(15 days)
The Digital Ultrasonic Diagnostic Imaging System DUS 60 is intended for diagnostic ultrasound imaging analysis in gynecology rooms. obstetrics rooms, examination rooms, intensive care units, and emergency rooms. The system 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 60 Digital Ultrasound Diagnostic Imaging System is a portable digital ultrasonic diagnostic 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 the following display modes: B-Mode, M-Mode, B+M Mode and PW Mode. This system controlled by software is a Track 3 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 2.0MHz-10.0MHz.
The provided text is a 510(k) summary for the Edan Instruments, Inc. Digital Ultrasonic Diagnostic Imaging System, Model DUS 60.
1. Table of Acceptance Criteria and Reported Device Performance:
The document explicitly states that clinical testing is not required for this device (Section 6, page 1). Instead, effectiveness and safety considerations are addressed through non-clinical tests. Therefore, there are no specific performance metrics or acceptance criteria for disease detection rates or diagnostic accuracy to be reported in a table of device performance in the typical sense for AI/CADe devices.
The acceptance criteria here pertain to compliance with recognized safety and performance standards for medical devices. The reported device "performance" is its compliance with these standards, demonstrating substantial equivalence to predicate devices.
| Acceptance Criteria (Non-Clinical Standards) | Reported Device Performance (Compliance) |
|---|---|
| IEC 60601-1 (Electrical Safety) | Conducted on the subject device (DUS 60) |
| IEC 60601-2-37 (Electrical Safety for Medical Devices) | Conducted on the subject device (DUS 60) |
| IEC 60601-1-2 (Electromagnetic Compatibility) | Conducted on the subject device (DUS 60) |
| Acoustic output testing (per "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" dated September 9, 2008) | Conducted on the subject device (DUS 60) |
| ISO 10993-1 (Biocompatibility - Part 1: Evaluation and testing) | Conducted on the subject device (DUS 60) |
| ISO 10993-5 (Biocompatibility - Part 5: Tests for in vitro cytotoxicity) | Conducted on the subject device (DUS 60) |
| ISO 10993-10 (Biocompatibility - Part 10: Tests for irritation and skin sensitization) | Conducted on the subject device (DUS 60) |
| Overall Comparison for Substantial Equivalence: | The DUS 60 is deemed substantially equivalent to predicate devices (DUS 6, DC-3) based on similar technology characteristics, same intended use, design principles, electrical classification, and accuracy. Differences (physical specifications, display monitor/mode) do not affect usage, safety, or effectiveness. |
2. Sample Size Used for the Test Set and Data Provenance:
- No specific test set or clinical data is mentioned. The device is cleared based on non-clinical testing and substantial equivalence to predicate devices. The phrase "Clinical testing is not required" (Section 6, page 1) confirms this.
- Therefore, there's no information on "sample size for the test set" or "data provenance (e.g. country of origin of the data, retrospective or prospective)."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
- Not applicable. As no clinical testing or specific test set with ground truth established by experts was required or mentioned, this information is not available.
4. Adjudication Method for the Test Set:
- Not applicable. No test set requiring expert adjudication is mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. The document does not mention any MRMC study. The device is not an AI/CADe system designed to improve human reader performance. It is a diagnostic ultrasound imaging system.
6. Standalone (Algorithm Only) Performance Study:
- Not applicable. This device is a hardware and software system for diagnostic imaging, not an algorithm being tested in isolation for specific standalone performance metrics like sensitivity or specificity for disease detection. Its "performance" is its ability to produce ultrasound images and operate according to its specifications and safety standards.
7. Type of Ground Truth Used:
- Not applicable. Since no clinical testing or performance evaluation against a specific disease outcome/diagnosis was required, there is no mention of ground truth types like expert consensus, pathology, or outcomes data. The "ground truth" in this context refers to the compliance with technical and safety standards.
8. Sample Size for the Training Set:
- Not applicable. The device is an ultrasound imaging system, not an AI/ML model that is trained on a dataset. Therefore, there is no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. As there is no training set mentioned, the establishment of ground truth for such a set is irrelevant.
§ 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.