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Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Fetal, Abdominal, Pediatric, Small Organ (breast, thyroid, testicle), Musculo-skeletal (Conventional), Musculo-sketal (Superficial). Invasive diagnosic or therapeutic procedures, Retroperitoneum, Female reproductive system and fetus. Superficial structures & pathologies, Peripheral Vessel, Magnetic Needle guidance

The eZono 4000 system is a portable, software-controlled sonography system based on a digital architecture. It supports linear and curvi-linear transducers. The eZono 4000 system has an ergonomic design optimized for stable handling without sharp edges and is very easy to carry with its low weight of 11.5lbs (5.2kg). The robust casing provided with an anti-slip bottom side. The brilliant 12-inch screen with more than 60 million colors makes it possible to acquire and display highresolution, real-time ultrasound images. The eZono Needle Guide System detects the position and orientation of magnetized needles in the presence of the probe and displays this information relative to the ultrasound image. This quides the operator to better visualize the needle in the ultrasound image during ultrasound guided needling procedures.

The provided document is a 510(k) Premarket Notification for the eZono™ 4000 Diagnostic Ultrasound System. It is a submission for a new medical device that seeks to demonstrate substantial equivalence to previously cleared predicate devices, rather than a study proving the device meets specific acceptance criteria through a clinical trial.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not applicable or directly available in this type of regulatory submission. The submission focuses on non-clinical tests to show conformity to standards and similarities in construction, operating principles, and specifications to predicate devices.

Here's an attempt to answer the questions based on the provided text, indicating "Not Applicable" or "Not Provided" where the information is not present in a 510(k) summary format:

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

This document does not contain a table of acceptance criteria in the sense of performance metrics typically found in a clinical study report (e.g., sensitivity, specificity, accuracy). Instead, it lists the standards to which the device conforms and the quality assurance measures applied during its development.

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

• Sample size for test set: Not Applicable. No clinical studies or test sets (in the sense of patient data for performance evaluation) are mentioned as having been required or conducted for this 510(k) submission.
• Data provenance: Not Applicable.

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 test set requiring expert-established ground truth is described.

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

• Not Applicable. No test set requiring adjudication 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

• MRMC study: Not Applicable. This is an ultrasound diagnostic system, and the submission is for substantial equivalence without clinical studies. It does not describe an AI component for interpretation or assistance that would necessitate an MRMC study.
• Effect size: Not Applicable.

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

• Not Applicable. The device is a diagnostic ultrasound system, not a standalone AI algorithm for interpretation. Its needle guidance feature assists the human operator.

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

• Not Applicable. No clinical studies requiring ground truth were conducted or referenced in this submission for device performance. The "ground truth" for the device's claims of safety and effectiveness relies on its conformance to established standards and its substantial equivalence to predicate devices.

8. The sample size for the training set

• Not Applicable. This submission describes a diagnostic ultrasound system and its software, not a machine learning model requiring a training set from patient data. The "training" for the device's development involved conformance to standards and engineering verification/validation.

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

• Not Applicable. As no training set for a machine learning model is mentioned, no ground truth establishment method for it is relevant.

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