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510(k) Data Aggregation
(21 days)
Velacur One (LI-1100)
Velacur is intended to provide estimates of tissue stiffness generated from shear wave speed measurements (40-70 Hz), ultrasound attenuation and Velacur Determined Fat Fraction (VDFF). The Velacur Determined Fat Fraction combines ultrasound attenuation and backscatter coefficient measurements. The device is indicated to non-invasively determine liver tissue stiffness, attenuation, and Velacur Determined Fat Fraction. VDFF is not intended to be used in pediatric patients. These are meant to be used in conjunction with other clinical indicators in order to aid in clinical management of patients with liver diseases, including hepatic steatosis.
The device is intended to be used in a clinical setting and by trained medical professionals.
The device that is the subject of this submission is the substantially equivalent to that cleared under K233977, Velacur.
Velacur ONE is a portable device intended to non-invasively measure the stiffness and attenuation of the liver via measurement of liver tissue shear modulus and ultrasound attenuation. This is done by measuring the wavelength or wave speed of mechanically created shear waves within the organ of the patient. Attenuation is measured directly via the loss in power of the ultrasound beam and Velacur Determined Fat Fraction is a combination of measured ultrasound attenuation and backscatter.
The device is designed to be used at the point of care, in clinics and hospitals. The device is used by a medical profession, an employee of the clinic/hospital. The activation unit is placed under the patient, while lying supine on an exam bed. The activation unit vibrates at frequencies 40, 50, and 60 Hz causing shear waves within the liver of the patient. The ultrasound transducer is placed on the patient's skin, over the intercostal space, and is used to take volumetric scans of the liver while shear waves are occurring. The device includes two algorithms designed to help users detect good quality shear waves and identify liver tissue. From the scan data, the device calculates tissue stiffness and attenuation.
Software and hardware changes were made to the device. The intended use of the device is unchanged. The user interface was updated to a more modern platform with the same workflow and outputs. The hardware components have been consolidated, combining the functionality of the computing unit and control unit. The activation unit has been designed to include more voice coils which are distributed throughout the unit. The power output and performance of the activation unit is unchanged.
The provided FDA 510(k) clearance letter and summary for Velacur ONE (LI-1100) focuses on substantiating equivalence to a predicate device (Velacur K233977) through bench testing and human factors testing. It explicitly states that "No clinical or animal testing was performed" for this specific submission, meaning there is no mention of a study involving human or animal subjects to prove the device's performance against clinical acceptance criteria.
Therefore, many of the requested details related to clinical study design, such as sample size for test sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth types, cannot be extracted from this document as these types of studies were not conducted for the Velacur ONE (LI-1100) submission.
The information provided primarily relates to the bench testing validation of the algorithms, which is a different type of validation than a clinical study.
Here's an analysis of the available information:
1. Table of Acceptance Criteria and Reported Device Performance (Bench Testing)
The document refers to "acceptance criteria" within the context of bench testing against phantoms and comparison to the predicate device.
| Metric | Acceptance Criteria (Implicit from "Less than" or "Greater than" statements) | Reported Device Performance (Velacur ONE) |
|---|---|---|
| Elasticity - Bias vs. CIRS values | Not explicitly stated an absolute numerical acceptance criteria, but "overall bias to the CIRS values was used as a comparison point for both systems to determine the substantial equivalence." The average difference between the bias of Velacur ONE and the predicate was 2.45%. | Average difference between bias of Velacur ONE and predicate: 2.45% |
| Elasticity - Precision (min/max/average) | Not explicitly stated an absolute numerical acceptance criteria, but "met all criteria necessary to support clinical suitability" and compared to predicate. Predicate range: 1.1% to 2.6% (average 2.1%). | Average Precision: 1.7% (min: 0.3%, max: 2.9%) |
| Elasticity - Bland-Altman Correlation | "No value falls outside the 1.96*STD lines." | Excellent correlation; no values outside 1.96*STD lines. |
| Elasticity - Substantial Equivalence | "Results of the two systems both passed the defined acceptance criteria when being compared to each other and are considered substantially equivalent." | Both systems passed and are considered substantially equivalent. |
| Attenuation - Overall Bias | Less than 10% | 9.1% |
| Attenuation - Precision (maximum) | Less than 10% | 0.9% (mean); Less than 10% (maximum) (For Velacur ONE) |
| VDFF - Overall Bias | Not explicitly stated numerical acceptance criteria for overall bias, but compared to predicate (9%) and "clinically meaningful cutoff value for any steatosis of 5%". | 8% (compared to predicate bias of 9%) |
| VDFF - Precision (maximum) | Less than 10% | 5.4% |
| VDFF - Pearson Correlation Coefficient (r) vs. Expected VDFF | Greater than 0.8 | 0.95 |
2. Sample Size and Data Provenance
- Test Set Sample Size:
- Elasticity: 6 Homogeneous phantoms.
- Attenuation: 6 attenuation phantoms.
- VDFF: 6 different phantoms.
- Note: These are phantoms, not patient data.
- Data Provenance: The data is from bench testing using phantoms, not clinical data from patients. Therefore, there is no country of origin or retrospective/prospective classification.
3. Number of Experts and Qualifications for Ground Truth
- Not applicable for this submission. Ground truth for bench testing is established by the known properties of the phantoms (e.g., CIRS values, labeled backscatter and attenuation). There is no mention of experts involved in establishing ground truth for the bench tests.
4. Adjudication Method for the Test Set
- Not applicable for this submission. As there's no clinical test set requiring human interpretation, no adjudication method is mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC study was done. The document explicitly states "No clinical or animal testing was performed."
6. Standalone Performance (Algorithm Only without Human-in-the-Loop)
- The performance data provided (bias, precision, correlation coefficients for elasticity, attenuation, and VDFF) appears to be standalone algorithm performance as measured on phantoms. The stated purpose of these tests is to validate the algorithms. While "User holds the probe against the skin, and software... is shown on the device display to indicate when the location is acceptable," the actual measurement and calculation of stiffness, attenuation, and VDFF are algorithmic. The performance metrics listed directly reflect the algorithm's output against the known phantom values.
7. Type of Ground Truth Used
- Phantom Properties: The ground truth for the bench testing was derived from the known and labeled properties of the reference phantoms (e.g., CIRS values for stiffness, labeled backscatter and attenuation for VDFF, and expected attenuation values).
8. Sample Size for the Training Set
- Not mentioned or applicable for this submission. This submission is a 510(k) for a modified device (Velacur ONE) claiming substantial equivalence to a predicate (Velacur). The focus is on verifying that the changes to the device (hardware consolidation, updated UI, new activation unit) do not negatively impact performance compared to the predicate, and that the algorithms maintain their validated performance. Details about the original training of the algorithms (which would have occurred for the predicate device's clearance) are not part of this specific document.
9. How the Ground Truth for the Training Set Was Established
- Not mentioned or applicable for this submission. Similar to point 8, this information would pertain to the original development and validation of the predicate device's algorithms, not this specific 510(k) for a modified device.
The study proves the device meets the acceptance criteria through extensive bench testing on phantoms, demonstrating that the modified Velacur ONE systems performs equivalently to its predicate (Velacur) and within pre-defined numerical tolerances for accuracy and precision when measuring phantom properties. This approach is common for 510(k) submissions of modified devices where clinical performance has already been established for the predicate.
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