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The Leltek Ultrasound Imaging System (Model: LU700 Series) 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 modes of operation include B mode, PWD mode, Color Doppler (CD) mode, Power Doppler mode, and the combined mode (B+M, B+CD, B+PWD). Specific clinical applications and exam types including:

LU700L
General abdominal imaging, Pediatric, Small organ (thyroid, prostate, scrotum, breast), Neonatal cephalic, Musculoskeletal (conventional),Musculosketal (superficial),Peripheral vessel ,Other (Carotid),Pulmonary,interventional guidance (free hand needle/ catheter)

LU710L
Ophthalmic, General abdominal imaging, Pediatric, Small organ (thyroid, prostate, scrotum, breast), Neonatal cephalic.Musculoskeletal (conventional),Musculoskeletal (superficial),Peripheral vessel ,Other
(Carotid),Pulmonary,interventional guidance (free hand needle/ catheter)

LU710LH
Ophthalmic, General abdominal imaging, Pediatric, Small organ (thyroid, prostate, scrotum, breast), Neonatal cephalic,Musculoskeletal (conventional),Musculoskeletal (superficial),Peripheral vessel ,Other
(Carotid),Pulmonary,interventional guidance (free hand needle/ catheter)

LU700C
General abdominal imaging,Musculoskeletal (conventional),Musculoskeletal (superficial),OB/Gyn,Peripheral vessel ,interventional guidance (free hand needle/ catheter)

LU710C
Fetal.General abdominal imaging.Small organ (thyroid, prostate, scrotum, breast).Urology.Musculoskeletal (conventional),OB/Gyn,Cardiac (pediatric),Peripheral vessel ,interventional guidance (free hand needle/ catheter)

LU710M
Fetal,General abdominal imaging,Pediatric,Small organ (thyroid, prostate, scrotum, breast),Neonatal cephalic. Urology. Musculoskeletal (conventional), OB/Gyn. Cardiac (pediatric), Peripheral vessel ,interventional guidance (free hand needle/ catheter)

LU710PA
Fetal, General abdominal imaging, Pediatric, Cardiac (adult), Cardiac (pediatric), Pulmonary

LU710E
Fetal, General abdominal imaging, Pediatric, Small organ (thyroid, prostate, scrotum, breast), Transvaginal,Urology,OB/Gyn,interventional guidance (free hand needle/ catheter)

The clinical environments where the system can be used include physician offices, clinics, and clinical point-of-care for diagnosis of patients.

The Leltek Ultrasound Imaging System (Model: LU700 Series) 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) mobile device.

• I. 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) mobile device and utilizes an icon touch-based user interface.
• III. 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

The provided text describes the Leltek Ultrasound Imaging System (Model: LU700 Series) seeking 510(k) clearance from the FDA. Based on the document, here's a breakdown of the acceptance criteria and study information:

1. A table of acceptance criteria and the reported device performance

The document does not provide a specific table of quantitative acceptance criteria and reported device performance in terms of diagnostic accuracy metrics (e.g., sensitivity, specificity, accuracy). Instead, the acceptance criteria are generally based on compliance with international safety and performance standards for medical electrical equipment and the device demonstrating "substantially equivalent" safety and effectiveness to predicate devices.

The reported device performance is primarily described as:

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

The document explicitly states: "The Leltek Ultrasound Imaging System did not require clinical testing to establish substantial equivalence." This indicates that no test set involving patient data was used for a clinical performance study. The evaluation was based on compliance with performance standards and comparison with predicate devices.

Therefore, information regarding sample size, country of origin, and retrospective/prospective nature of a test set is not applicable as no clinical test set was used.

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 test set was used and therefore no ground truth needed to be established by experts for a performance evaluation study.

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

Not applicable, as no clinical test set was used.

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. The document states "The Leltek Ultrasound Imaging System did not require clinical testing to establish substantial equivalence." This implies no clinical performance study, including an MRMC study with AI assistance, was conducted or required for this 510(k) submission.

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

The Leltek Ultrasound Imaging System is an ultrasound imaging system, not an AI algorithm. It provides imaging data for qualified physicians and healthcare professionals to conduct ultrasound scans and fluid flow analysis. Therefore, a "standalone algorithm only" performance study is not applicable to this device. Its performance is evaluated on its ability to produce safe and effective ultrasound images, not on an AI's diagnostic accuracy.

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

Not applicable in the context of a clinical performance study for an AI algorithm. The device itself is an imaging tool. Its "ground truth" for regulatory purposes revolves around its technical specifications, safety, and ability to generate images comparable to legally marketed predicate devices, as demonstrated through engineering tests and adherence to standards.

8. The sample size for the training set

Not applicable. The Leltek Ultrasound Imaging System is an imaging device, not an AI algorithm that requires a training set of data.

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

Not applicable, as there is no training set for this device.

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The Leltek Ultrasound Imaging System (Model: LU700 Series) 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 clinical environments where the system can be used include physician offices, clinics, hospitals, and clinical point-of-care for diagnosis of patients

The modes of operation include B mode, PWD mode, Color Doppler (CD) mode, Power Doppler mode, and the combined mode (B+M, B+CD, B+PWD). Specific clinical applications and exam types including: LU700C General abdominal imaging, musculoskeletal (conventional), musculoskeletal (superficial), peripheral vessel and OB/Gyn. LU700L General abdominal imagine, small organ (breast, thyroid), musculoskeletal (superficial) and peripheral vessel. LU710C Fetal, abdominal, pediatric, small organ (thyroid, prostate, scrotum, breast), musculoskeletal (conventional), urology, gynecology, cardiac adult, cardiac pediatric and peripheral vessel. LU710M Fetal, abdominal, pediatric, small organ (thyroid, prostate, scrotum, breast), musculoskeletal (conventional), urology, gynecology, cardiac adult, cardiac pediatric and peripheral vessel. LU710PA Fetal, abdominal, pediatric, cardiac adult, cardiac pediatric. LU710E Fetal, abdominal, small organ (thyroid, prostate, scrotum, breast), trans-vaginal, urology, gynecology.

The Leltek Ultrasound Imaging System (Model: LU700 Series) 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) 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) mobile device and utilizes an icon touch-based user interface.
• III. 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

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.

Here's an analysis of the provided text regarding the acceptance criteria and study proving device performance:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document (K210432) is a 510(k) summary for premarket notification of a medical device (Leltek Ultrasound Imaging System). It focuses on establishing substantial equivalence to predicate devices rather than defining and meeting specific analytical or clinical performance acceptance criteria in the traditional sense of a clinical trial.

Therefore, the "acceptance criteria" here are compliance with recognized safety and performance standards and demonstrating similar performance characteristics to the predicate devices. The "reported device performance" is the system's demonstrated compliance with these standards and its functional equivalence.

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

The document does not provide details on specific sample sizes for a "test set" in the context of clinical performance or image-based evaluation.

Instead, the submission relies on:

• Compliance with recognized performance and safety standards: This implicitly means testing against defined criteria within those standards.
• Bench testing and engineering verification: "Acoustic output, biocompatibility, cleaning, and disinfection effectiveness as well as wireless, thermal, electromagnetic and mechanical safety" were evaluated by tests, but specific sample sizes for these tests are not mentioned.
• Substantial equivalence argument: The core of the 510(k) relies on demonstrating that the new device performs as safely and effectively as a legally marketed predicate device (K191235) and a reference device (K192107).

The data provenance is related to the testing performed to ensure compliance with the listed standards. This would typically be internal testing by the manufacturer (LELTEK, Inc. in Taiwan) as part of their design, manufacturing, and quality control processes. The document does not indicate the use of external or clinical data for the performance evaluation in the way a clinical trial would. It states, "The Leltek Ultrasound Imaging System did not require clinical testing to establish substantial equivalence." (K210432, page 10).

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

Since the document explicitly states that clinical testing was not required, there was no "test set" in the clinical sense that would require expert-established ground truth for diagnostic accuracy. The evaluation focused on engineering, safety, and performance characteristics against established standards.

4. Adjudication Method for the Test Set

Not applicable, as a clinical "test set" requiring adjudication for diagnostic accuracy as described in the prompt was not part of this 510(k) submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The document states, "The Leltek Ultrasound Imaging System did not require clinical testing to establish substantial equivalence." (K210432, page 10). The submission is based on demonstrating technical and safety equivalence to predicate devices, not on a clinical comparison of diagnostic efficacy with human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not directly applicable in the context of this device. The Leltek Ultrasound Imaging System is an ultrasound imaging device, not an AI algorithm intended for automated diagnosis or interpretation. The "software" aspect refers to the app running on a mobile device and controlling the ultrasound hardware, not a standalone diagnostic algorithm. Therefore, "standalone" performance for an algorithm is not a relevant concept for this type of device based on the provided information.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

Given that clinical testing for diagnostic performance was not required, there was no "ground truth" of the type typically used for evaluating diagnostic accuracy (e.g., pathology, surgical findings, long-term outcomes, expert consensus on images). The ground truth for this submission was based on:

• Engineering specifications and measurements: To ensure parameters like acoustic output, image quality (implied by functional equivalence), and electrical safety met defined standards.
• Biocompatibility testing results: Against ISO 10993 standards.
• Compliance with cleaning/disinfection protocols.

8. The Sample Size for the Training Set

Not applicable. This device is an ultrasound imaging system, and the submission does not describe it as an AI/ML-based diagnostic algorithm that would require a "training set" of data in the sense used for machine learning. The "software" is for image acquisition, processing, and display, not for learning to diagnose from a dataset.

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/ML algorithm in this 510(k) submission.

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