(69 days)
The DUS-3000/DUS-3000Plus 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-3000/DUS-3000Plus 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); Transrectal and Transvaginal.
The DUS-3000/DUS-3000Plus Digital Ultrasound Diagnostic Imaging System is a portable digital ultrasonic diagnostic BMV 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 the 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, micro convex linear array, transrectal and transvaginal with a frequency range of approximately 2.5MHz-10MHz. The system consists of a main unit, a display and transducers.
This document is a 510(k) summary for the DUS-3000/DUS-3000Plus Digital Ultrasound Diagnostic Imaging System. It primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing and outlining the intended uses.
Based on the provided text, there is no detailed information regarding acceptance criteria, specific device performance metrics for a study, or a study that proves the device meets specific acceptance criteria related to diagnostic accuracy.
The summary states: "Clinical testing is not required" and focuses on non-clinical tests for safety standards and comparison to a predicate device to establish substantial equivalence. Therefore, many of the requested details about a performance study with acceptance criteria cannot be extracted from this document.
However, I can extract the following based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
No specific quantitative or qualitative acceptance criteria related to diagnostic performance (e.g., sensitivity, specificity, accuracy) are mentioned for the device. The document states that "clinical testing is not required" and instead relies on non-clinical testing for safety and demonstrating substantial equivalence to a predicate device.
The reported device "performance" is implicitly its adherence to various safety and general characteristics, as it is found substantially equivalent to the predicate.
| Acceptance Criteria Category | Specific Criteria (Expected) | Reported Device Performance (Achieved) |
|---|---|---|
| Diagnostic Performance | (Not specified) | (Not applicable, no clinical testing required) |
| Electrical Safety | IEC 60601-1 | Test conducted and met. |
| Electromagnetic Compatibility (EMC) | IEC 60601-1-2 | Test conducted and met. |
| Acoustic Output | Guideline "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" dated September 9 2008 | Test conducted and met. |
| Biocompatibility | ISO 10993-1, ISO 10993-5, ISO 10993-10 | Test conducted and met. |
| Substantial Equivalence | Similar technology, intended use, material, manufacturing, design, electrical classification, measurement mode, accuracy as predicate (EDAN Instruments DUS3/DUS6, K091680) | Verification and validation testing demonstrates substantial equivalence. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Test Set): Not applicable, as no clinical performance study was conducted.
- Data Provenance: Not applicable.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and their Qualifications
- Not applicable, as no clinical performance study was conducted.
4. Adjudication Method for the Test Set
- Not applicable, as no clinical performance study was conducted.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states "Clinical testing is not required."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
- Not applicable, as this device is a diagnostic ultrasound system, not an AI algorithm. It is a "Track 1 device" meaning it's a conventional medical device, not an AI/ML software as a medical device.
7. The Type of Ground Truth Used
- Not applicable, as no clinical performance study was conducted. The "ground truth" for the submission's claims is adherence to safety standards and demonstration of substantial equivalence to a predicate device.
8. The Sample Size for the Training Set
- Not applicable, as this device is a conventional diagnostic ultrasound system, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as this device is a conventional diagnostic ultrasound system, not an AI/ML algorithm that requires a training set.
§ 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.