(215 days)
The Cardiovascular Analyzer is intended to obtain Pulse Wave Velocity (PWV) and Pulse Rate (PR) through a combination of impedance plethysmography and weight measurements in adults 18 years of age and older. The Cardiovascular Analyzer also measures Body Weight and calculates BMI.
The Cardiovascular Analyzer is designed to perform non-invasive physiologic measurements for PWV, PR, and BW, and to calculate BMI. The Cardiovascular Analyzer uses strain gauge sensors to measure BW and the ballistocardiogram (BCG). The BCG provides an indication of the arterial pulsation in the aortic arch. The Cardiovascular Analyzer also uses impedance plethysmography (IPG) sensing to estimate the PR and arterial pulsation in the legs. PWV is then calculated using the subject's sternal height (measured with a height rod) and the Pulse Transit Time (PTT) derived from the BCG and IPG signals.
The Cardiovascular Analyzer is comprised of the following key components and accessories: Scale Platform, Console, USB Cable, Isolated Power Supply and Power Cord, Height Rod, Visual Guide Accessory and Console Wall Mount.
The device uses two sensing modalities (load cells and impedance electrodes) to perform the following three measurements: PWV, PR and BW. BMI is calculated using BW and the operator-entered subject's overall height measurement.
The provided text details the 510(k) premarket notification for the PhysioWave Cardiovascular Analyzer. However, it does not explicitly provide a table of acceptance criteria and the reported device performance. It states that "The comparison tests demonstrated very high correlation of all measured and calculated parameters between the new device and the comparison devices and satisfactorily passed the acceptance criteria." but does not list these criteria or the specific results.
Therefore, the following response will extract the available information and highlight what is not explicitly stated in the document.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly provide a table of acceptance criteria with corresponding device performance values. It generally states that the device "satisfactorily passed the acceptance criteria" for comparison tests against predicate and reference devices.
However, the primary parameters measured by the Cardiovascular Analyzer are:
- Pulse Wave Velocity (PWV)
- Pulse Rate (PR)
- Body Weight (BW)
- Body Mass Index (BMI) (calculated)
The study indicated "very high correlation of all measured and calculated parameters between the new device and the comparison devices."
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the clinical performance testing or side-by-side equivalence testing. It also does not explicitly state the country of origin of the data or whether the study was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not provide information on the number of experts used to establish ground truth or their qualifications.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method used for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. The focus is on the device's performance compared to predicate devices and a "gold standard" ECG monitor and patient scale.
6. Standalone (Algorithm Only) Performance
The testing included "side-by-side equivalence testing was performed for the BW, BMI, PR and PWV functions of the CA device against the comparison devices." This suggests a standalone evaluation of the device's measurements. The device has "automated algorithms to determine PTT based on the proximal and distal pulse measurements, to compute PWV, and also compute PR based upon the periodicity of the distal pulse." The software verification and validation section also indicates testing of the software's predetermined specifications.
7. Type of Ground Truth Used
The ground truth for the comparison tests was established by:
- Primary Predicate Device: AtCor Medical SphygmoCor® XCEL (K122129) for PWV and PR.
- Secondary Predicate Device / Gold Standard: Detecto Solo® scale (510(k)-exempt) for BW and BMI.
- Gold Standard: FDA-cleared ECG monitor for PR (implied for accuracy comparison, though not explicitly stated as "ground truth" for the CA in the same way as the predicates for specific parameters).
8. Sample Size for the Training Set
The document does not specify the sample size used for the training set.
9. How the Ground Truth for the Training Set Was Established
The document does not provide information on how ground truth was established for a training set. The device was likely developed using established algorithms and physical principles (ballistocardiogram and impedance plethysmography), and then validated against existing cleared devices and gold standards.
§ 870.2770 Impedance plethysmograph.
(a)
Identification. An impedance plethysmograph is a device used to estimate peripheral blood flow by measuring electrical impedance changes in a region of the body such as the arms and legs.(b)
Classification. Class II (special controls). The device, when it is a body composition analyzer which is not intended to diagnose or treat any medical condition, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.