(56 days)
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.
| Category | Acceptance Criteria (Implied by Predicate) | Reported Device Performance (Proposed Device) |
|---|---|---|
| Shear Wave Speed / Stiffness Measurement | ||
| Display Range | Shear wave speed (0.8-5.0 m/s), Stiffness (2.0-75 kPa), Interquartile range (IQR) and IQR/median ratio (Predicate: FibroScan® 502 Touch) | FT9000: Shear wave speed (0.8-5.2 m/s), Stiffness (2.0-80 kPa), Interquartile range (IQR) and IQR/median ratio |
| FT100 & Mini800: Similar to FT9000, but exact ranges not explicitly separated for TE display. | ||
| Bias | (-14.3%) - (3.6%) (Predicate: FibroScan® 502 Touch) | FT9000: (-4.7%) - (2.4%) |
| FT100: (-2.1%) - (3.5%) | ||
| Mini800: (-5.3%) - (1.2%) | ||
| Precision | (0.2%) - (1.9%) (Predicate: FibroScan® 502 Touch) | FT9000: (0.0%) - (1.6%) |
| FT100: (0.0%) – (3.8%) | ||
| Mini800: (0.0%) - (1.8%) | ||
| UAP Display Range | CAP (100-400 dB/m), Interquartile range (IQR) and IQR/median ratio (Predicate: FibroScan® 502 Touch) | UAP (90-450 dB/m), Interquartile range (IQR) and IQR/median ratio |
| UAP Bias | (0.0%) - (10.0%) (Predicate: FibroScan® 502 Touch) | FT9000: (-3.3%) - (2.0%) |
| FT100: (-1.6%) – (6.5%) | ||
| Mini800: (-6.9%) - (4.8%) | ||
| UAP Precision | (0.0%) - (1.0%) (Predicate: FibroScan® 502 Touch) | FT9000: (0.2%) - (1.5%) |
| FT100: (0.3%) - (2.0%) | ||
| Mini800: (0.2%) – (2.0%) |
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.
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.