(9 days)
The DUS 6/DUS 3 Digital Ultrasonic Diagnostic Imaging System is intended for diagnostic ultrasound imaging analysis in gynecology rooms, obstetrics rooms, examination rooms, intensive care units, and emergency rooms. The DUS 6/DUS 3 is intended for use by or on the order of a physician or similarly qualified health care professional for ultrasound evaluation of Fetus; Abdomen; Pediatrics; Small Organ; Neonatal Cephalic; Cardiology; Peripheral Vessel; Musculo-skeleton (both Conventional and Superficial); Urology (including prostate); Transrecta and Transvagina.
DUS 3/DUS 6 Digital Ultrasound Diagnostic Imaging System is a portable digital ultrasonic diagnostic B/W system applied in ultrasound diagnostic examination of abdominal, obstetrical, small parts, gynecological, orthopedic, cardiac, and urological applications. It is designed to produce ultrasound waves into body tissue and to present the returned echo information on the monitor, the resulting information is displayed in five display modes: B-Mode, 2B-Mode, 4B-Mode, M-Mode or the combined mode (i.e. B/M-Mode). This system controlled by software is a Track 1 device that employs an array of probes that include linear array, convex linear array, microconvex linear array, transrectal and transvaginal with a frequency range of approximately 2.5MHz-10.0MHz. The system consists of a main unit, a display and transducers.
The provided document, K091680, is a 510(k) summary for the Edan Instruments DUS 3/DUS 6 Digital Ultrasonic Diagnostic Imaging System. It describes the device, its intended use, and substantial equivalence to predicate devices. However, this document does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria related to clinical performance metrics like sensitivity, specificity, accuracy, or reader improvement.
Instead, it states:
1. Clinical test: Clinical testing is not required. (Section 6: Effectiveness and Safety Considerations)
This means the submission relies on non-clinical tests and a comparison to predicate devices to demonstrate substantial equivalence, rather than a study with specific clinical performance acceptance criteria.
Therefore, many of the requested details cannot be extracted from this document, specifically:
- A table of acceptance criteria and reported device performance (clinical).
- Sample size used for the test set and data provenance.
- Number of experts used to establish ground truth.
- Adjudication method.
- MRMC comparative effectiveness study results or effect size.
- Standalone performance details.
- Type of ground truth used (clinical).
- Sample size for the training set.
- How ground truth for the training set was established.
The document focuses on non-clinical testing for safety and compliance with standards. Below is a table summarizing what is available regarding non-clinical acceptance criteria and the "study" (non-clinical testing) conducted.
1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical)
| Acceptance Criteria (Non-Clinical Safety Standards) | Reported Device Performance |
|---|---|
| IEC 60601-1 Electrical Safety | Conducted on the subject device (Implied to meet standard) |
| IEC 60601-1-2 Electromagnetic Compatibility | Conducted on the subject device (Implied to meet standard) |
| Acoustic output testing (per FDA guideline) | Conducted on the subject device (Implied to meet standard) |
| ISO 10993-1, ISO 10993-5, ISO 10993-10 | Conducted on the subject device (Implied to meet standard) |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not applicable as no clinical test set was used for performance validation. Non-clinical tests were performed on the device itself.
- Data Provenance: Not applicable as clinical data was not used for effectiveness.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- Not applicable as no clinical ground truth was established by experts for performance evaluation.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable as no clinical test set required adjudication.
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 MRMC comparative effectiveness study was done. The device is a diagnostic ultrasound imaging system, not an AI-assisted diagnostic tool, and clinical testing was not required for its 510(k) clearance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a hardware imaging device, not a standalone algorithm. Its "performance" refers to image generation and safety, not diagnostic interpretation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable for clinical performance. For non-clinical tests, the "ground truth" would be the specifications and requirements of the safety standards (e.g., electrical safety limits, EMC compatibility levels, acoustic output limits, biocompatibility requirements).
8. The sample size for the training set:
- Not applicable as clinical data was not used for training any diagnostic algorithm.
9. How the ground truth for the training set was established:
- Not applicable as no training set was used with clinical ground truth for a diagnostic algorithm.
§ 892.1570 Diagnostic ultrasonic transducer.
(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.