(42 days)
The device is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Abdomen;Pediatric;Small Organ(breast,tests,thyroid);heart soft tissue; Peripheral Vascular; Musculo-skeletal(conventional) ; Ob/Gyn and Urology.
The CGMC OPUS 5000 diagnostic doppler ultrasound system is a compact and portable diagnostic ultrasound device,have integrated preprogrammed color ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications. The user interface includes a specialized control keyboard and color 15-inch LCD display. The all digital architecture with progressive dynamic receive focusing allows the system to maximize the utility of all imaging transducers to enhance the diagnostic utility and confidence provided by the system. The exam dependent default setting allows the user to have minimum adjustment for imaging the patient, while the in depth soft-menu control allows the advanced user to set the system for different situations. The architecture allows cost-effective system integration to a variety of upgrade-able options and features.
1. Acceptance Criteria and Reported Device Performance:
The document does not explicitly state quantitative acceptance criteria or a dedicated study demonstrating the device meets such criteria in terms of clinical performance (e.g., diagnostic accuracy, sensitivity, specificity). The submission is a 510(k) premarket notification, which primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed clinical performance studies.
However, the "Technological Characteristics" section can be interpreted as defining performance attributes related to the device's technical capabilities, which indirectly contribute to its overall performance. For a device like an ultrasound system, the acceptance criteria would typically align with the expected imaging modes, measurement capabilities, and acoustic output limits.
Here's a table summarizing the reported device performance based on the provided technical specifications, which would indirectly serve as acceptance criteria for functionality:
| Acceptance Criteria (Inferred from Technological Characteristics) | Reported Device Performance (CGMC OPUS 5000) |
|---|---|
| Display Modes: | |
| - Standard 2-D B-mode | Achieved |
| - M-mode | Achieved |
| - Harmonic Image | Achieved |
| - Color Doppler | Achieved |
| - Power Doppler | Achieved |
| - Pulsed Wave (PW) Doppler | Achieved |
| - Continuous Wave (CW) Doppler | Achieved |
| - Duplex 2-D/M-mode display | Achieved |
| - Duplex 2-D/Pulsed Doppler display | Achieved |
| - Triplex 2-D/CD/Pulsed Doppler display | Achieved |
| - Dual B and Color in real-time | Achieved |
| Measurement Capabilities: | Distance, area, circumference, calipers, velocity, PI, RI, Cardiac and Vascular package |
| Operating Controls: | |
| - TGC (8 slider, +/- 24dB) | Achieved |
| - Depth Range (3 to 24 cm) | Achieved |
| - Image Sector Size (32 lines to full B) | Achieved |
| - Dynamic Range (50-90 dB, 5 curves) | Achieved |
| - Grey Scale Control (8 Settings) | Achieved |
| - Focal Number (16 focal zone setting) | Achieved |
| - Persistence (30-90%) | Achieved |
| - Image Processing (Smoothing, edge enhancement) | Achieved |
| - PW sweeping speed (2,4,8 sec) | Achieved |
| - PW Wall filter setting (16 settings, 0.25 to 20% of PRF) | Achieved |
| - PW sample volume (0.5 to 10mm with 0.5mm step) | Achieved |
| - PW angle correction (0 to 70 degree) | Achieved |
| - Color ROI setting, steering, wall filter, packet size, filter | Achieved |
| - Zoom factor (1 to 10 continuously) | Achieved |
| Acoustic Output Limits: | |
| - Derated Ispta: 720mW/cm² maximum | Reported as 720mW/cm² maximum (implies compliance with limit) |
| - TIS/ITIB/TIC: 0.1-4.0 Range | Reported as 0.1-4.0 Range (implies compliance within range) |
| - Mechanical Index: 1.9 Maximum | Reported as 1.9 Maximum (implies compliance with limit) |
| - Derated Isppa: 190 W/cm²max | Reported as 190 W/cm²max (implies compliance with limit) |
The study that "proves" the device meets acceptance criteria for a 510(k) submission like this is typically a demonstration of substantial equivalence to a predicate device, rather than a de novo clinical trial with specific performance metrics. The document states:
"The SonoScape Ultrasound System SSI-1000 ( K042369 ) is of a comparable and substantially equivalent type. It has the same technological characteristics, key safety and effectiveness features, physical design, and has the same intended uses and basic operating modes as the predicate device."
This statement is the core "proof" for a 510(k). The manufacturer is asserting that their device's technical specifications and safety/effectiveness features are sufficiently similar to a previously cleared device, implying it will perform similarly.
2. Sample size used for the test set and the data provenance:
This document does not contain information about a specific "test set" in the context of a clinical performance study. The 510(k) submission relies on demonstrating substantial equivalence through technical characteristics and a comparison to a predicate device. There is no mention of a patient-based test set, its sample size, or its provenance (country of origin, retrospective/prospective). The closest equivalent of "testing" described would be engineering and acoustic output testing to confirm the device meets its stated specifications, but details about such testing are not provided in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
As there is no mention of a clinical "test set" requiring ground truth establishment by experts, this information is not available in the provided document.
4. Adjudication method for the test set:
Not applicable, as there is no mention of a clinical "test set" and thus no adjudication process for it.
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:
Not applicable. The CGMC OPUS 5000 is a diagnostic ultrasound system, not an AI-powered image analysis tool, and the document predates widespread AI integration in such devices. Therefore, no MRMC study or AI-related effectiveness is mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. The CGMC OPUS 5000 is an ultrasound machine, not a standalone algorithm. Its performance is intrinsically tied to human operation and interpretation.
7. The type of ground truth used:
Not applicable, as there is no mention of a performance study requiring ground truth for clinical outcomes. The "ground truth" for this 510(k) relies on the established safety and effectiveness of the predicate device and the technical specifications of the new device.
8. The sample size for the training set:
Not applicable. This device is an ultrasound system and its approval is based on substantial equivalence, not on machine learning algorithms trained on specific datasets.
9. How the ground truth for the training set was established:
Not applicable, for the same reasons as point 8.
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.