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WED-3100 Digital Ultrasound Scanner is intended for diagnostic ultrasound imaging analysis for abdomen, gynecology, obstetric, urology, small-parts.
The system is intended to use for the following type of studies: fetal, abdominal, pediatric, small organs, peripheral vascular, and musculo-skeletal (both conventional and superficial). The device is intended to adult, pregnant woman, pediatric and neonate.
The system is a prescription device intended to be used by or on the order of a physician or similar qualified health care professional. This device is not intended for home use.

This equipment is high resolution linear/convex ultrasound scanning diagnostic equipment. It adopts micro-computer control and digital scan converter (DSC), digital beam-forming (DBF), real time dynamic aperture (RDA), real time dynamic receiving apodization, real time dynamic receiving focusing (DRF), Digital frequency scan (DFS), frame correlation technologies to endue its image with clarity, stability and high resolution.

Here's an analysis of the provided text regarding the acceptance criteria and study for the KLOOO79 device (WED-3100 Digital Ultrasound Scanner).

It's important to note that this document is a 510(k) summary, which often provides a high-level overview. Detailed study protocols and results are typically found in the full 510(k) submission, which is not provided here. Therefore, some information requested might be absent or generalized.

Acceptance Criteria and Device Performance

The acceptance criteria for the device are generally implied by the technical specifications and the statement that "Laboratory testing was conducted to validate and verify that the proposed devices met all design specifications, including electrical safety, EMC, specifications." For specific performance criteria, we look at the 'Accuracy' and 'Resolution' values provided in the technical specifications.

Table of Acceptance Criteria and Reported Device Performance (Implied from Technical Specifications)

Study Details

The primary study mentioned to demonstrate effectiveness is a "Clinical Measurement Effectiveness Test." However, the details provided for this test are very limited.

1. Sample size used for the test set and the data provenance:

   • Sample Size: Not specified.
   • Data Provenance: Not specified. The manufacturer is based in China, but it's not explicitly stated where the clinical measurement effectiveness test was conducted or where data originated. The submission date is September 28, 2009, with the K number assigned on March 1, 2010; this doesn't indicate if the data was retrospective or prospective.

2. 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 specified. The document only states "Clinical Measurement Effectiveness Test was conducted." There is no mention of experts or their qualifications for establishing ground truth.

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

   • Not specified.

4. 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 or human reader study is mentioned. This device is a digital ultrasound scanner, not an AI-assisted diagnostic tool.

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

   • The "Clinical Measurement Effectiveness Test" is likely a standalone performance assessment of the device's measurement capabilities. However, it's not an AI algorithm. It assesses the accuracy of measurements performed by the ultrasound system itself.

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

   • For the "Clinical Measurement Effectiveness Test," the ground truth is implied to be highly accurate reference measurements against which the device's measurements (Distance, circumference, area, volume, heart rate, GA, FW, EDD) are compared. The common practice for such tests involves phantoms with known dimensions or established clinical methods for comparison, but the specific type is not detailed beyond "Effectiveness Test."

7. The sample size for the training set:

   • Not applicable. This device is a diagnostic ultrasound scanner, not a machine learning or AI product that requires a training set.

8. How the ground truth for the training set was established:

   • Not applicable. (See #7).

Additional Safety and Effectiveness Studies Mentioned:

Beyond the "Clinical Measurement Effectiveness Test," the document highlights several other studies/tests crucial for demonstrating safety and equivalence:

• Electrical Safety Standards: Testing against IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37.
• Acoustic Output: Testing against NEMA UD 2: 2004.
• Biocompatibility Standards: Testing against ISO 10993-5, ISO 10993-10, ISO 10993-12.

These studies demonstrate compliance with recognized industry standards related to the physical and biological safety of the device, rather than diagnostic effectiveness in a clinical human-in-the-loop context. The "Clinical Measurement Effectiveness Test" is the sole mention of a study to prove the device's diagnostic capability.

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