(213 days)
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.
| Feature/Metric | Acceptance Criteria (Not Explicitly Stated as AC) | Reported Device Performance (FT9000) | Predicate Device 1 (FibroScan® - K123806) Performance |
|---|---|---|---|
| Intended Use | Implicit: Match predicate's intended use for shear wave measurement as an aid to clinical management of liver disease and general purpose ultrasound imaging. | Measures 50Hz shear wave speed with 2.5MHz ultrasound in the liver as an aid to clinical management of liver disease. General purpose pulse echo ultrasound imaging and Doppler flow analysis for abdominal applications. | Provides 50Hz shear wave speed measurements through internal structures of the body; indicated for noninvasive measurement of shear wave speed at 50 Hz in the liver as an aid to clinical management of liver disease. |
| Operating Principle | Implicit: Transient elastography. | Transient elastography; uses mechanical vibrator (50 Hz shear waves) and ultrasound (2.5 MHz) to measure shear wave speed. | Transient elastography, Vibration control elastography imaging. |
| Probe Frequency (for elasticity) | Implicit: Similar to predicate. | 2.5MHz | 2.5 MHz (XL+ probe) / 3.5 MHz (M+ probe) |
| Stiffness Bias | Expected to be within acceptable range relative to predicate. | (-16.7%) – (8.6%) | (-13.9%) – (1.3%) |
| Stiffness Precision | Expected to be within acceptable range relative to predicate. | (0.9%) – (2.0%) | (0%) – (3.1%) |
| Imaging Modes | Implicit: General purpose ultrasound imaging capabilities for abdominal applications, similar to predicate 2 (Mindray DC-6) for general imaging. | B, B/B, B/C (CFM), B/C/D (CPWD) modes. Uses convex array probe with 2.1-5 MHz for abdominal imaging. | Predicate 2 (Mindray DC-6) has B-Mode, M-Mode, Pulsed (PW) Doppler mode, Color Doppler mode, Continuous Wave (CW) Doppler mode, Amplitude Doppler Mode, 3D Imaging or Harmonic Imaging, 4D Imaging. FT9000 has fewer modes/features than DC-6 (e.g., no CW Doppler, Amplitude Doppler, 3D/4D). |
| Compliance to Standards | IEC 60601-1, IEC 60601-1-2, NEMA UD 2-2004 (R2009), ISO 10993-5, ISO 10993-10 | Complied with all listed standards. | Complied with all listed standards (or equivalent at the time of predicate clearance). |
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.
§ 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.