(56 days)
The DUS-7000 Digital Color Doppler Ultrasound System is a general purpose ultrasonic imaging instruments intended for use by a qualified physician for evaluation of Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Cephalic (neonatal and adult), Trans-rectal, Trans-vaginal, Peripheral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (neonatal and adult), OB/Gyn and Urology.
DUS-7000 Digital Color Doppler Ultrasound System is an integrated The preprogrammed color ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications. The basic principle is that system transmits ultrasonic energy into patient body and implements post processing of received echoes to generate onscreen display of anatomic structures and fluid flow within the body. This system is a Track 3 device that employs a wide array of probes that include linear array, convex array and phased array with a frequency range of 2.0 MHz to 15.0 MHz. This system consists of a mobile console with keyboard control panel, power supply module, color LCD monitor and optional probes. This system is a mobile, general purpose, software controlled, color diagnostic ultrasound system. Its basic function is to acquire ultrasound data and to display the image in B-Mode (including Tissue Harmonic Image), M-Mode, TDI, Color-Flow Doppler, Pulsed Wave Doppler, Continued Wave Doppler and Power Doppler, or the combination of these modes, Elastography, 3D/4D.
The provided document is a 510(k) summary for the DUS-7000 Digital Color Doppler Ultrasound System, which is a submission to the FDA seeking substantial equivalence to a predicate device. This type of submission relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than proving performance against specific acceptance criteria through a full-scale study.
Therefore, the document does not contain information about acceptance criteria or a study that "proves the device meets the acceptance criteria" in the traditional sense of a clinical trial for novel devices. Instead, it focuses on demonstrating equivalence to an existing device.
Here's a breakdown of the requested information based on the provided document:
1. Table of acceptance criteria and the reported device performance:
This document does not establish specific acceptance criteria for a new device's performance (e.g., sensitivity, specificity, accuracy). Instead, it asserts that the DUS-7000 system has "similar technical characteristics" and "the same accuracy" as the predicate device (Sonoscape S22 Digital Color Doppler Ultrasound System, K142815).
A table outlining specific performance metrics for the DUS-7000 against pre-defined acceptance criteria is not provided in this submission. The device's performance is generally stated as being "capable of producing high detail resolution" and that "Elastography performance met design specifications, including accuracy and repeatability of strain ratio measurement and etc." without giving quantitative values or comparison points.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
The document explicitly states: "Clinical testing is not required." This indicates that no clinical test set was used to evaluate the device's performance in human subjects for this 510(k) submission. Non-clinical tests were performed to verify design specifications and compliance with standards. Therefore, there is no information on sample size or data provenance for a "test set" in the context of clinical performance.
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):
Since clinical testing was not required and no clinical test set was used, there is no information about experts establishing ground truth for a test set.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
As no clinical test set was used, there is no information on an adjudication method.
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:
The document does not mention any MRMC comparative effectiveness study or artificial intelligence (AI) assistance. The DUS-7000 is an ultrasound system, and the submission focuses on its equivalence to another ultrasound system, not on AI-driven performance or human reader improvement with AI.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
The document describes the DUS-7000 as a "general purpose ultrasonic imaging instruments intended for use by a qualified physician." It is a diagnostic imaging system that requires a human operator for interpretation. There is no indication of a standalone algorithm or AI performance being evaluated.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the non-clinical tests mentioned (electrical, mechanical, thermal, electromagnetic compatibility, biocompatibility, acoustic output, and phantom tests for elastography), the "ground truth" would likely be established by engineering specifications, physical measurements, and standard testing methodologies. However, specific details on how ground truth was established for these non-clinical tests are not provided. As stated earlier, no clinical ground truth was established for a performance study.
8. The sample size for the training set:
Since "Clinical testing is not required" and the device is an ultrasound imaging system rather than an AI/ML algorithm that typically requires a large training set of labeled data, there is no information provided about a training set or its sample size.
9. How the ground truth for the training set was established:
As there is no mention of a training set, there is no information on how its ground truth would have been established.
In summary: This 510(k) submission for the DUS-7000 Digital Color Doppler Ultrasound System primarily demonstrates substantial equivalence to a predicate device (Sonoscape S22) by showing similar intended use, design principles, technical characteristics (including various probes and imaging modes), and compliance with non-clinical safety standards. It explicitly states that clinical testing was not required for this submission, meaning no data is provided regarding clinical performance acceptance criteria, test set sizes, expert ground truth, or adjudication methods for clinical outcomes.
§ 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.