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The FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+) 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® Family of Products (Models: 502 Touch, 530 Compact, and 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 diagnosis and monitoring of adult patients with liver disease, as part of an overall assessment of the liver.

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

FibroScan® system consists of a system unit and a hand-held probe. It is based on Vibration-Controlled Transient Elastography (VCTE™) technology, and is designed to perform non-invasive measurements of liver shear wave speed and estimates of 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 results are displayed on the system unit.

The focus of this submission is the addition of the S+ probe to models FibroScan® 530 Compact and FibroScan® 430 Mini+. The S+ probe addresses a smaller anatomic size of pediatric patients, while using the same principle of operation, intended use and methodology (i.e. application to patient, signal measurement, processing and display), design, materials, manufacturing and testing processes as the previously cleared M+ and XL+ probes. In addition, the S+ probe developed for the 530 Compact and 430 Mini+ models is similar to the S+ probe cleared for the FibroScan® 502 Touch model of the FibroScan® Family of Products.

Here's a summary of the acceptance criteria and the study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" for clinical performance. Instead, it discusses the performance characteristics of the FibroScan® S+ probe (for pediatric use) and compares them to previously cleared predicate devices. The performance data presented are for bias and precision using phantoms.

Note: The document explicitly states that the S+ probe underwent verification tests to ensure no new issues regarding safety and effectiveness and that software updates were verified through system tests. This implies that the performance in these verification tests (including bias and precision) met predefined standards aligned with the existing cleared devices.

2. Sample size used for the test set and the data provenance:

The document mentions that performance data for bias and precision were obtained using CIRS phantoms E-1493-1 and E-1493-2. This indicates that the "test set" for these specific performance metrics consisted of physical phantoms designed to mimic tissue properties, not human patient data.

• Sample size: Not applicable in the traditional sense for human subjects, as phantoms were used. The number of measurements taken on the phantoms is not specified.
• Data provenance: Not applicable as it involves phantom testing, not patient data from a specific country or collected retrospectively/prospectively.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Number of experts: Not applicable. The "ground truth" for phantom studies is typically established by the known physical properties of the phantoms themselves, as measured by calibrated reference methods or specified by the manufacturer (CIRS).
• Qualifications of experts: Not applicable.

4. Adjudication method for the test set:

• Adjudication method: Not applicable, as phantom testing does not involve human interpretation or adjudication in the way clinical studies do. The measurements are objective readings from the device on the phantom.

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:

• MRMC study: No, a multi-reader multi-case comparative effectiveness study was not explicitly mentioned or performed. This submission is for the addition of a new probe (S+ probe) to existing FibroScan models, focusing on engineering and performance characteristics using phantoms, rather than clinical efficacy studies involving human readers and AI. The device itself (FibroScan) is a measurement device, not an AI-assisted diagnostic tool that would typically involve human reader improvement with AI.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

• Standalone performance: The performance data presented (bias and precision) is inherent to the device's measurement capabilities on phantoms and can be considered "standalone" in that it reflects the device's accuracy and reproducibility without direct human interaction influencing the measurement itself (though a human operates the device). However, it's not "algorithm only" in the sense of a standalone AI diagnostic algorithm performing a task without human intervention, but rather the performance of the integrated mechanical and ultrasound system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• Type of ground truth: The ground truth for the bias and precision data was established by the known physical properties of the CIRS phantoms E-1493-1 and E-1493-2. These phantoms are designed to have specific, measurable shear wave speed and attenuation characteristics.

8. The sample size for the training set:

• Training set sample size: Not specified. This submission focuses on the verification of a new probe with existing systems, not on the development or training of a new algorithm. The document states that the S+ probe uses the "same principle of operation, intended use and methodology...design, materials, manufacturing and testing processes as the previously cleared M+ and XL+ probes." This implies that the underlying technology and any inherent "training" (calibration, algorithm development) would have occurred for the original device and probes, not this incremental modification.

9. How the ground truth for the training set was established:

• Ground truth for training set: Not specified in this document. Given that the submission is for an incremental change (adding an S+ probe to existing models) and leverages the "same principle of operation," the ground truth establishment for any initial algorithm development or calibration would have been part of earlier submissions for the predicate devices. It can be inferred that in the context of elastography devices, ground truth for initial development would typically involve comparisons to established reference methods (e.g., biopsy for liver stiffness, or known properties of tissue-mimicking phantoms).

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The FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+) 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® Family of Products (Models: 502 Touch, 530 Compact, and 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 diagnosis and monitoring of adult patients with liver disease, as part of an overall assessment of the liver.

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

FibroScan® system consists of a system unit and a hand-held probe. It is based on Vibration-Controlled Transient Elastography (VCTE™) technology, and is designed to perform non-invasive measurements of liver shear wave speed and estimates of 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 results are displayed on the system unit.

This 510(k) submission (K173034) by Echosens for its FibroScan® Family of Products primarily focuses on a revision of the Indications for Use (IFU), changing "an aid to clinical management" to "an aid to diagnosis and monitoring" for adult patients. The submission explicitly states that no new hardware or software elements were included, and therefore, no new performance data were required in support of the submission.

This means that the document does not contain a new study proving the device meets new acceptance criteria related to its diagnostic and monitoring capabilities. Instead, it relies on the safety record and broad clinical use of the already cleared devices.

Therefore, many of the requested details regarding acceptance criteria and a new study are not present in the provided text. I will extract the information that is available based on the request and clearly state what is not found.

Acceptance Criteria and Device Performance

Since this submission is a revision of the Indications for Use and states "No new performance data were required," there are no new acceptance criteria or reported device performance metrics presented in this document specifically for the revised IFU. The document implicitly relies on the performance proven during the clearance of the predicate device (K160524) and prior versions of the FibroScan systems.

Study Details (for a new study validating the "aid to diagnosis and monitoring" claim)

No new study is presented in this 510(k) submission to demonstrate that the device meets new acceptance criteria for the revised "aid to diagnosis and monitoring" claim. The submission explicitly states: "No new hardware or software elements were included in the submission. Therefore, no new performance data were required in support of the submission."

Based on this, the following information is not applicable or not found in the provided text:

2. Sample size used for the test set and the data provenance: Not applicable, as no new performance study is presented.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 standalone device, and no MRMC study for AI assistance is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: The FibroScan is inherently a "standalone" device in the sense that it provides measurements directly. However, the submission does not detail a new standalone performance study for the revised IFU. It relies on previously established performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for a new study in this submission.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

Summary of available information from the document regarding studies and performance:

The basis for the revised Indications for Use (from "aid to clinical management" to "aid to diagnosis and monitoring") is stated as:

• "Its perfect safety record and broad clinical use as an aid to the diagnosis and monitoring of adult patients with liver disease support the revision of its indications for use."
• This suggests reliance on post-market surveillance, existing clinical practice, and prior clearance data rather than a new, specific clinical performance study for this particular change.

The submission focuses heavily on non-clinical testing to assure compliance with acoustic output, biocompatibility, cleaning and disinfection effectiveness, as well as thermal, electromagnetic, and mechanical safety, conforming to applicable standards (listed in the "Recognized Consensus Standards Used" section). This indicates that the device's fundamental physical and safety performance was established previously and confirmed to meet current standards.

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