(151 days)
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.
| Parameter | Acceptance Criteria (Reference) | Reported Device Performance |
|---|---|---|
| Blood Pressure | AAMI SP-10 guidelines | Measures within AAMI SP-10 guidelines |
| Heart Rate | Not explicitly stated | Provides continuous heart rate readings |
| Respiration Rate | Not explicitly stated | Provides respiration rate readings (performance equivalent to or better than predicate) |
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.
§ 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).