(53 days)
The diagnostic ultrasound system (U2) is applicable for adults, pregnant women, pediatric patients' ultrasound evaluation in hospitals and clinics. It is intended for use in abdominal, obstetrics, gynecology, pediatric, small parts, urology, peripheral vascular, musculosketal (conventional and superficial), endovaginal and cardiac clinical applications, by or on the order of a physician or similarly qualified health care professional.
U2 is a cart based diagnostic ultrasound system. U2 has the same intended use, similar product design, same performance effectiveness as the previous cleared U50 (K142511).
This is a 510(k) premarket notification for the U2 Diagnostic Ultrasound System. It asserts that the U2 system is substantially equivalent to the previously cleared U50 Diagnostic Ultrasound System (K142511).
Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly derived from the performance specifications of the predicate device (U50 Diagnostic Ultrasound System, K142511). The document states that the U2 has "the same performance effectiveness as the previous cleared U50 (K142511)". Therefore, the performance criteria for the U2 are identical to those of the U50.
| Feature / Parameter | Acceptance Criteria (based on predicate U50) | Reported Device Performance (U2) |
|---|---|---|
| General Imaging Mode | B-Mode, M-Mode, Color, PDI/DPDI, PW, CW | B-Mode, M-Mode, Color, PDI/DPDI, PW, CW |
| Measurements (B-Mode) | ||
| - Range of Depth/Distance | Maximum 324 mm | Maximum 324 mm |
| - Accuracy of Depth/Distance | ≤±5% | ≤±5% |
| - Range of Area | Maximum 1126 cm² | Maximum 1126 cm² |
| - Accuracy of Area | ≤±10% | ≤±10% |
| - Range of Angle | 0-180° | 0-180° |
| - Accuracy of Angle | ≤±3% | ≤±3% |
| - Range of Ratio | Maximum 1.0 | Maximum 1.0 |
| - Accuracy of Ratio | ≤±10% | ≤±10% |
| - Range of Volume | Maximum 999 cm³ | Maximum 999 cm³ |
| - Accuracy of Volume | ≤±15% | ≤±15% |
| Measurements (M-Mode) | ||
| - Range of Depth | Maximum 324mm | Maximum 324mm |
| - Accuracy of Depth | ≤±5% | ≤±5% |
| - Range of Time | Maximum 13s | Maximum 13s |
| - Accuracy of Time | ≤±5% | ≤±5% |
| - Range of Heart rate | Maximum 999bpm | Maximum 999bpm |
| - Accuracy of Heart rate | ≤±5% | ≤±5% |
| - Range of Slope | Maximum 999mm/s | Maximum 999mm/s |
| - Accuracy of Slope | ≤±10% | ≤±10% |
| Measurements (PW Mode Velocity) | ||
| - Range | 0.5-2.5m/s | 0.5-2.5m/s |
| - Accuracy | ≤±10% | ≤±10% |
| Measurements (CW Mode Velocity) | ||
| - Range | 0.5-2.5m/s | 0.5-2.5m/s |
| - Accuracy | ≤±10% | ≤±10% |
| Displayed Depth | 20-320mm (Probe Dependent) | 20-320mm (Probe Dependent) |
| Gray Scales | 256 | 256 |
| Dynamic Range | 150dB | 150dB |
| TGC | 8 segments | 8 segments |
| Zoom | Up to 400% | Up to 400% |
| Acoustic Output | Track 3: MI, TIS, TIC, TIB (TI Range 0-6.0), Derated ISPTA: 720 W/cm² max, Mechanic Index ≤1.9 max or Derated ISPPA 190 W/cm² max | Track 3: MI, TIS, TIC, TIB (TI Range 0-6.0), Derated ISPTA: 720 W/cm² max, Mechanic Index ≤1.9 max or Derated ISPPA 190 W/cm² max |
| Transducer Frequency | 2.0-15.0 MHz | 2.0-15.0 MHz |
| Cine Loop | 1227 frames | 1227 frames |
| Focus Number | Max=4 | Max=4 |
| Software Packages | Abdomen, obstetric, small parts, gynecology, cardiology, urology, vascular and Pediatrics | Abdomen, obstetric, small parts, gynecology, cardiology, urology, vascular and Pediatrics |
| Principle of Operation | Applying high voltage burst to piezoelectric material in transducer and detect reflected echo to construct diagnostic image | Applying high voltage burst to piezoelectric material in transducer and detect reflected echo to construct diagnostic image |
| Safety Standards Compliance | IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993-1, -5, -10, AIUM, NEMA UD 2, UD3 | IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993-1, -5, -10, NEMA UD 3, NEMA UD2, Acoustic output guidelines |
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide information on a specific test set sample size or data provenance (country of origin, retrospective/prospective) for a study of the U2's diagnostic performance. The submission relies on demonstrating substantial equivalence to a predicate device through non-clinical testing and comparison of technical specifications.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the document explicitly states: "Clinical testing is not required." Therefore, there was no test set requiring expert ground truth establishment for diagnostic performance.
4. Adjudication Method for the Test Set
This information is not applicable as no clinical test set requiring expert ground truth or adjudication was conducted.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study is mentioned or appears to have been conducted, as the basis for clearance is substantial equivalence without clinical testing. Therefore, there is no reported effect size for human readers improving with AI vs. without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This information is not applicable. The U2 Diagnostic Ultrasound System is a medical imaging device operated by a human, not an AI algorithm performing diagnostic tasks in a standalone capacity. The claim is for the system itself, not a specific AI diagnostic feature within it.
7. Type of Ground Truth Used
As per point 3, no clinical ground truth (expert consensus, pathology, outcomes data, etc.) was explicitly established for a test set to prove diagnostic performance. The clearance relies on equivalence to a predicate and compliance with performance and safety standards.
8. Sample Size for the Training Set
This information is not applicable. The document does not describe the development or evaluation of an AI algorithm, and therefore no training set for such an algorithm is mentioned. The U2 is a diagnostic ultrasound system, not an AI-powered diagnostic tool in the sense of requiring a training set for model development.
9. How the Ground Truth for the Training Set Was Established
This information is 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.