The Carematix™ Wellness System is a physiological monitoring system. The system collects, accumulates and transmits patient vital signs and other physiological data from a patient who may be remote from the healthcare practitioner to the practitioner. It is intended for patient home use for the following and can record physiological information such as:

Non-invasive blood pressure measurement;

Pulse rate measurement;

Blood glucose level using a Glucometer;

Blood hemoglobin oxygen saturation (%SpO2) using a digital Pulse Oximeter;

Prothrombin Time (PT) and International Normalized Ratio (INR) measurement using an inhome coagulation measurement system;

Peak Expiratory Flow Rate (PEFR) and Forced Expiratory Volume (FEV) measurements using an electronic peak flow meter;

Patient weight using a stand-on electronic scale

The results of these measurements are transmitted to a computer monitoring station in a clinical setting via common telephone lines from the patient's home setting.

Device Description

The Carematix™ Wellness System is intended to gather and transmit patient data from the home site or remote location to caregivers at a clinical facility where it provides supplemental information for the care of the patient.

The Carematix™ Wellness System consists of wireless radiofrequency transmitter adapters, a communication hub or receiving station, and an internet server:

The radiofrequency transmitter adapter is connected, either wired directly or to . a serial port, of monitoring devices currently in distribution having capability to monitor patient parameters for blood pressure, pulse rate, blood sugar, blood oxygen saturation, PT/INR, and FEV/PEFR.
The communications hub, or receiving station, collects and stores data transmitted from each of the radiofrequency transmitter adapters or wired device and transmits patient data to the internet server via PSTN. LAN. cellular, wireless etc.
The internet server receives the patient data from the home setting or remote . location where it is made available to the caregiver to track, graph, note variances, set alert criteria, and receive notifications when parameters are outside the criteria set.

AI/ML Overview

The provided text describes the Carematix™ Wellness System, a physiological monitoring system intended for home use to collect and transmit patient vital signs to caregivers.

However, the 510(k) summary does not contain the specific acceptance criteria or a detailed study proving the device meets them in the format requested. It only provides a general statement that "Verification and Validation tests were conducted for the Carematix Wellness System in accordance with Good Manufacturing Practices and the results met acceptable criteria." and that it conforms to IEC 60601-1.

Therefore, I cannot populate the table or answer most of the specific questions (2-9) about the study design, sample sizes, ground truth establishment, or expert involvement, as this information is not present in the provided document.

Here's what I can extract and state based on the text:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Not specified	"Verification and Validation tests were conducted... and the results met acceptable criteria."
Conformance to IEC 60601-1	"The Carematix™ Wellness System also conforms to requirements of IEC 60601-1"

Missing Information (Not available in the provided text):

Specific numerical acceptance criteria for each physiological measurement (e.g., accuracy, precision).
Detailed performance metrics (e.g., sensitivity, specificity, accuracy, error margins) for each vital sign measurement handled by the system.

2. Sample size used for the test set and the data provenance:

Not specified. The document only states that "Verification and Validation tests were conducted." It does not provide any details on the sample size of patients or data points, nor the country of origin, or whether the study was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not specified. The document does not mention the use of experts for establishing ground truth for any test set.

4. Adjudication method for the test set:

Not specified. There is no mention of any adjudication method.

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:

Not applicable / Not specified. The Carematix™ Wellness System is a data collection and transmission system for physiological parameters. It is not an AI-assisted diagnostic device that would involve "human readers" or an "AI assistance" component in the typical sense this question implies. The document does not mention any MRMC study.

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

Partially addressed indirectly, but not fully detailed. The device primarily acts as a data collection and transmission system. Its "performance" would likely be evaluated on the accuracy of data transmission and integration with monitoring devices, rather than a standalone a diagnostic algorithm. The document states "Verification and Validation tests were conducted," which would implicitly cover the standalone functionality of the data handling without human intervention in the loop of that specific function. However, no details on how this was evaluated are provided.

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

Not specified. Given the nature of vital sign monitoring, the ground truth would typically be established by comparing the device's readings against a gold standard reference device for each physiological parameter (e.g., a clinically validated blood pressure monitor, glucometer, etc.). However, the document does not explicitly state the type of ground truth used.

8. The sample size for the training set:

Not applicable / Not specified. This device is described as a system for collecting and transmitting physiological data, not an AI or machine learning model that typically requires a distinct "training set." Therefore, a training set in that context would not be relevant, and no such information is provided.

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

Not applicable / Not specified. As there's no mention of a training set for an AI/ML model, this question is not relevant based on the provided text.

Summary

{0}------------------------------------------------

510(k) Summary

Carematix™ Wellness System

MAY - 5 2010

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.

SUBMITTER

Carematix™, Inc. 209 W Jackson Blvd, Suite 800 Chicago, IL 60606

Contact Person

Sukhwant Khanuja, Ph. D. Chief Executive Officer Carematix™, Inc. 209 W Jackson Blvd, Suite 800 Chicago, IL 60606 Phone: (312) 627-9300 e-mail: skhanuja@carematix.com

Date Prepared:

February 15, 2010

NAME OF DEVICE

Carematix™ Wellness System

CLASSIFICATION NAMES

Radiofrequency Physiological Signal Transmitters and Receivers

DEVICE CLASSIFICATION

Regulatory Class: Product Code: Classification Panel: Regulation Number:

Class II DRG Cardiovascular Device Panel 21 CFR 870.2910

PREDICATE DEVICES

K040966; K073038- Carematix™ Wellness System, Carematix, Inc.

DESCRIPTION OF DEVICE

The Carematix™ Wellness System consists of wireless radiofrequency transmitter adapters, a communication hub or receiving station, and an internet server:

The radiofrequency transmitter adapter is connected, either wired directly or to . a serial port, of monitoring devices currently in distribution having capability to monitor patient parameters for blood pressure, pulse rate, blood sugar, blood oxygen saturation, PT/INR, and FEV/PEFR.
� The communications hub, or receiving station, collects and stores data transmitted from each of the radiofrequency transmitter adapters or wired device and transmits patient data to the internet server via PSTN. LAN. cellular, wireless etc.
The internet server receives the patient data from the home setting or remote . location where it is made available to the caregiver to track, graph, note

{1}------------------------------------------------

Special 510(k) Notification- Response for additional Information

variances, set alert criteria, and receive notifications when parameters are outside the criteria set.

Indications For Use

Non-invasive blood pressure measurement;

Pulse rate measurement;

Blood glucose level using a Glucometer;

Blood hemoglobin oxygen saturation (%SpO2) using a digital Pulse Oximeter;

Prothrombin Time (PT) and International Normalized Ratio (INR) measurement using an inhome coagulation measurement system;

Peak Expiratory Flow Rate (PEFR) and Forced Expiratory Volume (FEV) measurements using an electronic peak flow meter;

Patient weight using a stand-on electronic scale

The results of these measurements are transmitted to a computer monitoring station in a clinical setting via common telephone lines from the patient's home setting.

PERFORMANCE TESTING

Verification and Validation tests were conducted for the Carematix Wellness System in accordance with Good Manufacturing Practices and the results met acceptable criteria. The Carematix™ Wellness System also conforms to requirements of IEC 60601-1 and we consider it safe and

CONCLUSION

The Carematix™ Wellness System is substantially equivalent to the following 510(k) cleared devices:

Carematix™ Wellness System cleared under K040966 on June 2, 2004, and Carematix™ Wellness System cleared under K073038 on Jan 11, 2008.

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - GSA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - GSA" arranged around the circumference. Inside the circle is a stylized image of an abstract human figure with outstretched arms, resembling a bird in flight. The figure is composed of three curved lines that create a sense of movement and openness.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Carematix, Inc c/o Sukhwant Khanuja, PhD CEO 209 W Jackson Blvd, Suite 800 Chicago, IL 60606

MAY - 5 2010

Re: K100508

Trade/Device Name: Carematix Wellness System Regulation Number: 21 CFR 870.2910 Regulation Name: Radiofrequency physiological signal transmitter and receiver Regulatory Class: Class II (two) Product Code: DRG Dated: April 1, 2010 Received: April 5, 2010

Dear Dr. Khanuja:

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. 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.

{3}------------------------------------------------

Page 2 - Dr. Khanuja

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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

W.W. Watt

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Indications for Use

510(k) Number K100508

Device Name: CarematixTM Wellness System

Indications for Use:

The Carematix™ Wellness System is a physiological monitoring system. The system collects, accumulates and transmits patient vital signs and other physiological data from a patient who may be remote from the healthcare practitioner. It is intended for patient home use for the following and can record physiological information such as:

Non-invasive blood pressure measurement;

Pulse rate measurement;

Blood glucose level using a Glucometer;

Blood hemoglobin oxygen saturation (%SpO2) using a digital Pulse Oximeter;

Prothrombin Time (PT) and International Normalized Ratio (INR) measurement using an in-home coagulation measurement system:

Peak Expiratory Flow Rate (PEFR) and Forced Expiratory Volume (FEV) measurements using an electronic peak flow meter;

Patient weight using a stand-on electronic scale

The results of these measurements are transmitted to a computer monitoring station in a clinical setting via common telephone lines from the patient's home setting.

Prescription Use (per 21 CFR 801.109)

and/or

Over-the-counter Use

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

ivision of Cardiovascular Devices

510(k) Number K100508

Regulation Number and Section

§ 870.2910 Radiofrequency physiological signal transmitter and receiver.

(a)
Identification. A radiofrequency physiological signal transmitter and receiver is a device used to condition a physiological signal so that it can be transmitted via radiofrequency from one location to another, e.g., a central monitoring station. The received signal is reconditioned by the device into its original format so that it can be displayed.(b)
Classification. Class II (performance standards).