(49 days)
The diagnostic ultrasound system (U50) 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, musculoskeletal (conventional and superficial), endovaginal and cardiac clinical applications, by or on the order of a physician or similarly qualified health care professional.
The U50 is a portable Diagnostic Ultrasound System, which applies advanced technologies. Various image parameter adjustments, 12.1 inch LCD and diverse probes are configured to provide clear and stable images. The R2.2 version of the U50 utilizes the Linux operating system, which enables additional printer drivers and the inclusion of an USB DVD drive.
The provided document is a 510(k) summary for the Edan Instruments U50 Diagnostic Ultrasound System, dated November 15, 2017. It demonstrates substantial equivalence to a predicate device (U50 Diagnostic Ultrasound System / K142511 / Edan Instruments, Inc.) and does not describe a study involving an AI or algorithm.
Therefore, many of the requested points related to AI/algorithm studies (like sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance) cannot be answered from this document.
The document primarily focuses on bench testing and compliance with recognized standards to demonstrate the safety and effectiveness of the ultrasound system itself, and its substantial equivalence to the previously cleared predicate device.
Here's what can be extracted from the document regarding acceptance criteria and device performance:
1. Table of Acceptance Criteria (Performance Specifications) and Reported Device Performance:
The document provides a comparison of specifications between the subject device (U50 R2.2) and the predicate device (U50 R2.0), showing they are "Same." This implies that the predicate's performance serves as the acceptance criteria for the subject device.
| Category | Acceptance Criteria (Predicate U50 R2.0 Performance) | Reported Device Performance (Subject U50 R2.2) | Result/Comparison |
|---|---|---|---|
| B-Mode Measurement Accuracy | |||
| Range of Depth/Distance | Maximum 324 mm | Maximum 324 mm | Same |
| Accuracy of Depth/Distance | ≤ ±5% | ≤ ±5% | Same |
| Range of Area | Maximum 1126 cm² | Maximum 1126 cm² | Same |
| Accuracy of Area | ≤ ±10% | ≤ ±10% | Same |
| Range of Angle | 0-180° | 0-180° | Same |
| Accuracy of Angle | ≤ ±3% | ≤ ±3% | Same |
| Range of Ratio | Maximum 1.0 | Maximum 1.0 | Same |
| Accuracy of Ratio | ≤ ±10% | ≤ ±10% | Same |
| Range of Volume | Maximum 999 cm³ | Maximum 999 cm³ | Same |
| Accuracy of Volume | ≤ ±15% | ≤ ±15% | Same |
| M-mode Measurement Accuracy | |||
| Range of Depth | Maximum 324 mm | Maximum 324 mm | Same |
| Accuracy of Depth | ≤ ±5% | ≤ ±5% | Same |
| Range of Time | Maximum 13s | Maximum 13s | Same |
| Accuracy of Time | ≤ ±5% | ≤ ±5% | Same |
| Range of Heart Rate | Maximum 999 bpm | Maximum 999 bpm | Same |
| Accuracy of Heart Rate | ≤ ±5% | ≤ ±5% | Same |
| Range of Slope | Maximum 999 mm/s | Maximum 999 mm/s | Same |
| Accuracy of Slope | ≤ ±10% | ≤ ±10% | Same |
| PW mode velocity Measurement Accuracy | |||
| Range | 0.5-2.5 m/s | 0.5-2.5 m/s | Same |
| Accuracy | ≤ ±10% | ≤ ±10% | Same |
| CW mode velocity Measurement Accuracy | |||
| Range | 0.5-2.5 m/s | 0.5-2.5 m/s | Same |
| Accuracy | ≤ ±10% | ≤ ±10% | Same |
| Acoustic Output | |||
| Track 3 (MI, TIS, TIC, TIB) | TI Range 0-6.0 | TI Range 0-6.0 | Same |
| Derated ISPTA | 720 W/cm² maximum | 720 W/cm² maximum | Same |
| Mechanic Index | ≤1.9 maximum | ≤1.9 maximum | Same |
| Derated ISPPA | 190 W/cm² max | 190 W/cm² max | Same |
2. Sample size used for the test set and the data provenance:
- Test set sample size: Not applicable (N/A) for an AI/algorithm study as this document describes a traditional medical device (ultrasound system). Performance was demonstrated through engineering and manufacturing verification and validation, including compliance with international standards for safety and acoustic output.
- Data provenance: N/A. The testing involved technical evaluations rather than clinical data sets in the context of an AI study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. Ground truth in the context of AI/ML is not relevant here as it's a traditional ultrasound system. Performance evaluation relies on engineering specifications and standard compliance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. Not relevant for this type of device submission.
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:
- No. This is a traditional diagnostic ultrasound system, not an AI or AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is an ultrasound imaging system that requires a human operator for its intended use.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- N/A. For this device, "ground truth" relates to the accuracy of physical measurements and compliance with established industry and regulatory standards, rather than clinical diagnostic outcomes requiring expert consensus or pathology. Performance is demonstrated against objective technical specifications.
8. The sample size for the training set:
- N/A. This is not an AI/ML device.
9. How the ground truth for the training set was established:
- N/A. This is not an AI/ML device.
Study Proving Device Meets Acceptance Criteria:
The study proving the device meets the "acceptance criteria" (which are effectively its technical specifications and regulatory compliance requirements) is detailed in Section 10, "Effectiveness and Safety Considerations: Non-clinical test" of the 510(k) summary (page 22).
The document states:
"Verification and validation testing has been conducted on the U50 Ultrasound Imaging System. This premarket notification submission demonstrates that U50 Ultrasound Imaging System is substantially equivalent to the predicate devices."
Specifically, the device's performance was evaluated by demonstrating compliance with various national and international standards:
- Electrical Safety: IEC 60601-1:2005/A1:2012
- Electromagnetic Compatibility (EMC): IEC 60601-1-2 Edition 3:2007-03
- Specific Requirements for Medical Diagnostic Ultrasound: IEC 60601-2-37 Edition 2.0 2007
- Acoustic Output:
- NEMA UD 3, Edition 2004 (Standard for real-time display of thermal and mechanical acoustic output Indices)
- FDA guideline "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers' dated September 9, 2008.
- NEMA, UD2, Edition 2004 for acoustic output measurement methodology.
- Biocompatibility: ISO 10993-1:2009, ISO 10993-5:2009 and ISO 10993-10:2010
These non-clinical tests and compliance with recognized standards are the "studies" that demonstrate the device meets its acceptance criteria for safety and effectiveness, affirming its substantial equivalence to the predicate device. No clinical testing was required for this particular submission.
§ 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.