(9 days)
The ADC Compact Plus is indicated for use to provide diagnostic quality images to aid in physician diagnosis. The ADC Compact Plus is intended to be used mainly in chest, skeletal, and gastro-intestinal x-ray imaging applications.
The ADC Compact Plus is similar to the ADC Compact, but it has a different laser and smaller spot size for improved resolution and higher sensitivity. An improved detector improves the throughout. The electronics are being reorganized and made smaller, which will result in lower power requirements. However, the basic principles of operation are unchanged. The components that implement these principles of operation are simply being upgraded with better components that are now available.
The provided text describes the Agfa ADC Compact Plus, a computed radiography system, and its substantial equivalence to its predicate device, the ADC Compact. However, it explicitly states that performance data was NOT included in the submission for the Special 510(k) for Device Modification. Instead, the submission relies on declarations that the data demonstrate equivalence. Therefore, a detailed study proving the device meets specific acceptance criteria, including sample sizes, ground truth establishment, expert qualifications, or MRMC data, cannot be extracted from this document.
Here's what can be reported based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria or provide a table of performance metrics. It generally claims "proper performance to specifications" and mentions improvements:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| General Performance: | Proper performance to specifications through various in-house reliability and imaging performance demonstration tests. |
| Resolution: | Improved resolution (due to different laser and smaller spot size). |
| Sensitivity: | Higher sensitivity (due to improved detector). |
| Throughput: | Improved throughput (due to improved detector). |
| Power Requirements: | Lower power requirements (due to reorganized and smaller electronics). |
| Safety and Electrical: | Meets requirements of EN 60601-1-1 and EN 60601-1-2. |
2. Sample size used for the test set and the data provenance
The document does not provide any information on the sample size used for the test set or the data provenance. It states, "performance data were not included in the submission, but the declarations in Section IV provide certification that the data demonstrate equivalence."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not provide any information on the number or qualifications of experts used to establish ground truth for a test set.
4. Adjudication method for the test set
The document does not specify any adjudication method for a test set.
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
The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. The device described is a computed radiography system, not an AI-based diagnostic tool, so this type of study would not be relevant in this context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document does not describe a standalone algorithm performance study. The device is a hardware system for image acquisition.
7. The type of ground truth used
The document does not explicitly state the type of ground truth used for any testing.
8. The sample size for the training set
The document does not provide any information on a training set sample size.
9. How the ground truth for the training set was established
The document does not provide any information on how ground truth for a training set was established.
§ 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.