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510(k) Data Aggregation
(58 days)
The FibroScan® 430 Mini+ system is intended to provide 50Hz shear wave speed measurements and estimates of tissue stiffness as well as 3.5 MHz ultrasound coefficient of attenuation (CAP: Controlled Attenuation Parameter) in internal structures of the body.
FibroScan® 430 Mini+ is indicated for noninvasive measurement in the liver of 50 Hz shear wave speed and estimates of stiffness as well as 3.5 MHz ultrasound coefficient of attenuation (CAP: Controlled Attenuation Parameter).
The shear wave speed and stiffness, and CAP may be used as an aid to clinical management of adult patients with liver disease.
Shear wave speed and stiffness may be used as an aid to clinical management of pediatric patients with liver disease.
FibroScan® 430 Mini+, based on Vibration-Controlled Transient Elastography (VCTE™) technology, is designed to perform non-invasive measurements of liver shear wave speed and estimates of tissue stiffness. A mechanical vibrator produces low-amplitude elastic waves that travel through the skin and intercostal space into the liver. The FibroScan® 430 Mini+ CAP (Controlled Attenuation Parameter, ranging between 100 and 400 decibels per meter (dB/m), provides an estimation of the total ultrasonic wave attenuation (forward and return paths) at 3.5 MHz, measured concomitantly with tissue stiffness.
The FibroScan® 430 Mini+ system, a diagnostic ultrasound device, was evaluated for substantial equivalence to the FibroScan® 530 Compact system. The evaluation focused on the device's ability to measure shear wave speed and Controlled Attenuation Parameter (CAP) for liver stiffness and fat assessment, respectively.
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria for the FibroScan® 430 Mini+ were based on demonstrating comparable or better performance (bias and precision) to its predicate device, FibroScan® 530 Compact, when tested on calibrated phantoms.
| Performance Metric | Acceptance Criteria (based on predicate FibroScan® 530 Compact) | Reported Device Performance (FibroScan® 430 Mini+) |
|---|---|---|
| Shear Wave Speed Bias | M+ probe: <11% | M+ probe: ≤12% |
| XL+ probe: <12% | XL+ probe: <11% | |
| CAP Bias | M+ probe: <7% | (Not explicitly stated for 430 Mini+ but validated by identical acquisition platform) |
| XL+ probe: <3% | (Not explicitly stated for 430 Mini+ but validated by identical acquisition platform) | |
| Shear Wave Speed Precision | M+ probe: <1% | M+ probe: <1% (specifically [0.2%; 0.7%]) |
| XL+ probe: <2% | XL+ probe: <1% (specifically [0%; 0.7%]) | |
| CAP Precision | M+ probe: <1% | (Not explicitly stated for 430 Mini+ but validated by identical acquisition platform) |
| XL+ probe: <1% | (Not explicitly stated for 430 Mini+ but validated by identical acquisition platform) |
The study concluded that the bias and precision of the shear wave speed measured by the FibroScan® 430 Mini+ are within the same range or better than those of the predicate FibroScan® 530 Compact device. The CAP bias and precision were considered valid for the FibroScan 430 Mini+ due to the identical acquisition platform (US board and firmware), ultrasound module, and software core used in both devices.
2. Sample Size Used for the Test Set and Data Provenance
The evaluation was performed on calibrated phantoms. The document does not specify the exact number of phantoms used or the number of measurements taken, but it refers to "calibrated phantoms with known elasticity and attenuation."
The data provenance is from non-clinical testing in a controlled environment, not from human subjects or a specific country of origin. This implies it was performed as part of product development and validation by the manufacturer.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The ground truth was established using calibrated phantoms with known elasticity and attenuation. This implies that the ground truth values (nominal shear wave speed and nominal CAP) were determined through the manufacturing and calibration process of the phantoms, rather than through expert human assessment. No human experts were involved in establishing the ground truth for this non-clinical phantom study.
4. Adjudication Method for the Test Set
Not applicable. The test set used calibrated phantoms with objectively defined "ground truth" values, so no adjudication method by human experts was required.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not conducted as this was a non-clinical phantom study to assess the performance of the device itself, rather than its impact on human reader performance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done
Yes, a standalone performance evaluation was conducted. The study assessed the accuracy and precision of the FibroScan® 430 Mini+ device itself (algorithm and hardware) by measuring shear wave speed and CAP on calibrated phantoms. There was no human "in the loop" performance being evaluated; the focus was solely on the device's measurements compared to known physical properties.
7. The Type of Ground Truth Used
The ground truth used was based on the known physical properties (elasticity and attenuation) of calibrated phantoms.
8. The Sample Size for the Training Set
The document does not specify a training set size. This non-clinical study focused on performance validation against a predicate device using phantoms, not on machine learning model training.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as a training set for an AI/machine learning model is not mentioned in the context of this device's non-clinical evaluation. The ground truth for the device's validation was established by the known characteristics of the calibrated phantoms.
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