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Esaote's Model 6440 is intended to perform diagnostic general ultrasound studies including: Fetal, Abdominal, Intraoperative (Abdominal), Pediatric, Small organs, Neonatal, Neonatal Cephalic, Adult Cephalic, Transvaginal, Musculoskeletal (Conventional), Musculoskeletal (Superficial), Urological, Cardiovascular Pediatric, Transoesophageal (cardiac), Peripheral Vessel.

The 6440 system provides imaging for guidance of biopsy and imaging to assist in the placement of needles and catheters in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications.

The Virtual Navigator software option for Esaote model 6440 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 real time ultrasound image. Virtual Navigator can be used in the following applications: 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 be 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).

Model 6440 is a mainframe ultrasound system used to perform diagnostic general ultrasound studies. The primary modes of operation are: 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, Qualitative Elastosonography (ElaXto) and Quantitative Elastosonography (QElaXto).

Model 6440 has the Virtual Navigator software option integrated, designed to support a radiological clinical ultrasound examination (first modality) and follow a percutaneous procedure providing additional image information from a second 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.

Model 6440 is equipped with a LCD color display where acquired images and advanced image features are shown. Model 6440 control panel is equipped with a pull-out Qwerty alphanumeric keyboard that allows data entry. The touchscreen has an emulation of the Qwerty alphanumeric keyboard that allows data entry and has additional controls and mode-depending keys, integrated in the touchscreen.

Model 6440 can drive Phased Array (PA), Convex Array (LA), Doppler and Volumetric probes.

Model 6440 is equipped with an internal Hard Disk Drive 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.

The marketing name for Model 6440 will be called MyLab9 eXP.

This is a 510(k) premarket notification for the Esaote 6440 Ultrasound System. The document does not describe a study proving the device meets specific acceptance criteria in terms of diagnostic performance (e.g., sensitivity, specificity, accuracy) for an AI/CADe device. Instead, it demonstrates substantial equivalence to predicate devices through technical comparisons and compliance with relevant safety and performance standards for a general ultrasound system and its integrated software options.

The document discusses performance data related to:

• Biocompatibility Testing: For transducers, conducted according to FDA Blue Book Memorandum #G95-1 and ISO 10993-1. These tests included cytotoxicity, sensitization, and irritation.
• Electrical Safety and Electromagnetic Compatibility (EMC): Compliance with IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-37 standards.
• Software Verification and Validation Testing: Documentation provided as per FDA guidance, and the software was classified as a "moderate" level of concern.
• Mechanical and Acoustic Testing: Acoustic output testing according to NEMA Standards Publication UD 2-2004 Revision 3 (R2009) and UD 3-2004 Revision 2 (R2009).

Since this document primarily addresses a substantial equivalence determination for a general ultrasound system and its software options based on compliance with standards and technical comparisons, it does not contain the specific information typically associated with a study proving diagnostic performance against quantitative acceptance criteria for an AI/CADe device.

Therefore, many of the requested categories (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth, training set size and ground truth establishment) are not applicable in this context, as they pertain to clinical performance studies for AI/CADe devices, which are not detailed in this submission.

However, based on the provided text, I can infer a general "acceptance criteria" related to functional performance and safety, and the "reported device performance" is that it "passes" these criteria through various non-clinical tests.

1. Table of Acceptance Criteria and the Reported Device Performance:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not Applicable. The submission describes non-clinical testing (biocompatibility, electrical safety, software V&V, mechanical/acoustic) and comparisons to predicate devices, not a clinical study with a test set of patient data to assess diagnostic performance.

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. See explanation above.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not Applicable. See explanation above.

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:
Not Applicable. This submission does not describe an AI-assisted diagnostic study or any MRMC study. The "Virtual Navigator" software option is described as providing "additional image information from a second imaging modality," not as an AI or CADe system intended to assist human readers in improving diagnostic tasks.

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. While it contains software, no standalone diagnostic algorithm performance study is described.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not Applicable. See explanation above. The "ground truth" for the non-clinical tests would be the established specifications and standards for each test (e.g., successful cell growth for cytotoxicity, compliance with electrical limits).

8. The sample size for the training set:
Not Applicable. There is no mention of a training set as this is not an AI/CADe device submission detailing such a development process.

9. How the ground truth for the training set was established:
Not Applicable. See explanation above.

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