(63 days)
The device is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Abdomen, Cardiac, Small Organ (breast, testes, thyroid), heart soft tissue, Peripheral Vascular, Musculo-skeletal (Conventional and Superficial), Pediatric, Fetal, Cephalic. Ob/Gyn.
The UP600 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.
The major features of the UP600:
- 128 Channel all digital beam former
- Progressive dynamic receive focusing
- Wide band all digital demodulation
- Native resolution digital scan converter
- Hand carried for portable use
- Remote access image management through LAN port
- USB2.0 flash drive for image transport and software upgrade
- Supports 2D B-mode, M-mode, Harmonic Image, Color, Power Doppler, Pulse wave Doppler, and CW.
Here's a breakdown of the acceptance criteria and study information based on the provided 510(k) summary for the BenQ Medical Technology UP600 Diagnostic Doppler Ultrasound System (K121983).
It's important to note that this 510(k) summary focuses on substantial equivalence to a predicate device, as is typical for most 510(k) submissions. This means the device's performance is demonstrated to be equivalent to an already legally marketed device (in this case, the GE Voluson i (K053435)). Therefore, detailed clinical studies with specific acceptance criteria for diagnostic performance (e.g., sensitivity, specificity, accuracy) are generally not included in such summaries. The focus is on technical characteristics, safety, and intended use being comparable.
Acceptance Criteria and Reported Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Characteristic | Acceptance Criteria (Implicit: Comparable to Predicate Device) | Reported Device Performance (Summary Statements) |
|---|---|---|
| Technological Characteristics (General) | Same technological characteristics as predicate (GE Voluson i (K053435)) | "Same technological characteristics, key safety and effectiveness features, physical design, and has the same intended uses and basic operating modes as the predicate device." |
| Intended Use | Same intended uses as predicate. | "general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Abdomen, Cardiac, Small Organ (breast, testes, thyroid), heart soft tissue, Peripheral Vascular, Musculo-skeletal (Conventional and Superficial), Pediatric, Fetal, Cephalic, Ob/Gyn." |
| Safety and Effectiveness | Key safety and effectiveness features comparable to predicate. Meets applicable voluntary and measurement standards. | "Key safety and effectiveness features" are comparable. Meets EC 60601-1, AIUM/NEMA UD2, AIUM NEMA UD3, AIUM Acoustic Output Measurement and Labeling Standard (1998), EN 60601-1, EN 60601-1-2, EN 60601-2-37, ISO 10993. |
| Image Quality (Implied) | Capable of producing high detail resolution comparable to predicate. | "capable of producing high detail resolution intended for clinical diagnostic imaging applications." |
| Acoustic Output | Within specified safety limits. | Track 3; MI, TIS, TIC, TIB. Derated Ispta: 720mW/cm2 maximum, TIS/TIB/TIC: 0.1-4.0 Range, Mechanical Index: 1.9 Maximum, or Derated Isppa: 190 W/cm2 max. |
| Operational Modes | Supports standard ultrasound imaging modes. | Supports 2D B-mode, M-mode, Harmonic Image, Color, Power Doppler, Pulse wave Doppler, and CW. |
| Transducer Compatibility | Specific transducers perform as intended with the system. | C52 Curved Linear Array 2-5MHz, L115 Linear Array 5-11MHz, P42 Phase Array 80 elements 2-4MHz. Each transducer listed with intended applications. |
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary does not mention a specific test set sample size or data provenance (e.g., country of origin, retrospective/prospective clinical data) for assessing diagnostic performance. This is typical for a substantial equivalence submission where the performance is largely inferred from the predicate device through technical comparisons and adherence to standards rather than new clinical outcome studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the 510(k) summary. Given the absence of a specific test set or clinical study for diagnostic performance, there would be no need for experts to establish ground truth data in this context.
4. Adjudication Method for the Test Set
This information is not provided as there is no mention of a clinical test set requiring adjudication in the summary.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance
No MRMC comparative effectiveness study was done or reported in this 510(k) submission. This device is a diagnostic ultrasound system, not an AI-powered diagnostic aid.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable. The UP600 is a diagnostic ultrasound system, not an algorithm, and its performance is inherently human-in-the-loop (operated by a qualified physician).
7. The Type of Ground Truth Used
Based on the 510(k) summary, the "ground truth" for the device's acceptable performance is primarily established through demonstration of substantial equivalence to a legally marketed predicate device (GE Voluson i (K053435)) and compliance with recognized safety and performance standards for diagnostic ultrasound equipment (e.g., IEC, AIUM/NEMA). There isn't a clinical "ground truth" derived from patient outcomes or pathology mentioned for the purpose of proving diagnostic accuracy for this specific submission.
8. The Sample Size for the Training Set
This information is not applicable/not provided. The UP600 is a hardware and software system for ultrasound imaging; it is not an AI-based device that relies on a "training set" in the machine learning sense for its core diagnostic function. Its development would involve engineering and testing against technical specifications, not a data-driven training regimen.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/not provided as there is no "training set" in the context of an AI/ML algorithm for this device.
§ 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.