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The VeriCor is indicated for use in estimating non-invasively, left ventricular end-diastolic (LVEDP) pressure. This estimate, when used along with clinical signs and other patient test results. including weights on a daily basis, can aid the clinician in the selection of further diagnostic tests in the process of reaching a diagnosis and formulating a therapeutic plan when abnormalities of intravascular volume are suspected.

The device has been clinically validated in males only. Use of the device in females has not been investigated. Certain patient conditions should be considered as a basis for excluding individual patients for testing based on a possible risk to them of the Valsalva maneuver, such as the following:.

• Weight 160mmHg or diastolic BP > 100mmHg)
• 12. Hypotension (systolic BP

The VeriCor device is intended to be used as one of several tools that will assist the cardiologist in assessment of the volume status of a patient, i.e., when the questions of either volume overload or volume depletion arises. A principal measure of intravascular volume status is the filling pressure in the left ventricle as best reflected by the left ventricular enddiastolic pressure (LVEDP). Measurement of the left ventricular enddiastolic pressure requires the placement of a catheter in the left ventricle of the heart to measure the pressures directly. This procedure involves a moderate risk to the patient but could result in arterial hemorrhage, stroke and death. Accordingly, it cannot be used as a routine procedure for patient assessment or for monitoring over time.

An estimate of LVEDP may be obtained with somewhat less risk to the patient by catheterization of the pulmonary artery as described above. The resulting measurement, called the Pulmonary Capillary Wedge Pressure (PCWP), correlates well with LVEDP. PCWP is widely used as an alternative to direct measurement of LVEDP, even though it has potential for complications and limitations in accuracy that are recognized.

The proposed device, the VeriCor, is intended to provide another point on the risk/benefit curve for assessment tools. The VeriCor is non-invasive, so it involves much less risk than catheterization of either the left ventricle or the pulmonary artery. The VeriCor device provides measurements that are well correlated with PCWP measurements.

The Colin CBM7000 Pulse Tonometer and the W. E. Collins Airway Pressure Monitor each have an interface connection for a computer to read data from the devices. In the VeriCor, a computer reads data from these devices during a sequence of procedures with the patient, including the Valsalva maneuver, and, using a proprietary algorithm, converts the data to estimates of the left ventricular pressure.

The digital manometer is used to measure the airway strain of the patient blowing into the mouthpiece. The pulse tonometer provides an instantaneous and continuous measure of non-invasive blood pressure before, during and after the Valsalva manuever. Data are recorded from both devices so as to provide a baseline followed by a minimum of eight and a maximum of 15 seconds of modest expiratory strain which is followed by 15 to 20 seconds of post-strain recording. The computer controller acquires the data from the devices and provides a dialog with the health-professional user. The user coaches the patient to perform the necessary actions, and one or more practice sessions are used to ensure that the patient can perform those actions correctly.

The provided text describes the VeriCor device, its intended use, and its substantial equivalence to predicate devices, but it does not contain detailed acceptance criteria or a specific study proving the device meets those criteria, nor does it provide a performance table with reported device performance against acceptance criteria.

The document states: "The performance testing carried out on the device assures substantial equivalence" and "The results from clinical studies of the device are presented in the 510(k)." However, the content of these studies or the specific performance metrics and acceptance thresholds are not included in the provided snippets.

Therefore, I cannot populate the table or answer most of the questions directly. However, based on the available information, I can infer some details.

Here's an attempt to answer the questions based on the limited information:

1. A table of acceptance criteria and the reported device performance

No explicit acceptance criteria or a performance table are provided in the given text. The document only mentions that the device provides measurements "well correlated with PCWP measurements" and that "performance testing carried out on the device assures substantial equivalence." Specific numerical thresholds for this correlation or other performance metrics are absent.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not specified. The document mentions "clinical studies" but does not provide details on sample size, data provenance, or whether the study was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not specified. The document does not describe how ground truth was established for the clinical studies.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not specified.

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. The VeriCor is described as a device that aids clinicians in assessing intravascular volume status by non-invasively estimating LVEDP. It's not an AI-based interpretation tool for human readers in the sense of image analysis. It provides an estimate, which is then used "along with clinical signs and other patient test results." Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device's function as described.

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

The device itself is a "standalone" system in the sense that it generates the LVEDP estimate. The description states: "the VeriCor, a computer reads data from these devices during a sequence of procedures with the patient, including the Valsalva maneuver, and, using a proprietary algorithm, converts the data to estimates of the left ventricular pressure." This suggests an algorithm-only component for the estimation. However, the output is intended to be used by a clinician, implying a human-in-the-loop is essential for diagnosis and therapeutic planning. The clinical validation would have assessed the performance of this algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Given the device aims to estimate Left Ventricular End-Diastolic Pressure (LVEDP), and it's stated that "PCWP [Pulmonary Capillary Wedge Pressure] is widely used as an alternative to direct measurement of LVEDP," it is highly probable that Pulmonary Capillary Wedge Pressure (PCWP) measurements, obtained via catheterization, were used as the ground truth or a strong reference standard for validating the VeriCor's estimates. The document states: "The VeriCor device provides measurements that are well correlated with PCWP measurements."

8. The sample size for the training set

Not specified. The document mentions clinical studies for validation but does not separate training and test sets or provide their sizes.

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

Not specified. (See point 7 for the likely nature of the ground truth if it were described).

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