(128 days)
Agfa's DX-D Imaging Package is indicated for use in general projection radiographic applications to capture for display diagnostic quality radiographic images of human anatomy. The DX-D Imaging Package may be used wherever conventional screen-film systems may be used.
Agfa's DX-D Imaging Package is not indicated for use in mammography.
Agfa's DX-D Imaging Package is a solid state flat panel x-ray system, a direct radiography (DR) system (product code MQB) intended to capture images of the human body. It is a combination of Agfa's NX workstation and one or more flat-panel detectors.
This submission is to add the DR10s and DR14s Flat Panel Detectors to Agfa's DX-D Imaging Package portfolio. The DX-D Imaging Package with the DR 10s and DR 14s wireless panels will be labeled as the Pixium 2430EZ and Pixium 3543EZ. DR 10s and DR 14s are commercial trade names used by Agfa HealthCare for marketing purposes only.
Principles of operation and technological characteristics of the new and predicate device are the same. There are no changes to the intended use/indications of the new device is physically and electronically identical to the predicate, K142184. It uses the same workstation and the similatorphotodetector flat panel detectors to capture and digitize the images as predicate K142184.
This document describes the 510(k) summary for Agfa's DX-D Imaging Package, focusing on the newly added DR10s and DR14s Flat Panel Detectors. The submission aims to demonstrate substantial equivalence to a predicate device (K142184).
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a dedicated "acceptance criteria" table with specific quantitative thresholds. Instead, the acceptance criteria are implied to be equivalence to the predicate device (K142184) and performance falling within expected parameters for radiographic systems. The reported device performance is presented through comparison with other Agfa flat-panel detectors on the market, including the predicate.
Below is a table summarizing the performance characteristics of the new detectors (DR 10s, DR 14s) and the predicate (represented by DX-D 10, DX-D 20, DX-D 40 from the comparison table, as the predicate K142184's individual detector specs aren't explicitly broken out separately):
| Characteristic | DX-D 10 Flat-Panel Detector (Predicate Example) | DR 10s Wireless Detector (New Device) | DR 14s Wireless Detector (New Device) | Acceptance Criteria (Implied) | Reported Device Performance (Summary) |
|---|---|---|---|---|---|
| Scintillator | CsI, GOS | CsI | CsI, GOS | Equivalent to predicate (CsI, GOS) | DR 10s uses CsI, DR 14s uses CsI, GOS. Deemed equivalent. |
| Cassette size | 35x43cm/14x17in | 24x30cm | 35x43cm/14x17in | Appropriate for general radiography. | Different sizes, but appropriate for general radiography. |
| Pixel Size | 139 µm | 148 µm | 148 µm | Comparable to predicate (139-140 µm). | Slightly larger pixel size but deemed equivalent. |
| A/D Conversion | 14 bits | 16 bits | 16 bits | Comparable to predicate (14 bits). | Higher (16 bits) – considered an improvement. |
| Interface | Ethernet | AED & Synchronized | AED & Synchronized | Reliable interface. | AED & Synchronized. |
| Communication | Tethered | Wireless | Wireless | Reliable communication. | Wireless (new feature). |
| Power | I/O Interface Box: 100-240 VAC, 47-63 Hz | Battery: replaceable & rechargeable | Battery: replaceable & rechargeable | Reliable power. | Battery-powered for wireless operation. |
| Weight | 3.9 kg (8.6 lbs) | 1.6 kg (3.53 lbs) | 2.8 kg (6.17 lbs) | Ergonomically acceptable. | Lighter than predicate examples (due to wireless nature). |
| DQE @ 1lp/mm | 0.530/0.608 | 0.523 | 0.521/0.292 | Equivalent to predicate. | Comparable values, "equivalent to other flat-panel detectors." |
| DQE @ 2lp/mm | 0.219/0.298 | 0.476 | 0.449/0.189 | Equivalent to predicate. | Comparable values, "equivalent to other flat-panel detectors." |
| DQE @ 3lp/mm | 0.092/0.147 | 0.295 | 0.296/0.071 | Equivalent to predicate. | Comparable values, "equivalent to other flat-panel detectors." |
| MTF @ 1lp/mm | 0.205/0.456 | 0.637 | 0.638/0.526 | Equivalent to predicate. | Comparable values, "equivalent to other flat-panel detectors." |
| MTF @ 2lp/mm | 0.106/0.304 | 0.360 | 0.363/0.208 | Equivalent to predicate. | Comparable values, "equivalent to other flat-panel detectors." |
| MTF @ 3lp/mm | 0.092/0.147 | 0.199 | 0.198/0.081 | Equivalent to predicate. | Comparable values, "equivalent to other flat-panel detectors." |
| Image Acquisition/hr. | 150 | 240 | 240 | At least equivalent to predicate (150). | Higher (240) – considered an improvement. |
The overall acceptance criteria for the study is "Substantial Equivalence" to the predicate device (K142184), demonstrated through:
- Identical Indications for Use.
- Same principles of operation and technological characteristics (despite some hardware differences).
- Performance data (laboratory and clinical evaluations) ensuring equivalence.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size:
- For laboratory image quality (DQE, MTF) comparisons and grid evaluation: The document does not specify a numerical sample size in terms of images or measurements. It states "equivalent test protocols as used for the cleared detectors" were used and the results "confirmed that the DX-D Imaging Package with DR 10sC, DR14sC, and DR14sG flat-panel detectors was equivalent to other flat-panel detectors Agfa currently markets including the predicate (K142184)."
- For usability and functionality evaluations: Not specified.
- For Image Quality Validation testing (using anthropomorphic phantoms): Not specified.
- For in-hospital image quality comparisons ("clinical evaluations"): "anonymized" patient images were utilized, but the number of images or cases is not specified.
- Data Provenance: The data appears to be retrospective (for human image data, implied from "anonymized to remove all identifying patient information" and "No animal or clinical studies were performed in the development of the new device. No patient treatment was provided or withheld.") and laboratory-generated (for DQE, MTF, grid, usability, and phantom studies). The country of origin is not explicitly stated.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- For laboratory image quality, grid evaluation, usability/functionality:
- "qualified individuals employed by the sponsor" conducted these evaluations.
- "qualified independent radiographers" conducted usability and functionality evaluations.
- "a qualified internal radiographer" conducted the grid evaluation.
- "qualified independent radiographers" evaluated anthropomorphic phantoms.
- For in-hospital image quality comparisons:
- "qualified independent radiologists" conducted these comparisons.
- Qualifications: "Qualified independent radiographers" and "qualified independent radiologists" are mentioned. Specific experience levels (e.g., "10 years of experience") are not provided. The term "qualified" implies they possess the necessary expertise for the task.
4. Adjudication Method for the Test Set
The document does not explicitly state an adjudication method (e.g., 2+1, 3+1). The "clinical evaluations" and "in-hospital image quality comparisons" mention "qualified independent radiologists" in plural, suggesting a consensus or comparison approach among them, but details are not provided.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC comparative effectiveness study was done in the sense of measuring human reader improvement with vs. without AI assistance.
- The studies conducted were focused on demonstrating that the new device's image quality and performance were equivalent to the predicate device and other established systems, meaning human readers would perform similarly with the new device as with the predicate.
6. Standalone (Algorithm Only) Performance Study
- No standalone algorithm performance (AI-only) study was done for diagnostic interpretation. The device is an imaging package (hardware detectors and workstation) for capturing and displaying images, not an AI diagnostic algorithm.
7. Type of Ground Truth Used
- For laboratory image quality (DQE, MTF, grid): The "ground truth" is based on physical measurements and standardized test protocols.
- For usability and functionality: The "ground truth" is based on expert assessment by radiographers against pre-defined workflow and compatibility requirements.
- For image quality validation (phantoms): The "ground truth" is based on expert assessment by radiographers of the generated images, likely comparing features to expected phantom characteristics and established image quality standards.
- For in-hospital image quality comparisons: The "ground truth" is implicitly based on radiological expert consensus (potentially with existing patient reports as a reference, though this is not specified), primarily for qualitative comparison against images produced by predicate devices.
8. Sample Size for the Training Set
The document does not mention a training set, as this device (an X-ray imaging package) is not an AI diagnostic device that requires a training set in the typical machine learning sense. The "software validation testing" refers to verification and validation of the software components against predefined requirements, not training a machine learning model.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set for an AI algorithm is mentioned or implied.
§ 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.