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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 Model 6400 is a mainframe ultrasound system diagnostic general ultrasound studies including Cardiac, Transesophageal Cardiac, Peripheral Vascular, Neonatal Cephalic, Small organs, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative (Abdominal), Laparoscopic and Other: Urologic. Model 6400 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, Neonatic, Adult Cephalic, Small organs, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative (Abdominal), Laparoscopic and Other: Urologic. Model 7400 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 7410 is a compact ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal Cardiac, Peripheral Vascular, Neonatal Cephalic, Small organs, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative (Abdominal), Laparoscopic and Other. Urologic. Model 7410 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. Models 7400 and 7410 are portable systems equipped with a handle. The system sizes and weights allow them to be carried using its handle. The primary modes of operation are for both models: B-Mode, Tissue Enhancement Imaging (TEl), Multi View (MView), Doppler, Color Flow Mapping (CFM), Amplitude Doppler (AD), Tissue Velocity Mapping (TVM), 3D and 4D. Models 6400 and 7400 manages Qualitative Elastosonography (ElaXto).

All models 6400, 7400 and 7410 are equipped with a LCD color display where acquired images and advanced image features are shown. All models 6400, 7400 and 7410 can drive Phased array, Convex array, Linear array, Doppler probes and Volumetric probes). Model 6400 control panel is equipped with a pull-out Qwerty alphanumeric keyboard that allows data entry.

Models 7400 and 7410 the touchscreen has an emulation of the Qwerty alphanumeric keyboard that allows data entry. All models 6400, 7400 and 7410 are equipped with wireless capability. Models 7400 and 7410 have been designed to be powered by battery.

Both models 6400 and 7400 are already cleared via K142008. Model 7410 is already cleared via K142077.

Models 6400, 7400 and 7410 Upgrades, defined herein, combine the cleared features of both 6400, 7400 and 7410 systems with new capabilities, listed below:

• 1. Management of Intraoperative (Abdominal) application on 7410 Upgrade.
• 2. Management of Laparoscopic application on both 7400 and 7410 Upgrades.
• 3. Addition of Transrectal/Urology and Transvaginal applications in 3D/4D on 7410 Upgrade.
• 4. Addition of Urology application in 3D/4D on both 6400 and 7400 Upgrades.
• 5. Implementation of the QAS feature on 6400 and 7400 Upgrades.
• 6. Implementation of the Needle Visibility feature on all 6400, 7400 and 7410 Upgrades.
• 7. Implementation of the on-board tutorial MyLibrary feature on all 6400, 7400 and 7410 Upgrades.

The 6400, 7400 and 7410 Upgrades are manufactured under an ISO 9001 and ISO 13485 certified quality system.

The provided document is a 510(k) premarket notification for Esaote S.p.A.'s 6400, 7400, and 7410 Ultrasound Systems. It details the intended use, technological characteristics, and a summary of non-clinical tests conducted. The document does not describe a study that uses acceptance criteria and reports device performance in terms of specific metrics like sensitivity, specificity, or AUC as one might find for an AI/ML medical device. Instead, it focuses on demonstrating substantial equivalence to predicate devices based on intended use, technological characteristics, and adherence to performance standards.

Therefore, many of the requested items (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, training set size, training set ground truth) are not applicable or not available from this 510(k) summary, as it is related to an ultrasound system, not an AI/ML device that typically involves such evaluations.

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

1. Table of acceptance criteria and the reported device performance

The document does not specify quantitative acceptance criteria or reported device performance metrics like sensitivity or specificity. Instead, the "acceptance criteria" are implied by demonstrating substantial equivalence to predicate devices and adherence to recognized performance standards. The "device performance" is therefore considered equivalent to the predicate devices and compliant with these 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 states "No clinical tests were performed," indicating that direct patient data or test sets for performance evaluation in the context of AI/ML or diagnostic accuracy studies were not used for this submission. The evaluation was based on non-clinical performance and substantial equivalence to existing 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)

Not applicable. No clinical tests were performed, hence no ground truth was established by experts for a test set in this 510(k) submission.

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 is not a submission for an AI-assisted device requiring an MRMC study.

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

Not applicable. This is not an AI/ML medical device capable of standalone performance.

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

Not applicable. No clinical tests involving ground truth determination were performed.

8. The sample size for the training set

Not applicable. As this is not an AI/ML device, there is no "training set."

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

Not applicable. No "training set" or corresponding ground truth establishment is relevant to this traditional ultrasound system submission.

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