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The Leltek Ultrasound Imaging System (Model: LU700) is a software-based imaging system and accessories intended for use by qualified physicians and healthcare professionals who has the ability to conduct ultrasound scan process for evaluation by ultrasound imaging system or fluid flow analysis of the human body. The device is intended for use in environments where healthcare is provided by trained healthcare professionals, but not intended for use in emergency medical service, ambulance, or aircraft.

Specific clinical applications and exam types including:

For LU700C:

General abdominal imaging, musculoskeletal (conventional), musculoskeletal (superficial), peripheral vessel and OB/ Gyn. The modes of operation include B mode. M mode. PWD mode, Color Doppler (CD) mode. Power Doppler mode. and the combined mode(B+M, B+CD, B+PWD).

For LU700L:

General abdominal imaging, small organ (breast, thyroid), musculoskeletal (conventional), musculoskeletal (superficial) and peripheral vessel. The modes of operation includes B mode, M mode, Color Doppler (CD) mode, Power Doppler mode, and the combined mode(B+M, B+CD, B+PWD).

The Leltek Ultrasound Imaging System is a portable, software controlled, handheld ultrasound system used to acquire and display hi-resolution, real-time ultrasound data through a commercial off-the-shelf (COTS) Android mobile device.

l. The imaging system software runs as an app on a mobile device.

II. The imaging system software can be download to a commercial off-the-shelf (COTS) Android mobile device and utilizes an icon touch-based user interface.

lll. The imaging system consists of a series of wireless transducers employing Wi-Fi-based technology to communicate with traditional tablet/smartphone devices via direct Wi-Fi. This allows the user to export ultrasound images and display them across a range portable personal device.

IV. The imaging system houses a built-in battery, multichannel beamformer, prescan converter and Wi-Fi components

This document describes the regulatory clearance (K191235) for the Leltek Ultrasound Imaging System (Model: LU700) by the US FDA. The information provided is a summary of the device, its intended use, and a comparison to predicate devices, focusing on demonstrating substantial equivalence rather than explicit acceptance criteria and a detailed study report. As such, the document does not contain a typical detailed clinical study report with acceptance criteria, sample sizes for test and training sets, expert qualifications, or adjudication methods for ground truth, nor MRMC study results.

However, based on the provided text, we can infer and construct some of the requested information, particularly regarding the performance standards (which act as implicit acceptance criteria for safety and effectiveness) and the basis for proving compliance.

Here's an analysis of the provided information relative to your request:

Acceptance Criteria and Device Performance

The document does not present explicit "acceptance criteria" in the format of defined metrics and thresholds (e.g., "sensitivity must be > X%, specificity > Y%"). Instead, the acceptance of the device is based on its compliance with a robust set of internationally recognized performance and safety standards, and its substantial equivalence to legally marketed predicate devices. The "reported device performance" is primarily the assertion that the device meets these standards and, therefore, is safe and effective for its intended use.

Inferred Acceptance Criteria (Based on Compliance Standards) and Reported Performance:

Study Details (Based on available information)

This document is a 510(k) summary, which generally focuses on demonstrating substantial equivalence through non-clinical performance testing and comparison to predicates, rather than extensive clinical trials for a novel device.

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

   • Test Set Sample Size: Not specified. The document states that "The Leltek Ultrasound Imaging System did not require clinical testing to establish substantial equivalence." This implies that the 'test set' primarily encompasses data from bench testing, engineering validation, and comparison to technical specifications and predicate device performance, rather than a clinical dataset.
   • Data Provenance: Not specified, but given the manufacturing location (Taiwan R.O.C.), it's plausible that much of the engineering and bench test data would originate from there. It's non-clinical data, likely from internal verification and validation activities.

2. 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 Specified: Since clinical testing was not required for substantial equivalence, clinical ground truth established by experts (like radiologists) on patient data was not a primary component of this submission. The "ground truth" for the non-clinical tests would be defined by the technical specifications, reference standards, and established engineering principles.

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

   • Not Applicable: No clinical test set requiring expert adjudication is described in the document.

4. 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: The document explicitly states, "The Leltek Ultrasound Imaging System did not require clinical testing to establish substantial equivalence." This is not an AI-assisted device, it's a diagnostic ultrasound imaging system; therefore, an MRMC study comparing human readers with and without AI assistance would not be relevant or expected for this type of device and submission.

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

   • Not Applicable: This is a diagnostic ultrasound imaging system, not an AI algorithm. Its performance is based on its ability to acquire and display images/Doppler data, not standalone diagnostic interpretation.

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

   • Technical Specifications and Standard Compliance: The "ground truth" for this device's performance demonstration is its adherence to the technical specifications outlined in its design and its compliance with the various international safety and performance standards listed (e.g., IEC 60601 series, ISO 10993 series). This is evidenced through a combination of engineering tests (e.g., acoustic power measurements against limits, electrical safety tests, EMC tests), biocompatibility tests, and software verification and validation against requirements and design specifications.

7. The sample size for the training set:

   • Not Applicable / Not Specified: This is not a machine learning/AI device requiring a "training set." The device is a hardware and software system for image acquisition and display.

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

   • Not Applicable: As above, there is no "training set" for this type of device.

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