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The FibroScan® device (Models: 502 Touch, 530 Compact, 430 Mini+, 230, and 630) is intended to measure liver stiffness (E) using Vibration Controlled Transient Elastography™ (VCTE™) at 50 Hz shear wave frequency and liver ultrasound attenuation coefficient (CAP™)* at 3.5 MHz. FibroScan® 630 Expert is also intended to measure spleen stiffness using VCTE™ at 100 Hz shear wave frequency.

FibroScan liver stiffness measurements (LSM) by VCTE™ may aid the physician in determining the likelihood of cirrhosis and may be used, taken in context with other clinical and laboratory data, as an aid in the assessment of liver fibrosis. FibroScan CAP™ measurements may be used, taken in context with other clinical and laboratory data, as an aid in the assessment of hepatic steatosis.

FibroScan® is indicated as a non-invasive aid for the clinical management, diagnosis, and monitoring of adult and pediatric patients with confirmed or suspected liver disease, as part of an overall assessment of the liver. Results in the pediatric population should be interpreted while considering the clinical condition and the overall patient profile.

The FibroScan® device is intended for use by healthcare professionals in hospitals, clinics or any facility where healthcare is provided.

*CAP™ refers to ultrasound attenuation coefficient (originally defined as Controlled Attenuation Parameter). CAP™ on S+ probe is only available with SmartExam capability.

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 provided text is a 510(k) summary for the Echosens FibroScan® device. It details the device's indications for use and compares it to predicate devices. However, the document does not contain specific acceptance criteria or an explicit study proving the device meets acceptance criteria in the format of a clinical trial with predefined endpoints and statistical significance levels.

Instead, the submission relies on the concept of substantial equivalence to previously cleared devices (K203273 and K212035) and a comprehensive review of existing clinical literature and practice guidelines to support the expanded indications for use and labeling changes. The argument is that since the fundamental technology and hardware are the same as the cleared predicate devices, and the software updates do not impact performance, new clinical performance data in the form of a dedicated prospective study was not required.

Therefore, the requested information cannot be fully extracted in the typical format of a clinical study report. Here's what can be inferred and stated based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

As stated, the document does not present explicit acceptance criteria or a dedicated performance study with specific metrics in tabular format. The "performance" described is the device's consistent and robust correlation with established medical conditions, supported by existing literature.

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

• Test Set (Clinical Evidence for expanded claims): The "test set" for the expanded indications are collections of retrospective clinical literature reviews and professional guidelines.
  • Liver Fibrosis/Cirrhosis: 3 longitudinal studies (290 patients), 18 meta-analyses (369 studies, >40,000 patients).
  • Hepatic Steatosis: 6 meta-analysis publications (138 studies, ~12,900 patients).
  • Probe Use across Morphology: 41 papers (~8,570 patients).
    • S+ probe: 3 studies (n=250)
    • M+ probe: 29 studies (n=5,950)
    • XL+ probe: 9 studies (n=2,369)
  • Pediatric Use: 24 papers (n=6,573) for diagnosis, 6 additional papers (n=293) for monitoring.
  • Suspected Liver Disease: 10 studies (n=5,650 patients).
  • Active Implants: 2 studies (141 patients).
  • Pregnant Women: 3 studies (611 pregnant women).
• Data Provenance: The document does not specify the country of origin for the individual studies in the clinical literature review but indicates it's a "comprehensive clinical literature," implying international data. All studies are retrospective in the context of this submission, meaning they were published prior to this 510(k) submission.

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

The document does not specify the number of experts used to establish the ground truth for the test set in the context of this submission. The ground truth for the underlying studies in the literature review would have been established by the relevant medical professionals (e.g., pathologists for liver biopsies, radiologists, hepatologists) in those individual studies. The statement "Papers used in support of the changes were focused on studies in which FibroScan® results are compared to the ground truth of liver biopsy" indicates the ultimate gold standard used in many of these studies.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for a test set in the formal sense (e.g., 2+1, 3+1). The "adjudication" is implicitly done through the scientific peer-review process of the published literature and the consensus reflected in professional clinical guidelines that support the use of FibroScan.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done as part of this 510(k) submission. The submission is based on substantial equivalence and a literature review supporting expanded indications for a device with established efficacy.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The FibroScan® device, by its nature, is a diagnostic imaging tool that measures physical parameters (liver stiffness, attenuation). While it generates quantitative data (LSM, CAP values), these are intended to be used by a healthcare professional "in context with other clinical and laboratory data, as an aid in the assessment." Therefore, it inherently involves human interpretation. The question of "algorithm only" performance typically applies to AI-driven diagnostic image analysis systems providing a direct diagnosis or flagging pathologies. FibroScan provides quantitative measurements for interpretation by a human.

7. Type of Ground Truth Used

The primary ground truth for the majority of the supporting literature, especially for liver fibrosis and steatosis, is liver biopsy. The document explicitly states: "Papers used in support of the changes were focused on studies in which FibroScan® results are compared to the ground truth of liver biopsy." For other claims, the "ground truth" would be established clinical diagnoses, patient outcomes, and medical assessments based on a combination of clinical, laboratory, and other imaging data.

8. Sample Size for the Training Set

The document does not specify a "training set" sample size for this 510(k) submission. The FibroScan® device is based on physical measurement principles (VCTE™ and CAP™) rather than a machine learning algorithm that requires a separate training set in the typical sense. The underlying algorithms for shear wave speed and attenuation calculation would have been developed and validated through engineering and physical modeling, potentially with internal data, but this is not a "training set" for an AI model.

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

As there is no "training set" in the context of an AI/ML algorithm development as typically understood, this question is not directly applicable. The core technology relies on well-established physics. The calibration and validation of the device's measurements against physical phantoms or established reference standards would be part of its engineering development, rather than establishing "ground truth" for a training set of patient data.

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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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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.

Ask a specific question about this device

The FibroScan® 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.

FibroScan® 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 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.

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 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/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 the new FibroScan® 630, available in two configurations: FibroScan® 630 'Prime' (FS630P) and FibroScan® 630 'Expert' (FS630E). Both FS630P and FS630E include improvements of the FibroScan appearance and user interface.

The FS630P version has the same indications as the previously cleared models and is only indicated for non-invasive measurement of 50 Hz shear wave speed in the liver and estimates of its stiffness, as well as determination of a 3.5 MHz ultrasound coefficient of attenuation (CAP: Controlled Attenuation Parameter). The FS630E includes an expansion of the intended use to include noninvasive measurement of shear wave speed at 100Hz in the spleen and estimates of its stiffness as well as an inclusion of a B-Mode ultrasound imaging system to help the user locate the liver or spleen.

Here's a breakdown of the acceptance criteria and the study details for the FibroScan® 630, based on the provided text:

Acceptance Criteria and Device Performance for FibroScan® 630

The acceptance criteria for the FibroScan® 630 are implicitly defined by its equivalence to the predicate device, FibroScan® 530 Compact, and the clinical support for its expanded indications. The reported device performance is presented as a comparison to the predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document explicitly states that the FibroScan® 630 is considered "equivalent" to the predicate in terms of bias and precision. Therefore, the acceptance criteria are to perform comparably to the predicate device within a specified range, or to have a similar safety and effectiveness profile. Numerical acceptance criteria are given for the liver and spleen shear wave speed and CAP bias and precision, which must fall within a range similar to or better than the predicate devices.

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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).

Ask a specific question about this device

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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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.

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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.

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The FibroScan® system is intended to provide 50Hz shear wave speed measurements and estimates of tissue stiffness through internal structures of the body.

FibroScan® is indicated for noninvasive measurement of shear wave speed and estimate of stiffness at 50 Hz in the liver. The shear wave speed may be used as an aid to clinical management of pediatric and adult 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 expansion of the indications for use for the FibroScan system by Echosens to pediatric patients. In order to address the smaller anatomic size of pediatric patients, a new probe (S+) was developed, and the indications for use of the previously cleared M+ probe were modified. The new probe uses 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. The device specifications are similar to those of the predicate device. The system's software was upgraded to accommodate these changes.

The FibroScan® system, specifically the new S+ probe and revised software, aims to expand its indications for use to pediatric patients. The study primarily focused on non-clinical testing to demonstrate that the device meets its specifications and is substantially equivalent to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the FibroScan® system are derived from the performance parameters of its predicate devices, FibroScan® (#K123806) and Aixplorer® (#K132274), particularly concerning bias and precision in shear wave speed measurements.

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

The document explicitly states that non-clinical testing was performed on phantoms with known elasticity. It does not specify a sample size for these phantoms or their provenance beyond "known elasticity." There is no mention of a human test set in this section of the document.

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

As the testing was performed on phantoms with "known elasticity," there were no human experts involved in establishing the ground truth for the test set.

4. Adjudication method for the test set

Not applicable, as the testing was performed on physical phantoms with established properties, not on cases requiring 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

No MRMC comparative effectiveness study was done or reported in this document. The device operates as a standalone measurement tool and is not described as an AI-assisted interpretation system for human readers.

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

Yes, a standalone performance evaluation was done for the device. The reported "bias" and "precision" values were obtained directly from the device's measurements on phantoms without human intervention in the measurement process itself. The document emphasizes the algorithm/device's performance in measuring shear wave speed and estimating stiffness.

7. The type of ground truth used

The ground truth used for the non-clinical testing was the known elasticity of the phantoms.

8. The sample size for the training set

The document describes non-clinical testing and substantial equivalence claims based on technical characteristics and phantom performance. It does not mention a training set in the context of machine learning or AI algorithm development. The "system's software was upgraded to accommodate these changes," but no details on software training are provided.

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

Not applicable, as no training set (in the context of machine learning) is mentioned as being used or developed for this submission. The software upgrade is described as accommodating changes related to the new probe and expanded indications, rather than being trained on a specific dataset.

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The FibroScan® system is intended to provide 50Hz shear wave speed measurements and estimates of tissue stiffhess as well as 3.5 MHz ultrasound coefficient of attenuation (CAP: Controlled Attenuation Parameter) in internal structures of the body.

FibroScan® 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®, 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 speed of propagation of the shear (elastic) wave is measured using ultrasounds. A new FibroScan® parameter labeled CAP (Controlled Attenuation Parameter), ranging between 100 and 400 decibels per meter (dB/m), provides an estimation of the total aforementioned ultrasonic wave attenuation (forward and return paths) at 3.5 MHz, measured concomitantly with tissue stiffness.

The provided text describes the FibroScan® system, which performs non-invasive measurements of liver shear wave speed and tissue stiffness, as well as an ultrasound coefficient of attenuation (CAP). The new submission (K150949) focuses on the addition of CAP measurements.

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 acceptance criteria are not explicitly stated in numerical thresholds, but rather as comparative performance to the predicate devices. The performance is assessed in terms of bias and precision for both shear wave measurements (from the predicate FibroScan®) and the new CAP measurements (from the candidate FibroScan®).

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