Search Results

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.

Ask a specific question about this device

The Caretaker Advanced Hemodynamic Parameters provides calibrated cardiac output/stroke volume (CO/SV), left ventricular ejection time (LVET), and heart rate variability (HRV) in adult patients to the existing Caretaker Remote Display App And Caretaker Software Library (K181196) via Pulse Decomposition Analysis ("PDA")(K211588, K163255, K151499). To provide CO/SV measurements. the Caretaker platform is to be calibrated with a thermodilution measurement, or other accurate reference determination of cardiac output, to ensure accuracy. The device is intended for use by physicians or other properly trained medical personnel in a hospital or other appropriate clinical setting.

The Caretaker Advanced Hemodynamic Parameters is a firmware upgrade that runs on the Caretaker platform to provide additional hemodynamic measures to the Caretaker Remote Display App And Caretaker Software Library, K181196, and CareTaker Physiological Monitor, (K211588, K163255, K151499). These parameters are not intended to predict or detect cardiovascular mortality or any other condition, disease, and/or patient outcome.

The provided text, primarily an FDA 510(k) Summary, describes the Caretaker Advanced Hemodynamic Parameters device and its substantial equivalence to predicate devices for measuring Cardiac Output/Stroke Volume (CO/SV), Left Ventricular Ejection Time (LVET), and Heart Rate Variability (HRV).

While the document outlines the device's intended use, comparison to predicates, and general claims of "clinically validated evidence" and "equivalent performance," it does not provide specific acceptance criteria or the detailed results of a study that proves the device meets predefined acceptance criteria for accuracy or clinical performance. The provided text focuses on the 510(k) submission and the substantial equivalence claim.

Therefore, many of the requested details about acceptance criteria and study particulars cannot be extracted from this document. I will highlight what can be inferred or found, and explicitly state what information is missing.

Here's an attempt to answer your questions based solely on the provided text:

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

The document does not explicitly state specific numerical acceptance criteria (e.g., mean absolute error, concordance limits) for the advanced hemodynamic parameters (CO/SV, LVET, HRV). It broadly claims "equivalent performance" to the predicate devices.

Therefore, a table of acceptance criteria and reported device performance cannot be generated from the given text.

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

• Cardiac Output / Stroke Volume (CO/SV):
  • Sample Size: Not explicitly stated. The text mentions "patient groups" and characteristics like "76% hypertension," "26% diabetes," and "Less than 16%... have a normal BMI

Ask a specific question about this device

The Caretaker Remote Display App and Caretaker Software Library are indicated for use when remote display and/or forwarding of securely transmitted wireless data from the Caretaker Physiological Monitor device (K163255) is required. The Remote Display App and the Software Library provides bi-directional data transfer capabilities with the Caretaker Physiological Monitor device (K163255). To facilitate communications between the Caretaker Physiological Monitor device and other FDA Cleared patient monitors and Remote Data Displays (RDDS), the Caretaker Software Library provides a well-defined interface for 3rd party data integrations.

In addition to providing data display and forwarding, the Remote Display App can operate as an MDDS for 3rd party wireless medical devices. The alerts in the subject device are only to be used for historical review and are not intended for time-critical intervention.

The Software Library is intended only for use by licensed partners of the company, and the Caretaker Remote Display App is intended for use by clinicians or other properly trained medical personnel. Both the Remote Display App and Software Library are for prescriptive use only.

CareTaker Medical's App ("CareTaker Remote Display App") is a software App that runs on Commercial, Off the Shelf (CoTS) hardware to provide additional controls and features to the CareTaker4 Physiological Monitor, K163255, as well as an interface to other devices.

The App is a software platform that displays and stores physiological parameters and waveforms from patient monitoring medical devices. CareTaker Remote Display App can also forward this data to third party systems, including Electronic Medical Records systems.

The integrated CareTaker Software library provides new control and configuration functions to a connected CareTaker4 Physiological Monitor. This library can also be used by 3rd parties to develop their own Apps that are capable of controlling a CareTaker4 as well. The library does not and cannot control any other medical devices or systems it is connected with.

CareTaker Remote Display App can function without the CareTaker Software Library, in which case it is the same as the RDDS in K163255.

The provided text describes the 510(k) premarket notification for the CareTaker Remote Display App and CareTaker Software Library (K181196). However, it does not explicitly detail acceptance criteria or a specific study proving the device meets those criteria in the format requested. The document focuses on demonstrating substantial equivalence to predicate devices (VIOS Monitoring System, K150992, and Airstrip ONE Web Client, K160862) and confirming safety and effectiveness through nonclinical testing, usability, and risk assessment.

Based on the available information, I can extrapolate some aspects, but many details regarding specific acceptance criteria, performance metrics, sample sizes, expert qualifications, and study methodologies (like MRMC or standalone performance) are not explicitly stated in this document.

Here's an attempt to answer the questions based on the provided text, highlighting where information is not available:

Acceptance Criteria and Device Performance Study (K181196)

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

The document does not provide a quantitative table of acceptance criteria and reported device performance. Instead, it makes general statements about safety and effectiveness and substantial equivalence to predicate devices. The "performance" described relates to the functionality of displaying, storing, forwarding, and alarming patient data, and controlling a connected physiological monitor.

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

• Sample Size: Not specified. The document mentions "nonclinical testing" and testing for interoperability using a CareTaker4 Physiological Monitor, a SpO2 monitor, and a temperature patch.
• Data Provenance: Not specified. The nature of the "nonclinical testing" implies it was likely laboratory or simulated data, rather than patient data from a specific country, but this is not explicitly stated. It is described as "nonclinical" which typically refers to bench or simulated tests.

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 applicable. This device is an app and software library for displaying and forwarding vital signs data and controlling a monitor. It does not involve interpretation of medical images or complex diagnostic tasks that would require human expert ground truth establishment in the way an AI diagnostic device would. The "ground truth" for its performance would be the accuracy of data transmission, display, and control commands, which are validated through technical and interoperability testing, not expert consensus on medical findings.

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

Not applicable, as described above. The validation focuses on technical functionality and interoperability, which are typically assessed against technical specifications and communication protocols, not subjective human interpretations requiring adjudication.

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 MRMC study was done or mentioned. This is not an AI diagnostic device that assists human interpretation. Its function is to display, store, and forward data from an existing medical device and provide control.

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

The device itself is a software application. Its "standalone" performance would refer to its ability to correctly receive, display, store, forward, and transmit control commands. The document indicates that "nonclinical testing" was performed, including testing connections to the CareTaker4 Physiological Monitor, SpO2 monitor, and temperature patch, and testing data forwarding via WiFi and USB. This can be considered the standalone performance evaluation of the software's core functionalities. No human-in-the-loop performance study is described beyond the intended use by clinicians.

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

The "ground truth" for this device's performance would be the accurate transmission, display, and storage of physiological parameters, and the correct execution of control commands. This is verified against the known outputs/states of the connected medical devices and standard communication protocols. It is not based on expert medical consensus or pathology.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device in the context of image interpretation or diagnostic prediction that requires a "training set." It's a software application designed for data display, forwarding, and control.

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

Not applicable (as it's not an AI/ML device requiring a training set).

Ask a specific question about this device