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Esaote's MyLabSix ultrasound system is a mainframe ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal Cardiac, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small Organs, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative Abdominal, Laparoscopic and Other: Urologic. The system provides imaging for guidance of biopsy and imaging to assist in the placement of needles in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications.

The MyLabSix is a mainframe ultrasound system used to perform diagnostic general ultrasound studies. Its primary modes of operation are: B-Mode, Amplitude Doppler (AD), Tissue Enhancement Imaging (TEI), Multi View (MView), Tissue Velocity Mapping (TVM), Color Flow Mapping (CFM), Pulse Wave Doppler, 3D and 4D. The MyLabSix is equipped with a free orientable LCD Color Display were acquired images and advanced images are shown. The MyLabSix is also equipped with a height adjustable/rotating keyboard. A second LCD Display for additional controls and mode-depending keys, includes touch screen technology and is integrated in the control panel. The MyLabSix can drive phased (PA), convex (CA), linear array (LA) probes, Doppler probes and Volumetric probes. The MyLabSix is equipped with an internal Hard Disk 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 MyLabSix is already cleared via K141486. The MyLabSix Upgrade, defined herein, combine the cleared features of MyLabSix system with new software capabilities, listed below: 1. Management of motorized probes (Bi-Scan probes) that allow volumetric acquisition in 3D/4D mode for Transrectal/Urologic and Transvaginal applications 2. Management of Laparoscopic application 3. Implementation of the Needle Visibility feature 4. Implementation of the on-board tutorial MyLibrary feature. The MyLabSix Upgrade is manufactured under an ISO 9001 and ISO 13485 certified quality system.

The acceptance criteria and study proving it are described below.

1. Table of Acceptance Criteria and Reported Device Performance:

Study Proving Device Meets Acceptance Criteria:

The provided document describes a 510(k) premarket notification for the MyLabSix Ultrasound System Upgrade (K161168). The study proving the device meets acceptance criteria is primarily a non-clinical bench testing and comparison to predicate devices, rather than a human clinical trial.

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

• Sample Size for Test Set: Not applicable in the traditional sense of patient data. The "test set" here refers to the extensive series of non-clinical tests and comparisons performed on the device and its components. No patient data or images were used to "test" the algorithm's performance in a diagnostic capacity.
• Data Provenance: Not applicable for patient data. The "data" evaluated were the results from engineering, electrical, acoustic, and biological safety tests performed on the MyLabSix Ultrasound System Upgrade. This would originate from the manufacturer's (Esaote Europe B.V.) internal testing and quality control processes.

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

• Not applicable. As this was a non-clinical evaluation focusing on technical specifications and substantial equivalence, the concept of "ground truth" established by clinical experts for diagnostic accuracy does not apply. The "ground truth" was adherence to established industry safety and performance standards (e.g., IEC, ISO, NEMA).

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

• Not applicable. Adjudication methods are typically used in clinical studies when multiple human readers interpret data, and their findings need to be reconciled to establish a consensus ground truth. This submission relies on objective engineering measurements and direct comparison to predicate devices' specifications and established standards.

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. An MRMC study was not conducted. The submission explicitly states: "No clinical tests were performed." The MyLabSix is an ultrasound system and an upgrade to existing systems for expanded functionalities and modes, not an AI-assisted diagnostic tool.

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

• Not applicable. The MyLabSix is an ultrasound system that provides imaging, not a standalone AI algorithm. Its performance is evaluated based on its ability to generate images and provide functional modes, assumed to be interpreted by human operators.

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

• For the non-clinical tests, the "ground truth" was compliance with established national and international safety, acoustic, and performance standards (e.g., IEC 60601 series, ISO 10993-1, NEMA UD 2, NEMA UD 3).
• For the expanded clinical applications, the "ground truth" for demonstrating substantial equivalence was the existence of legally marketed predicate devices (MyLabSeven, SonoSite Edge, MyLabOne) that already possess the new functionalities being added to the MyLabSix Upgrade. The claim is that the technology used to implement these features is equivalent to those already cleared.

8. The sample size for the training set:

• Not applicable. This is a medical device for imaging, not a machine learning or AI algorithm in the context of diagnostic interpretation that would require a "training set" of patient data.

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

• Not applicable, as there was no training set in the context of an AI algorithm.

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Esaote's MyLabSix ultrasound system is a mainframe ultrasound svstem used to perform diagnostic general ultrasound studies including Cardiac. Transesophageal Cardiac. Peripheral Vascular. Neonatal Cephalic. Adult Cephalic. Small Organs. Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative Abdominal, and Other: Urologic. The system provides imaging for guidance of biopsy and imaging to assist in the placement of needles in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications.

The MyLabSix is a mainframe ultrasound system used to perform diagnostic general ultrasound studies. Its primary modes of operation are: B-Mode, Amplitude Doppler (AD), Tissue Enhancement Imaging (TEI), XView, Multi View (MView). Trapezoidal View (TP View), Tissue Velocity Mapping (TVM), RF-based Quality Intima Media Thickness (QIMT) ,Color Flow Mapping (CFM) and Pulse Wave Doppler.

The MyLabSix is equipped with a free orientable LCD Color Display were acquired images and advanced images are shown.

A second LCD Display for additional controls and mode-depending keys, includes touch screen technology and is integrated in the control panel.

The MyLabSix can drive phased (PA), convex (CA), linear array (LA) probes, Doppler probes and Volumetric probes.

The MyLabSix is equipped with an internal Hard Disk and with an 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 MyLabSix is manufactured under an ISO 9001:2008 and ISO 13485:2003 certified quality system.

The provided 510(k) summary for the MyLabSix Esaote Europe Ultrasound System explicitly states: "No clinical tests were performed." Therefore, there is no information in this document regarding acceptance criteria or a study proving that the device meets such criteria through clinical performance.

The submission focuses entirely on demonstrating substantial equivalence to predicate devices (MyLabSeven and MyLabFive) and conformity to non-clinical safety and performance standards. The information provided heavily emphasizes the technological characteristics and intended uses being equivalent to already cleared devices, rather than presenting a performance study with specific acceptance criteria.

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Esaote's MyLabOne is an arm-held ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small Organ, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Obstetrics/Gynaecology, Transvaginal, Transrectal, Pediatric, Intraoperative Abdominal, and Other: Urology. The system provides imaging for guidance of biopsy and imaging to assist in t the placement of needles and catheters in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications.

The MyLabOne is a battery operated, portable ultrasound system used to perform diagnostic general ultrasound studies. Its primary modes of operation are: B-Mode, M-Mode, Amplitude Doppler (AD), Tissue Enhancement Imaging (TEI), Color Flow Mapping (CFM) and Pulse Wave Doppler.

The MyLabOne is equipped with a LCD Color Display. The LCD Display includes touch screen technology for a simple and intuitive activation of functions and data entry for patient information and screen annotations.

The MyLabOne can drive phased (PA), convex (CA) and linear array (LA) probes. The MyLabOne is equipped with an internal Hard Disk and with an optional external 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. Optional accessory devices available for the MyLabOne include a monochrome or color page printer, a desk stand (for use on a desk or cart) and a mobile trolley equipped with four swiveling wheels and peripheral holder.

The provided document is a 510(k) summary for the Esaote MyLabOne Ultrasound System, seeking clearance for a new ultrasound device. It primarily focuses on demonstrating substantial equivalence to predicate devices and detailing the intended uses and technical characteristics of the new system and its associated transducers.

Crucially, the document does not contain information about acceptance criteria for device performance, nor does it describe a specific study proving the device meets particular acceptance criteria in terms of diagnostic accuracy or clinical effectiveness.

Instead, the submission relies on the concept of substantial equivalence to predicate devices (K083882 MyLabFive and K092058 NanoMaxx). The "studies" mentioned are non-clinical verification and validation tests conducted in accordance with design controls per CFR 820.30, and compliance with various international standards related to safety and acoustic output.

Therefore, many of the requested details cannot be extracted directly from this document. However, based on the information provided, here's what can be inferred or explicitly stated:

Acceptance Criteria and Device Performance

Since this is a 510(k) for substantial equivalence, the "acceptance criteria" are primarily that the new device (MyLabOne) and its transducers perform comparably to the predicate devices in terms of image modes, safety, acoustic output, and measurement capabilities.

There is no table of acceptance criteria and reported device performance related to diagnostic accuracy or clinical outcomes because such studies are generally not required for 510(k) clearances that rely on substantial equivalence for ultrasound imaging systems unless new claims or significant technological differences are introduced.

The document states:

• "The MyLabOne image modes are available on other FDA cleared ultrasound systems. for instance the Esaote MyLabFive and Sonosite NanoMaxx."
• "The MyLabOne, the Esaote MyLabFive and the SonoSite NanoMaxx provide a similar measurements and analysis package, with equal accuracy and precision."
• "The MyLabOne, the Esaote MyLabFive and the SonoSite NanoMaxx are designed to meet the IEC60601-1 and the IEC60601-2-37 safety requirements."
• "The MyLabOne, the Esaote MyLabFive and the SonoSite NanoMaxx provide an Acoustic Output Display feature per AIUM / NEMA standards, with equivalent Ispta and MI maximal values."

This implies that the performance is accepted if it adheres to the capabilities, safety standards, and acoustic output levels of the legally marketed predicate devices.

Specific Requested Information:

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

   • Acceptance Criteria (Inferred from Substantial Equivalence):
     • Clinical uses similar to predicate devices.
     • Compliance with safety standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37).
     • Compliance with biocompatibility standards (ISO 10993-1 for transducers if applicable, though not specified for device itself).
     • Acoustic output display feature per AIUM/NEMA standards.
     • Equivalent maximal Ispta and MI values to predicate devices.
     • Similar measurement and analysis package with equal accuracy and precision to predicate devices.
     • Equivalent image modes to predicate devices.
   • Reported Device Performance: The document generally states that the MyLabOne is substantially equivalent and provides these features and compliance. Specific quantitative performance metrics (e.g., image resolution, diagnostic accuracy rates) are not provided in this 510(k) summary.

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 / Not Provided for clinical performance. The document does not describe a clinical "test set" in the context of diagnostic accuracy or effectiveness studies. "Verification and validation tests" were done in accordance with design controls, which typically involve engineering and performance testing, not clinical data sets for diagnostic accuracy.

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 / Not Provided. As no clinical test set for diagnostic performance is described, there's no mention of experts establishing ground truth for such a set.

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

   • Not Applicable / Not Provided.

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. This document describes a general-purpose ultrasound imaging system. It is not an AI-powered diagnostic device, and therefore, no MRMC study or AI assistance evaluation is mentioned.

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

   • No. This is an ultrasound imaging system, not a standalone algorithm.

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

   • Not Applicable / Not Provided for clinical diagnostic use. For engineering verification and validation, ground truth would refer to reference standards, phantoms, or simulated signals for technical performance parameters (e.g., acoustic output, measurement accuracy), but these details are not elaborated in the summary.

8. The sample size for the training set:

   • Not Applicable / Not Provided. This is not an AI/ML device that requires a training set in the conventional sense.

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

   • Not Applicable / Not Provided.

In summary: The K101605 510(k) submission for the MyLabOne Ultrasound System relies on demonstrating substantial equivalence to previously cleared predicate devices by confirming similar intended uses, technological characteristics, and compliance with relevant safety and performance standards. It does not include primary clinical studies with specific diagnostic performance metrics, test sets, or ground truth establishment by experts, as these are typically not required for this type of submission for a general ultrasound imaging system.

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Esaote's MyLabFive is a compact ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small organ, Musculoskeletal (Conventional and Superficial). Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Laparoscopic, Intraoperative Abdominal, and Other Urologic. The 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 MyLabFive is a portable ultrasound system used to perform diagnostic general ultrasound studies. Its primary modes of operation are: B-Mode. M-Mode, Multi View (MView), Amplitude Doppler (AD), Tissue Velocity Mapping (TVM) and Tissue Enhancement Imaging (TEI). Optional is Doppler and Color Flow Mapping (CFM). The MyLabFive is equipped with a LCD Color Display. The full alphanumeric keyboard allows complete on-screen data entry of patient information and on-screen annotations. The MyLabFive can drive phased (PA), convex (CA), linear array (LA) and Doppler probes. The MyLabFive is equipped with an internal Hard Disk and with an optional external 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. Optional accessory devices available for the MyLabFive include an S-VHS video recorder, a monochrome or color page printer and a mobile trolley equipped with an insulation transformer.

The provided text is a 510(k) summary for the Esaote MyLabFive Ultrasound System. It focuses on demonstrating substantial equivalence to predicate devices (Esaote MyLab40 and MyLab30 Gold Cardiovascular) rather than presenting a standalone study with acceptance criteria and performance data for the MyLabFive itself.

Therefore, the requested information cannot be fully extracted as there isn't a dedicated "study that proves the device meets the acceptance criteria" in the format typically used for performance validation of new algorithms or diagnostic tests. Instead, the document asserts equivalence based on shared technical capabilities, software, safety standards, acoustic output, and measurement accuracy with previously cleared devices.

However, I can extract information related to the claimed performance and what would typically constitute acceptance criteria in such a submission:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative "acceptance criteria" or "reported device performance" in terms of specific metrics like sensitivity, specificity, accuracy, or quantitative measurements that would be expected for a new diagnostic algorithm. Instead, it relies on the concept of substantial equivalence to predicate devices. The implicit acceptance criterion is that the MyLabFive performs as well as or is equivalent to the predicate devices for its intended uses and various operational modes.

The stated performance claim is:

• "The MyLabFive, ESAOTE 7340 (MyLab30 Gold Cardiovascular) and the ESAOTE Europe MyLab40 provide a similar measurements and analysis package, with equal accuracy and precision."

This statement implies that the accuracy and precision of the MyLabFive are considered acceptable if they are equal to those of the predicate devices. However, no specific numerical values for accuracy or precision are provided for either the MyLabFive or its predicates in this summary.

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

This information is not provided in the 510(k) summary. The document does not describe any specific clinical or technical test sets used to independently validate the MyLabFive's performance. The basis for equivalence is the shared design, software, and established performance of the predicate devices.

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)

This information is not provided. As no specific test set is described, there is no mention of experts or ground truth establishment in this context.

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

This information is not provided.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not done and is not mentioned. The MyLabFive is an ultrasound imaging system, not an AI-assisted diagnostic tool in the sense of providing automated interpretations or modifications to human reader performance. The document focuses on the imaging capabilities and operational modes.

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

A standalone performance study of an algorithm is not discussed or presented. The device is an ultrasound system that produces images for human interpretation.

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

This information is not provided. Since no specific performance study for the MyLabFive is detailed, the type of ground truth is not applicable. The basis for clearance is substantial equivalence, implying that the predicate devices' performance was considered adequate and that the MyLabFive performs similarly.

8. The sample size for the training set

This information is not provided. The MyLabFive is an imaging system, not an AI/ML device that would typically involve a "training set" in the context of machine learning.

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

This information is not provided for the reason stated in point 8.

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The MyLab40 is a compact console ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small Organ, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative Abdominal and Other: Urologic.

The MyLab40 is a compact console ultrasound system used to perform general diagnostic ultrasound studies. Its primary modes of operation are: B-Mode, M-Mode, Doppler, 3D/4D, Color Flow Mapping and on lower frequency probes, Tissue Enhancement Imaging (TEI). The system is equipped with a LCD color display and can drive Phased Array (PA), Convex Array (CA), Linear Array (LA) and Doppler probes. The MyLab40 is able to produce Real Time 2D images and 3D images in manual mode with all probes. The system in combination with the BC431 or BS230 probe, offer the possibility to also produce automatic 3D and Real Time 4D images. The MyLab40 is manufactured under an ISO9001:2000 and ISO13485:2003 certified quality system.

The provided text is a 510(k) summary for the MyLab40 Ultrasound System and does not contain information about acceptance criteria or a study proving that the device meets such criteria.

The document focuses on:

• Device Description: General purpose ultrasound system and its modes of operation.
• Intended Use: A broad range of diagnostic ultrasound studies.
• Technological Characteristics: A comparison table showing the MyLab40's technical specifications and indications for use against predicate devices (MyLab30 and MyLab20). This comparison primarily asserts substantial equivalence rather than detailing specific performance criteria or a study designed to meet them.
• Transducer Indications for Use: Detailed tables for various transducers outlining their applicable clinical applications and modes of operation.

Therefore, I cannot provide the requested information as it is not present in the given text.

To answer your request, the input document would need to include sections detailing:

1. Acceptance Criteria: Specific performance thresholds the device must meet (e.g., accuracy, precision, sensitivity, specificity for a particular measurement or diagnostic task).
2. Study Design and Results: A description of a study conducted to demonstrate the device's performance against these criteria, including:
   • Sample size and data provenance for the test set.
   • Details on ground truth establishment (number/qualifications of experts, adjudication method, type of ground truth).
   • Whether MRMC or standalone performance studies were conducted, and their results.
   • Training set details (sample size, ground truth establishment).

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The IMT.LAB software is a Windows 2000/XP software application package to be used on a personal computer for the automatic measurement of the intima media thickness of the carotid artery from video images obtained from Esaote ultrasound systems.

The IMT LAB software is a Windows 2000/XP software application package that runs on a stand-alone personal computer. Video images from the carotid artery made with a standard ultrasound system can be used as input for the IMT.LAB software package. These images can be transferred digitally by means of a DICOM, BMP, or JPEG files from the ultrasound system to the IMT.LAB software. IMT.LAB uses proprietary techniques and algorithms to measure the Intima Media Thickness (IMT) from the far wall of the carotid artery. This information is used in addition to other medical data by a physician to help assess the cardiovascular health of a patient.

IMT.LAB can store the images and the measurement results on the hard disk for future reference.

Here's a summary of the provided 510(k) document regarding the IMT.LAB software, focusing on acceptance criteria and study details.

Please note: The provided 510(k) summary (K062598) primarily focuses on establishing substantial equivalence to predicate devices and does not contain detailed information about specific performance acceptance criteria or a dedicated study demonstrating the device meets those criteria. The document asserts equivalence based on intended use and technological characteristics. Therefore, many of the requested fields will be marked as "Not Provided in Document."

IMT.LAB Software: Acceptance Criteria and Study Details (K062598)

This 510(k) summary for the IMT.LAB software primarily establishes substantial equivalence to previously cleared devices. It describes the device's intended use as an automatic measurement tool for carotid artery Intima Media Thickness (IMT) from ultrasound images. The document does not detail specific performance acceptance criteria or present a formal study proving the device meets such criteria in the way a clinical trial or performance study report might. Instead, equivalence is drawn to predicate devices that presumably already met applicable performance standards.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not Provided in Document
• Data Provenance: Not Provided in Document (No specific test set or study is detailed)

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

• Number of Experts: Not Provided in Document
• Qualifications of Experts: Not Provided in Document

4. Adjudication Method for the Test Set

• Adjudication Method: Not Provided in Document

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

• MRMC Study Done?: No
• Effect Size of Human Readers with AI vs. Without AI: Not Applicable (No MRMC study was described)

6. Standalone (Algorithm Only) Performance Study

• Standalone Study Done?: No (The document describes the software and its intended use, but not a standalone performance study with metrics.)

7. Type of Ground Truth Used (for Test Set)

• Type of Ground Truth: Not Provided in Document

8. Sample Size for the Training Set

• Sample Size for Training Set: Not Provided in Document

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

• Method for Establishing Ground Truth: Not Provided in Document

Summary of Device Claimed Equivalence:

The IMT.LAB software is deemed substantially equivalent based on similarity in:

• Intended Use: Automatic measurement of intima media thickness of the carotid artery from ultrasound images.
• Image Source: Ultrasound images.
• Operating Environment: Standalone application on a personal computer with Microsoft Windows.
• Image Format: DICOM, JPEG, and Windows BMP (IMT.LAB v2.0 as submitted, vs. only JPEG and BMP for predicate SonoCalc, and AVI/BMP for QLAB).
• Features: Image storage, report generation, automatic distance measurement.
• Classification: 90LLZ (Radiological Image Processing System).

The 510(k) process for this device relies on demonstrating that the new version (IMT.LAB C:2.0) has technological characteristics and intended use that are equivalent to already legally marketed predicate devices, rather than presenting a de novo performance study against pre-defined acceptance criteria.

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Esaote's MyLab15/MyLab20 is a compact console ultrasound system intended to be used by a physician to perform general diagnostic ultrasound studies including Fetal, Abdominal, Pediatric, Small organ, Neonatal Cephalic, Cardiac, Transrectal, Transvaginal, Peripheral Vascular, Musculoskeletal (Conventional and Superficial), Intraoperative: Abdominal, and Other: Urological.

The MyLab15/20 is a compact console ultrasound system used to perform general diagnostic ultrasound studies. Its primary modes of operation are: B-Mode, M-Mode, PW Doppler and Color Flow Mapping and Tissue Enhancement Imaging (TEI). MyLab15/20 is able to produce real time 2D images and 3D images (in manual mode) with all probes. The system, in combination with the probe BC432P, offers the possibility to also produce automatic 3D and real time 4D images

The provided text is a 510(k) summary for the Esaote MyLab15/20 Ultrasound System (K061755). This document primarily focuses on demonstrating substantial equivalence to predicate devices for new indications and transducer types. It does not contain information about acceptance criteria or a study proving device performance against such criteria in the context of diagnostic accuracy, clinical effectiveness, or AI algorithm performance.

The document states that the device is an ultrasound imaging system and its performance is implicitly demonstrated through substantial equivalence to other legally marketed ultrasound systems.

Therefore, most of the requested information (acceptance criteria, study details, sample sizes, expert qualifications, adjudication, MRMC, standalone performance, ground truth types for test/training sets, training set sample size, and ground truth establishment for training set) is not present in the provided text.

Based on the available information, here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the given 510(k) summary. The document focuses on demonstrating substantial equivalence to predicate devices for specific clinical applications and imaging modes, not on presenting acceptance criteria and performance data against those criteria in a quantitative manner (e.g., sensitivity, specificity, accuracy).

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

This information is not provided in the document. The submission is not related to a clinical study assessing diagnostic performance against a test set. It's a regulatory submission for device clearance based on equivalence.

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

This information is not provided in the document. No test set or ground truth establishment process is described.

4. Adjudication Method for the Test Set

This information is not provided in the document. No test set or adjudication method is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

This information is not provided in the document. The document pertains to an ultrasound imaging system, not an AI-assisted diagnostic tool, and therefore, an MRMC study for AI assistance would not be applicable here.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This information is not provided in the document. The device is an ultrasound imaging system, not an AI algorithm, so standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used

This information is not provided in the document. No specific ground truth is mentioned as the basis for performance evaluation in this 510(k) submission.

8. The Sample Size for the Training Set

This information is not provided in the document. As this is not an AI/algorithm submission, a "training set" in that context is not relevant.

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

This information is not provided in the document. Similar to point 8, this is not relevant to the type of device and submission described.

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