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The Liverscan C is intended to provide shear wave speed measurements and estimates of tissue stiffness as well as ultrasound coefficient of attenuation (MAP: Mobile 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 Liverscan C is indicated for non-invasive measurement in the liver of 50 Hz shear wave speed and estimates of stiffness as well as determining a 3.5MHz ultrasound coefficient of attenuation (MAP: Mobile Attenuation Parameter).

The shear wave speed and stiffness, and MAP 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.

This device is designed to be used in a doctor's office to measure the stiffness and ultrasonic attenuation of the liver in patients with liver disease. It does so in a painless and completely noninvasive manner.

The Liverscan C is intended to provide shear wave speed measurements and estimates of tissue stiffness as well as ultrasound coefficient of attenuation (MAP: Mobile 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 Liverscan C is indicated for non-invasive measurement in the liver of 50 Hz shear wave speed and estimates of stiffness as well as determining a 3.5MHz ultrasound coefficient of attenuation (MAP: Mobile Attenuation Parameter).

The shear wave speed and stiffness, and MAP 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.

The provided document is a 510(k) Premarket Notification from the FDA, asserting that the "Portable Liver Elastography Ultrasound Diagnostic System (Liverscan C)" is substantially equivalent to a legally marketed predicate device.

Crucially, this document focuses on demonstrating substantial equivalence through non-clinical testing and comparison to a predicate device, rather than presenting a clinical study of the device's performance against defined acceptance criteria for diagnostic accuracy.

Therefore, I cannot extract information related to acceptance criteria for diagnostic accuracy and a study proving the device meets those criteria, as an independent clinical study demonstrating diagnostic performance was not performed, or at least not provided in this document for the purpose of the 510(k) submission.

Specifically, section 10, "Clinical Tests Performed," explicitly states: "No clinical test data was used to support the decision of substantial equivalence."

The "acceptance criteria" discussed in the document relate to engineering and safety standards (e.g., IEC standards for electrical safety, EMC, usability, software, biocompatibility, and performance) and functional tests, which the device did meet. However, these are not diagnostic performance metrics.

For completeness, I can describe what the document does provide regarding "acceptance criteria" and "device performance" in terms of engineering and regulatory compliance:

Summary of "Acceptance Criteria" and "Device Performance" as presented in the 510(k) document (focused on substantial equivalence, not diagnostic accuracy):

The document defines "acceptance criteria" in terms of compliance with various international standards for medical devices and successful completion of bench tests. The "device performance" is reported as meeting these standards and demonstrating substantial equivalence to a predicate device.

Missing Information: Due to the nature of a 510(k) submission focused on substantial equivalence through non-clinical testing, the document does not contain any information regarding:

• A table of diagnostic performance acceptance criteria (e.g., sensitivity, specificity, accuracy for a specific liver condition).
• Sample size used for a clinical test set for diagnostic accuracy.
• Data provenance for a clinical test set.
• Number of experts used to establish ground truth for a clinical test set.
• Qualifications of experts for establishing ground truth for a clinical test set.
• Adjudication method for a clinical test set.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness study.
• Effect size of human readers improving with AI vs. without AI assistance.
• Standalone (algorithm only) diagnostic performance.
• Type of clinical ground truth used (e.g., pathology, outcomes data).
• Sample size for a clinical training set (as no clinical AI algorithm study is detailed).
• How ground truth for a clinical training set was established.

Therefore, I cannot populate the table and answer the requested questions as they pertain to clinical diagnostic performance, because the provided text explicitly states that no clinical test data was used for this 510(k) submission. The "study that proves the device meets the acceptance criteria" in this context refers to bench testing against engineering and safety standards to demonstrate substantial equivalence, not a clinical validation of diagnostic accuracy.

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