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Shear Wave Quantificational Ultrasound Diagnostic System, Transient Elastography based device, is intended to provide 50Hz shear wave speed measurements and estimates of tissue stiffness as well as Ultrasound Attenuation Parameter (UAP) in internal structures of the body.
Shear Wave Quantificational Ultrasound Diagnostic System is indicated as a non-invasive aid for the clinical management, diagnosis, and monitoring of adult and pediatric patients with confirmed or suspected liver disease, as part of an overall assessment of the liver. Results in the pediatric population should be interpreted while considering the clinical condition and the overall patient profile.
Shear Wave Quantificational Ultrasound Diagnostic System is intended for general purpose pulse echo ultrasound imaging and Doppler flow analysis of the human body. It can be used in the following applications: Abdominal, including locating of the liver.
The system must be operated by qualified and appropriately trained healthcare professionals in a professional healthcare facility environment.

The proposed device is a general purpose, mobile, software-controlled, diagnostic ultrasound system. It consists of a fibrosis scanning probe, an imaging probe, a main unit, a probe holder, an AC/DC adapter and a foot switch. The fibrosis scanning probe is a single element probe used for elasticity measurement, while the imaging probe is a convex probe used for ultrasound imaging. The system uses transient elastography to measure shear wave speed non-invasively and estimates of tissue stiffness as well as Ultrasound Attenuation Parameter (UAP) in internal structures of the body. A mechanical vibrator in the fibrosis scanning probe produces low-frequency shear waves at 50 Hz that travel through the skin and intercostal space into the liver. The propagation speed of the shear wave is captured using ultrasound at 2.5 MHz. Under imaging mode, the system acquires and displays ultrasound images in B,M,CFM,PWD modes. The system uses imaging probe with nominal Frequency of 2.5-4.5 MHZ on abdomen for general purpose pulse echo ultrasound imaging and Doppler flow analysis of the human body. The ultrasonic imaging also helps to find a proper location for the transient elastography examination.
There are a total of 9 models in this product, all of which share the same intended use, physical design and principle of technology. The only differences among these models are software functions configuration and availability of imaging probe.

Here's a breakdown of the acceptance criteria and study information based on the provided FDA 510(k) Clearance Letter:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the device seem to be implicitly established by demonstrating comparable performance to the predicate device, K200136. The provided document focuses on reporting the device's performance metrics and comparing them to those of the predicate.

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

The provided document does not specify the sample size used for the test set or the data provenance (e.g., country of origin of the data, retrospective or prospective). It simply states that "Non-clinical tests were conducted to verify that the proposed device met all design specifications."

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

The document does not provide information regarding the number of experts used to establish ground truth or their qualifications. The non-clinical testing appears to be based on technical specifications and comparisons rather than expert-derived ground truth for patient data.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method for a test set. This type of information is typically relevant for studies involving human interpretation or subjective assessment, which is not clearly described as part of these non-clinical tests.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed or, at least, is not reported in this document. The submission explicitly states "Clinical investigation: Not applicable," which further confirms the absence of such a study.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)

The device, a "Shear Wave Quantificational Ultrasound Diagnostic System," is an imaging system that provides measurements (shear wave speed, tissue stiffness, UAP) and imaging capabilities. Its performance metrics (Bias and Precision for liver stiffness and UAP) are reported as technical measurements, suggesting a standalone assessment of the algorithm/device's measurement capabilities. The context of the "non-clinical tests" reinforces this. However, it's important to note that while the measurements are standalone, a human operator is still required to acquire the data with the ultrasound probe.

7. Type of Ground Truth Used

Based on the nature of the reported performance metrics (Bias and Precision for physical measurements like liver stiffness and UAP) and the statement "Non-clinical tests were conducted to verify that the proposed device met all design specifications," the ground truth was likely established using phantom studies or other controlled technical measurements with known stiffness and attenuation properties, rather than expert consensus, pathology, or outcomes data from human subjects.

8. Sample Size for the Training Set

The document does not provide information about the sample size for a training set. Given that "Clinical investigation: Not applicable" is stated, and the focus is on non-clinical testing and comparison to a predicate, it's possible that the device's algorithms were developed and validated internally using proprietary data or phantom studies, but these details are not disclosed in the clearance letter.

9. How the Ground Truth for the Training Set Was Established

The document does not provide information on how the ground truth for a training set was established. As mentioned in point 8, the "Not applicable" for clinical investigation suggests that the development and validation of the device's algorithms might have relied on non-clinical data, potentially using phantoms with known properties.

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Shear Wave Quantificational Ultrasound Diagnostic System (Models: FT9000, FT100 and Mini800), Transient Elastography based device, is intended to provide 50Hz shear wave speed measurements and estimates of tissue stiffness as well as Ultrasound Attenuation Parameter (UAP ) in internal structures of the body.

Shear Wave Quantificational Ultrasound Diagnostic System (Models: FT9000, FT100 and Mini800), is indicated for noninvasive measurement in the liver of 50 Hz shear wave speed and estimates of stiffness as well as Ultrasound Attenuation Parameter ( UAP ).

The shear wave speed and stiffness, and UAP may be used as an aid to diagnosis and monitoring of patients with liver disease, as part of an overall assessment of the liver.

Shear Wave Quantificational Ultrasound Diagnostic System (Models: FT9000), is intended for general purpose pulse echo ultrasound imaging and Doppler flow analysis of the human body. It can be used in the following applications: Abdominal, including location of the liver.

The Shear Wave Quantificational Ultrasound Diagnostic System, Models: FT9000, FT100 and Mini800, iLivTouch brand, is a general purpose, mobile, software-controlled, diagnostic ultrasound system. FT9000 is equipped with two probes, a fibrosis scanning probe used in elastography mode and an imaging probe used in imaging mode. The fibrosis scanning probe is used for elasticity measurement while the imaging probe is a convex probe used for ultrasound imaging. But the model FT100 and Mini800 is equipped with only one fibrosis scanning probe.FT100 and Mini800 have the same appearance structure and hardware, but the software is different.

Under elastography mode, the system uses transient elastography to measure shear wave speed non-invasively and estimates of tissue stiffness as well as Ultrasound Attenuation Parameter (UAP) in internal structures of the body. A mechanical vibrator produces low-amplitude shear waves at 50 Hz that travel through the skin and intercostal space into the liver. The propagation speed of the shear wave is measured using ultrasound at 2.5 MHz.

Under imaging mode, the system acquires and displays ultrasound images in B, B/B, B/C (CFM), B/C/D (CPWD) modes. The system uses convex array probe with a frequency range of 2.1MHz to 5 MHz on abdomen for general purpose pulse echo ultrasound imaging and Doppler flow analysis of the human body. The ultrasonic imaging also helps to find a proper location for the transient elastography examination.

Here's an analysis of the provided text regarding the acceptance criteria and study information for the Shear Wave Quantificational Ultrasound Diagnostic System:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) summary directly compares the proposed device to predicate devices. The "acceptance criteria" are implied by the similarities to the predicate devices and the performance characteristics stated. The reported device performance is given in terms of bias and precision for shear wave speed, stiffness, and UAP measurements.

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

The document explicitly states: "No clinical study is included in this submission." This means there is no test set of human data for the proposed device analyzed in this submission. The performance metrics (bias and precision) likely refer to phantom studies or bench testing rather than clinical data. The document does not provide details on the sample size for these non-clinical tests or their provenance.

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

Since no clinical study was included, there were no experts used to establish ground truth for a human test set. For the phantom/bench testing, the ground truth would typically be established by the known physical properties of the phantom materials and calibrated measurement equipment. No specific details about such experts or their qualifications are provided for non-clinical testing.

4. Adjudication Method for the Test Set

As there was no human test set, no adjudication method was applicable or described.

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

No MRMC comparative effectiveness study was done as "no clinical study is included in this submission." Therefore, no effect size of human readers improving with or without AI assistance is provided.

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

The performance metrics (bias and precision) presented in the tables are indicative of standalone performance (algorithm only) as applied to non-clinical tests (e.g., phantoms). The document states the proposed devices passed "related performance test (eg UD2 test)" and "measurement accuracy by accuracy testing and software validation." These imply standalone testing, but no specific study details are provided beyond these results.

7. The Type of Ground Truth Used

For the performance metrics listed, the ground truth was based on known physical properties of phantoms or calibrated measurement systems used in non-clinical performance and safety testing (e.g., UD2 test).

8. The Sample Size for the Training Set

The document does not provide any information regarding a training set sample size. This suggests that the device's algorithms were either established using pre-existing knowledge (e.g., physics-based models for shear wave propagation) or that any internal development/training data was not part of this 510(k) submission, which focused on demonstrating substantial equivalence through technical characteristics and non-clinical performance to existing predicate devices.

9. How the Ground Truth for the Training Set Was Established

As no training set is mentioned, no information on how its ground truth was established is provided.

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Shear Wave Quantificational Ultrasound Diagnostic System, Model FT9000, is intended to measure the speed of 50Hz shear wave with 2.5MHz ultrasound wave in the liver. The shear wave speed may be used as an aid to clinical management of patients with liver disease.

Shear Wave Quantificational Ultrasound Diagnostic System, Model FT9000, is intended for general purpose pulse echo ultrasound imaging and Doppler flow analysis of the human body. It can be used in the following applications: Abdominal.

The Shear Wave Quantificational Ultrasound Diagnostic System, Model FT9000, is a general purpose, mobile, software-controlled, diagnostic ultrasound system with an on-screen display for thermal and mechanical indices related to potential bioeffect mechanisms. The system is equipped with two probes, a fibrosis scanning probe used in elastography mode and an imaging probe used in imaging mode. The fibrosis scanning probe is used for elasticity measurement while the imaging probe is a convex probe used for ultrasound imaging.

Under elastography mode, the system uses transient elastography to measure shear wave speed non-invasively and estimate tissue stiffness in liver. A mechanical vibrator produces low-amplitude shear waves at 50 Hz that travel through the skin and intercostal space into the liver. The propagation speed of the shear wave is measured using ultrasound at 2.5 MHz.

Under imaging mode, the system acquires and displays ultrasound images in B, B/B, B/C (CFM), B/C/D (CPWD) modes. The system uses convex array probe with a frequency range of 2.1MHz to 5 MHz on abdomen for general purpose pulse echo ultrasound imaging and Doppler flow analysis of the human body. The ultrasonic imaging also helps to find a proper location for the transient elastography examination.

The provided document, K173595, focuses on demonstrating substantial equivalence to predicate devices rather than proving device performance against specific clinical acceptance criteria through a dedicated study. Therefore, most of the requested information about acceptance criteria and a study proving their fulfillment is not present in this 510(k) summary.

The document explicitly states: "No clinical study is included in this submission." This means there is no clinical trial data to evaluate device performance against clinical acceptance criteria.

However, based on the information available, here's a breakdown of what can be derived:

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

The document does not provide a formal table of acceptance criteria for clinical performance that the device is tested against. Instead, it compares the technical characteristics and performance specifications of the proposed device ("FT9000 Shear Wave Quantificational Ultrasound Diagnostic System") to two predicate devices: FibroScan® (K123806) and Mindray DC-6 (K072164).

The only "performance" discussed in relation to a quantitative metric is "Stiffness" when comparing FT9000 to FibroScan®. This comparison is likely based on internal testing or technical specifications, not a clinical trial.

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

There is no clinical test set or data described in this submission, as it explicitly states "No clinical study is included in this submission." The reported "performance" metrics for stiffness bias and precision likely come from internal lab testing on phantoms or simulated data, rather than human subjects. Therefore, provenance information is not applicable for a clinical test set.

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 study or test set with expert-established ground truth is presented.

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

Not applicable, as no clinical study or test set is presented.

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 a diagnostic ultrasound system for shear wave quantification and general imaging. It is an aid to clinical management, but there is no mention of "AI assistance" or a MRMC study involving human readers with and without such assistance. The submission focuses on device functionality and safety, not on improving human reader performance.

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

The device itself, in its shear wave measurement mode, provides a quantitative output (shear wave speed) without human interpretation in the measurement step itself. The "stiffness bias" and "precision" figures likely represent standalone performance against a known standard (e.g., a tissue phantom). However, the overall interpretation of that shear wave speed for clinical management is still human-dependent. There is no specific study described to quantify this standalone performance in a clinical context.

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

For the "Stiffness" metrics (bias and precision), the ground truth would likely be a known, quantifiable stiffness value of a phantom material used in laboratory testing. For the general ultrasound imaging functionality, compliance with NEMA UD 2-2004 (R2009) implies performance against physical phantom targets and established acoustic output standards.

8. The sample size for the training set

Not applicable. There is no mention of a machine learning component or a "training set" in the context of the device's development as described in this 510(k) summary. The device relies on established ultrasound physical principles and signal processing, not a trained AI model.

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

Not applicable. As there's no mention of a training set, the establishment of its ground truth is irrelevant here.

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