(181 days)
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.
| Metric (Acceptance Criteria implied by predicate performance) | Reported Device Performance (Subject Device) | Predicate Device Performance (K200136) |
|---|---|---|
| Liver Stiffness | ||
| TE Bias Liver Stiffness | (-2.1%) – (3.5%) | FT9000: (-4.7%) - (2.4%) |
| Mini800: (-5.3%) – (1.2%) | ||
| FT100: (-2.1%) – (3.5%) | ||
| TE Precision Liver Stiffness | (0.0%) – (3.8%) | FT9000: (0.0%) – (1.6%) |
| Mini800: (0.0%) – (1.8%) | ||
| FT100: (0.0%) – (3.8%) | ||
| UAP (Ultrasound Attenuation Parameter) | ||
| UAP Bias | (-1.6%) – (6.5%) | FT9000: (-3.3%) – (2.0%) |
| Mini800: (-6.9%) - (4.8%) | ||
| FT100: (-1.6%) – (6.5%) | ||
| UAP Precision | (0.3%) – (2.0%) | FT9000: (0.2%) – (1.5%) |
| Mini800: (0.2%) – (2.0%) | ||
| FT100: (0.3%) – (2.0%) |
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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