(19 days)
Agfa's Computed Radiography Systems with DX-G Digitizers are indicated for use in providing diagnostic quality images to aid the physician with diagnossis.
Systems can be used with either Musica or Musica 2 image processing to create radiographic images of the skeleton (including skull, spinal column and extremities) chest, abdomen and other body parts.
System options and accessories are available for:
- Pediatric imaging ●
- Full leg/full spine .
- Radiotherapy planning and QC .
- Musica2 Platinum (thorax, abdomen or musculoskeletal regions of adult or ● pediatric patients)
- Musica2 Neonatal .
Agfa's Computed Radiography Systems with NX Workstations are not indicated for use in mammography.
The new devices are computed radiography imaging systems of similar design and construction to the predicates. The devices capture radiographic exposures on phosphor plates that are then scanned with a laser to create an electronic image. Electronic images can then be manipulated, printed, or sent to a softcopy capable display or archive such as a PACS system.
New DX-G digitizers provide the following new benefits:
- The ability to use both standard and needle phosphor image plates with a single digitizer.
- 0 Input and output cassette storage buffers that allow the x-ray technologist to load up to five exposed cassettes at a time. The cassettes can be of any type and size, freeing the technologist from having to process and wait on each image separately.
- . An image data format that provides slightly improved latitude for over-exposures.
The principles of operation of the new and predicate devices are the same. They have the same underlying technological characteristics.
The provided text describes a 510(k) summary for AGFA Computed Radiography (CR) Systems with DX-G Digitizers. It asserts substantial equivalence to a predicate device and mentions general testing, but it does not contain details about specific acceptance criteria or a dedicated study proving performance against such criteria.
Therefore, I cannot populate most of the requested fields definitively. Here's what I can extract or infer based on the provided text, and where information is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Equivalent diagnostic quality to predicate device | "Descriptive characteristics and performance data are adequate to ensure equivalence." (General statement, no specific metrics provided) |
| Proper performance to specifications | "Agfa's Computed Radiography (CR) Systems with DX-G Digitizers have been tested for proper performance to specifications through various internal tests." (No specific criteria or results provided) |
| Compliance with EN 60601-1-1 and EN 60601-1-2 | "Components have been tested and shown to meet the requirements of EN 60601-1-1 and EN 60601-1-2." (No specific test results provided) |
| Maintenance of intended therapeutic/diagnostic effect | "Differences in devices do not alter the intended therapeutic/diagnostic effect." (General statement) |
| Ability to use both standard and needle phosphor image plates with a single digitizer | Implied by device description of new benefits. No specific test results. |
| 0 Input and output cassette storage buffers allowing loading of up to five exposed cassettes | Implied by device description of new benefits. No specific test results. |
| Image data format providing slightly improved latitude for over-exposures | Implied by device description of new benefits. No specific test results. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified.
- Data Provenance: Not specified. The document mentions "various internal tests," which suggests company-generated data, but details like country of origin or whether it was retrospective/prospective are not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not specified. The document does not describe a study involving expert review for ground truth.
4. Adjudication method for the test set
- Not specified. No such study is described.
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 MRMC study described. This device is a Computed Radiography system (hardware and associated basic image processing), not an AI-based diagnostic tool. Therefore, a study assessing human reader improvement with/without AI assistance would not be applicable or expected in this context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No standalone algorithm performance study is described or applicable in the context of this device. This is a foundational imaging system, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not specified. Given the nature of a CR system, ground truth for image quality might be assessed through objective metrics (e.g., SNR, resolution, contrast), but no details are provided. Ground truth for diagnostic accuracy would typically involve comparison to an established clinical gold standard, which is not detailed here for any performance claim.
8. The sample size for the training set
- Not applicable / Not specified. This device is an imaging system; the text does not describe an AI/machine learning component that would require a "training set" in the typical sense. Any internal image processing (like Musica/Musica2) would be based on algorithms, not necessarily a trained machine learning model from a distinct training set.
9. How the ground truth for the training set was established
- Not applicable / Not specified. As no training set is described for an AI/ML component, the method for establishing its ground truth is also not mentioned.
§ 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.