(90 days)
To provide diagnostic quality images for aid in physician diagnosis. This is used in the X-Ray imaging modality, mainly in Chest, Skeleton, and Gastro-Intestinal imaging applications.
The ADC COMPACT is a Computed Radiography Imaging System. This system replaces conventional X-Ray cassettes that contain one or two intensifying screens and photographic light sensitive film. Computed radiography utilizes filmless cassettes. Instead of screens and photographic film to obtain the diagnostic image, the system employs what is termed as an imaging plate. This plate is coated with photo stimulatable storage phosphors that are sensitive to the X-Ray energy, and capable of retaining a latent image. This imaging plate is inserted into a device that scans it and releases the latent image in the form of light which is converted into a digital bit stream. This bit stream of image data is stored, and introduced to the PACS (Picture Archiving and Computerized System) network in DICOM format.
The major difference between the ADC COMPACT and the previous model in commercial distribution is the actual physical size of the portion of the system that reads and digitizes the imaging plates.
The provided text describes a Computed Radiography Imaging System called the ADC COMPACT. However, it does not contain specific information about detailed acceptance criteria, device performance metrics, or study designs (like sample sizes, expert qualifications, or ground truth establishment) that would typically be found in a clinical study report.
The document is a 510(k) summary and an FDA clearance letter, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed metrics.
Therefore, I cannot provide the requested table and study details. The text only mentions:
- Acceptance Criteria/Performance (General):
- The device "replaces conventional X-Ray cassettes" and uses "filmless cassettes" with "imaging plates."
- It is "capable of retaining a latent image."
- It converts the latent image into a "digital bit stream" for PACS in DICOM format.
- It provides "diagnostic quality images for aid in physician diagnosis."
- The software has been "evaluated and verified with respect to level of concern utilizing the methods suggested by the Office of Device Evaluation (ODE)." The software risk falls into the "Broadly Acceptable, or Lower Level of Concern range."
- AGFA has "conducted adequate safety and effectiveness testing in clinical environments that would be relevant to an assessment of substantial equivalence." (No details provided)
The document explicitly states that the "major difference between the ADC COMPACT and the previous model...is the actual physical size of the portion of the system that reads and digitizes the imaging plates." This implies that the core image quality and diagnostic capabilities are assumed to be similar to the predicate device (ADC 70, K904519A).
Without a detailed performance study in the provided text, the specific information for your questions 1 through 9 cannot be extracted.
§ 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.