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510(k) Data Aggregation
(22 days)
The FibroScan® 530 Compact 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® 530 Compact 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® 530 Compact, 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® 530 Compact 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.
This document describes the FibroScan® 530 Compact system, an ultrasound device for measuring liver shear wave speed (tissue stiffness) and Controlled Attenuation Parameter (CAP). The device is intended to aid in the clinical management of adult and pediatric patients with liver disease. The provided text outlines a 510(k) summary for FDA clearance, comparing the new device to a predicate device (FibroScan® K150949).
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by comparing the performance of the FibroScan® 530 Compact against its predicate device (FibroScan® K150949). The goal is to demonstrate "similar or better" performance.
| Metric (Type) | Acceptance Criteria (Predicate Performance Range) | Reported Device Performance (FibroScan® 530 Compact Range) | Outcome (vs. Predicate) |
|---|---|---|---|
| Shear Wave Speed Bias (M+ probe) | <13% ([-11.5%; 0.7%]) | <11% ([-12.9%; -2.6%]) | Better |
| Shear Wave Speed Bias (XL+ probe) | <16% ([-13.9%; 1.3%]) | <12% ([-14.3%; -2.3%]) | Better |
| CAP Bias (M+ probe) | <5% ([-4.9%; -0.4%]) | <7% ([-1.5%; 4.7%]) | Similar |
| CAP Bias (XL+ probe) | 10% ([-3.5%; 6.5%]) | <3% ([1.4%; 3.9%]) | Similar |
| Shear Wave Speed Precision (M+ probe) | <2% ([0.6%; 1.9%]) | <1% ([0%; 0.9%]) | Better |
| Shear Wave Speed Precision (XL+ probe) | <4% ([0%; 3.1%]) | <2% ([0%; 1.5%]) | Better |
| CAP Precision (M+ probe) | <1% ([0%; 0.1%]) | <1% ([0.6%; 1.0%]) | Similar |
| CAP Precision (XL+ probe) | <1% ([0.4%; 1%]) | <1% ([0.9%; 1.3%]) | Similar |
2. Sample Size Used for the Test Set and the Data Provenance
The document explicitly states that the "accuracy and precision of the device was tested for shear wave speed and CAP on calibrated phantoms with known elasticity and attenuation". It does not mention testing on human subjects or clinical data in this section regarding performance.
Therefore:
- Sample size for the test set: Not explicitly stated in terms of number of phantoms or measurements, but it refers to "calibrated phantoms."
- Data provenance: Phantom data. Country of origin is not specified, but the manufacturer is Echosens in Paris, France. The data is non-clinical/in-vitro.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. The ground truth for the test set (calibrated phantoms) is the "known elasticity and attenuation" of the phantoms, which are physical properties, not an expert opinion.
4. Adjudication Method for the Test Set
Not applicable. As the ground truth is based on the known physical properties of calibrated phantoms, there is no need for expert adjudication.
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 is a medical device (ultrasound system) that provides quantitative measurements (shear wave speed and CAP). The assessment focuses on the accuracy and precision of these measurements relative to a predicate device using phantoms, not on human reader performance with or without AI assistance. The document does not describe human-in-the-loop performance or AI components that would assist human readers in interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Yes, the performance data presented is for the device itself (algorithm/system only) without human-in-the-loop performance. The device measures shear wave speed and CAP automatically; there isn't an explicit "algorithm" in the AI sense, but the device's measurement system operates in a standalone capacity.
7. The Type of Ground Truth Used
The ground truth used for the performance testing cited is the known elasticity and attenuation of calibrated phantoms.
8. The Sample Size for the Training Set
Not applicable. The document describes a 510(k) submission for a medical device that measures physical properties. It is not an AI/ML device that requires a "training set" in the conventional sense. The "training" would be part of the device's original design and calibration process, not user-driven data training.
9. How the Ground Truth for the Training Set Was Established
Not applicable, for the same reason as point 8.
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