(66 days)
The URS-50RF 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 Canon Dynamic/Static DR URS-50RF is a portable digital radiography that can take images of any part of the body. It directly converts the X-ray images captured by the LANMIT (Large Area New MIS Sensor and TFT) 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.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Canon Dynamic/Static DR Model URS-50RF Fluoroscopic Digital X-Ray System:
Summary of Device and Study Information (K093688)
This 510(k) summary describes a fluoroscopic digital X-ray system, the Canon Dynamic/Static DR URS-50RF, intended to generate fluoroscopic images for vascular angiography, diagnostic and interventional procedures, and cardiology. It aims to replace image intensifier technology. The submission focuses on demonstrating substantial equivalence to predicate devices, primarily through performance testing and software validation.
1. Table of Acceptance Criteria and Reported Device Performance
Note: The provided document is a 510(k) summary. For medical devices, particularly those establishing substantial equivalence, explicit "acceptance criteria" are often phrased in terms of meeting or exceeding the performance of legally marketed predicate devices, or complying with relevant standards. The document does not list specific numerical acceptance criteria for image quality, diagnostic accuracy, or clinical endpoints. Instead, it makes a general statement about performance.
| Acceptance Criteria Category | Specific Acceptance Criteria (as implied/stated) | Reported Device Performance |
|---|---|---|
| Safety & Effectiveness | Device is safe and effective | Device demonstrated safe and effective operation. |
| Performance Comparability | Device performs comparably to predicate devices | Device performs comparably to predicate devices. |
| Substantial Equivalence | Device is substantially equivalent to predicate devices | Device is substantially equivalent to predicate devices. |
| Technological Characteristics | Technological characteristics are equal to or better than predicate devices | Technological characteristics are equal to or better than predicate devices, and units are functionally identical. |
| Electrical Safety | Compliance with relevant electrical safety standards | Electrical safety testing performed, unit complies with US Performance Standard for radiographic equipment. |
| Electromagnetic Compatibility (EMC) | Compliance with relevant EMC standards | Electromagnetic Compatibility testing performed. |
| Software Validation | Software is validated | Software Validation performed. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The document mentions "Tests were performed on the device," but does not specify the number of cases, images, or subjects used for performance testing.
- Data Provenance: Not specified. It's unclear if the testing involved human subjects, phantoms, or simulated data, or the country of origin of any data used. Given the nature of a 510(k) for an imaging device, it's highly probable that bench testing with phantoms and potentially some limited clinical evaluation (if required to show equivalence for image quality) was involved, but details are absent.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication Method for the Test Set
- Adjudication Method: Not specified. With no mention of expert review or ground truth establishment, no adjudication method is detailed.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not specifically mentioned or implied in the provided 510(k) summary. The summary focuses on demonstrating substantial equivalence to already marketed devices based on technological characteristics and general performance testing, rather than a direct comparison of physician performance with and without AI assistance.
- Effect Size of Human Reader Improvement: Not applicable, as no MRMC study (or AI assistance) was described.
6. Standalone (Algorithm Only) Performance Study
- Standalone Study: This device is a hardware fluoroscopic digital X-ray system, not an AI algorithm. Therefore, the concept of a "standalone (algorithm only)" performance study does not apply in this context. The performance described relates to the entire system's ability to acquire and process images.
7. Type of Ground Truth Used
- Type of Ground Truth: Not explicitly stated. The performance testing is generally described as validating that the device is "safe and effective" and "performs comparably" to predicate devices. For an imaging system, ground truth might involve:
- Physical Measurements: Using phantoms to verify spatial resolution, contrast resolution, noise, dose efficiency, etc.
- Clinical Image Quality Assessment: Expert review of images to ensure diagnostic interpretability, though this isn't detailed as "ground truth" establishment in the psychological sense.
- Comparison to Predicate: Performance is often benchmarked against images from the predicate device.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This device is a hardware imaging system, not an AI or machine learning algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set Establishment: Not applicable, as there is no training set for a hardware device.
§ 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.