relies on demonstrating substantial equivalence to a predicate device (ADC Compact Plus) through a "Special 510(k) for Device Modification." This type of submission typically focuses on showing that modifications to an already cleared device do not introduce new questions of safety or effectiveness.
Here's a breakdown of the requested information based on the provided text, and where gaps exist:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in the document. The submission focuses on substantial equivalence, implying the CR25.0 meets the performance of the predicate device. | "no loss of resolution or other measures of image quality" compared to the predicate device (ADC Compact Plus). |
| "proper performance to specifications through various in-house reliability and imaging performance demonstration." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified. The document states that "performance data was collected," but details of the test set (number of images, cases, etc.) are not provided.
- Data Provenance: Not specified. It's implied that "in-house" testing was conducted, but the country of origin or whether it was retrospective/prospective is not mentioned.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not specified. There is no mention of expert review or ground truth establishment in relation to a test set for performance evaluation.
4. Adjudication Method for the Test Set
- Not specified. Since no expert review is mentioned, no adjudication method is detailed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- No, a MRMC comparative effectiveness study is not mentioned. The submission focuses on device modification and substantial equivalence, not a comparative study with human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
- The CR25.0 is a computed radiography imaging system, not an AI algorithm. Therefore, the concept of "standalone performance" for an algorithm does not directly apply in this context. The device's performance is inherently tied to producing diagnostic-quality images for human interpretation. The "imaging performance demonstration" refers to the system's ability to produce images, not an automated diagnostic output.
7. The Type of Ground Truth Used
- Not explicitly stated. Given the nature of a computed radiography system, "diagnostic quality images" for physician diagnosis is the primary output. The performance evaluation would likely focus on objective image quality metrics (e.g., resolution, signal-to-noise ratio, contrast) that ensure the produced images are suitable for clinical interpretation, rather than a specific disease outcome or pathology. The "ground truth" would be the technical specifications and expected image characteristics of a diagnostic imaging system.
8. The Sample Size for the Training Set
- Not applicable as the CR25.0 is a computed radiography imaging system, not an AI/machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable for the same reason as above (not an AI/machine learning algorithm).
Summary of Study (Based on Provided Text):
The "study" described is not a traditional clinical trial or comparative effectiveness study. It's a demonstration of substantial equivalence for a modified device (CR25.0) to its predicate (ADC Compact Plus).
- Objective: To demonstrate that the CR25.0, a modified version of the ADC Compact Plus, has "no loss of resolution or other measures of image quality" and meets essential performance specifications, thereby maintaining substantial equivalence to the legally marketed predicate device.
- Methodology: The submission states that "performance data was collected" through "various in-house reliability and imaging performance demonstration" tests. It also claims adherence to international standards (EN 60601-1-1 and EN 60601-1-2) for safety and essential performance. The specific details of these tests (e.g., types of phantoms used, metrics measured, experimental protocols) are not included in this summary, as per the format of a Special 510(k). The basis for acceptance is stated as "the declarations in Section IV provide certification that the data demonstrate equivalence."
- Conclusion: The manufacturer concluded that the CR25.0 is substantially equivalent to the predicate device, implying that its performance meets the requirements for a diagnostic imaging system as established by the predicate. FDA's clearance confirms this finding.
§ 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.