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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

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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).

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CareTaker is intended to noninvasively and continuously measure a patient's blood pressure ("BP"), heart rate ("HR"), ould respiration rate ("RSP"), which are derived from the pulse pressure waveform using the scientific method of Pulse Decomposition Analysis ("PDA") for use on adult patients at rest. CareTaker is calibrated using a manual method or any A MI 81060 compliant BP device, or is automatically calibration mode. All parameters derived by Care Taker are reported to an integrated LCD screen and optionally to a remote display monitor (RDDS) via standard radio transmission protocols. The device is intended for use by clinicians or other properly trained medical personnel and does not provide any physiological alarm functions.

CareTaker is a cardiovascular monitoring device that non-invasively measures continuous blood pressure, heart rate and respiration rate via a finger cuff based on the scientific method of Pulse Decomposition Analysis ("PDA"). CareTaker is calibrated using any manual or AAMI 81060 compliant blood pressure device or is automatically calibrated using its self-calibration mode.

The provided text describes the CareTaker4 Physiological Monitor (K163255), a device intended for noninvasive and continuous measurement of blood pressure, heart rate, and respiration rate in adult patients at rest. The information regarding acceptance criteria and the study proving device performance is extracted below:

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

The document references adherence to AAMI SP-10 guidelines for blood pressure measurement but does not explicitly state the numerical acceptance criteria from these guidelines. It states that both the predicate CareTaker and the CareTaker4 measure blood pressure "within AAMI SP-10 guidelines," and similarly for the comparison with the Nexfin HD.

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

This information is not provided in the given text.

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)

This information is not provided in the given text.

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

This information is not provided in the given text.

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

The document describes the device for direct measurement and does not mention human-in-the-loop performance or MRMC studies. Therefore, this information is not applicable/not provided.

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

Yes, the device's performance, particularly for blood pressure measurement, is described in a standalone context relative to AAMI SP-10 guidelines. The clinical validation attesting to adherence to SP10 standards implies a standalone performance evaluation.

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

For blood pressure, the ground truth appears to be based on the AAMI SP-10 guidelines, which typically involve comparisons against a reference standard known to be accurate (e.g., intra-arterial measurement or a highly accurate non-invasive oscillometric device). The device itself can be calibrated using a "manual method or any AAMI 81060 compliant BP device." The text states "clinically validated evidence attesting adherence to SP10 standards," suggesting a comparison against established clinical reference methods for blood pressure.

For heart rate and respiration rate, the ground truth methods are not explicitly stated, but the comparison to predicate devices (which analyze pulsatile signals for respiration rate) suggests a comparison against established methods for measuring these parameters.

8. The sample size for the training set

This information is not provided in the given text.

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

This information is not provided in the given text. The text does not distinguish between training and test sets or detail the ground truth establishment for a training set.

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CareTaker is intended to noninvasively and continuously measure a patient's blood pressure ("BP") and heart rate ("HR"), which are derived from the pulse pressure waveform using the scientific method of Pulse Decomposition Analysis ("PDA") for use on adult patients at rest. CareTaker is calibrated using a manual sphygmomanometer. All parameters derived by CareTaker are reported to a remote display monitor via standard radio transmission. CareTaker does not provide any physiological alarm functions. The device is intended for use by clinicians or other properly trained medical personnel in a hospital or other appropriate clinical settings.

CareTaker is a cardiovascular monitoring device that noninvasively measures continuous blood pressure and heart rate via a finger cuff based on the scientific method of Pulse Decomposition Analysis ("PDA")

Here's a breakdown of the acceptance criteria and study information for the CareTaker Wireless Vital Signs Monitor, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not explicitly stated in the document for the clinical study. It only mentions "a clinical study."
• Data Provenance: Not explicitly stated regarding country of origin or whether it was retrospective or prospective. It is described as "a clinical study to compare with an arterial catheter."

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Not explicitly stated in the document. The ground truth was established by comparison to an "arterial catheter," which is a direct and invasive measurement of blood pressure, generally considered the gold standard.

4. Adjudication Method for the Test Set

Not applicable. The ground truth was based on arterial catheter measurements, not expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed or described in this document. This device is a measurement tool, not an interpretive diagnostic system typically requiring MRMC studies for human reader performance.

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

Yes, the device's performance was evaluated in a standalone manner. The clinical study compared the device's measurements directly against an arterial catheter, without human-in-the-loop interpretation impacting the primary performance metrics (blood pressure accuracy). The device does require trained personnel to operate it, but its core measurement algorithm's accuracy was tested independently.

7. The Type of Ground Truth Used

The ground truth for the clinical study was established by direct comparison to an arterial catheter. This is considered a gold standard for blood pressure measurement, moving beyond expert consensus to direct physiological measurement.

8. The Sample Size for the Training Set

Not applicable/not stated. The document describes a post-market notification (510(k)) where the device's performance is being validated, not the development or training of its underlying algorithm. The "Pulse Decomposition Analysis ('PDA')" is a scientific method, implying it's a pre-established analytical approach, not necessarily a machine learning model that requires a distinct training set in the context of this regulatory document.

9. How the Ground Truth for the Training Set was Established

Not applicable/not stated, for the same reasons as #8. The PDA method itself would have been developed and validated through scientific research, but this document focuses on the device's compliance.

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