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EMP-2100 Full Digital Ultrasound Diagnostic System is a general-purpose, digital ultrasound diagnostic system for abdomen, gynecology, obstetric, urology, small-parts, and cardiology application.

The system is intended to use for the following type of studies: fetal organ, abdominal, pediatric, small organs, neonatal cephalic, cardiac, transvaginal, 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.

EMP-2100 Full Digital Ultrasound Diagnostic Device is a portable digital ultrasonic diagnostic B/W system applied in ultrasound diagnostic examination of abdomen, gynecology, obstetric, urology, small-parts, and cardiology application.

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 five display modes as listed below. This system is a Track 1 device that employs an array of probes that include linear array, convex linear array and microconvex linear array with a frequency range of approximately 2.5MHz~7.5MHz.

The subject device is not for life-supporting or life-sustaining, not for implant. The device or transducers are not provided sterile and the transducer does not need sterilization and the transducer is reusable but does not need re-sterilization.

The system consists of a main unit, a display and four transducers.

The provided 510(k) summary for the EMP-2100 Full Digital Ultrasound Diagnostic System is primarily a substantially equivalent analysis comparing the device to a predicate device (DP-6600 Digital Ultrasonic Diagnostic Imaging System). It does not contain the acceptance criteria and a detailed study report that proves the device meets those criteria, as typically found in comprehensive performance studies for AI/CAD devices.

Instead, the submission focuses on demonstrating that the EMP-2100 device is as safe and effective as the predicate device by highlighting similarities and explaining that any differences do not affect basic design principles, usage, effectiveness, or safety.

Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes, ground truth establishment, and expert involvement for a study proving acceptance criteria are not present in this document because this type of study was not performed or detailed as part of this 510(k) submission.

Here's a breakdown of what can be extracted and what is not available based on the provided text:

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

• Acceptance Criteria: The document implies that the acceptance criterion is "substantially equivalent" to the predicate device in terms of effectiveness and safety. However, no specific quantitative or qualitative acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) are provided in a table format.
• Reported Device Performance: The only performance test explicitly mentioned is a "Clinical Measurement Effectiveness Test" to evaluate its measurement accuracy. No specific results, metrics (like accuracy values), or detailed findings from this test are reported. The document states: "The subject device has same classification information, same indication for use, similar product design, same performance effectiveness, performance safety as the predicate device." This is a general statement rather than specific performance data.

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

• Not available. The document mentions a "Clinical Measurement Effectiveness Test" but does not provide any details about the sample size (number of patients or cases), data provenance, or whether it was retrospective or prospective.

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 available. Since the details of the "Clinical Measurement Effectiveness Test" are not provided, there is no information on how ground truth was established, who the experts were, or their qualifications.

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

• Not available. No details on adjudication methods for any test set are provided.

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 done/Not applicable. This device is an ultrasound diagnostic system (hardware and software for imaging), not an AI/CAD system intended to assist human readers in interpretation. Therefore, a MRMC study evaluating human reader improvement with AI assistance would not be relevant to this product.

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

• Not applicable. This is a diagnostic imaging system, not an algorithm being tested in isolation. The "Clinical Measurement Effectiveness Test" would likely involve the system's ability to acquire and display accurate measurements, which is an inherent function of the device.

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

• Not available. The document does not specify the type of ground truth used for the "Clinical Measurement Effectiveness Test."

8. The sample size for the training set

• Not applicable/Not available. As this is a traditional ultrasound system and not an AI/Machine Learning product, there is no concept of a "training set" in the context of algorithm development.

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

• Not applicable/Not available. (See point 8).

Summary of what is present:

The submission highlights that the EMP-2100 is substantially equivalent to the predicate device (DP-6600 Digital Ultrasonic Diagnostic Imaging System) based on:

• Same classification information and intended use.
• Similar product design.
• "Same performance effectiveness" (general statement, no specific metrics provided).
• "Performance safety" (general statement, verified by electrical safety and EMC testing to IEC 60601-1 and 60601-1-2, and biocompatibility testing to ISO 10993-1).

The core of the "proof" that the device meets acceptance criteria ("effectiveness and safety") is the claim of substantial equivalence to a legally marketed predicate device, rather than a detailed study demonstrating quantitative performance metrics against specific, pre-defined acceptance thresholds.

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