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The FibroScan® Family of Products (Models: 502 Touch, 530 Compact, 430 Mini+, and 630) 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® Family of Products (Models: 502 Touch, 530 Compact, 430 Mini+, and 630) 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® 630 (Expert) is also indicated for noninvasive measurement in the spleen of 100 Hz shear wave speed and estimates of stiffness that may be used as an aid to diagnosis, monitoring and clinical management of adult patients with liver disease, as part of an overall assessment of the liver.

*CAP for pediatric patients with liver disease is only available with SmartExam capability on FibroScan® Models: 530 Compact, 430 Mini+, and 630

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/spleen 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/spleen. 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 an updated version of FibroScan software (CLPC 4.1) for all previously cleared FibroScan® Family of Products. The software version CLPC 4.1 involves the following changes:

• Streamlined software platform across between all devices
• Simplified user interface
• Functional enhancements:
• Continuous CAP (Controlled Attenuation Parameter) measurement (CAPc)
• CAPc applied to S+ probe
• SmartDepth adjustment of measurement depth to patient anatomy
• Improved probe localization step

FibroScan® Family of Products (Models: 502 Touch, 530 Compact, 430 Mini+, and 630) has the same intended use as the previously cleared FibroScan models. The submission expands the indications for use of the system to include use of the S+ probe for estimation of CAP.

Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Device: FibroScan® Family of Products (Models: 502 Touch, 530 Compact, 430 Mini+, and 630) with updated software (CLPC 4.1)

Intended Use: To provide shear wave speed measurements and estimates of tissue stiffness as well as ultrasound coefficient of attenuation (CAP) in internal structures of the body, primarily the liver (and spleen for FibroScan® 630 Expert). Used as an aid to clinical management, diagnosis, and monitoring of adult and pediatric patients with liver disease.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the demonstration of "substantial equivalence" to the predicate devices (Echosens's FibroScan® Family of Products #K181547 and FibroScan® 630 #K200655) in terms of bias and precision for shear wave speed and CAP measurements, and improved usability (applicability, success rates, consistency, examination durations) for SmartDepth.

• Bias: M+ probe: Predicate 17.1%, Candidate 15.3%. XL+ probe: Predicate 12.9%, Candidate 14.1%. (Similar performance)
• Precision: M+ probe: Predicate 0.5%, Candidate 0.5%. XL+ probe: Predicate 1%, Candidate 0.7%. (Similar performance)
  Static Multiple Measurements (Rotating Turntable):
• Bias: M+ probe: Predicate 0.8%, Candidate 0.8%. XL+ probe: Predicate 16.2%, Candidate 12.2%. (Similar performance)
• Precision: M+ probe: Predicate 3.2%, Candidate 0.5%. XL+ probe: Predicate 2.8%, Candidate 1.7%. (Similar performance)
  Overall Equivalence: Bias values for standard CAP shown to be comparable (under 5% difference) between all FibroScan systems. |
  | Continuous CAP (CAPc) (Liver) | Bias: Range and mean values of CAPc bias (6.9% - 12.2%) were substantially equivalent to standard CAP bias in the candidate device (static single spot: 14.1% - 15.3%; static multi-spot: 0.8% - 12.2%).
  Precision: Range and mean values of CAPc precision (0.3% - 2.1%) were equivalent to standard CAP precision in the candidate device (static single spot: 0.5% - 0.7%; static multi-spot: 0.5% - 1.7%).
  S+ Probe Applicability: Precision results of CAPc with the S+ probe (both S1 and S2 exam) were equivalent to precision results using M+ and XL+ probes.
  Correlation with M+ & XL+ (Phantoms): CAPc measurements on S+ probe highly correlated with M+ and XL+ values and within their range.
  Bias & Precision Equivalence: No significant bias between standard CAP and CAPc on phantoms; CAPc showed better precision (lower variability) and better robustness. |
  | SmartDepth (Liver) | Shear Wave Speed & Stiffness (LSM): LSM with SmartDepth were substantially equivalent to LSM without SmartDepth.
  Improved Usability: Improved applicability, success rates, consistency, and examination durations compared to standard fixed depth. |
  | Shear Wave Speed (Spleen, FibroScan® 630 Expert) | Bias: Comparable values (under 5% differences) to the FibroScan® 630 Expert reference device configuration system (#K200655). |

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

• CAPc Validation: 195 participants (from two retrospective in-vivo studies).
• SmartDepth Validation: 566 participants (from three retrospective in-vivo studies).
• Provenance: All clinical validation studies were retrospective in-vivo. The document does not specify the country of origin for the clinical data.
• Non-Clinical Testing: Calibrated tissue-mimicking phantoms and a heterogeneous phantom were used.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

The document mentions "biopsy as a reference" for SmartDepth validation. For CAPc validation, "MRI-PDFF as a reference" was used. The number of experts involved in interpreting these reference standards and their specific qualifications are not provided in the text.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method (e.g., 2+1, 3+1) for establishing the ground truth from biopsy or MRI-PDFF. It simply states these were used as "references."

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not specifically mentioned or described. The studies focused on comparing the device's performance (bias, precision, etc.) of the new software features against either the previous software version/predicate device or established reference standards (MRI-PDFF, biopsy). There is no information about how human readers improved with or without AI assistance, as this is a diagnostic device for physical measurements, not an image interpretation AI.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, the performance data presented (bias, precision for shear wave speed, CAP, and CAPc) reflects the standalone performance of the device's algorithms and its physical measurement capabilities, without human interpretation in the loop as the primary metric. The device measures physical parameters (shear wave speed, stiffness, attenuation) directly. The "indications for use" state these measurements "may be used as an aid to clinical management," implying a human clinician interprets the device's output.

7. The Type of Ground Truth Used

• SmartDepth Validation: Biopsy
• CAPc Validation: MRI-PDFF (Magnetic Resonance Imaging Proton Density Fat Fraction)
• Non-Clinical Performance: Known values in calibrated tissue-mimicking phantoms.

8. The Sample Size for the Training Set

The document does not provide information about the sample size used for the training set. The studies described are for validation (test sets) of the updated software features.

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

As training set details are not provided, information on how its ground truth was established is also not available in this document.

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