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ArteVu is intended to noninvasively and continuously measure a patient's blood pressure and pulse rate, which are derived from the pulse pressure waveform using the scientific method of pulse waveform decomposition, for use on adult patients aged between 50 and 86 years who are resting in a supine or similarly reclined position.

ArteVu is calibrated using an ISO 81060-2 compliant sphygmomanometer. All parameters derived by ArteVu are shown on a compatible remote display monitor (RDDS) via wired transmission. The device is intended for use by clinicians or other properly trained medical personnel in professional healthcare facilities.

ArteVu is an automatic, continuous, and non-invasive blood pressure (CNBP) monitoring system designed for adult patients at rest and intended for use by medical professionals. The device features a disposable Finger Clip containing a tactile sensor that detects pulse pressure waveforms at the fingertip. ArteVu utilizes the scientific method of pulse waveform decomposition to derive blood pressure and pulse rate, with initial calibration performed using a non-invasive upper arm cuff. These measurements are displayed on a compatible remote monitor, updated every two seconds via wired transmission. ArteVu incorporates technical and physiological alarms to enhance reliability, providing continuous and accurate monitoring while alerting users to abnormal conditions.

The provided FDA 510(k) clearance letter for ArteVu does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and the study proving the device meets these criteria. Specifically, it lacks a table of acceptance criteria with reported device performance metrics and explicit details on how ground truth was established for training and testing sets.

However, based on the information available, here's a structured response addressing the requested points to the best of what the document provides:

Acceptance Criteria and Study for ArteVu

The document states that ArteVu's safety and effectiveness were validated through a clinical study that adhered to the acceptance criteria of ISO 81060-2 for substantial equivalence to the predicate device, CareTaker4. It also incorporated elements from IEEE 1708, ISO 81060-3, ISO 80601-2-61, and IEC 60601-2-27. While it doesn't provide a specific table of numerical acceptance criteria or reported values for ArteVu, it implicitly relies on the standards set by ISO 81060-2 for non-invasive sphygmomanometers. This standard typically defines accuracy requirements for blood pressure measurements.

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

The document does not provide an explicit table with numerical acceptance criteria and ArteVu's reported performance metrics against those criteria. It only states that the study design "adhered to the acceptance criteria of ISO 81060-2."

If this were a complete submission, such a table would typically include:

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: 109 subjects. The document states, "ArteVu's safety and effectiveness have been validated through a clinical study conducted in Taiwan involving 109 subjects." Since this is the primary validation study mentioned, it serves as the test set for the device's performance claims.
• Data Provenance: The clinical study was "conducted in Taiwan." The data is prospective, as it was collected as part of a clinical study to validate the device.
• Subject Recruitment: Subjects were recruited from "operating rooms and intensive care units."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The document states that ArteVu is calibrated using an "ISO 81060-2 compliant sphygmomanometer" and that the study design "adhered to the acceptance criteria of ISO 81060-2." This strongly implies that the ground truth for blood pressure measurements was established using a reference standard device (the compliant sphygmomanometer) and not necessarily by a panel of human experts. Therefore, the concept of "number of experts" for establishing ground truth via consensus (as might be seen in image-based AI studies) does not directly apply here. The "experts" would be the clinical personnel performing the reference measurements according to the ISO standard.

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

Since the ground truth for blood pressure measurements in this context is established by a reference device (ISO 81060-2 compliant sphygmomanometer) and not by subjective interpretation of medical images or conditions by multiple human readers, a numerical adjudication method (like 2+1 or 3+1) is not applicable or mentioned. The accuracy of the sphygmomanometer itself is the standard.

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

• No, an MRMC comparative effectiveness study was not done as described in the document. This type of study is commonly used for AI in diagnostic imaging (e.g., radiology) where AI assists human interpretation. ArteVu is a continuous non-invasive blood pressure monitoring system, so its primary function is measurement, not assisting human readers in interpreting complex medical data.
• Therefore, there is no mention of effect size related to human readers improving with or without AI assistance.

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

• Yes, in essence, a standalone performance assessment was conducted for the device's core function. ArteVu is described as an "automatic, continuous, and non-invasive blood pressure (CNBP) monitoring system." Its performance (accuracy against a reference standard) is evaluated directly, implying it operates as an algorithm determining BP from the pulse waveform. The clinical study validated the device's ability to "achieve comparable safety and effectiveness" to the predicate device, which is a standalone measurement. While it displays measurements for "clinicians or other properly trained medical personnel," the core measurement derivation is done by the device itself, making it a standalone function in terms of its output.

7. The type of ground truth used

• The primary ground truth used is a reference standard measurement from an ISO 81060-2 compliant sphygmomanometer. This standard specifies the requirements for non-invasive sphygmomanometers and their clinical validation. The document explicitly states, "ArteVu is calibrated using an ISO 81060-2 compliant sphygmomanometer" and that the "study design adhered to the acceptance criteria of ISO 81060-2."

8. The sample size for the training set

• The document does not specify the sample size for the training set used to develop or train the ArteVu algorithm. The 109 subjects mentioned are for the validation/test set. Typical 510(k) summaries often do not disclose detailed training set information unless it's critical to the novelty or specific performance claims of an AI/ML device. While ArteVu uses a "scientific method of pulse waveform decomposition," it's unclear if this involves a machine learning model that requires a dedicated training set as opposed to an algorithm based on established physiological models.

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

• Since the training set size is not provided, the method for establishing its ground truth is also not described in this document. If ArteVu's algorithm involved machine learning, it's highly probable that similar methods (i.e., reference standard measurements from compliant sphygmomanometers) would have been used for training data as for the test data.

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