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Esaote's Model 6425 Ultrasound System is a mainframe ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal Cardiac, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small Organs, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative Abdominal, Laparoscopic and Other: Urologic. The system provides imaging for guidance of biopsy and imaging to assist in the placement of needles in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications.

Device Description

The model 6425 is a mainframe ultrasound system used to perform diagnostic general ultrasound studies. Its primary modes of operation are: B-Mode, M-Mode, Amplitude Doppler (AD), Tissue Enhancement Imaging (TEI), Multi View (MView), Tissue Velocity Mapping (TVM), Color Flow Mapping (CFM), Pulse Wave Doppler, 3D and 4D. Model 6425 is equipped with a free orientable LCD Color Display were acquired images and advanced images are shown. Model 6425 is also equipped with a height adjustable/rotating keyboard. A second LCD Display for additional controls and mode-depending keys, includes touch screen technology and is integrated in the control panel. Model 6425 can drive phased (PA), convex array (CA), linear array (LA) probes, Doppler probes and Volumetric probes. Model 6425 is equipped with an internal Hard Disk and with a DVD-RW disk drive that can be used for image storage. Data can also be stored directly to external archiving media (Hard-Disk, PC, server) via a LAN/USB port.

AI/ML Overview

The provided text is a 510(k) Pre-market Notification for the Esaote S.p.A Model 6425 Ultrasound System. It details how the device is substantially equivalent to legally marketed predicate devices.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" for performance metrics like sensitivity, specificity, or accuracy in a traditional sense. Instead, it demonstrates substantial equivalence to predicate devices for its intended uses and technological characteristics. The "performance" is implicitly deemed acceptable if it matches or is comparable to the already cleared predicate devices.

The acceptance criteria are implied to be meeting the safety and performance standards of the predicate devices (Model 6400 and Model 6420) and conforming to relevant medical device safety standards.

Acceptance Criteria (Implied)	Reported Device Performance (Summary)
Intended Use Equivalence	Clinical uses for the Model 6425 are equivalent to Model 6400. The device performs diagnostic general ultrasound studies including various listed applications.
Technological Equivalence	Employs the same fundamental technological characteristics as predicate devices (Model 6400 and Model 6420). Key image modes are available on these cleared systems.
Safety Standard Conformity	Conforms to IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, NEMA UD 2-2004, and NEMA UD 3-2004.
Acoustic Output Display	Provides an Acoustic Output Display feature per AIUM/NEMA standards, with equivalent Ispta and MI maximal values to predicates.
Measurement Accuracy	Provides a similar measurements and analysis package, with equal accuracy and precision as predicate devices.
Digital Storage	Has digital storage capabilities, including network connectivity, similar to predicate devices.
Biocompatibility	Evaluated as part of non-clinical tests.
Cleaning & Disinfection	Evaluated as part of non-clinical tests.
Thermal & Mechanical Safety	Evaluated as part of non-clinical tests.

2. Sample Size Used for the Test Set and Data Provenance

The document explicitly states: "No clinical tests were performed." Therefore, there is no test set sample size or data provenance related to clinical performance in this submission. The basis for clearance is substantial equivalence to previously cleared devices which would have undergone testing.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Since no clinical tests were performed for this specific submission, there is no information regarding experts used to establish ground truth for a test set.

4. Adjudication Method for the Test Set

As no clinical tests were performed, there is no mention of an adjudication method for a test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, the document explicitly states, "No clinical tests were performed." Therefore, no MRMC comparative effectiveness study was conducted for this submission. The device is cleared based on demonstrating substantial equivalence to predicate devices, not on proving improved effectiveness with or without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The device described is an "Ultrasound System," implying it is a hardware and software system for image acquisition and display, operated by a human. There is no mention of an "algorithm only" or "standalone" performance evaluation in the context of AI or automated analysis. The clearance is for the ultrasound system itself.

7. The Type of Ground Truth Used

Given that no clinical tests were performed, there is no information on a specific ground truth used for this submission. The clearance relies on the established safety and performance of the predicate devices.

8. The Sample Size for the Training Set

No information is provided regarding a training set as the submission focuses on substantial equivalence of a new ultrasound hardware system rather than an AI/ML algorithm that would typically require a training set.

9. How the Ground Truth for the Training Set Was Established

As no training set is mentioned in the context of an AI/ML algorithm, this information is not applicable and is not provided in the document.

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