(64 days)
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.
| Acceptance Criteria (Inferred from intent) | Reported Device Performance (Supported by Literature Review) |
|---|---|
| Safe and effective measurement of liver stiffness (LSM) for aiding in assessment of liver fibrosis and determining likelihood of cirrhosis. | LSM and Fibrosis/Cirrhosis: Supported by 3 longitudinal studies (290 patients) and 18 meta-analyses (369 studies, >40,000 patients) demonstrating consistent and robust correlation between LSM and fibrosis, and LSM as an indicator of cirrhosis. Strong support from professional society clinical guidelines. No adverse events related to performing FibroScan® examinations reported in pediatric studies. |
| Safe and effective measurement of liver ultrasound attenuation coefficient (CAP™) for aiding in assessment of hepatic steatosis. | CAP™ and Steatosis: Supported by 6 meta-analysis publications (138 studies, ~12,900 patients) demonstrating consistent and robust correlation between CAP™ and steatosis. Strong support from professional society clinical guidelines. No adverse events related to performing FibroScan® examinations reported in pediatric studies. |
| Safe and effective use across patient morphology (probe selection). | Probe Use and Morphology: Supported by 41 papers (~8,570 patients). Specifically: S+ probe (older than 18, 3 studies, n=250), M+ probe (younger than 14, 29 studies, n=5,950), XL+ probe (younger than 18, 9 studies, n=2,369). Studies showed no adverse events related to probe use and supported effectiveness based on LSM, CAP, or both. |
| Safe and effective use for clinical management, diagnosis, and monitoring in adult and pediatric patients with confirmed or suspected liver disease. | Pediatric Use: Supported by 24 papers (n=6,573) for diagnosis aid and 6 additional papers (n=293) for monitoring aid. No adverse events recorded. Suspected Liver Disease Patients: Supported by 10 studies (n=5,650 patients) assessing suspected patients using TE. Clinical guidelines also support TE use in these patients. |
| Safety for patients with active implants and pregnant women (removal of contraindications). | Active Implants/Pregnancy: Supported by technical considerations (acoustic/mechanical output) and 2 studies (141 patients with active implants) and 3 studies (611 pregnant women) showing effective device performance with no adverse events. A warning statement was added regarding lack of extensive studies. |
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.
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.