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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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