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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, Neonatic, Small organs, Musculoskeletal (Conventional and Superlicial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative abdomninal, Laparoscopic and Other: Urologic. The 6400 system provides imaging for guidance of biopsy and imaging to assist in the placement of needles 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, Adult Cephalic, Small organs, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transrectal, Pediatric, Intraoperative abdominal 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 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), Multi View (MView), Doppler, Color Flow Mapping (CFM), Amplitude Doppler (AD), Tissue Velocity Mapping (TVM), 3D and 4D. 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 models are equipped with wireless capability. Model 7400 has been designed to be powered by battery.

Both 6400 and 7400 have been cleared via K111302, K132231 and K132466.

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

• 1. Management of Quality Intima Media Thickness (QIMT) on both 6400 and 7400 upgrades.
• Management of Elastosonograpy qualitative analysis (ElaXto) on both 6400 and 7400 upgrades. 2.
• 3. Management of Laparoscopic application on 6400 upgrade.

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

The provided text describes a 510(k) premarket notification for Esaote S.p.A.'s 6400 and 7400 Ultrasound Systems. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel clinical effectiveness with specific performance metrics defined by acceptance criteria and clinical studies.

Therefore, the document does not contain information about explicit acceptance criteria for a device's performance (e.g., sensitivity, specificity, accuracy thresholds) or a study specifically designed to prove the device meets such criteria in terms of diagnostic effectiveness for new functionalities.

Instead, the submission focuses on demonstrating that the new functionalities and upgrades to the existing ultrasound systems (6400 and 7400) employ the same fundamental technological characteristics as their predicate devices and that no clinical tests were performed to establish new performance metrics. The clearance is based on adherence to safety and performance standards for ultrasound devices and equivalence to previously cleared devices for various clinical applications and modes of operation.

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

1. Table of acceptance criteria and the reported device performance:

This information is not applicable in the context of this 510(k) submission for substantial equivalence. The document doesn't define specific "acceptance criteria" in terms of diagnostic performance metrics (e.g., sensitivity, specificity, accuracy) for the upgraded device or report results of a study demonstrating these. The "performance" is implicitly deemed equivalent to the predicate devices and compliant with general safety standards. The document primarily focuses on listing the intended uses and modes of operation, and noting which applications are "Previously cleared by FDA" (P) or "Added under Appendix E" (E), implying that these additions are equivalent to those found in other cleared devices.

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

No sample size for a test set is provided as no clinical tests were performed. The submission explicitly states: "No clinical tests were performed."

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

Not applicable, as no clinical tests requiring expert-established ground truth were performed.

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

Not applicable, as no clinical tests requiring adjudication 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 FDA submission is for a conventional ultrasound system and its upgrades, not an AI-assisted device. Therefore, no MRMC study or assessment of human reader improvement with AI assistance would have been conducted or reported.

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

Not applicable. This submission is for an ultrasound system, not a standalone algorithm.

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

Not applicable. Since no clinical tests were performed, there was no need to establish ground truth for a test set related to diagnostic effectiveness. The ground truth for safety and performance would relate to engineering specifications and compliance with standards.

8. The sample size for the training set:

Not applicable. The submission does not describe the development of a machine learning algorithm or AI component, thus there is no training set in the context of an AI model.

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

Not applicable. As there is no mention of a training set for an AI model, the method for establishing its ground truth is not relevant here.

In summary, this document is a 510(k) premarket notification for an ultrasound system upgrade, which relies on demonstrating substantial equivalence to previously cleared devices and adherence to recognized safety and performance standards, rather than presenting new clinical study data with specific acceptance criteria and performance metrics.

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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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