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.

Device Description

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.

AI/ML Overview

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.

Summary

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August 13, 2021

Caretaker Medical Jeff Pompeo President & CEO 941 Glenwood Station Ln #301 Charlottesville, Virginia 22901

Re: K211588

Trade/Device Name: Caretaker Platform Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN, DRG Dated: May 12, 2021 Received: May 24, 2021

Dear Jeff Pompeo:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

LCDR Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K211586

Device Name Caretaker Platform

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary of Safety and Effectiveness

1. 12 Mav 2021 Preparation Date:
1. Submitted by:

Caretaker Medical, LLC 941 Glenwood Station Ln; Suite 301 Charlottesville, Virginia 22901 User Fee Organization Number 397095 Owner/Operator #: 10054848

3) Contact Person/Prepared by: Jeff Pompeo President & CEO Phone: 434-409-1945 Email: Jeff@caretakermedical.net

4) Device Identification:

Trade Name: Common Name: Alternate Marketing Names:

Caretaker Physiological Monitor System Caretaker Platform Vitalstream GT5

Classification: 21 CFR 870.1130. Product Code: DXN -System, Measurement, Blood-Pressure, Non-Invasive Device Class: II

Predicate Devices: Caretaker4 Physiological Monitor (K151499, K163255), Caretaker 5) Monitor (K181196)
Device Description: The Caretaker Platform is a hemodynamic monitoring system that non-6) 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.
1. Intended Use: 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.

8) Comparison to Predicates:

Summary of methodology

Comparison bench-testing was performed to compare the current device to the predicate Caretaker4 since both use the Pulse Decomposition Analysis (PDA) method for the tracking of hemodynamic parameters. The comparison tests focused on the algorithmic performance 510(k) Summary Page 1 of 2

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because the physiological sensing and electronic processing hardware that constitutes both device's front ends are the same.

The bench tests are performed in the Caretaker Analyzer GUI (CA GUI), which is a customdesigned environment for the development and testing of the algorithms that analyze and process incoming arterial pulse signal data to produce vital signs.

The CA GUI can perform comprehensive testing across platforms and versions, i.e. the performance of PDA algorithms, both in firmware and desktop software versions for both CT4 and DUT CT5, can be assessed by selecting appropriate menu items.

Provision of continuous non-invasive hemodynamic parameters

Both devices measure blood pressure within AAMI SP-10 guidelines. Both devices require calibration and are intended for use on adult patients administered by trained medical staff. Both systems are identical with regard to electronic circuitry, pneumatic layout and components and algorithmic pulse analysis. The new model CT5 has a touch screen interface which the predicate device does not have. Both systems operate at a coupling pressure significantly lower than normal diastole with a lower risk of occluding blood flow to the monitored digit, making the technology safer

Provision of spot-check non-invasive hemodynamic parameters

Both the predicate Caretaker and the present system use an oscillometric sweep to obtain pointin-time measurements within AAMI guidelines. The predicate device used this sweep solely for the purpose of self-calibration before switching to its relative change monitoring mode. In addition to the self-calibration, the present CT5 can also be set to periodically wake and use the same sweep to get multiple point-in-time measurement at isochronal periods set by the end user.

Provision of use of software

Both the predicate Caretaker and the present system use the same Caretaker Remote Monitor App software and APIs. The new CT5 device includes additional feature keys to set different configuration options for various hemodynamic parameters that were always on by default in the previous device. The feature keys are unique to each physical device serial number and are set at time of manufacture to create different models (all using the same hardware).

9) Conclusions:

Provision of non-invasive hemodynamic parameters

The Caretaker Platform is substantially equivalent to the predicate Caretaker device in regard to providing continuous, non-invasive hemodynamic monitoring. The spot-check mode of the present system is substantially equivalent to the self-calibration mode of the predicate.

Provision of use of software

The Caretaker Platform is substantially equivalent to the Caretaker Remote Monitor App and APIs in that the same software is used with the addition of the feature keys described above.

Regulation Number and Section

§ 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).