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The FibroScan® 230 is intended to provide shear wave speed measurements and estimates of tissue stiffness as well as ultrasound coefficient of attenuation (CAP: Controlled Attenuation Parameter) in internal structures of the body. The Shear wave speed and stiffness measurements may be used as an aid to clinical management of adult patients with liver disease.

The FibroScan® 230 is indicated for non-invasive measurement in the liver of 50 Hz shear wave speed and estimates of stiffness as well as determining a 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 diagnosis and monitoring of adult patients with liver disease, as part of an overall assessment of the liver.

Shear wave speed and stiffness, and CAP may be used as an aid in the clinical management of pediatric patients with liver disease.

FibroScan® System and its probes is an active non-implantable medical device using ultrasound and based on Vibration- Controlled Transient Elastography (VCTE™) technology. It is designed to perform non-invasivemeasurements of liver shear wave speed and estimate tissue stiffness. The probe, containing a mechanical vibrator, produces low-amplitude elastic waves that travel through the skin and intercostal space into the liver. Ultrasound is used to track the shear (elastic) wave, measure its speed and provide estimated stiffness.

The focus of this submission is the new FibroScan® 230, which separates the FibroScan® System into two parts: a smaller equipment unit (which includes the hand-held probes) and the FibroScan® application, installed on the user's computer. The FibroScan® Application displays the user interface of the system and interacts with the equipment unit through a USB connection. The FibroScan® Application may also interact with the Echosens Cloud through an internet network. Only the FibroScan® 230 equipment and FibroScan® application are included in the FibroScan® 230 system while the Echosens cloud and the end-user computer are not part of the FibroScan® 230 medical device.

The provided document describes the FibroScan® 230 device and its substantial equivalence to its predicate device, the FibroScan® 530 Compact. The primary objective of the study was to demonstrate that the FibroScan® 230 performs comparably to the predicate device in measuring liver shear wave speed and Controlled Attenuation Parameter (CAP).

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" for the FibroScan 230's performance in a tabular format as would be typical for a new device's efficacy study. Instead, the performance evaluation is focused on demonstrating substantial equivalence to the predicate device, FibroScan® 530 Compact. The implicit acceptance criterion is that the bias and precision measurements of the candidate device (FibroScan® 230) for shear wave speed and CAP must be comparable to or within the same ranges as those of the predicate device.

Note: The exact numerical values for the predicate device's precision in shear wave speed are not explicitly stated in this document, only that the candidate's performance is "very similar." For CAP, the exact bias range for the predicate is provided (1.8%-10.1%).

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: The document does not specify a distinct "test set" in terms of patient cohorts. Instead, the performance evaluation was done through non-clinical testing primarily using phantoms.
  • For shear wave speed and CAP bias/precision evaluation: This involved direct comparison testing where the predicate and candidate devices were tested contemporaneously using the "same probes, phantoms, and experimental setup."
  • For CAP results: "dynamic testing (>200 measurements) on multiple spots" was performed on phantoms.
• Data Provenance: This was a non-clinical study involving phantom testing. Therefore, there is no patient data provenance (e.g., country of origin, retrospective/prospective clinical data) relevant to this specific evaluation. The study relies on engineered phantoms designed to mimic tissue properties.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Number of Experts: Not applicable. Given that the study was a non-clinical evaluation using phantoms, human expert interpretation or ground truth derived from expert consensus on imaging was not involved. The ground truth for the phantoms (e.g., stiffness values, attenuation coefficients) would be established by the phantom manufacturer or by physical characterization methods.
• Qualifications of Experts: Not applicable for the reasons above.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. The study relies on direct instrument measurements from phantoms, not human interpretations requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• MRMC Study Done? No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "No clinical data was required for this submission." The comparison was purely technical, focusing on the equivalence of physical measurements (shear wave speed and CAP) between the new device and its predicate using phantoms.
• Effect Size of Human Readers: Not applicable, as no MRMC study with human readers was performed.

6. Standalone (Algorithm Only) Performance

• Standalone Performance Done? Yes, in essence. The evaluation focuses on the performance of the device's measurement capabilities (algorithm and hardware combined) in a controlled environment (phantom testing), without human interpretation as part of the primary outcome being assessed for substantial equivalence. The device outputs quantitative measurements of shear wave speed and CAP, and the study validates the accuracy and precision of these measurements against a known "ground truth" (the phantom's properties) and against the predicate device.

7. Type of Ground Truth Used

• Type of Ground Truth: The ground truth was established by the physical properties of the phantoms used in the non-clinical testing. These phantoms are designed to have known or precisely characterized shear wave speeds and attenuation coefficients, allowing for direct comparison with the device's measurements.

8. Sample Size for the Training Set

• Training Set Sample Size: The document does not mention a distinct "training set" for the FibroScan® 230 in the context of an AI/machine learning algorithm that learns from data. This device is described as operating based on "Vibration-Controlled Transient Elastography (VCTE™) technology" which involves physical principles of ultrasound and mechanical vibration, rather than a data-driven AI model in the typical sense that would require a large training dataset for learning. Therefore, the concept of a "training set" as understood in AI/ML is not directly applicable here. Any internal model parameters would likely be calibrated during manufacturing and testing, not "trained" on a separate dataset in the AI sense.

9. How the Ground Truth for the Training Set Was Established

• How Ground Truth for Training Set was Established: Not applicable, as there is no explicitly mentioned "training set" used for model training as in many AI/ML applications. The device's operation is based on established physical principles and calibrated parameters.

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