(14 days)
Agfa's DX-D 300 is indicated for use in providing diagnostic quality images to aid the physician with diagnosis.
Systems can be used with MUSICA2 image processing to create radiographic images of the skeleton (including skull, spinal column and extremities) chest, abdomen and other body parts.
Agfa's DX-D 300 is not indicated for use in mammography.
The device is a combination of a conventional x-ray system with digital image capture equipment. The new device is a simple combination of the two predicate devices with minor modifications. The DX-D 300 uses Agfa's familiar NX workstation with MUSICA-TM image processing and flat panel detectors of the scintillator-photodetector type (Cesium lodide or Gadolinium Oxysulfide),
With the new device, users have the ability to control patient exposure settings from the NX workstation. Principles of operation and technological characteristics of the new and predicate devices are the same.
Agfa's DX-D 300 includes both a traditional U-Arm x-ray system for patient exposure and digital image capture equipment.
The x-ray system includes one of four 50-80 kW generators and one of three Toshiba x-ray tubes. U-arm rotation, height, source-to-image distance and detector rotation are controlled by dual speed motors at the unit or by a remote control. Sensors on the equipment ensure patient safety at all times. An optional rolling patient table is available.
A Cesium Iodide or Gadolinium Oxysulfide flat panel detector is used to capture the image. Previews are available to the operator in as little as one second after exposure. MUSICA"1M image processing provides consistent image quality. DICOM connectivity allows images to be directed to the user's PACS system, archive or hard copy printer. The workstation can also be connected other Agfa computed radiography systems at the facility.
Here's a breakdown of the acceptance criteria and the study information for the AGFA DX-D 300, based on the provided text:
Summary of Device and Acceptance:
The AGFA DX-D 300 is a stationary digital x-ray system, combining a conventional x-ray system with digital image capture. Its intended use is to provide diagnostic quality images for a physician's diagnosis across various body parts (skeleton, chest, abdomen, etc.), excluding mammography.
The acceptance of this device for market clearance was based on demonstrating substantial equivalence to two legally marketed predicate devices: Agfa's DX-D Imaging Package (K092669) and Sedecal's X Plus LP Plus x-ray system (K062335). The core argument for acceptance is that the DX-D 300 is a simple combination of these two proven technologies with only minor modifications.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Demonstrated Equivalence to Predicates) | Reported DX-D 300 Performance |
|---|---|
| Intended Use Statement (Nearly identical to predicates) | Same as predicates |
| Technological Characteristics | Same as predicates |
| DICOM Communications | Same as predicate |
| Detector Material (GOS or CsI scintillator) | Same as predicate |
| Detector Sizes (14x17 in. & 17x17 in) | Same as predicate |
| Active Matrix (3056x3056, 3072x2560) | Same as predicate |
| Pixel Size (139 µm) | Same as predicate |
| Fill Factor (100%) | Same as predicate |
| Dynamic Range (14 bit DR, 12 bit CR) | Same as predicate |
| Maximum Image Acquisitions/hr. (150) | Same as predicate |
| Image Processing (MUSICA2) | Same as predicate |
| Operating System (Windows XP Pro) | Same as predicate |
| Display System (Standard PC or cleared medical display) | Same as predicate |
| Operator Workstation (Agfa NX with Soft Console Software) | Agfa NX with Soft Console Software |
| Power Supply (47-63 Hz, 90-264V auto ranging) | Same as predicate |
| Electrical Safety (IEC-60601) | Same as predicate |
| Performance Standard (N/A for Agfa predicates) | N/A (referencing 21CFR1020.30 for Sedecal predicate) |
| Generators (N/A for Agfa predicates) | Same as predicate (Choice of four models, 50-80 KW) |
| Tubes (N/A for Agfa predicates) | Same as predicate (Choice of three Toshiba models) |
| Safety and Performance Standards Conformance | Conforms to listed IEC, ACR/NEMA, ISO standards (see below) |
| IEC 60601-1-1 | Conforms |
| IEC 60601-1-2 | Conforms |
| ACR/NEMA PS3.1-3.18 | Conforms |
| IEC 60601-1-3 | Conforms |
| IEC 60601-1-4 | Conforms |
| IEC 60601-2-7 | Conforms |
| IEC 60601-2-28 | Conforms |
| IEC 60601-2-32 | Conforms |
| ISO 14971 | Conforms |
| ISO 13485 | Conforms |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: "Sample images have been provided." The document does not specify an exact number of images or patients used for performance validation.
- Data Provenance: Not explicitly stated whether the sample images were retrospective or prospective, or their country of origin. Given the nature of the submission (demonstrating substantial equivalence through technical specifications and conformance to standards rather than clinical performance), these images likely served as illustrative examples rather than part of a formal clinical test set designed to establish diagnostic accuracy endpoints.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not provided. The submission states, "No clinical testing was performed in the development of the DX-D 300." Therefore, there was no expert review process described for establishing ground truth from images or cases in a clinical trial context.
4. Adjudication method for the test set
- None specified. As no clinical testing with expert review was described, there was no adjudication method.
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 such study was done. The DX-D 300 is a digital x-ray imaging system, not an AI-powered diagnostic device designed to assist human readers. The submission explicitly states, "No clinical testing was performed."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. The DX-D 300 is a hardware and software system for image acquisition and processing (MUSICA2), not a standalone algorithm performing diagnostic interpretations. Its performance is related to image quality and technical specifications, not automated diagnosis.
7. The type of ground truth used
- Not applicable in a diagnostic accuracy sense. The "ground truth" for this submission was primarily established by demonstrating
technical conformance to standards(e.g., IEC, ACR/NEMA, ISO) andequivalency of technical specificationsto the predicate devices. The "performance of the complete system has been validated" likely refers to engineering verification and validation testing against these technical standards, rather than clinical ground truth (e.g., pathology, outcomes).
8. The sample size for the training set
- Not Applicable. The DX-D 300 is not an AI/machine learning device that requires a training set in the conventional sense. The MUSICA2 image processing is a predefined algorithm rather than one that "learns" from data.
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set for an AI algorithm for this device, there is no corresponding ground truth establishment.
§ 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.