(55 days)
D2RS & D2RS9090 Digital Dynamic Remote System is indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic, and interventional procedures. It is also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures. It is intended to replace fluoroscopic images obtained through image intensifier technology. Not intended for mammography applications.
The D2RS & D2RS9090 are direct digital dynamic remote-controlled fluoroscopy and radiography systems equipped with the latest generation of Canon Flat Panel Detector (FPD). The single FPD can perform both fluoroscopy and radiography and is detachable and portable for direct projections to create a unique and highly versatile 3-in-1 imaging solution. The receptor panel directly converts the X-ray images captured by the sensor into a high-resolution digital images. The instrument is suited for use inside a patient environment. This unit converts the X-rays into digital signals. The unit can acquire still and moving images. The system includes a remotely controlled tilting/elevating table. A new tilting table has been introduced (D2RS9090). This new variant of D2RS consists of a modification of the foot of the remote controlled table. Instead of being down the table, this one is now behind. This allows a tilting from -90 to +90° (versus -25 to 90° with previous version) and an elevation from 368 to 1455 cm (versus 640 to 930 cm with previous version). The control console has been updated to a more modern looking design but is functionally identical to the predicate.
The provided text describes a 510(k) premarket notification for a medical device called D2RS & D2RS9090 Digital Dynamic Remote System. The submission aims to establish substantial equivalence to a predicate device (D2RF Digital Dynamic Remote System). Here's a breakdown of the requested information based on the provided text, with notes where information is not explicitly stated.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally implied to be "as safe and effective as the predicate device" and compliance with relevant IEC standards and FDA guidances. The performance is assessed against these implicit criteria and through a comparison of technological characteristics.
| Acceptance Criteria (Implied / Explicit) | Reported Device Performance and Evidence |
|---|---|
| Technological Equivalence / Superiority (Implicit) | Comparison Table (New Device vs. Predicate): |
| Indicatons for Use remain unchanged | Same Indications for Use: D2RS & D2RS9090 is indicated for generating fluoroscopic images of human anatomy for vascular angiography, diagnostic, and interventional procedures, and for cardiology, diagnostic, and interventional procedures. Intended to replace image intensifier technology, not for mammography. (Matches predicate) |
| Updated Digital Panel Performance (Superior or Equivalent) | New Panel: Canon CXDI-RF Wireless B1 (Predicate used Canon CXDI-50RF) |
- Dimension: 480 x 460 mm (vs. 492.8 x 503.1 mm)
- Useful Area: 42 x 43 cm (vs. 35 x 43 cm) - Superior
- Scintillator: CsI (Same)
- Pixel Pitch: 160 µm (Same)
- Spatial Resolution: 3.1 lp/mm (Same)
- Matrix: 2592 x 2656 pixels (vs. 2208 x 2688 pixels) - Superior
- AD Conversion: 16 bits (vs. 14 bits) - Superior
- DQE: 60% (0.5 lp/mm) (vs. 59% (0.5 lp/mm)) - Superior
- MTF: 38% (2 lp/mm) (vs. 30% (2 lp/mm)) - Superior
- Fps Max: 30 fps (Same)
- Interface: Ethernet/Wireless WiFi (vs. Ethernet) - Superior
- DICOM 3: YES (Same)
- Operating Temperature: 15-40°C (Same) |
| New Tilting Table Functionality (Superior or Equivalent) | New Tilting Table (D2RS9090): Tilting from -90 to +90° (vs. -25 to 90° for predicate) - Superior. Elevation from 368 to 1455 cm (vs. 640 to 930 cm for predicate) - Superior. |
| Compliance with International Standards and FDA Guidance (Explicit) | Bench/Performance Testing Data: Systems covering all generator/panel combinations were assembled and tested and found to be operating properly. Software validated per FDA Guidance for Software. Cybersecurity recommendations followed per FDA Guidance. New digital x-ray panel tested per FDA Guidance for Solid State X-ray Imaging Devices.
Compliance with: IEC 60601-1, IEC 60601-1-3, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-28, IEC 60601-2-54, IEC 62304. Unit complies with US Performance Standard for radiographic equipment. |
| Diagnostic Quality of Images (Implicit based on indications for use) | Clinical Evaluation: A board certified radiologist reviewed both static and moving images and found them to be of excellent diagnostic quality. |
| Overall Safety and Effectiveness (Conclusion for Substantial Equivalence Dt.) | Conclusion: Based on comparison of technological characteristics and bench/clinical results, the modified and updated system is as safe and effective as the predicate device and is therefore substantially equivalent. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not explicitly stated. The text mentions "both static and moving images" were reviewed, but doesn't quantify the number of images or cases.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: "A board certified radiologist" (singular) was used.
- Qualifications: "board certified radiologist." Specific experience level (e.g., years of experience) is not mentioned.
4. Adjudication method for the test set
- Adjudication Method: "A board certified radiologist reviewed... and found them to be of excellent diagnostic quality." This implies a single-reader review rather than an adjudication process involving multiple experts. No formal adjudication method (like 2+1 or 3+1) is mentioned.
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 Study: No, an MRMC comparative effectiveness study was not explicitly done. The study described is a single-reader review for diagnostic image quality, comparing the device's output to an implicit standard of "excellent diagnostic quality," likely in comparison to the predicate device's expected performance. This submission is for an imaging system, not an AI-assisted diagnostic tool.
- Effect Size: Not applicable, as no MRMC study with AI assistance was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable in the context of this submission. The device is an X-ray imaging system, where human interpretation of the images is inherent to its use. The "algorithm" here refers to the system's image acquisition and processing capabilities, not an AI for diagnosis. The clinical evaluation focuses on the quality of the images produced for human interpretation.
7. The type of ground truth used
- Type of Ground Truth: The ground truth for the clinical evaluation was based on the subjective assessment of a "board certified radiologist" who determined the images to be of "excellent diagnostic quality." This is an expert opinion/consensus implicitly benchmarked against diagnostic standards. It is not pathology, or outcomes data.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. The device described is an X-ray imaging system, not an AI/machine learning algorithm that requires a training set in the conventional sense. The "training" of such a system involves engineering and calibration to produce high-quality images according to technical specifications and clinical needs, rather than learning from a dataset.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable. As mentioned above, this is an X-ray imaging system, not an AI/ML algorithm that generates a "ground truth" during a training phase.
In summary, the submission focuses on demonstrating substantial equivalence primarily through technological comparison to a predicate device, adherence to relevant technical standards, and a qualitative assessment of image quality by a radiologist. It is not an AI-based diagnostic device; therefore, many of the questions related to AI studies (MRMC, training sets, etc.) are not directly applicable.
§ 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.