(323 days)
OPUS 5100 Diagnostic Doppler Ultrasound System is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Fetal, Abdomen; Pediatric; Small Organ(breast, thyroid, tests); Cephalic (adult and neonatal); Trans-rectal; Trans-vaginal; Musculo-skeletal(Conventional and Superficial); Ob/GYN; Urology; Cardiac (adult and pediatric) and Peripheral Vascular.
OPUS 5100 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 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. The major features include: 128 Channel all digital beam former; progressive dynamic receive focusing; wide band all digital demodulation; native frequency digital scan converter; hand carried for portable use; remote access image management through LAN port: USB 2.0 drive for image storage and retrieving; Supports 2D Bmode (including Tissue Harmonic image, M-mode, TDI, Color Flow Doppler, Power Doppler, Pulse wave Doppler and Continuous Wave Doppler, or a combination of these modes, 3D/4D.
Here's a summary of the acceptance criteria and study information for the OPUS 5100 Diagnostic Doppler Ultrasound System, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria or device performance metrics for diagnostic accuracy. Instead, the "acceptance criteria" are implied by the successful testing against established safety and performance standards. The reported device performance is that it met these standards.
| Acceptance Criteria (Implied) | Reported Device Performance (as stated in document) |
|---|---|
| Compliance with IEC 60601-1:2005 (Safety) | Complies with IEC 60601-1 |
| Compliance with IEC 60601-1-2:2007 (Electromagnetic Compatibility) | Complies with IEC 60601-2 |
| Compliance with IEC 60601-2-37:2008 (Performance of Ultrasound) | Complies with IEC 60601-2-37 |
| Compliance with NEMA UD3:2004 (Acoustic Output Indices) | Complies with NEMA UD3 |
| Compliance with NEMA UD2:2004 (Acoustic Output Measurement) | Complies with NEMA UD2 |
| Compliance with ISO 10993-5:2009 (Cytotoxicity) | Complies with ISO 10993-5 |
| Compliance with ISO 10993-10:2010 (Irritation & Skin Sensitization) | Complies with ISO 10993-10 |
| Acoustic Output (Derated Ispta ≤ 720 mW/cm²) | 720 mW/cm² (max.) |
| Acoustic Output (TIS/TIB/TIC range 0.2 ~ 4.0) | 0.2 ~ 4.0 (Range) |
| Acoustic Output (Mechanical Index ≤ 1.9) | 1.9 (max.) |
| Acoustic Output (Derated Isppa ≤ 190 W/cm²) | 190 W/cm² (max.) |
2. Sample Size Used for the Test Set and Data Provenance
No patient-specific test set or data provenance (country of origin, retrospective/prospective) is mentioned in the document. The testing described is limited to laboratory and standard compliance testing, not clinical studies involving patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. The document explicitly states "No clinical testing was required." The "ground truth" for the device's technical specifications was established by the technical standards themselves and verified through laboratory testing.
4. Adjudication Method for the Test Set
Not applicable. As no clinical test set was used, no adjudication method was mentioned or required.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No. The document clearly states that "No clinical testing was required." Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed or reported.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was Done
Not applicable. This device is a diagnostic ultrasound system, which inherently involves a human operator (a qualified physician) for its intended use. There is no mention of an AI algorithm or standalone performance being evaluated. The device performance is assessed through its compliance with safety and performance standards for ultrasound equipment.
7. The Type of Ground Truth Used
The ground truth used for this submission is related to adherence to established national and international safety, electromagnetic compatibility, acoustic output, and biocompatibility standards for medical electrical equipment and diagnostic ultrasound equipment. This is effectively technical and performance standard compliance.
8. The Sample Size for the Training Set
Not applicable. This document describes a traditional medical device (ultrasound system) clearance, not an AI/ML-driven device. Therefore, no training set for an algorithm is mentioned or relevant.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set mentioned, there is no information on how its ground truth would have been established.
§ 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.