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Esaote's Model 6400 is a mainframe ultrasound system 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 and Other: Urologic. The 6400 system provides imaging for guidance of biopsy and imaging to assist in the placement of needles in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications.

Esaote's Model 7400 is a compact 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 and Other: Urologic. The 7400 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.

Model 6400 is a mainframe system equipped with wheels allowing them to move the system. Model 7400 is a portable system equipped with a handle. The system size and weight allow it to be carried using its handle. The primary modes of operation are for both models: B-Mode, M-Mode, Tissue Enhancement Imaging (TEI), XView, Multi View (MView), Trapezoidal View (TPView), Doppler, Color Flow Mapping (CFM), Amplitude Doppler (AD) and Tissue Velocity Mapping (TVM). Both 6400 and 7400 are equipped with a LCD color display where acquired images and advanced image features are shown. Both 6400 and 7400 can drive Phased, Convex, Linear array and Doppler probes. 6400 control panel is equipped with a pull-out qwerty alphanumeric keyboard that allows data entry. On 7400 model the touchscreen has an emulation of the qwerty alphanumeric keyboard that allows data entry. Both 6400 and 7400 models are equipped with wireless capability. Model 7400 was designed to be powered by battery.

Both 6400 and 7400 have been cleared via K111302.

6400 and 7400 Upgrade, defined herein, combine the cleared features of both 6400 and 7400 systems with other new software capabilities, listed below:

• 1. Management of motorized probes (Bi-Scan probes) that allow volumetric acquisition.
• 2. Management of 3D/4D mode of operation.
• 3. Management of the acquisition of consecutive ultrasound images on extended surface. The final image is composed of the consecutive frames placed side (Panoramic View or VPan).

The 6400 and 7400 Upgrades are manufactured under an ISO 9001:2000 and ISO 13485 certified quality system.

This 510(k) summary for the Esaote 6400 and 7400 Ultrasound Systems (K132231) indicates that no clinical tests were performed to establish acceptance criteria or demonstrate device performance.

Instead, the submission relies on demonstrating substantial equivalence to previously cleared predicate devices and conformity to applicable medical device safety and performance standards.

Therefore, most of the requested information regarding acceptance criteria and performance studies, if they were based on clinical data, cannot be extracted from this document as such studies were explicitly stated as not performed.

However, I can extract information related to the device's technological characteristics and the non-clinical tests performed.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

Since no clinical studies were performed, there are no specific performance metrics (e.g., sensitivity, specificity, accuracy) or quantitative acceptance criteria for diagnostic capability that can be reported from this document.
The acceptance criteria are implicitly based on:

• Substantial Equivalence: The new features and devices (6400 and 7400 Upgrades) are deemed substantially equivalent to previously cleared predicate devices (Esaote 6200, 7340, 6400, 7400 models). This means their performance is expected to be no worse than the predicate devices, which were already deemed safe and effective.
• Conformity to Safety Standards: The devices meet various international and national safety standards.

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

• Not Applicable. No clinical test set data was used as "No clinical tests were performed." The submission relies on comparative data with predicate devices and non-clinical engineering tests.

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

• Not Applicable. No clinical tests were performed, so no expert ground truth for a clinical test set was established as part of this submission.

4. Adjudication Method for the Test Set:

• Not Applicable. 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 device is an ultrasound imaging system, not an AI-assisted diagnostic tool in the sense of software interpreting images for human readers. No MRMC comparative effectiveness study was done for AI assistance. The submission focuses on hardware and software feature upgrades to existing ultrasound systems.

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 algorithm.

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

• Not Applicable. For the purpose of establishing clinical performance, no ground truth data from clinical trials was used, as no clinical trials were performed. The "ground truth" for substantial equivalence is based on the cleared status and established safety and effectiveness of the predicate devices and conformity to engineering standards.

8. The sample size for the training set:

• Not Applicable. No clinical data was used for training purposes, as no clinical tests or AI/machine learning components requiring such training are described.

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

• Not Applicable. No clinical training set was used.

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Esaote's Model 6400 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, and Other: Urologic. The 6400 system provides imaging for guidance of biopsy and imaging to assist in the placement of needles in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications.

Esaote's Model 7400 is a compact ultrasound system 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, and Other: Urologic. The 7400 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.

6400 is a mainframe system equipped with wheels allowing to move the system. 7400 is a portable system equipped with a handle. The system size and weight allow it to be carried using its handle. The primary modes of operation are: B-Mode, M-Mode, Tissue Enhancement Imaging (TEI), XView, Multi View (MView), Trapezoidal View (TPView), Doppler, Color Flow Mapping (CFM), Amplitude Doppler (AD) and Tissue Velocity Mapping (TVM). Both 6400 and 7400 are equipped with a LCD color display where acquired images and advanced image features are shown. Both 6400 and 7400 can drive Phased, Convex, Linear array, Doppler probes and Volumetric probes. 6400 control panel is equipped with a pull-out Qwerty alphanumeric keyboard that allows data entry. On 7400 model the touchscreen has an emulation of the Qwerty alphanumeric keyboard that allows data entry. Both 6400 and 7400 systems are equipped with wireless capability. The 6400 and 7400 systems are manufactured under an ISO 9001:2000 and ISO 13485 certified quality system.

The provided text is a 510(k) summary for the Esaote 6400 and 7400 Ultrasound Systems. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than efficacy through clinical studies and acceptance criteria as would be expected for a novel device. As such, the information typically requested in your prompt (e.g., acceptance criteria, test set, experts, adjudication, MRMC studies, standalone performance, ground truth for test/training sets, and training set size) is not explicitly present in this document.

The document explicitly states: "No clinical tests were performed." This indicates that the device's performance was not evaluated against specific acceptance criteria through a clinical study in the way your prompt describes. Instead, the submission relies on demonstrating similarity to existing, legally marketed predicate devices.

However, I can extract information related to the device's characteristics and the non-clinical tests performed to support its safety and performance.

Here's the summary of what can be inferred and what is explicitly stated:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated as this is a 510(k) submission based on substantial equivalence, not a novel device requiring new efficacy criteria. The "acceptance criteria" here are effectively demonstrating equivalence to the predicate devices.
• Reported Device Performance: The primary performance characteristic claimed is "substantial equivalence" to predicate devices, meaning it performs similarly in its intended uses. The document highlights functional equivalence and compliance with safety standards.

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 document explicitly states "No clinical tests were performed." Therefore, there is no test set in the context of clinical performance evaluation. Non-clinical tests were performed on the devices themselves to ensure compliance with standards.

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, there was no test set requiring ground truth established by experts.

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

• Not applicable. 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. No clinical tests were performed, and this device is an ultrasound imaging system, not an AI-powered diagnostic tool that assists human readers.

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 algorithm.

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

• Not applicable. No clinical tests were performed to evaluate an algorithm against ground truth. The "ground truth" in this submission relates to compliance with engineering and safety standards (e.g., whether acoustic output measures meet NEMA standards, or whether the device can perform the listed modes of operation as intended).

8. The sample size for the training set:

• Not applicable. This submission is for an ultrasound imaging system, not an AI/ML algorithm that requires a training set.

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

• Not applicable. This submission is for an ultrasound imaging system, not an AI/ML algorithm that requires a training set and associated ground truth.

Conclusion from the Document:

The Esaote 6400 and 7400 Ultrasound Systems received 510(k) clearance based on demonstrating substantial equivalence to existing predicate devices (Esaote 7350, 7340, and 8100). The submission focuses on showing that the new devices have the same technological characteristics, intended uses, and meet the same non-clinical safety and performance standards as the legally marketed predicates. No clinical studies were performed to establish performance against specific acceptance criteria for a novel functionality.

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The AIDA diagnostic ultrasound system is intended for Peripheral Vessel applications. The system provides an automated intima-media thickness measurement of peripheral vessels such as the common carotid in the BIMT mode of operation for heart rate range of 20-150 beats per minute. The AIDA ultrasound system is contraindicated for fetal use.

The AIDA diagnostic ultrasound system is a portable ultrasound system optimized to perform a non-invasive examination of the peripheral vessels. It provides an automated measurement of the intima-media thickness (IMT) of peripheral arteries such as the common carotids and allows the user to search for arterial plaques using real-time B-mode imaging. The touchscreen keyboard allows the user to input various parameters relating to traditional cardiovascular risk factors. A built in calculator provides risk scores commonly used in a variety of geographical locations (Framingham Risk Score, PROCAM Health Check Score, Reynolds Risk Score, Risk score based on the SCORE Project). This information is supplemented with an IMT measurement of the artery to generate a comprehensive report of cardiovascular risk assessment.

The provided text does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The document is a 510(k) Premarket Notification for the AIDA Diagnostic Ultrasound System GM-72P00A. It primarily focuses on:

• Administrative Information: Submitter's name, address, contact, date, trade name, model, common name, classification, and regulatory class.
• Device Description: What the device is (portable ultrasound system optimized for peripheral vessels, automated IMT measurement, plaque search, cardiovascular risk assessment).
• Standards Compliance: List of various UL, IEC, ISO, and NEMA standards the device is designed to comply with.
• Intended Use: Specifically for Peripheral Vessel applications, automated IMT measurement of peripheral vessels (like common carotids) in BIMT mode, heart rate range 20-150 bpm, and contraindication for fetal use.
• Technological Comparison to Predicate Device: States substantial equivalence to previously cleared devices (K093171, K081794, K022567) based on transmitting ultrasonic energy, post-processing echoes for display, and specialized measurement capabilities.
• FDA Correspondence: Letter from FDA confirming substantial equivalence and providing guidance.
• Indications for Use Statement: Reiterates the intended use for peripheral vessels, BIMT mode, and heart rate range.
• Clinical Application Table for Transducer L13-5V1: Specifies the clinical applications for the L13-5V1 transducer, noting "Peripheral vessel" as a new indication (N) using Combined mode B + IMT.

Therefore, I cannot provide the requested information in a table or answer the specific questions about the study, sample sizes, ground truth, or MRMC study, as this data is not present in the provided text.

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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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