(81 days)
The Caretaker Platform is intended for non-invasive, continuous or spot-check measurement of hemodynamic parameters. Parameters can be reported to an integrated screen and optionally to Remote Data Display Systems (RDDS) and/or the Caretaker Remote Monitor App via standard wireless or wired data transmission protocols. The device is intended for use by clinicians or other properly trained personnel on adult patients at rest.
The Caretaker Platform is a hemodynamic monitoring system that non-invasively measures various parameters via a finger cuff based on the scientific method of Pulse Decomposition Analysis ("PDA"). The Caretaker physical device is calibrated using any manual or AAMI 81060 compliant blood pressure device or is automatically calibrated using its selfcalibration mode. The Caretaker Remote Monitor consists of an App that runs on Remote Data Display Systems (RDDS) and a set of APIs to for additional command and control functions developed on Android, Windows, or Linux systems.
The provided text does not contain detailed information about specific acceptance criteria tables for device performance or the study that proves the device meets these criteria in the format requested. The document is an FDA 510(k) clearance letter and summary for the Caretaker Platform, which focuses on demonstrating substantial equivalence to a predicate device rather than a detailed performance study against pre-defined acceptance criteria.
However, I can extract information related to the device's performance claims and the comparison methodology used for the 510(k) submission, and frame it in the context of what would typically be part of such a study.
Here's an attempt to answer based on the provided text, highlighting what is implicitly or explicitly stated and what is not available in the document:
1. A table of acceptance criteria and the reported device performance:
The document mentions AAMI (Association for the Advancement of Medical Instrumentation) guidelines for blood pressure measurement, specifically AAMI SP-10. This implies that the device is expected to meet the accuracy and precision standards outlined in AAMI SP-10 for non-invasive blood pressure monitors.
While a table isn't provided, the text states:
- "Both devices measure blood pressure within AAMI SP-10 guidelines."
- "Both the predicate Caretaker and the present system use an oscillometric sweep to obtain point-in-time measurements within AAMI guidelines."
Implicit Acceptance Criteria (based on AAMI SP-10, not explicitly stated in metrics in the text):
| Acceptance Criteria Category | Specific Acceptance Criteria (Implied by AAMI SP-10) | Reported Device Performance (as stated) |
|---|---|---|
| Blood Pressure Accuracy | Mean difference (± SD) against reference method within predefined limits (e.g., ±5 mmHg for mean, ±8 mmHg for standard deviation) | "Both devices measure blood pressure within AAMI SP-10 guidelines." |
| Spot-check Measurement Accuracy | Mean difference (± SD) against reference method within predefined limits. | "Both the predicate Caretaker and the present system use an oscillometric sweep to obtain point-in-time measurements within AAMI guidelines." |
| Continuous Monitoring Accuracy | Performance for continuous measurement (details not specified, but implied to be comparable to predicate). | "The Caretaker Platform is substantially equivalent to the predicate Caretaker device in regard to providing continuous, non-invasive hemodynamic monitoring." |
2. Sample sized used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
The document describes "comparison bench-testing" and "bench tests" performed in a "Caretaker Analyzer GUI (CA GUI)". This implies a retrospective analysis of existing data or simulated data, rather than a prospective clinical trial with human subjects.
- Sample Size for Test Set: Not specified. The document mentions testing "across platforms and versions" and assessing "performance of PDA algorithms," but no number of subjects or data points is provided.
- Data Provenance (e.g., country of origin): Not specified.
- Retrospective or Prospective: The description of "bench-testing" and using a "custom-designed environment for the development and testing of the algorithms" suggests a retrospective, in-silico, or lab-based analysis rather than a prospective clinical study involving new patient data collection.
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 available in the provided text. The evaluation described is algorithmic performance comparison, not diagnostic performance requiring expert interpretation against a ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not available in the provided text. Adjudication methods are typically used when human readers or experts are involved in establishing ground truth or evaluating performance, which is not described here.
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, a multi-reader multi-case (MRMC) comparative effectiveness study was not described or implied in the provided text. The device is a non-invasive blood pressure measurement system, not an AI-assisted diagnostic tool that would typically involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The description of the study as "comparison bench-testing" focused on "algorithmic performance" using a "Caretaker Analyzer GUI (CA GUI)" strongly suggests that a standalone (algorithm-only) performance evaluation was conducted. The goal was to compare the new device's algorithm to the predicate device's algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The document does not explicitly state the "ground truth" method. However, for blood pressure measurements, the ground truth is typically established by:
- Invasive arterial line measurements (gold standard).
- Auscultatory methods (e.g., sphygmomanometer with stethoscope) performed by trained personnel according to standardized protocols.
Given the context of AAMI SP-10, it's highly probable that the predicate device's performance (and by extension the compared device's performance) was assessed against a reference blood pressure measurement method, likely non-invasive but highly standardized and validated (e.g., "manual or AAMI 81060 compliant blood pressure device" mentioned for calibration). The study itself was a comparison between two device algorithms, rather than directly against a clinical ground truth like pathology or outcomes.
8. The sample size for the training set:
This information is not available in the provided text. The 510(k) submission primarily focuses on the comparison of the new device to a predicate, not the internal development or training of the algorithms.
9. How the ground truth for the training set was established:
This information is not available in the provided text. As noted, the document focuses on the comparison to a predicate for regulatory clearance, not the detailed development process (including training data specifics) of the device's algorithms.
§ 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).