(166 days)
The Duet DRF is a digital image acquisition system to be used in conjunction with a solid state detector during radiography or fluoroscopy x-ray examination to capture, digitalize, review images and format images according to DICOM protocol to be sent through network connection. This device is not intended for mammography use
The Duet DRF is a Digital Radiography system, featuring an integrated flat panel digital detector (FPD) same as in K080859 DRF 4343, Villa sistemi medicali S.p.A. (this is the 510(k) for the system that incorporate the same flat panel detector and state of the art object-oriented software and connectivity.
The provided text describes the 510(k) submission for the Duet DRF device, a Digital Radiography system. However, it does not contain the detailed information requested regarding the acceptance criteria, specific performance study results, sample sizes for test sets or training sets, expert qualifications, or ground truth establishment methods.
The document states:
"The device has been designed verified and validated complying with 21CFR 820.30 regulations. Tests data demonstrate that the Duet DRF meets the required specifications. No adverse affects have been detected."
This is a general statement indicating that testing was performed to verify and validate the device, and that it met specifications. It does not provide the specifics needed for the requested information.
Therefore, for your current input, much of the requested information cannot be extracted. I will outline what can be gleaned and state where information is missing.
Here's a breakdown of the requested information based on the provided text, highlighting what is missing:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document. The document generally states that "Tests data demonstrate that the Duet DRF meets the required specifications." However, what those specific specifications or acceptance criteria were (e.g., image resolution, signal-to-noise ratio, image acquisition speed, diagnostic accuracy) and the quantitative results are not provided. | Not specified in the document. No specific metrics or performance values are reported. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified.
- Data Provenance: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
- Ground Truth Establishment Method for Test Set: Not specified. The document does not describe how ground truth was established for "tests data."
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not specified.
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
- MRMC Comparative Effectiveness Study: Not mentioned. The device is described as a "digital image acquisition system," not an AI-assisted diagnostic tool. Therefore, a study on human reader improvement with AI assistance would not be applicable based on the device description.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Standalone Performance Study: Not explicitly mentioned in terms of diagnostic accuracy or a specific algorithm study. The "tests data" mentioned suggests performance tests were done for the system (hardware and software), but not specifically for a standalone algorithm's diagnostic capability. The device's primary function described is image acquisition, digitalization, review, and formatting, not automated diagnosis.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: Not specified.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable/Not specified. The document primarily describes a hardware system for image acquisition. There's no indication of a machine learning model that would require a "training set" in the context of diagnostic AI.
9. How the ground truth for the training set was established
- Ground Truth for Training Set Establishment: Not applicable/Not specified, as there is no mention of a training set.
Summary of Device and Safety/Effectiveness Claims from the Document:
- Device Name: Duet DRF
- Device Type: Digital Radiography system with an integrated flat panel digital detector.
- Purpose: To capture, digitalize, review, and format X-ray images during radiography or fluoroscopy examinations, sending them via DICOM protocol.
- Predicate Device: K080859 DRF 4343
- Intended Use: Not for mammography.
- Safety & Effectiveness Claim: The device has been designed, verified, and validated complying with 21CFR 820.30 regulations. "Tests data demonstrate that the Duet DRF meets the required specifications. No adverse affects have been detected." The manufacturer believes it is substantially equivalent in safety and effectiveness to the predicate device.
Conclusion:
The provided text serves as a 510(k) summary, which often focuses on substantial equivalence to a predicate device and general declarations of meeting regulatory requirements. It does not delve into the detailed technical specifications, specific acceptance criteria, or performance study methodologies and results that would typically be found in a detailed validation report. Therefore, most of the specific questions about acceptance criteria, test set details, expert involvement, and ground truth establishment cannot be answered from this document.
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. 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). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic 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. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.