(288 days)
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
| Parameter / Criteria | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Blood Pressure | AAMI SP-10 (AAMI/ANSI/ISO 81060) guidelines | Compliant with ISO 81060-2 standard |
| Safety | IEC 60601-1 (general medical electrical equipment safety) | Verified safe |
| Electromagnetic | IEC 60601-1-2 (electromagnetic compatibility of medical electrical equipment) | Verified electromagnetically compatible |
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.
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).