(106 days)
Agfa's Computed Radiography (CR) System with CR 12-X Digitizer is indicated for use in general projection radiographic applications to capture for display diagnostic quality radiographic images of human anatomy. The system may be used wherever conventional screen-film systems are used.
Agfa's Computed Radiography (CR) System With CR 12-X Digitizer is not indicated for use in mammography.
Agfa's Computed Radiography (CR) Systems with CR 12-X Digitizer is a solid state x-ray imaging device. Principles of operation and technological characteristics of the new and predicate devices are largely the same as other computed radiography systems:
Phosphor coated imaging plates and cassettes for image capture. Laser digitizer for generating the electronic image. NX workstation for image previewing, processing and routing.
ACCEPTANCE CRITERIA AND STUDY ANALYSIS FOR AGFA CR 12-X DIGITIZER (K131408)
The Agfa CR 12-X Digitizer received 510(k) clearance based on its substantial equivalence to predicate devices (Agfa CR 10-X Digitizer (K121948) and 3Disc America's Fire CR+ Digitizer (K102619)). The primary method for proving substantial equivalence was through technical comparisons and phantom image quality tests, as clinical images were deemed unnecessary given the modifications from the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in a quantitative sense for performance metrics like sensitivity or specificity. Instead, the approach is based on demonstrating that the CR 12-X Digitizer performs equivalently to the predicate devices, particularly the CR 10-X, regarding image quality and functional specifications. The "acceptance" is implied by demonstrating substantial equivalence, meaning the device meets the same safety and effectiveness standards as its predicate.
| Feature/Metric | Acceptance Criteria (Implied by Predicate Equivalence) | Reported Device Performance (CR 12-X Digitizer) |
|---|---|---|
| Image Quality | Equivalent to CR 10-X Digitizer (K121948) | Image quality tests comparing CR 12-X to CR 10-X predicate using phantom images showed equivalence. |
| Scanning Resolution | 100µm (CR 10-X), 100µm & 200µm (FireCR+) | 100µm, 150µm, 200µm selectable resolutions |
| Throughput (35x43 cm plates/hr) | 34 @ 100µm (CR 10-X); 20 @ 200µm, 70 @ 100µm (FireCR+) | 60 @ 200µm; 72 @ 150µm; 90 @ 100µm |
| Image Plate Phosphors | BaSrFBrI:Eu | Same as both predicates (BaSrFBrI:Eu) |
| Scanning Technology | Point at-a-time | Same as both predicates (Point at-a-time) |
| Dynamic Range (acquisition) | 16 bit, sq. root compressed | Same as both predicates (16 bit, sq. root compressed) |
| Image Processing | MUSICA, MUSICA2 (CR 10-X) | Same as CR 10-X (MUSICA, MUSICA2) |
| Safety & Effectiveness | Conformance to product safety, radiology, and imaging standards (e.g., IEC 60601-1, IEC 60601-1-2) | Device completed verification and validation to confirm it meets specifications and operates as planned; risk assessment concluded medical risk is not higher than previous released systems. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document states that phantom images were used for evaluation. However, the specific number of phantom images or the sample size of the test set is not explicitly provided.
- Data Provenance: The data used for testing was generated internally by Agfa as part of their verification and validation process. The type of data (phantom images) means the provenance is synthetic/controlled rather than real patient data from a specific geographical region. All testing was presumably conducted in a controlled lab environment. The study is prospective in the sense that the tests were designed and executed to evaluate the new device, but the "data" itself (phantom images) is not from a retrospective or prospective clinical cohort.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Number of Experts: The document states that "internal and experts" were involved in comparing the CR 12-X to the CR 10-X predicate for image quality tests. The exact number of experts is not specified.
- Qualifications of Experts: The specific qualifications (e.g., years of experience, subspecialty) of these "experts" are not detailed in the provided text.
4. Adjudication Method for the Test Set:
- The document implies a comparison was made by "internal and experts." However, the adjudication method (e.g., majority vote, consensus, blinded review, 2+1, 3+1) is not described.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:
- No Multi Reader Multi Case (MRMC) comparative effectiveness study was mentioned or performed. The evaluation focused on substantial equivalence through technical comparisons and phantom image quality tests. No assessment of human reader improvement with or without AI assistance was conducted or reported, as this is neither an AI device nor an MRMC study.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done:
- This device is a Computed Radiography system (a digitizer), not an algorithm or AI solution. Therefore, the concept of "standalone (algorithm only)" is not applicable to this submission. The device performs image acquisition and initial processing before human review.
7. The Type of Ground Truth Used:
- For the image quality tests, the ground truth was based on the image characteristics of the predicate device (CR 10-X Digitizer) using phantom images. The goal was to show that the CR 12-X produced images of equivalent diagnostic quality. Since phantom images were used, the "ground truth" refers to the expected image characteristics as defined by the predicate and established imaging standards.
8. The Sample Size for the Training Set:
- This submission does not discuss a "training set" in the context of machine learning or AI. The device is a CR digitizer, and its performance is based on hardware and firmware design, not a trained algorithm in the AI sense. Therefore, the concept of a training set is not applicable.
9. How the Ground Truth for the Training Set Was Established:
- As the concept of a "training set" is not applicable, the establishment of its ground truth is also not applicable.
§ 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.