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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
  Districts: Cardiac Adult, Cardiac Pediatric
  Invasive access: Transesophageal

• Vascular
  Districts: Neonatal, Adult Cephalic, Vascular
  Invasive access: Not applicable

• General Imaging
  Districts: Abdominal, Breast, Musculoskeletal, Neonatal, Pediatric, Small Organs (Testicles), Thyroid, Urological
  Invasive access: Intraoperative (Abdominal), Laparoscopic, Transrectal

• Women Health
  Districts: OB/Fetal, Gynecology
  Invasive access: Transrectal, Transvaginal

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.

6600 Ultrasound System is a general-purpose diagnostic ultrasound system, based on a mainframe platform that can be easily moved thanks to four swivelling wheels.

6600 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.

6600 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. 6600 Ultrasound System also manages Elastosonography, 3D/4D and CnTI.

Several types of probes are used to cover different needs in terms of geometrical shape and frequency range.

6600 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.

6600 Ultrasound System is equipped with wireless capability.

6600 Ultrasound System will be available on the market in two models with the following commercial names: MyLabA50, MyLabA70. The difference between MyLabA50 and MyLabA70 models is only in the licenses configuration.

6600 Ultrasound System, defined herein, introduces new features and accessories listed below:

1. AutoOB: AutoOB (Automatic Obstetric Biometric Measurement) is a tool based on A.I. algorithms that supports the clinician in performing the Obstetric Biometric Measurements during an Obstetric ultrasound examination.

2. AutoCM: AutoCM (Automatic Cardiac Measurement), is a tool based on A.I. algorithm that supports the clinician in performing the Cardiac Measurements during a Cardiac ultrasound examination.

3. XStrain RV: XStrain allows clinicians to quantify endocardial velocities of contraction and relaxation and local deformation of the heart (Strain/Strain rate). XStrain RV is an advanced processing package for the Right Ventricle analysis.

4. New probes: C 1-8E, L 3-15E and P 1-5E, available for MyLabA50 model.

5. New probes: C 1-8A and P 1-5A available for MyLabA70 model.

6600 Ultrasound System employs the same fundamental technological characteristics as its predicate device cleared via K230179.

The document describes the FDA 510(k) clearance for the Esaote 6600 Ultrasound System, specifically highlighting the AI-powered features: AutoOB (Automatic Obstetric Biometric Measurement) and AutoCM (Automatic Cardiac Measurement). The study performed aimed to demonstrate the statistical equivalence between the AI-powered automatic measurements and manual measurements.

Here's a breakdown of the acceptance criteria and the study details for the AI functionalities:

AutoOB (Automatic Obstetric Biometric Measurements) Feature AI-powered

Acceptance Criteria and Reported Device Performance

For Scan Plane Classification Algorithm:

For Automatic Measurement Algorithm:

Note: The document states "All test results are in line with the acceptance criteria" for both algorithms, indicating that the reported performance met the acceptance criteria.

Study Details for AutoOB

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

   • Scan plane classification algorithm: 265 images (test dataset)
   • Automatic measure algorithm: 521 images (test dataset)
   • Data Provenance: Based on female, pregnant, Caucasian patients. The document does not explicitly state the country of origin but implies data was collected by Esaote (an Italian company) and its predicate device users. The information available suggests it's retrospective data, as images were "saved during the examinations."

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

   • Number of Experts: Two experts established the ground truth for both training and test datasets.
   • Qualifications: Clinicians specialized in Radiology with 30 and 24 years of experience in Ob-fetal ultrasound imaging.

3. Adjudication method for the test set:

   • Method: Consensus reading. Each expert contributed to the annotation, then reviewed the annotations of the other. A consensus reading was done whereby the two radiologists discussed if they agreed on or not.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, an MRMC study comparing human readers with and without AI assistance was not reported for AutoOB. The study focused on the equivalence between manual and AI measurements, rather than human reader performance improvement.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Yes, the study evaluates the performance of the algorithm in classifying scan planes and performing measurements automatically, comparing them to expert-derived ground truth. This is a standalone evaluation of the algorithm's accuracy.

6. The type of ground truth used: Expert consensus by a panel of two radiologists.

7. The sample size for the training set:

   • Scan plane classification algorithm: 25597 images
   • Automatic measure algorithm: 11698 images

8. How the ground truth for the training set was established: The consensus of the same expert panel (two radiologists with 30 and 24 years of experience) was used as ground truth for the training datasets, following the same adjudication method.

AutoCM (Automatic Cardiac Measurements) Feature AI-powered

Acceptance Criteria and Reported Device Performance

For Segmentation and Measurement Algorithm:

Note: The document states "All test results are in line with the acceptance criteria," indicating that the reported performance met the acceptance criteria.

Study Details for AutoCM

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

   • Test set sample size: 100 images
   • Data Provenance: Based on both female and male Caucasian adult patients. The test dataset was "acquired and labelled in a different medical center" than where the training data experts established ground truth, implying prospective or at least independently collected retrospective data. The country of origin is not explicitly stated.

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

   • Number of Experts for Test Set Ground Truth: One expert.
   • Qualifications for Test Set Ground Truth: Clinician specialized in Cardiology with 36 years of experience.
   • (For training set ground truth, two cardiologists with 30 and 24 years of experience were used).

3. Adjudication method for the test set:

   • Method: The test dataset was labelled by a single clinician. Therefore, no formal adjudication of multiple readers on the test set is reported for the AutoCM feature. (For the training set, a consensus reading of two cardiologists was performed).

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, an MRMC study comparing human readers with and without AI assistance was not reported for AutoCM. The study focused on the equivalence between manual and AI measurements.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Yes, the study evaluates the performance of the algorithm in performing cardiac measurements automatically, comparing them to expert-derived ground truth. This is a standalone evaluation of the algorithm's accuracy.

6. The type of ground truth used: Expert ground truth. For the training set, it was expert consensus (two cardiologists). For the test set, it was established by a single expert.

7. The sample size for the training set: 2011 images

8. How the ground truth for the training set was established: The consensus of an expert panel consisting of two clinicians specialized in Cardiology with 30 and 24 years of experience was used. Each contributed to the annotation and then reviewed the annotations of the other, with a consensus reading to resolve disagreements.

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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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The general-purpose magnetic resonance imaging (MRI) device is designed to scan any targeted area of the body, to collect, display and analyze MR images and other real-time imaging procedures.

Imaging portions of calf, knee, ankle, foot, thigh, hand, wrist, forearm, elbow, arm, shoulder, hip, lumbar column, sacral column, cervical column, thoracic spine, pelvis, temporomandibular joint (included only for "Open" configuration), head (included only for "Open" configuration).

MRI provides better soft tissue contrast than CT and can differentiate better between fat, water, muscle, and other soft tissue than CT (CT is usually better at images provide information to physicians and can be useful in diagnosing a wide variety of diseases and conditions.

The new Magnifico EVO 23 employs the same fundamental scientific technology as its predicate device, the first version of Esaote Magnifico, cleared via K212419.

The modifications, do not affect the intended use or alter the fundamental scientific technology of the device.

The software, used on the proposed Magnifico system has been modified, from EVO 21 to include the

• LSDWI sequence for brain examination

• · MR Angiography
  · Maximum Intensity Projection (MIP)

• and to support:
  · Additional multi-channel technology coil for body

• · Enhancement of PC board with new processor
  Maqnifico keeps all the other technological characteristics of the first cleared, version, as the 0.4T permanent Magnet, based on NdFeB (neodymium), C-shape.

The provided text indicates that the device in question is the Magnifico Open (100009900) and Magnifico MSK (100009910) MRI systems, specifically focusing on the new EVO 23 software release.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with numerical targets. Instead, it describes general categories of testing and qualitative conclusions. The reported device performance is described as meeting these criteria.

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

The document does not specify a numerical sample size for the test set. It mentions "Sample clinical images for the new features were reviewed."

The data provenance (country of origin, retrospective/prospective) is not specified in the provided text.

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

• Number of Experts: One expert.
• Qualifications: An "ACR registered radiologist." The document does not specify their years of experience.

4. Adjudication Method for the Test Set

The adjudication method is not explicitly stated as a formal process like 2+1 or 3+1. Given that only one expert (an ACR registered radiologist) reviewed the sample clinical images for new features, it appears to be a single-reader review rather than a consensus or adjudicated process.

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

No, an MRMC comparative effectiveness study comparing human readers with and without AI assistance was not mentioned in the provided text. The study focuses on the substantial equivalence of the device itself and the diagnostic quality of its output.

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

The device is an MRI system, not an AI algorithm performing diagnostic tasks independently. The "software" modifications refer to new sequences (LSDWI, MR Angiography) and features (MIP), which are integrated into the MRI system to produce images, and these images are then assessed by a human expert. Therefore, a standalone algorithm-only performance study in the context of diagnostic AI is not applicable here. The software verification and validation, along with image quality tests, implicitly evaluate the system's standalone performance in generating medically relevant images.

7. The Type of Ground Truth Used

The ground truth for evaluating the "diagnostic quality" of the sample clinical images for new features was expert consensus/opinion. Specifically, it was the opinion of a single "ACR registered radiologist."

8. The Sample Size for the Training Set

The document does not provide any information about a training set since the device is an MRI system with new imaging sequences and features, not a machine learning model that requires a distinct training phase. The software changes involve implementation of established imaging techniques and display methods.

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

As no training set is mentioned or applicable in the context of the described device and its modifications, this information is not provided.

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The multifunctional ultrasound scanner MyLabX90 is used to collect, display, and analyze ultrasound images during ultrasound imaging procedures in combination with supported echographic probes.

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 upgraded 6440 systems, MyLabX90 is a mainframe systems equipped with wheels allowing to move the system.

MyLabX90 scanners are based on a mainframe easily movable platform.

MyLabX90 scanners have four swiveling wheels. they have a range of height adjustments for onetime installation, the main screen can be easily moved due to an optional articulated arm. Due to their small footprint they can fit in any real-world clinical environment.

The possibility to adjust both the main screen. control panel and touchscreen brightness enables the use of MyLab in any environment even with really different lighting conditions:

from the really bright scenario of the operative room, to the dark scenario of the examination room, passing through the medium-light environment of the bed-side examination setting.

The primary modes of operation are for both models: B-Mode, M-Mode, Tissue Enhancement Imaging (TEI), Multi View (MView), Doppler, Color Flow Mapping (CFM), Amplitude Doppler (AD), Tissue Velocity Mapping (TVM), 3D and 4D. Model 6440 manages Qualitative Elastosonography (ElaXto).

Model 6440 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.

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 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.

Model 6440 is equipped with wireless capability.

Model 6440 is already cleared via K173291.

The marketing name for new devices of Model 6440 will be:

MyLabX90 ●

MyLabX90, defined herein, combines the cleared features of 6440 system with new capabilities, listed below:

• 1. Cardio Package with new AUTO E.F. The AutoEF, based on Artificial Intelligence, detects and track, automatically, the LV endocardial border to calculate LV Volumes (Diastolic Volume - Systolic Volume) and EF (Ejection Fraction). The software module (powered with A.I.) is registered by Pie Medical Imaging B.V. as Caas Qardia (K212376)
• 2. eDetect for Breast Lesions contouring function supports the operator by detecting the lesion contour (with A.I. algorithm) in Breast measurements, after that the operator has identified the region, with suspicious lesions, and applied the ROI marker. At the end of the detection the operator can confirm/edit the proposed contour or redraw it completely. In addition, several morphologic parameters (following Bi-Rads : shape, orientation and circumscribed) are automatically proposed to the customer and upon validation is inserted in the final report. The tool is available in Breast application.
• 3. XStrain allows clinicians to quantify endocardial velocities of contraction and relaxation and local deformation of the heart (Strain rate). Based on 2D speckle tracking technology with Angle-independent technology. A.I. Powered for auto border detection of left ventricle (LV).
• 4. The QAI (Quality Attenuation Imaging) application allows to perform a Colored Quantitative Attenuation analysis of tissues in Real-time. Based on the attenuation analysis along the ROI. In QAI attenuation parameter values are converted and color coded and displayed inside the Region Of Interest (ROI). A different set of palettes is available, with dynamic control and transparency.
• The Prostate Biopsy Stepper is enabling the compatibility with CIVCO Classic and GfM 5. MST50 steppers displaying a Grid Template overlays for precise guided-biopsies. The Stepper help stabilizes and follows accurate needle path during transperineal procedure. Stepper functionality is available in Fusion imaging / UroFusion environment.
• HyperDoppler, based on Color Doppler Flow Mapping (CDFM) technology, provides different 6. map representation to highlight the intracardiac flow properties
• 7. Transducer Element Check
• 8. New transducers 2CWL, 5CWL, CX 1-8, LX 3-15, LMX 4-20, PX 1-5 and TE 3-8
• 9. New biopsy kits JSM-198 and JSM-113.

Here's a breakdown of the acceptance criteria and study details for the "eDetect for Breast Lesions contouring" and "Endocardium border segmentation" AI features, based on the provided document:

eDetect for Breast Lesions Contouring

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document provides example values for "Absolute Difference [mm²]" and "Absolute Difference [mm]" for the image contouring, which are then converted to "Percentage Error (%)". The "Average Error < 0.15" acceptance criteria refers to the contouring accuracy, specifically the "Average Error" metric in relation to the contour. For the BIRADS parameters, only success rates are provided as criteria, without specific numerical results in the example given.

2. Sample Size and Data Provenance

• Test Set Sample Size: 100 images collected from 20 different patients.
• Data Provenance: The document states that both training and test datasets are based on female patients and report US images of breast examinations. The country of origin is not explicitly stated. It is a retrospective collection as the images were "saved during exam".

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: Two certified radiologists.
• Qualifications: Certified radiologists who performed data evaluation for border contouring. Their experience matured within different structures, where they operated independently and at different times.

4. Adjudication Method for Test Set

• Method: Consensus reading. The two radiologists each contributed to the annotation and then reviewed the annotations of the other. They discussed their agreement or disagreement to reach a consensus.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No MRMC comparative effectiveness study was explicitly mentioned or described for this AI feature. The study focuses on evaluating the AI's performance against human annotations, not on human readers with and without AI assistance.

6. Standalone Performance (Algorithm Only)

• Yes, the acceptance criteria and reported performance are for the standalone algorithm, comparing its output to expert annotations.

7. Type of Ground Truth Used

• Expert Consensus: The ground truth for the test set was established by the consensus of two certified radiologists.

8. Sample Size for Training Set

• Training Set Sample Size: 828 images collected from 450 different patients.

9. How Ground Truth for Training Set Was Established

• Data Annotation was performed by operators, including information about lesion size, morphology, position, vascularization, and diagnosis given by a physician. The specifics of how this annotation was established (e.g., single expert, consensus) are not detailed for the training set, but it implies human annotation.

Endocardium Border Segmentation (Auto E.F.)

This AI feature is part of the "Cardio Package with new AUTO E.F.", which is based on AI algorithms registered by Pie Medical Imaging B.V. as Caas Qardia (K212376). The provided document summarizes the testing for this component but directs to the full report in section 1.7.5 for complete details.

1. Table of Acceptance Criteria and Reported Device Performance

The table in the document provides more granular results for A2C, A4C, and combined measures, all falling within the acceptance criteria.

2. Sample Size and Data Provenance

• Test Set Sample Size: 200 individually segmented frames.
• Data Provenance: The echocardiographic images were collected from patients of varying age and gender. The total dataset (training, validation, test) originated from 399 patients. The data was collected from different institutions using different echocardiographic systems (Esaote Mylab Alpha system and another ultrasound scanner, not Esaote). The country of origin is not explicitly stated. It is considered retrospective as annotations were performed on received ultrasound images.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: Three cardiologists and one clinical researcher.
• Qualifications: The three cardiologists had "more than 20 years of experience," and the clinical researcher had "more than 5 years of experience with the analysis of cardiac ultrasound."

4. Adjudication Method for Test Set

• Method: An internal guideline for annotation of the LV blood pool endocardium contour was developed using information gathered from "external experts" (the cardiologists and clinical researcher mentioned above). This implies that a consensus or expert-derived guideline was used to establish the ground truth, rather than an explicit multi-reader adjudication process on each case in the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No MRMC comparative effectiveness study was explicitly mentioned or described for this AI feature. The study focuses on evaluating the AI's performance against expert-defined ground truth, not on human readers with and without AI assistance.

6. Standalone Performance (Algorithm Only)

• Yes, the acceptance criteria and reported performance are for the standalone algorithm, comparing its segmentation output to the ground truth.

7. Type of Ground Truth Used

• Expert-Derived Guidelines: The ground truth was established by using an internal guideline developed from information gathered from expert cardiologists and a clinical researcher. This implies a standardized annotation process based on expert knowledge.

8. Sample Size for Training Set

• Training Set Sample Size: 1221 image frames
• Validation Set Sample Size: 306 image frames
• Total for training/validation: 1527 image frames (A2C, A3C, and A4C combined).

9. How Ground Truth for Training Set Was Established

• Annotations on the received ultrasound images were performed using a customized CAAS Qardia 1.0 application. The basis for these annotations would have been the internal guideline developed by the experts (three cardiologists with >20 years of experience and one clinical researcher with >5 years of experience mentioned in the "Truthing" process).

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The general-purpose magnetic resonance imaging (MRI) system is designed to scan any targeted area of the body, to collect, display and analyse MR images and other real-time imaging procedures. Imaging portions of the upper limb, including the hand, wrist, forearm, elbow, arm and shoulder, imaging portions of the lower limb, including the foot, ankle, calf, knee, thigh and hip, imaging the temporomandibular joint and imaging the cervical, the thoracic, the lumbar and the sacral sections as portions of the spinal column, imaging the pelvis and imaging the head. Outcomes related to diagnosis Magnifico is a Magnetic Resonance (MR) system that produces cross-section images of the limbs, joints, spinal column, pelvis and head. MRI provides better soft tissue contrast than CT and can differentiate better between fat, water, muscle, and other soft tissue than CT (CT is usually better at imaging bones). These images provide information to physicians and can be useful in diagnosing a wide variety of diseases and conditions.

Magnifico is a Magnetic Resonance (MR) system with two configurations: 1. Magnifico Open, "Whole body" configuration (all above listed, in intended use, anatomical regions) 2. Magnifico MSK, musculoskeletal configuration (all above listed anatomical regions, excluded head and pelvis) which produces images of the internal structures of the patient's limbs, joints and spinal column. The system comprises four main parts: - Patient Table - . Magnetic Unit, containing a permanent magnet - Console, comprising a PC, keyboard, mouse, monitor and operating table - Electronic box Magnifico has an open magnet that makes comfortable MRI exam for all patients, including claustrophobic patients, in particular children. Additionally, Magnifico comes with a transparent headcoil for enhanced patient comfort.

The provided text is a 510(k) summary for the Esaote Magnifico MRI system. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, the document focuses on regulatory compliance, technological characteristics, and safety standards for the MRI system itself, rather than the performance of an AI/ML powered device.

Therefore, based on the provided text, I cannot answer the specific questions about acceptance criteria and study details for an AI/ML powered device. The document describes image quality being "of good diagnostic quality by the board-certified radiologist, Dr. Mark Awh," but this is a general statement about the MRI system's output and does not constitute a detailed study validating an AI/ML algorithm's performance against specific acceptance criteria.

The questions you've asked are typically relevant for AI/ML-driven diagnostic or prognostic devices that analyze medical images. The Magnifico, as described, is the imaging hardware.

If there were an AI/ML component for analysis within the Magnifico system, or integrated with it, that information is not detailed in this 510(k) summary.

In summary, the provided document does not contain the information required to answer your questions regarding acceptance criteria and the study that proves an AI/ML powered device meets those criteria.

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The multifunctional ultrasound scanner MyLabX75 Family is used to collect, display, and analyze ultrasound images during ultrasound imaging procedures in combination with supported echographic probes
-Cardiac [Adult and Pediatric]
-Vascular [Neonatal, Adult Cephalic, Vascular generic] -General Imaging [Abdominal, Breast, Musculo-skeletal, Neonatal, Pediatric, Small Organs (Testicles), Thyroid, Urological ] with invasive access Intraoperative (Abdominal), Laparoscopic, Transrectal. -Women Health [OB/Fetal, Gynecology with invasive access (Transrectal, Transvaginal)]
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 Musculoskeletal applications. The ultrasonic medical diagnostic equipment is intended to mechanical and electronic ultrasound probes (convex array, linear array and phased array) and Doppler probes.
The Fiber Guidance option assists ultrasound guidance in the phases of insertion and positioning of the introducer needle and optical fiber and procedure monitoring.

Model 6430, commercial names MyLabX75 and MyLab XPro75, 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 6430 has a software option integrated, called PLA, 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 6430 is equipped with a LCD color display where acquired images and advanced image features are shown. Model 6430 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 6430 can drive Phased Array (PA), Convex Array (LA), Linear Array (LA), Doppler and Volumetric probes.
Model 6430 is equipped with an internal Hard Disk Drive. Data can also be stored directly to external archiving media (Hard-Disk, PC, on server) via a LAN/USB port.
6430 project is mainly design change of 6450 devoted to reducing cost and to differentiate design and performances, 6430 will introduce in the Esaote's Mid-ultrasound tier functionalities that, at the moment are present only in our High -End Ultrasound tier, such as 2D Shear Wave Elastography (2D-SWE) and Virtual Navigator.
The marketing names for Model 6430 will be MyLabX75 and MyLab XPro75.
The difference between MyLab XPro75 is only in the licenses configuration: on MyLab XPro75 all the options are included while in the MyLabX75 some licenses can be ordered by customer.

The provided text is a 510(k) summary for the Esaote MyLabX75 and MyLab XPro75 ultrasound systems. It explicitly states that no clinical tests were performed to demonstrate that the device meets acceptance criteria. The submission relies entirely on non-clinical data and equivalence to a predicate device.

Therefore, many of the requested details about acceptance criteria and study design are not applicable or cannot be extracted from this document.

Here's what can be extracted based on the information provided:

1. A table of acceptance criteria and the reported device performance

The document does not specify quantitative acceptance criteria for performance; rather, it focuses on safety and technological equivalence.

2. Sample size used for the test set and the data provenance

• Not Applicable. No clinical test set was used as "No clinical tests were performed." The submission relies on non-clinical data, typically engineering verification and validation.

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

• Not Applicable. No clinical test set was used, and thus no expert ground truth establishment for a clinical study.

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, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not Applicable. No clinical effectiveness study, and specifically no MRMC study, was performed. This device is an ultrasound system, not an AI-assisted diagnostic tool in the context of human reader improvement.

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

• Not Applicable. This is an ultrasound imaging system, not a standalone diagnostic algorithm. The performance evaluation was based on non-clinical engineering tests and comparison to a predicate device's technological characteristics and safety standards.

7. The type of ground truth used

• Not Applicable. As no clinical studies were performed, there was no ground truth for patient outcomes or expert consensus on diagnostic accuracy required in this submission. The "ground truth" for the non-clinical tests would be the compliance with engineering specifications and safety standards.

8. The sample size for the training set

• Not Applicable. This document does not describe the development or training of any machine learning algorithms. It is a traditional 510(k) for an ultrasound imaging system.

9. How the ground truth for the training set was established

• Not Applicable. As no machine learning training set is mentioned.

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MyLabSigma is intended to perform diagnostic general ultrasound studies including:

Fetal, Abdominal, Intraoperative (Abdominal), Laparoscopic, Pediatric, Small organs, Neonatal,

Neonatal Cephalic, Adult Cephalic, Transvaginal, Musculoskeletal (Conventional),

Musculoskeletal (Superficial), Urological, Cardiovascular Adult, Cardiovascular Pediatric,

Transoesophageal (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 Musculoskeletal applications.

The ultrasonic medical diagnostic equipment is intended to mechanical and electronic ultrasound probes (convex array, linear array and phase array) and Doppler probes.

The upgraded 7410 system (MyLabSigma), is a portable system equipped with a handle. The system sizes and weights allow them to be carried using its handle. The primary modes of operation are: B-Mode, M-Mode, Tissue Enhancement Imaging (TEI), Multi View (MView), Doppler, Color Flow Mapping (CFM), Amplitude Doppler (AD), Tissue Velocity Mapping (TVM), 3D and 4D.

Model 7410 is equipped with a LCD color display where acquired images and advanced image features are shown. Model 7410 can drive Phased array. Linear array. Doppler probes and Volumetric probes (Bi-Scan probes). The control panel is equipped with a touchscreen that has an emulation of the Qwerty alphanumeric keyboard that allows data entry.

Model 7410 is equipped with wireless capability.

Model 7410 is already cleared via K161359.

The marketing name for new devices of Model 7410 will be:

• MyLabSigma ●
  MyLabSigma, defined herein. combine the cleared features of 7410 system with new capabilities, listed below:

• Addition of Auto NT (Automatic Nuchal Translucency) option, allows to automatically capture Nuchal Translucency measurement.

• Addition of Auto EF (Automatic Ejection Fraction) option, allows to automatically capture Ejection Fraction measurement.

• . Management of probes L3-11, L4-15, mC 3-11 and P2 3-11.

• . Full screen option.

• . Windows 10 Operative System.

The 7410 new version is manufactured under a quality system compliance with 21CFR 820 requirements and certified according to ISO 9001:2015 and ISO 13485:2016.

Here's a breakdown of the acceptance criteria and the study information based on the provided text, using the specified format. It's important to note that this document is a 510(k) summary for a medical device (ultrasound system), and therefore, the "study" described is a demonstration of substantial equivalence rather than a traditional clinical trial proving specific performance metrics beyond those of predicate devices.

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a quantitative table of acceptance criteria and reported device performance in the way a clinical study might for specific diagnostic metrics. Instead, it asserts substantial equivalence to predicate devices (K161359, K183191, K173291) by demonstrating that:

• The fundamental technological characteristics are the same.
• Clinical uses have not changed or are equivalent to those of previously cleared devices.
• Added options (Auto NT, Auto EF, certain probe management, capacitive touchscreen, full screen mode, Windows 10 OS) are identical or equivalent to features cleared on other Esaote models.
• The device conforms to relevant safety standards.
• Performance (Ergonomics, General Usability, and Image Quality) is in line with predicate and reference devices.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document states, "No clinical tests were performed." Therefore, there is no specific patient-based test set or data provenance to report in this context. The evaluation was based on non-clinical tests (safety, software validation, performance characteristic comparisons).

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, as no clinical tests were performed and thus no "ground truth" was established from patient data. The ground truth for engineering and system performance would be defined by the relevant standards and specifications.

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

Not applicable, as no clinical tests were performed.

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 is for an ultrasound system, not an AI-assisted diagnostic device, and no MRMC study was mentioned or performed.

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

Not applicable. This is not an algorithm-only device. The submission focuses on the ultrasound system and its integrated features.

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

The "ground truth" for this submission is based on adherence to recognized medical device safety standards (e.g., IEC, NEMA, ETSI standards) and the established performance and safety profiles of the predicate devices. For features like "Auto NT" and "Auto EF," the ground truth is their functional equivalence to previously cleared implementations on other Esaote models.

8. The sample size for the training set

Not applicable, as this is not a machine learning device that requires a training set in the typical sense. The software validation was performed as a part of a system function test.

9. How the ground truth for the training set was established

Not applicable, as no training set for a machine learning model was used. Software validation involved testing functions and confirming their operation with traceability of anomalies, likely against predefined functional specifications and requirements.

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O-scan is a Magnetic Resonance (MR) system that produces transversal, sagittal, coronal and oblique section images of limbs and joints. It is designed for imaging portions of the arm, including hand, wrist, forearm, and elbow, but excluding the upper part of the arm and portions of the leg, including foot, ankle, calf, and knee, but excluding the thigh. The M.R. images produced by O-scan correspond to the spatial distribution of the protons (hydrogen nuclei) which verify the properties of magnetic resonance and depend on the MR parameters spin-lattice relaxation time (T1), spin-spin relaxation time (T2), nucleus density, flow velocity and "chemical shift". When interpreted by a medical expert trained in use of MR equipment, the images can provide diagnostically useful information.

The changes performed on the modified O-scan, with respect to the cleared version – O-scan K092469 are due to the upgrade of the software system. These modifications, which do not affect the intended use or alter the fundamental scientific technology of the device, are the following:

• A new Software version (EVO'18) including the following features:
  • 1. AGilExam (automatic slice positioning for the examination of the anatomical regions of knee, ankle and wrist)
  • 2. 3D Viewer; this is an option that starting from the acquired data cube allows the running of a 3D viewer in which to reconstruct the desired 3D series, both using the three projections of the acquired package and generating a special MPR curve as reference. (Previously cleared by FDA via K180592 on G-Scan Brio)

This FDA 510(k) summary for the Esaote O-Scan device does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in terms of diagnostic accuracy or effectiveness in a clinical setting.

The submission focuses on establishing substantial equivalence to previously cleared devices based on software modifications and compliance with safety standards rather than clinical performance claims.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

No acceptance criteria for diagnostic performance or reported clinical device performance are mentioned in this document. The submission states "No clinical tests are included within this submission."

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. No clinical tests or test sets are described.

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. No clinical tests or ground truth establishment for a test set are described.

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

Not applicable. No clinical tests or adjudication methods are described.

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. No MRMC study is mentioned. The software modifications are described as improvements for display, analysis, and comparison, but no quantification of reader improvement is provided. The document mentions "AGilExam (automatic slice positioning for the examination of the anatomical regions of knee, ankle and wrist)" and "3D Viewer," which might relate to AI or image processing, but no comparative effectiveness study with human readers is presented.

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

Not applicable. No standalone algorithm performance study is mentioned. The device is an MR system that produces images "When interpreted by a medical expert trained in use of MR equipment."

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

Not applicable. No ground truth for clinical performance is described.

8. The sample size for the training set

Not applicable. No training set for a clinical performance study is described.

9. How the ground truth for the training set was established

Not applicable. No ground truth for a training set is described.

Summary of what the document does include regarding device evaluation:

The submission focuses entirely on non-clinical tests to demonstrate substantial equivalence:

• Software Verification: The new software version (EVO'18) with AGilExam and 3D Viewer features was evaluated for verification.
• Compliance with Safety Standards: The O-Scan was found to conform to various medical device safety standards, including:
  • IEC 60601-1 (Medical electrical equipment - General requirements for basic safety and essential performance)
  • IEC 60601-1-2 (Electromagnetic compatibility)
  • IEC 60601-1-6 (Usability)
  • IEC 60601-2-33 (Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis)
  • ISO 14971 (Medical devices - Application of risk management to medical devices)
  • ISO 62304 (Medical device software - Software life cycle processes)
  • IEC 62366 (Medical devices - Application of usability engineering to medical devices)
  • NEMA MS-1 (Magnetic Resonance Terminology)
  • NEMA MS-3 (Quality Control Procedures for Magnetic Resonance Imaging Devices)

The conclusion states that "The non-clinical testing demonstrates that the O-Scan is as safe, as effective, and performs as well as or better than the predicate." This "effectiveness" is inferred from compliance with standards and the nature of the software modifications, not from clinical performance data.

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G-scan Brio is a Magnetic Resonance (MR) system that produces transversal, sagittal and coronal and oblique crosssection images of the head, limbs, joints and spinal column. It is intended for imaging portions of the upper limb, including the hand, wrist, forearm, elbow, arm and shoulder, imaging portions of the lower limb, including the foot, ankle, calf, knee, thigh and hip, imaging the temporomandibular joint and imaging the cervical, the thoracic and the lumbosacral sections as portions of the spinal column.

G-scan Brio images correspond to the spatial distribution of protons (hydrogen nuclei) that determine magnetic resonance properties and are dependent on the MR parameters, including spin-lattice (T1), spin-spin relaxation time (T2), nuclei density, flow velocity and "chemical shift". When interpreted by a medical expert trained in use of MR equipment, the images can provide diagnostically useful information.

The changes performed on the modified G-scan Brio, with respect to the cleared version – G-scan Brio K161973 – are due to the upgrade of the software system. These modifications, which do not affect the intended use or alter the fundamental scientific technology of the device, are the following:

• A new Software version (EVO'17) including the following features:
  • o New software feature Q-Spine (Quantitative Spine)
  • o New software feature 3D Viewer
  • o The availability of the E-MRI viewer eXP, the software used as an extension on PC.

Esaote has decided to develop and release an upgrade for software EVO. The EVO'17 includes two new features Q-Spine and 3D Viewer. The function Q-Spine has been already cleared by FDA under the name OrthoCAD System via K120288. The function 3D Viewer has been already cleared by FDA under the name 3Viseon/Surgery via K072653. E-MRI viewer eXP, the software used as an extension on PC, is equivalent to E-MRI Brio Viewer, which is currently available on the G-Scan Brio MRI systems, cleared via K161973.

The provided 510(k) summary for the G-scan Brio device does not include any acceptance criteria or a study demonstrating the device meets such criteria related to its imaging performance or diagnostic accuracy.

Instead, this submission (K180592) focuses on a software upgrade for an already cleared MRI system (G-scan Brio K161973). The upgrades consist of new software features (Q-Spine, 3D Viewer, and E-MRI viewer eXP), which are stated to have been previously cleared under separate 510(k)s (K120288 and K072653) or are equivalent to existing functionalities.

Therefore, the submission relies on the substantial equivalence of these software modifications and the underlying MRI hardware to previously cleared devices.

Here's an analysis of the provided information based on your requested criteria:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• No test set or clinical data is presented for this 510(k) submission. The document explicitly states: "No clinical tests are included within this submission." The submission relies on non-clinical testing (safety standards, software verification) and the substantial equivalence to previously cleared devices.

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

• Not applicable. No clinical test set was used in this submission.

4. Adjudication method for the test set

• Not applicable. No clinical test set was used in this submission.

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

• No MRMC study was done and no AI components are described beyond standard image processing features. The software features (Q-Spine, 3D Viewer) are presented as tools for display, analysis, and comparison, not as AI systems for diagnosis or reader assistance.

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

• Not applicable. The device is an MRI system, not a standalone algorithm. The software features are enhancements to the MRI system for image display and analysis, to be interpreted by a medical expert. Their performance is described as "equivalent" or relying on previous clearances, not as standalone algorithm performance.

7. The type of ground truth used

• Not applicable. No clinical data was used in this submission. For the non-clinical testing, conformance to safety standards is the "ground truth" for those specific aspects.

8. The sample size for the training set

• Not applicable. No training set data is presented for this submission as it's not an AI/ML device relying on such for its core function.

9. How the ground truth for the training set was established

• Not applicable. No training set data is presented for this submission.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study proving the device meets the "acceptance criteria" (which, in this case, are primarily related to safety standards and substantial equivalence) consists of non-clinical testing and referencing prior 510(k) clearances.

• Non-Clinical Testing: The manufacturer conducted non-clinical tests to demonstrate compliance with various international and national standards for medical electrical equipment, risk management, and software verification (e.g., IEC 60601-1, ISO 14971, ISO 62304, NEMA MS-1, NEMA MS-3). The submission states that the device "has been found to conform" to these standards.
• Substantial Equivalence Argument: The core of the "proof" for the G-scan Brio's updated software lies in the argument of substantial equivalence to predicate and reference devices.
  • The updated G-scan Brio (K180592) is compared to the cleared G-scan Brio K161973.
  • New software features Q-Spine and 3D Viewer are stated to have been "already cleared by FDA" under K120288 (OrthoCAD System) and K072653 (3Viseon/Surgery) respectively.
  • The E-MRI viewer eXP is considered "equivalent to E-MRI Brio Viewer," which is available on the G-Scan Brio MRI systems cleared via K161973.

Conclusion stated in the document: "The non-clinical testing demonstrates that the G-scan Brio is as safe, as effective, and performs as well as or better than the predicate. G-scan Brio is substantially equivalent to the legally marketed devices and conforms to applicable medical device safety and performance standards."

In essence, this 510(k) relies on regulatory precedent and adherence to recognized safety standards rather than a de novo clinical study with specific performance acceptance criteria for diagnostic capability.

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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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