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Esaote's Model 6200 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), Intraoperative (Neurological), Laparoscopic and Other: Urologic.

The 6200 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.

Esaote's Model 6250 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), Intraoperative (Neurological), Laparoscopic and Other: Urologic.

The 6250 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.

The Virtual Navigator software option for Esaote models 6200 and 6250 is intended to support a radiological clinical ultrasound examination (first modality) and follow percutaneous procedures or surgical operations providing additional image information from a second imaging modality (CT, MR, US and PET). The second modality provides additional security in assessing the morphology of the ultrasound image. Virtual Navigator can be used in the following application: Abdominal, Gynecological, Musculoskeletal, Obstetrics, Pediatric, Urologic, Small Organs, Intraoperative (Abdominal), Intraoperative (Neurological), Peripheral Vascular and Transcranial for radiological examinations only.

The second modality image is not intended to be used as a standalone diagnostic image since it represents information of a patient that could not be congruent with the current (actual) patient position and shall therefore always been seen as an additional source of information.

The Virtual Navigator tracking system is contraindicated for patients, personnel and other people who use an electronic life support device (such as a cardiac pacemaker or defibrillator).

Both 6200 and 6250 upgrades are mainframe ultrasound systems used to perform diagnostic general ultrasound studies. The primary modes of operation are for both systems: B-Mode, Tissue Enhancement Imaging (TEI), M-Mode, Multi View (MView), Doppler (both PW and CW), Color Flow Mapping (CFM), Amplitude Doppler (AD), Tissue Velocity Mapping (TVM), 3D and 4D, Elastosonography. Both 6200 and 6250 models are equipped with a LCD color display where acquired images and advanced image features are shown.

The Virtual Navigator is a software option designed to support a radiological clinical ultrasound examination (first modality) and follow a percutaneous procedure providing additional image information from a 2nd imaging modality (CT, MR, US and PET). The user is helped in assessing the patient anatomy by displaying the image generated by the 2nd modality.

Both 6200 and 6250 models including the Virtual Navigator software option have been cleared via 510(k) 153277.

Both 6200 and 6250 upgrades, defined herein, combine the cleared features of both 6200 and 6250 models with new capabilities, listed below:

• . Implementation of the MyLabRemote feature on both 6200 and 6250 upgrades
• । Addition of in Elastosonography (ElaXto) analysis in Intraoperative (Neurological) application on both 6200 and 6250 upgrades
• -Management of Quantitative Elastosonographic analysis (QElaXto) in Abdominal application on 6200 upgrade
• -Implementation of the Automatic Nuchal Translucency feature on both 6200 and 6250 upgrades
• -Addition of new probes on both 6200 and 6250 upgrades

Furthermore, the Virtual Navigator upgrade, defined herein, combine the cleared features of the Virtual Navigator with new software capabilities compatible to both 6200 and 6250 upgrades related to the Virtual Navigator software option and listed below:

• Availability in Intraoperative (Abdominal) and Intraoperative (Neurological) applications in the Virtual Navigator upgrade environment
• -Availability of Elastosonography (ElaXto) analysis in Intraoperative (Abdominal) and Intraoperative (Neurological) applications in the Virtual Navigator upgrade environment
• -Availability of Quantitative Elastosonographic analysis (QElaXto) for Abdominal application in the Virtual Navigator upgrade environment
• -Navigation software new user interface on Virtual Navigator upgrade

The marketing names for 6200 and 6250 upgrades will be called MyLabEight respectively.

The different versions of 6200 and 6250 models and their upgrades are differentiated by part numbers.

Both 6200 and 6250 upgraded models are manufactured under an ISO 9001 and ISO 13485 certified quality system.

The provided document is a 510(k) Premarket Notification from Esaote S.p.A. to the FDA for their 6200 Ultrasound System and 6250 Ultrasound System. This document outlines the general intended uses and provides some technical specifications and conformity to safety standards. It does not contain information about the acceptance criteria for a specific AI-powered device, nor does it detail a study proving such a device meets those criteria, as there is no mention of an AI-powered device beyond the "Virtual Navigator" which is described as supporting, not replacing, human radiological review.

The document states: "The Virtual Navigator software option for Esaote models 6200 and 6250 is intended to support a radiological clinical ultrasound examination (first modality) and follow percutaneous procedures or surgical operations providing additional image information from a second imaging modality (CT, MR, US and PET). The second modality provides additional security in assessing the morphology of the ultrasound image. Virtual Navigator can be used in the following application: Abdominal, Gynecological, Musculoskeletal, Obstetrics, Pediatric, Urologic, Small Organs, Intraoperative (Abdominal), Intraoperative (Neurological), Peripheral Vascular and Transcranial for radiological examinations only. The second modality image is not intended to be used as a standalone diagnostic image since it represents information of a patient that could not be congruent with the current (actual) patient position and shall therefore always been seen as an additional source of information."

This description indicates that the Virtual Navigator is an image fusion tool for enhanced visualization, not an AI diagnostic system with specific numerical performance metrics. Therefore, the requested information (acceptance criteria, specific study results, sample sizes, expert involvement, and ground truth for AI performance) is not present in this document.

The document focuses on demonstrating substantial equivalence of the ultrasound systems and the Virtual Navigator software option (which appears to be an image fusion tool, not an AI with diagnostic capabilities as typically understood in the context of acceptance criteria measured by metrics like AUC, sensitivity, specificity, etc.) to previously cleared predicate devices. The "Summary of Clinical Tests" explicitly states: "No clinical tests were performed."

Therefore, I cannot populate the requested table or answer the specific questions about acceptance criteria and a study proving an AI device meets them using only the provided text. The document is primarily a regulatory filing for a medical imaging device and its software features, demonstrating safety and performance equivalence, not a detailed report on the validation of an AI diagnostic algorithm against predefined performance metrics.

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