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The ESI-5000 ultrasound system main applications are in general radiology, obstetrics/gynecology, cardiology, and peripheral vessel 2D imaging, spectral Doppler analysis, and color Doppler Imaging.

It is a multi function real time ultrasound imaging system, featuring 2D imaging, M mode, Spectral Pulsed and CW Doppler, and Color Flow, using a variety of linear array, curved array, annular array, and mechanical sector probes, in the frequency range of 3.5 MHz. to 10 MHz.

The provided text is a summary for a 510(k) premarket notification for the ESI-5000 ultrasound system, dated June 2, 1996. It primarily focuses on the device's intended use, its comparison to predicate devices, and its compliance with acoustic output standards, particularly for fetal Doppler capabilities.

Unfortunately, the provided text does not contain the detailed information required to fill out the requested table and answer questions 2 through 9 regarding acceptance criteria and a study proving the device meets those criteria, as these pertain to performance metrics and clinical validation usually found in a separate study report.

The text does mention "safety and effectiveness" and "acoustic output compliance" as key aspects, but it doesn't present them in the format of quantitative acceptance criteria with reported device performance.

Here's an attempt to structure the information that is present, while highlighting what's missing:

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

Missing Information for Table: The text describes features and compliance, but doesn't provide specific numerical performance metrics for imaging quality (e.g., resolution, penetration, sensitivity) that would typically be associated with acceptance criteria for clinical efficacy. The "reported device performance" entries above are inferred from the statement "Regarding safety and effectiveness, the main features of the ESI-5000 are compared to the main features of the following predicate ultrasound systems," implying substantial equivalence.

The following questions cannot be answered from the provided text:

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 does not describe a clinical test set or its 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)

• No mention of experts or ground truth establishment for a test set.

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

• No mention of adjudication methods.

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

• This document is from 1996, pre-dating widespread AI integration in medical devices in this context. No MRMC study is mentioned.

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

• This pertains to AI/algorithm performance, which is not applicable to this 1996 ultrasound device summary.

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

• No ground truth for a performance study is mentioned.

8. The sample size for the training set

• No training set is mentioned in the context of device performance validation.

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

• Not applicable as no training set is mentioned.

Summary of Document Focus:

The K935024 summary primarily focuses on demonstrating substantial equivalence to predicate devices for safety and effectiveness and compliance with acoustic output standards, particularly due to its fetal Doppler capabilities. It is a regulatory submission summary, not a detailed clinical study report. Therefore, it lacks the specific performance data, methodological details, and validation study information typically found in such reports.

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