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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), 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), 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, Musculo-skeletal, Obstetrics, Pediatric, Urologic, Small Organs, 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 should not be used on or around persons with a cardiac pacemaker, and should not be used around life supporting equipment.

Both 6200 and 6250 models are mainframe ultrasound systems used to perform diagnostic general ultrasound studies. The primary modes of operation are for both systems: B-Mode, XView, Multi View (MView), Trapezoidal View (TPView), Doppler, Color Flow Mapping, Amplitude Doppler (AD), Tissue Velocity Mapping (TVM) and Tissue Enhancement Imaging (TEI). Both 6200 and 6250 are equipped with an 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 or US). The user is helped in assessing the patient anatomy by displaying the image generated by the 2nd modality.

6200 models including Virtual Navigator software option have been cleared by K100931; 6250 models including Virtual Navigator software option have been cleared by K103152. Virtual Navigator has also been cleared for use with 6100 and 6150 models by K081386.

The purpose of this submission is to introduce an upgrade to both Esaote 6200 and 6250 models to add additional software capabilities. 6200 and 6250 Upgrades, defined herein, combine the cleared features of both 6200 and 6250 models with other new software capabilities related to the Virtual Navigator software option and listed below:

• Navigation Software new user interface .
• Tracking System new Ascension tracking module managing also needle and motion . sensors
• Second Modality Data Acquisition multi dataset management (MRI, PET, CT, US via . Dicom - US including acquisition and navigation)
• New Indications: Gynecological, Obstetrics, Pediatric, Small Organs, Transcranial .
• Registration Techniques added one point registration .
• Target Definition introduced intelligent positioning .
• Planning updated needle table .
• 3D Panoramic ●

The 6200 and 6250 Upgrades are manufactured under an ISO 9001:2000 and ISO 13485 certified quality system.

The provided text is a 510(k) Summary for the Esaote 6200 and 6250 Ultrasound Systems, specifically for upgrades and additional software capabilities, including the Virtual Navigator. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria or clinical study results for novel performance claims.

Here's a breakdown of why many sections of your request cannot be fulfilled based on the provided text:

• No new performance claims: The core of this submission is to demonstrate that the upgraded devices have "substantially equivalent" technological characteristics and intended uses to previously cleared devices. This means that explicit "acceptance criteria" and "device performance" in terms of clinical accuracy or effectiveness for new features are generally not established or reported in such a submission. Instead, the upgrades are deemed equivalent to existing cleared devices and features.
• No clinical tests performed: The document explicitly states: "No clinical tests were performed." Therefore, there will be no information on sample size for test sets, data provenance, number of experts, adjudication methods, MRMC studies, or standalone algorithm performance for the current submission.
• "Ground Truth" not applicable for a substantial equivalence submission of this nature: Since clinical performance is not being newly established, there's no need for "ground truth" to be defined for primary performance endpoints in this context. The substantial equivalence argument relies on the safety and performance characteristics being similar to already cleared devices.

Based on the provided text, here is the information that can be extracted or deduced:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document as it is a 510(k) submission focused on substantial equivalence to predicate devices, not on establishing new performance claims with specific acceptance criteria. The submission states that the "6200 and 6250 Upgrades are substantially equivalent to the legally marketed devices and conform to applicable medical device safety and performance standards."

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

Not applicable/Not provided. The document explicitly states: "No clinical tests were performed." Therefore, there is no test set, sample size, or data provenance from clinical trials to report for this submission.

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

Not applicable/Not provided. As no clinical tests were performed and no new performance claims requiring ground truth establishment were made, this information is not relevant to this submission.

4. Adjudication Method for the Test Set

Not applicable/Not provided. As "No clinical tests were performed," there was no test set or adjudication method.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No. The document explicitly states: "No clinical tests were performed." Therefore, no MRMC study was conducted for this submission.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done

No. The document explicitly states: "No clinical tests were performed." Given that the submission focuses on upgrades to an ultrasound system and its software (Virtual Navigator), the "algorithm only" performance would typically refer to the Virtual Navigator's accuracy, but this was not evaluated in a standalone clinical fashion as part of this submission. Its equivalence is based on prior clearances and comparison to a predicate device's feature.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

Not applicable/Not provided. As "No clinical tests were performed," a new ground truth was not established for performance assessment in this submission. The device's safety and effectiveness are established through conformance to standards and substantial equivalence to predicate devices that would have had their performance and safety previously evaluated.

8. The Sample Size for the Training Set

Not applicable/Not provided. This submission is for an upgrade to existing ultrasound systems and software, asserting substantial equivalence to previously cleared devices. It does not describe a new algorithm that would have a distinct training set. The upgrades relate to user interface, tracking systems, multi-dataset management, new indications, registration techniques, target definition, and 3D Panoramic features, which are presented as either previously cleared features or substantially equivalent to features on predicate devices.

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

Not applicable/Not provided. As there is no described training set for a new algorithm in this submission, the method for establishing ground truth for such a set is not relevant or provided.

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