EasyCare Online transfers and displays to clinicians, usage and therapeutic information that has been transmitted remotely from the patient's flow generator located in the home. EasyCare Online also provides remote settings capabilities.

EasyCare Online is intended to support the standard follow-up care of patients that have been prescribed a compatible ResMed flow generator for the treatment of obstructive sleep apnea or respiratory insufficiency.

Device Description

EasyCare Online is a web application that can transfer, store, manage and display usage and therapy data from ResMed flow generators. The data is transferred from the flow generators either wirelessly through a communications module or with the aid of an SD card, to a central database and then displayed in a clinician computer, through a web application.

EasyCare Online is used to monitor and optimize the therapy of patients diagnosed with sleep apnea or respiratory insufficiency, who are using a ResMed therapy device. The application enables patient usage data to be shared across several different user groups for the primary purpose of monitoring patient compliance. Clinical users, Home Medical Equipment (HME) providers and other healthcare specialists can access data to monitor patient compliance. Also, clinical users and HMEs are able to address any noncompliance issues in a timely manner and provide the necessary patient support, including the modification of device settings.

AI/ML Overview

The provided text is a 510(k) summary for the EasyCare Online device. It describes the device, its intended use, and argues for its substantial equivalence to previously cleared predicate devices. However, it does not contain a detailed study proving the device meets specific acceptance criteria with performance metrics, sample sizes, or information about ground truth establishment.

The document states:
"Design and non-clinical verification activities were performed on EasyCare Online as a result of the risk analysis and design process. Verification testing included end-to-end testing to verify data transfer integrity between the flow generator and EasyCare Online. All tests confirmed the product met the predetermined acceptance criteria."

This statement indicates that verification testing occurred and acceptance criteria were met, but it does not provide the details requested in your prompt.

Therefore, I cannot populate the table or provide specific details about the study, as they are not present in the provided text.

Based on the available information, here's what can be inferred and what cannot be determined:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Data Transfer Integrity (between flow generator and EasyCare Online)	"All tests confirmed the product met the predetermined acceptance criteria." (Specific metrics and criteria are not provided)

Study Information (Based on available text)

Sample size used for the test set and the data provenance: Not specified in the provided text. The testing mentioned is "end-to-end testing to verify data transfer integrity," which sounds like functional verification rather than a clinical study with patient data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not specified. The testing described focuses on data transfer integrity, not diagnostic or therapeutic accuracy that would require expert-established ground truth on patient data.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable/not specified.
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. EasyCare Online is a data transfer and display system for clinicians, not an AI diagnostic or assistive tool that would involve human readers or MRMC studies.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The "end-to-end testing to verify data transfer integrity" can be considered a standalone functional test, but it does not evaluate "performance" in the sense of clinical accuracy or decision-making.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for verifying data transfer integrity would likely involve comparing transmitted data against source data, rather than clinical ground truth.
The sample size for the training set: Not applicable. The device is a data management and display system, not a machine learning model that requires a training set.
How the ground truth for the training set was established: Not applicable.

Summary of what the document implies about the "study":

The "study" was primarily functional verification and non-clinical testing to ensure data transfer integrity and compatibility with new flow generator models. It was not a clinical effectiveness study assessing diagnostic accuracy or therapeutic outcomes, nor did it involve the use of AI algorithms on patient data that would necessitate the detailed ground truth and expert validation methods you've inquired about. The device is described as a system for transferring and displaying patient usage and therapeutic information, rather than a device making automated clinical decisions.

Summary

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K123557

・.

February 2013

· ·

510(k) Summary

Date Prepared	16-November-2012 (Amended on 11-Mar-2013)
Submitter	Manuel Urena
	Regulatory Affairs Manager
	ResMed Ltd, Australia
	1 Elizabeth Macarthur Drive
	Bella Vista, NSW 2153, Australia
	+ 61 2 88842766
Official Contact	Jim Cassi
	Vice President Quality Assurance Americas
	ResMed Corp
	9001 Spectrum Center Boulevard
	San Diego, CA 92123
	+1 858 836 6081
	Jim.Cassi@resmed.com
Device name	EasyCare Online
Product code	73 MNS (Primary)
	73 BZD (Secondary)
Classification reference	(Accessory to) Ventilator, Non-Continuous (Respirator)
	(21 CFR 868.5905, Product Code 73 BZD)
	(Accessory to) Ventilator, Continuous, Non-Life-Supporting (21 CFR 868.5895, Product Code 73 MNS)
Predicate devices	EasyCare Online (K093684)
	ResScan (K113815)
Reason for submission	Indications for use have been expanded.

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5.1 Intended Use

5.2 Basis for Determination of Substantial Equivalence

This modified EasyCare Online has the following similarities to the previously cleared predicated devices:

. Same intended use
Same operating principle .
Same technology .
Same manufacturing (deployment) process .

The modified EasyCare Online implemented changes to provide compatibility with the VPAP ST-A (K113288) flow generator, a device indicated for patients with respiratory insufficiency, with FDA product code 73 MNS. This addition modified the Intended Use Statement, as the condition of respiratory insufficiency was added. This change does not affect the safety and efficacy of the device, as the interface with the VPAP ST-A uses the existing data types and communications mechanisms that are utilised to interface with the flow generators already supported by the predicate devices. The modified device is substantially equivalent to the predicate devices EasyCare Online (K093684) and ResScan (K113815) which includes compatibility with S9 AutoSet, cleared under K091947; VPAP III ST-A, cleared under K033276; and Stellar, cleared under K103167.

Design and non-clinical verification activities were performed on EasyCare Online as a result of the risk analysis and design process. Verification testing included end-to-end testing to verify data transfer integrity between the flow generator and EasyCare Online. All tests confirmed the product met the predetermined acceptance criteria. ResMed has determined that new version of EasyCare Online is substantially equivalent to the predicate device. The new version of EasyCare Online has not altered safety or effectiveness.

5.3 Device Description

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5.4 Conclusion

The modified version of EasyCare Online is substantially equivalent to the predicate devices, EasyCare Online (K093684) and ResScan (K113815).

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features an abstract eagle design, with three stylized lines representing the eagle's body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle, indicating the department's name and country.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 14, 2013

Jim Cassi ResMed LTD Vice President Quality Assurance Americas 9001 Spectrum Center Boulevard SAN DIEGO CA 92123

Re: K123557

Trade/Device Name: EasyCare Online Regulation Number: 21 CFR 868.5895 Regulation Name: Ventilator, continuous, non-life-supporting Regulatory Class: Class II Product Code: MNS Dated: February 11, 2013 Received February 11, 2013

Dear Mr. Cassi:

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.

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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 (OS) 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/CDRH/CDRHQffices/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 vours.

Kwame @ اللام السياري | Kwamer for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

. >>

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Response -EasyCare Online Traditional 510(k) Premarket Notification ResMed Ltd

Indications for Use Statement

510(k) Number: K123557 EasyCare Online Device Name:

Indications for Use:

Prescription Use x (Part 21 CFR 801 Subpart D)

and / or

Over the counter use

(Part 21 CFR 801 Subpart C)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Albert E. o=U.S. Government ou=HHS. Moyal -S for LS

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number:

Regulation Number and Section

§ 868.5895 Continuous ventilator.

(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).