(89 days)
The diagnostic ultrasound system (DUS 60) is applicable for ultrasound evaluation in hospitals and clinics. It is intended for use in Abdominal; obstetric, gynecology, pediatrics; small parts; urology, peripheral vascular, musculoskeletal (conventional and superficial), and cardiac clinical applications, by or on the order of a physician or similarly qualified health care professional.
The DUS 60 is a portable Diagnostic Ultrasound System, which applies advanced technologies such as Phased Inversion Harmonic Compound Imaging (eHCI), Double-Beam-Forming (D Beam), Speckle Resistance Imaging(eSRI), scan receiving aperture(SRA) and Spatial Compounding Imaging, etc. Various image parameter adjustments, 12.1 inch LCD and diverse probes are configured to provide clear and stable images. It is intended for diagnostic ultrasound imaging analysis in hospitals and clinics.
It is designed to produce ultrasound waves into body tissue and present the returned echo information on the monitor; which can be displayed in the following modes: B/2B/4B-Mode, M-Mode, B+M Mode or PW Mode. Supported probe types include convex, linear, micro-convex, endocavity (transvaginal, endorectal) probes. The device can detect the probe automatically.
The system consists of 7 major functional blocks, including a main unit, a display subsystem, a transducer and transceiver subsystem, digital beamformer, keyboard and power subsystem.
The provided 510(k) summary does not contain information about a study with acceptance criteria and device performance metrics in the way typically associated with AI/ML-driven device evaluations (e.g., sensitivity, specificity, accuracy).
Instead, this submission for the Edan Instruments DUS 60 Digital Ultrasonic Diagnostic Imaging System focuses on Substantial Equivalence to legally marketed predicate devices. The "effectiveness and safety considerations" are primarily based on non-clinical tests and a comparison to predicate devices, asserting that its design and performance are similar.
Therefore, the sections of your request related to acceptance criteria for diagnostic performance, sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance are not applicable to this specific 510(k) submission.
Here's a breakdown of the information that is available in the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Electrical Safety | Compliance with IEC 60601-1 | Device is conducted on IEC 60601-1 (implying compliance, though specific results are not provided). |
| Electromagnetic Compatibility | Compliance with IEC 60601-1-2 | Device is conducted on IEC 60601-1-2 (implying compliance). |
| Ultrasonic Safety & Essential Performance | Compliance with IEC 60601-2-37 | Device is conducted on IEC 60601-2-37 (implying compliance). |
| Acoustic Output | Compliance with FDA guideline "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" (Sept 9, 2008) | Acoustic output testing as per the guideline (implying compliance). Specific output levels are not provided. |
| Biocompatibility | Compliance with ISO 10993-1, ISO 10993-5, ISO 10993-10 | Device is conducted on ISO 10993-1, ISO 10993-5, and ISO 10993-10 (implying compliance), particularly for needle-guide bracket material. |
| Intended Use & Design | Same intended use and similar product design as predicate devices. | The subject device has "same intended use, similar product design" as predicate devices. |
| Performance Effectiveness & Safety | Same performance effectiveness and safety as predicate devices. Differences do not affect basic design principles, usage, effectiveness, or safety. | The subject device has "same performance effectiveness, performance safety as the predicate devices." Differences "do not affect" these. |
2. Sample size used for the test set and the data provenance:
- Not applicable. The submission states: "Clinical test: Clinical testing is not required." The evaluation is based on non-clinical testing and comparison to predicate devices, not on a clinical test set with patient data for performance evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No clinical test set or ground truth established by experts is mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No clinical test set or adjudication process is mentioned.
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 device is a diagnostic ultrasound imaging system, not an AI-assisted diagnostic tool described in the typical sense of a MRMC study for AI. The submission does not mention any AI component or human-in-the-loop performance improvement study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is a hardware device (ultrasound system), not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. No clinical ground truth is mentioned. The ground for "equivalence" is based on adherence to safety and performance standards, and comparison of technical specifications and intended use with predicate devices.
8. The sample size for the training set:
- Not applicable. This submission does not describe an AI/ML device requiring a training set.
9. How the ground truth for the training set was established:
- Not applicable. This submission does not describe an AI/ML device requiring a training set or ground truth establishment.
In summary: This 510(k) submission for the DUS 60 Digital Ultrasonic Diagnostic Imaging System demonstrates substantial equivalence through adherence to recognized electrical, safety, acoustic, and biocompatibility standards, and by affirming that its intended use and general design principles are the same as previously cleared predicate devices. It does not involve or require clinical performance studies, AI/ML components, or associated analyses like those requested in your prompt.
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.