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The DUS-6000 Digital Ultrasonic Diagnostic Imaging System 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 applications by or on the order of a physician or similarly qualified health care professional.

The DUS-6000 Digital Ultrasonic Diagnostic Imaging System 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. 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 to present the returned echo information on the monitor; the resulting information is displayed in the following display modes: BB/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 document is a 510(k) premarket notification for the DUS-6000 Digital Ultrasonic Diagnostic Imaging System. It describes the device, its intended use, and claims substantial equivalence to a predicate device. However, it explicitly states: "Clinical testing is not required."

Therefore, the document does not contain any information about an acceptance criteria table or any study that proves the device meets specific acceptance criteria related to its diagnostic performance. The filing focuses on demonstrating equivalence to a previously cleared device through non-clinical tests (safety standards, acoustic output) and comparison of technical characteristics and intended use.

This means I cannot provide the requested information for acceptance criteria and a study proving device performance, as it is explicitly stated that clinical testing was not performed or required for this 510(k) submission.

Here's a breakdown of what can be extracted or inferred from the provided text, primarily based on the absence of information:

1. A table of acceptance criteria and the reported device performance

• No information available. The document states "Clinical testing is not required." and does not provide any performance metrics or acceptance criteria for diagnostic accuracy or effectiveness.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• No test set or clinical data described. Since clinical testing was deemed "not required," there is no information about a test set, sample size, or data provenance.

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. No clinical test set or ground truth establishment is described.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

• Not applicable. No clinical test set or adjudication process is described.

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

• Not applicable and no AI involved directly. This device is a diagnostic ultrasound imaging system, not an AI-assisted diagnostic tool. No MRMC study or AI performance evaluation is mentioned.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

• Not applicable. This device is a diagnostic ultrasound imaging system, where human operation and interpretation are inherent. No standalone algorithm performance is discussed.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Not applicable. No clinical test set or ground truth establishment is described.

8. The sample size for the training set

• Not applicable. This document describes a medical device (ultrasound system), not a machine learning algorithm that requires a training set.

9. How the ground truth for the training set was established

• Not applicable. As above, no training set or ground truth establishment relevant to machine learning is described.

Summary of Device and Basis for Clearance (as per the document):

• Device Name: DUS-6000 Digital Ultrasonic Diagnostic Imaging System
• Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body in various clinical applications (Abdominal, obstetric, gynecology, pediatrics, small parts, urology, peripheral vascular, musculoskeletal, cardiac).
• Regulatory Clearance Basis: Substantial equivalence to the predicate device, DUS 60 ultrasound system (K131830), manufactured by EDAN Instruments Inc.
• Evidence for Equivalence:
  • Similar technology characteristics.
  • Same intended use.
  • Same design principle.
  • Same electrical classification.
  • Same accuracy (claimed, but not explicitly demonstrated through clinical performance data in this document).
  • Same needle-guide bracket material, property, and sterilization methods as the predicate.
• Non-Clinical Tests Conducted (relevant to safety and basic performance):
  • IEC 60601-1 Electrical Safety
  • IEC 60601-1-2 Electromagnetic Compatibility
  • IEC 60601-2-37 Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
  • Acoustic output testing as per FDA guidelines (September 9, 2008).
  • ISO 10993-1, ISO 10993-5, and ISO 10993-10 Biological Evaluation of medical devices.

The document explicitly states that "Clinical testing is not required," which means the submission relies on non-clinical data, comparison to the predicate device, and adherence to recognized standards to demonstrate safety and substantial equivalence, rather than new clinical performance studies or specific diagnostic acceptance criteria.

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