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The multifunctional ultrasound scanner is used to collect, display and analyze ultrasound images during ultrasound imaging procedures in combination with supported echographic probes.
Main application: Cardiac, Vascular, General Imaging, Women Health. Districts: Cardiac Adult, Cardiac Pediatric, Neonatal, Adult Cephalic, Vascular, Abdominal, Breast, Musculoskeletal, Neonatal, Pediatric, Small Organs (Testicles), Thyroid, Urological, OB/Fetal, Gynecology. Invasive access: Transesophageal, Not applicable, Intraoperative (Abdominal), Laparoscopic, Transrectal, Transvaginal.

Virtual Navigator option supports a radiological clinical ultrasound examination (first modality) by providing additional image information from a second imaging modality. As second imaging modality it is intended any image coming from CT, MR, US, PET, XA and NM.
The second modality provides additional security in assessing the morphology of the real time ultrasound image.

The primary modes of operation are: B-Mode, M-Mode, Tissue Enhancement Imaging (TEI), Multi View (MView), Doppler (both Pulsed Wave (PW) and Continuous Wave (CW)), Color Flow Mapping (CFM), Power Doppler, Tissue Velocity Mapping (TVM), Combined modes, Elastosonography, 3D/4D and CnTI.
The ultrasound scanner is suitable to be installed in professional healthcare facility environment and is designed for ultrasound practitioners.

6450 Ultrasound System is a general-purpose diagnostic ultrasound system, based on a mainframe platform that can be easily moved thanks to four swivelling wheels.
6450 Ultrasound System consists of a control panel assembly with LCD monitor and a console with the device electronics and connectors, housed in an ergonomic cart designed to be both highly mobile and adjustable for a range of users and operating conditions.
6450 Ultrasound System use the physical properties of the ultrasound (i.e. sound waves with frequency above 20 kHz and that are not audible to the human ear) for the visualization of deep structures of the body by recording the reflections or echoes of ultrasonic pulses directed into the tissues and of the Doppler effect, i.e. the frequency-shifted ultrasound reflections produced by moving targets (usually red blood cells) in the bloodstream, to determine both direction and velocity of blood flow in the target organs.
The primary modes of operation are: B-Mode, M-Mode, Tissue Enhancement Imaging (TEI), Multi View (MView), Doppler (both PW and CW), Color Flow Mapping (CFM), Power Doppler, Tissue Velocity Mapping (TVM), Combined modes. 6450 Ultrasound System also manages Elastosonography (ElaXto, QElaXto, QElaXto 2D), 3D/4D and CnTI.
Several types of probes are used to cover different needs in terms of geometrical shape and frequency range.
6450 Ultrasound System can drive Phased Array, Convex Array, Linear Array, Doppler probes and Volumetric probes (Bi-Scan probes).
The control panel is equipped with a pull-out Qwerty alphanumeric keyboard that allows data entry. The touchscreen has an emulation of the Qwerty keyboard that allows data entry and has additional controls and mode-depending keys, integrated in the touchscreen.
6450 Ultrasound System is equipped with wireless capability.
6450 Ultrasound System will be available on the market in two models with the following commercial names: MyLabE80, MyLabE85.
The difference between MyLabE80 and MyLabE85 models is only in the licenses configuration.
For both models, there is the ETC (Easy To Clean) version, having a keyboard with special controls and material, compatible with disinfection procedures.
6450 Ultrasound System, defined herein, introduces new features and accessories listed below:

1. XStrain LA: XStrain allows clinicians to quantify endocardial velocities of contraction and relaxation and local deformation of the heart (Strain/Strain rate). XStrain LA is an advanced processing package for the Left Atrium analysis.
2. New probe: IHX 6-25
   6450 Ultrasound System employs the same fundamental technological characteristics as its predicate device cleared via K192157.

The provided FDA clearance letter (K241671) describes a 510(k) submission for the Esaote 6450 Ultrasound System (MyLabE80/E85). While it states that "The proposed device did not require clinical studies to support substantial equivalence," it does detail non-clinical testing, specifically for a new feature called "XStrain LA." This section will focus on the acceptance criteria and study proving the device meets these criteria for the XStrain LA feature, as it's the only performance validation detail provided.

Note: The document is primarily a 510(k) clearance letter, which focuses on demonstrating substantial equivalence to a predicate device rather than comprehensive clinical performance studies often seen with novel high-risk devices or completely new AI functionalities. The XStrain LA validation described appears to be a non-clinical performance test against a reference software, not a separate clinical study with human readers.

Acceptance Criteria and Reported Device Performance

The acceptance criterion for the XStrain LA feature is based on the Intraclass Correlation Coefficient (ICC) when comparing its results (LASr, LAScd, LASct) to a recognized reference software (TomTec AutoSTRAIN). The specific acceptance thresholds are not explicitly stated as numerical values in the document but are implied by the reported results being "valid." Given the context of a 510(k) summary, these would typically be pre-defined thresholds considered adequate for clinical equivalence or sufficient performance.

Here's a table summarizing the acceptance criteria (implied by the study design) and the reported performance for the XStrain LA feature:

Study Details for XStrain LA Feature Validation

1. Sample size used for the test set and the data provenance:

   • Sample Size: Undisclosed, but described as "five batches of image data." The exact number of patients or images within these batches is not specified.
   • Data Provenance: The data comes from various sources, indicating a retrospective collection:
     • Batch 1: Acquired using an Esaote MyLab Alpha system in a multi-vendor strain comparison study (Farsalinos, Daraban, Ünlü, & Thomas, 2015).
     • Batch 2: Acquired using an Esaote MyLab Alpha system in another multi-vendor strain comparison study (Mirea, et al., 2018).
     • Batch 3: Acquired at the cardiology department of the Amsterdam Medical Center.
     • Batch 4: Acquired at the cardiology department of Auxologico hospital Milan.
     • Retrospective/Prospective: All described data acquisition appears to be retrospective, utilizing existing datasets from previous studies or clinical archives.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • The "ground truth" for the test set is established by the TomTec AutoSTRAIN software (part of TomTec Arena TTA2 LOT 42.0), which is used as the "prior reference" or "reference software."
   • For the data acquisition from the Amsterdam Medical Center and Auxologico hospital Milan, the images were acquired by "experienced cardiographers." This refers to the acquisition of the images themselves, not the establishment of the "ground truth" for the strain analysis. The document does not specify human experts involved in manually adjudicating or segmenting images solely for the purpose of establishing ground truth for this particular validation study's comparison to the reference software.

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

   • No human adjudication method is described for the test set's ground truth. The comparison is directly between the Esaote 6450 Ultrasound System's XStrain LA results and the results from the TomTec reference software.

4. 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:

   • No MRMC comparative effectiveness study was performed as described in this document. The validation focuses on the performance of the XStrain LA feature (an advanced processing package) itself against a reference software, not on human reader improvement with or without this feature.

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

   • Yes, the validation of XStrain LA against the TomTec reference software can be considered a form of standalone performance assessment, as it evaluates the algorithm's output directly against a computational reference, rather than its impact on a human reader's diagnostic accuracy. The process described is: "A strain analysis is done for one complete heart cycle on each of the image runs... The LASr, LAScd and LASct results for each image run are compared to the corresponding TomTec reference." This is a direct comparison of algorithmic output.

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

   • The ground truth is established by a reference software/algorithm: TomTec AutoSTRAIN. This is a computational ground truth, specifically a widely used and validated commercial software for cardiac strain analysis.
   • The initial contouring and frame index used for the Esaote system's analysis were set to be "equal to the ones used during the creation of the TomTec references," indicating consistency in the input conditions for comparison.

7. The sample size for the training set:

   • The document does not provide any information regarding the training set sample size for the XStrain LA feature. This is typical for a 510(k) summary that focuses on validation of a specific feature rather than the entire development lifecycle of a complex AI model.

8. How the ground truth for the training set was established:

   • The document does not provide any information regarding how the ground truth for the training set was established.

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Esaote's Model 6450, commercial names MyLabX8 and MyLabX8 eXP, is intended to perform diagnostic general ultrasound studies including: Fetal, Abdominal, Intraoperative (Abdominal), Laparoscopic, Pediatric, Small organ, Neonatal, Neonatal Cephalic, Adult Cephalic, Transvaginal, Musculoskeletal (Conventional), Musculoskeletal (Superficial), Urological, Cardiovascular Pediatric, Transesophageal (cardiac), Peripheral Vessel.

The equipment 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 Musculosketal applications. The ultrasonic medical diagnostic equipment is intended to be connected to mechanical and electronic ultrasound probes (convex array, linear array and phased array) and Doppler probes.

The Virtual Navigator software option for Esaote 6450 system 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, 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).

Model 6450, commercial names MyLabX8 and MyLabX8 eXP, 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 6450 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 6450 is equipped with a LCD color display where acquired images and advanced image features are shown. Model 6450 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 6450 can drive Phased Array (PA), Convex Array (LA), Linear Array (LA), Doppler and Volumetric probes.

Model 6450 is equipped with an internal Hard Disk Drive. Data can also be stored directly to external archiving media (Hard-Disk, PC, server) via a LAN/USB port.

The marketing names for Model 6450 will be MyLabX8 and MyLabX8 eXP.

The provided text does not contain specific acceptance criteria, reported device performance metrics, or detailed study information for the 6450 Ultrasound System. It is a 510(k) summary and clearance letter for a medical device, which primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria.

Therefore, most of the requested information cannot be extracted from this document, as no formal clinical study with performance criteria was conducted for this submission.

Here's a breakdown of what can be inferred or directly stated:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable. The document explicitly states "No clinical tests were performed." The submission relies on demonstrating substantial equivalence to a predicate device (Esaote 6440 - MyLab9 eXP, K173291), not on meeting specific performance acceptance criteria through a clinical study for this 510(k). The non-clinical tests (acoustic output, biocompatibility, cleaning/disinfection, thermal, electromagnetic, and mechanical safety) are stated to conform to relevant standards but no specific acceptance criteria or performance metrics are detailed in the text.

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

Not applicable. No clinical test set was used as "No clinical tests were performed."

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

Not applicable. No clinical test set was used, and therefore, no expert-established ground truth for such a set was required or reported.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set was used.

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

No. The document states "No clinical tests were performed," so an MRMC comparative effectiveness study was not conducted.

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

Not applicable. The device is an ultrasound system with a software option (Virtual Navigator). While software verification and validation were performed, this is not a standalone algorithm performance study as typically understood for AI/ML devices. The Virtual Navigator software option is intended to support a radiological clinical ultrasound examination, implying a human (radiologist) in the loop.

7. The Type of Ground Truth Used

Not applicable in the context of a clinical performance study. For the non-clinical tests performed (acoustic output, safety, etc.), the "ground truth" is adherence to established engineering and medical device safety standards (e.g., IEC 60601-1, NEMA UD-2).

8. The Sample Size for the Training Set

Not applicable. This submission does not describe an AI/ML algorithm that would undergo training with a dataset in the typical sense. The Virtual Navigator software option is a feature for image guidance using information from a second modality, implying image registration and fusion, but not a trainable algorithm with a distinct training set.

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

Not applicable. As no training set is described, no ground truth establishment for a training set is mentioned.

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