InfoSmart™ is a software application for use with compatible Fisher & Paykel Healthcare OSA Flow generators. It allows for remote collection and management of device usage and therapeutic information. It also allows for remote therapy reporting and adjustment of device settings by a clinician.

Device Description

InfoSmart™ is a software reporting tool which provides reports on sleep therapy data including compliance, AHI, leak and pressure. This software can be used to report on data from compatible Fisher & Paykel Healthcare medical devices. The software enables the Health Service Provider to: Access and review a patient's compliance and efficacy reports. Change device settings Manage equipment information. Manage patient information Share the above data with other health service providers and organisations involved in a patient's therapy. InfoSmart™ may be provided as an on-premises software application, or a web application. Data from a compatible device can be transferred to InfoSmart™ in a number of ways; including a serial cable, a USB stick, or wirelessly though a communications module. Data is transferred to a central database from which it can be accessed and displayed on the health service provider's computer.

AI/ML Overview

The provided text does not contain detailed acceptance criteria or a study proving the device meets those criteria with specific performance metrics. The document is a 510(k) summary for the F&P InfoSmart™ software, outlining its substantial equivalence to a predicate device (InfoGSM).

However, it does mention general categories of performance testing. Based on the available information, here's an attempt to answer your questions:

1. Table of acceptance criteria and the reported device performance

The document states: "All tests confirmed that the software met the predetermined acceptance criteria." However, the specific quantitative acceptance criteria and detailed reported performance metrics are not provided. The testing categories are:

Acceptance Criteria Category	Reported Device Performance (General)
Functionality	Met predetermined acceptance criteria
Reporting	Met predetermined acceptance criteria
Device compatibility	Met predetermined acceptance criteria

The "Performance testing" section also explicitly states the focus for each:

Reporting: "Report testing focuses on report accuracy, ensuring all data processing performed by the software is accurate, and that this information is correctly reflected in therapy reports."
Functionality: "Functional acceptance testing covers the functional requirements of the product, ensuring all functions and features perform according to specification."
Device compatibility testing: "ensures all supported devices function correctly with the software and that data is uploaded from the device. Testing also ensures that device settings can be changed by the software and that these changes are accurately reflected within the device."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the sample size for any test sets, nor does it provide information on the data provenance (country of origin, retrospective/prospective).

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 document. The device is a software application for managing and reporting therapy data and device settings, not an AI or diagnostic device that typically requires expert-established ground truth for its performance assessment in a clinical context.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the document.

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 such study was conducted or reported. This device is a data management and reporting tool, not an AI for diagnostic image interpretation or similar tasks that would typically involve an MRMC study.

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

The "Performance testing" section describes non-clinical testing of functionality, reporting, and device compatibility. This testing assesses the algorithm's performance in terms of data processing, report accuracy, and interaction with compatible devices, which could be considered standalone performance in the context of this type of software. However, no specific "standalone" study is explicitly named or detailed beyond these general testing categories.

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

Given the nature of the device (software for collecting, managing, reporting usage/therapeutic information, and adjusting device settings), the "ground truth" would likely involve:

Expected data values: Comparing processed data to source data from the OSA flow generators to ensure accuracy.
Expected functionality: Verifying that software features work as designed according to specifications.
Expected device behavior: Ensuring that settings changes communicated by the software are correctly applied by the compatible devices.

The document states "report accuracy" and "all data processing performed by the software is accurate," implying a comparison to known or calculated correct values.

8. The sample size for the training set

The document does not mention a "training set." This type of software, while complex, is not typically described as using machine learning models that require training sets in the same way an AI diagnostic algorithm would. Its development would involve traditional software engineering and testing.

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

As no training set is mentioned in the context of a machine learning model, this question is not applicable based on the provided text.

Summary

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

January 24, 2017

Fisher & Paykel Healthcare Ltd. Jayanti Karandikar Regulatory Affairs Specialist 15 Maurice Paykel Place East Tamaki, Auckland 2013 New Zealand

Re: K161686 Trade/Device Name: F&P InfoSmart™ Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: Class II Product Code: BZD Dated: December 16, 2016 Received: December 22, 2016

Dear Jayanti Karandikar:

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.

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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 contact the Division of Industry and Consumer Education 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. 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

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 Industry and Consumer Education 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,

Tejashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Tina Kiang, Ph.D. Acting 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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Indications for Use

510(k) Number (if known) K161686

Device Name F&P InfoSmart™

Indications for Use (Describe)

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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F&P InfoSmart- Traditional 510(k)

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510(k) Summary 5

Contact person/submitter	Jayanti Karandikar
Date prepared	22 December 2016
Contact details	Address: 15 Maurice Paykel PlaceEast TamakiAuckland 2013, New ZealandTelephone: +64 9 574 0100Fax: +64 9 574 0158
Trade name	F&P InfoSmart™
Common name	InfoSmart
Classification name	Non Continuous Ventilator (IPPB)Class II (21 CFR §868.5905)Product code BZD (Anaesthesiology)
Predicate device	InfoGSM (K110316)

5.1 Device Description

The software enables the Health Service Provider to:

Access and review a patient's compliance and efficacy reports
. Change device settings
Manage equipment information ●
. Manage patient information
Share the above data with other health service providers and organisations involved in a patient's therapy.

InfoSmart™ may be provided as an on-premises software application, or a web application. Data from a compatible device can be transferred to InfoSmart™ in a number of ways; including a serial cable, a USB stick, or wirelessly though a communications module. Data is transferred to a central database from which it can be accessed and displayed on the health service provider's computer.

5.2 Intended Use and Indications for Use

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5.3 Technological Characteristics Comparison

Design/technologicalcharacteristic	Subject device(InfoSmart™)	Predicate device(InfoGSM )	Comments
Features	Web variant:	Web variant:	Comments
	Centralised database	Centralised database	InfoSmart™ provides similar features to its predicate with the web variant being identical.
	Device usage andcompliance reports	Device usage and compliancereports	The on-premises variant has similar features to the web except that it does not support web based data transfer. Data is still communicated to the central database via other means ie serial cable, removable media via USB.
	Efficacy reports	Efficacy reports
	Settings management	Settings management
	Equipment management	Equipment management
	Patient management	Patient management
	Support for web baseddata transfer options	Support for web based datatransfer options
	On-premises variant:
	Centralised database
	Device usage andcompliance reports
	Efficacy reports
	Settings management
	Equipment management
	Patient management
Data upload	Web variant:	Wireless	Both the InfoSmart™ web variant andthe predicate device software providefor wireless data transfer. Removablemedia and serial data transmission arealso supported by one or morevariants. Regardless of thetransmission medium, identical data istransmitted.
	Wireless, removablemedia
	On-premises variant:Removable media, serialcable
Applicationtype	InfoSmart™ is provided astwo variants:Web based applicationon-premises application	InfoSmart™ Web is providedas a Web based applicationonly.	InfoSmart™ is identical to thepredicate device software wherein itprovides a web variant.The on-premises of InfoSmart™consists of a software application thatcan be installed on a local PC orserver. Similar to its web counterpart,InfoSmart™ on-premises version,allows users to download data to thesystem, generate reports and adjustdevice settings.
Reporting	Therapy compliance andefficacy reporting.	Therapy compliance andefficacy reporting.	Identical
OperatingEnvironment	Office, hospital or other clinicalsetting	Office, hospital or otherclinical setting	Identical
CompatibleFlowGenerators	FPH OSA Flow Generators(BZD)	FPH OSA Flow Generators(BZD)	Identical type of therapy devices
	InfoSmart™ Web Version:• F&P ICON series(Auto/Premo/Novo)• Sleepstyle 200 AutoSeries (HC254)InfoSmart on-premises:• Sleepstyle 200 series(HC234, 238)• Sleepstyle 600 Series(HC604)• F&P ICON series(Auto/Premo/Novo)	InfoSmart Web version• F&P ICON series(Auto/Premo/Novo)• Sleepstyle 200 AutoSeries (HC254)
Device Settingschanged by thesoftware	Web version/On-premises version:• Device operating mode• Therapeutic pressures• Comfort settings• User Interface	Web version:• Device operating mode• Therapeutic pressures• Comfort settings• User Interface	Identical
Performancetesting	• Functionality• Reporting• Device compatibility	• Functionality• Reporting• Device compatibility	Identical• Reporting- Report testingfocuses on report accuracy,ensuring all data processingperformed by the software isaccurate, and that thisinformation is correctly reflectedin therapy reports.• Functionality- Functionalacceptance testing covers thefunctional requirements of theproduct, ensuring all functionsand features perform accordingto specification.• Device compatibility testing-ensures all supported devicesfunction correctly with thesoftware and that data isuploaded from the device.Testing also ensures that devicesettings can be changed by thesoftware and that these changesare accurately reflected withinthe device.
Indications for use
Purpose andfunction	InfoSmart transmits patientcompliance and efficacy datafrom the CPAP devices andallows this data to be reviewedby a clinician. In addition,remote adjustment of CPAPdevice settings is possible.InfoSmart™ Web is intendedfor use with F&P ICON seriesand Sleepstyle 200 AutoSeries flow generators andInfoSmart on-premises isintended for use with F&PICON series, Sleepstyle 200series and Sleepstyle 600Series flow generators.	The F&P InfoGSM™ isintended for home and clinicaluse as an accessory for theF&P ICON™ CPAPdevices. The F&P InfoGSM™transmits patient complianceand efficacy data from theCPAP device and allows thisdata to be reviewed by aclinician. In addition, remoteadjustment of CPAP devicesettings is possible.The InfoGSM™ is intended foruse with F&P HealthcareICON™ CPAP devices onlyand should not be connectedto any other device.	InfoSmart™ has a similar purpose over its predicate device software InfoSmart Web in that it allows for remote collection and management of device and therapeutic information. It also allows for adjustment of device settings.InfoSmart™ consists of an on- premises which is a software application that can be installed on a local PC or server.Similar to its web counterpart InfoSmart™ on-premises version, allows users to download data to the system, generate reports and adjust device settings.Expanding the scope to include additional F&P devices does not affect the functionality or safety of InfoSmart™.

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F&P InfoSmart– Traditional 510(k)

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The key differences are that InfoSmart™:

. Has an intended use with an expanded scope to be used with compatible F&P devices versus the predicate which was indicated to be used with the ICON CPAP devices only. Plus the subject device includes an on-premises variant which is to be installed on a PC or server. Introduction of additional compatible F&P devices and an on-premises variant does not introduce any safety or functionality concerns.
. Supports various means of data transfer. Depending on the variant, data can be obtained from a device via removable media, serial cable or wirelessly. The web variant of InfoSmart™ is identical to the predicate device software where in data can be obtained wirelessly from a compatible device via a communications module. The on-premises variant uses other methods via removable media or serial cable which does not affect the data transmitted.

5.4 Non-Clinical Performance Data

Verification and validation testing on the subject InfoSmart™ was carried out ensuring data was transferred, uploaded and displayed accurately and that device settings updates were accurately communicated back to the compatible device. All tests confirmed that the software met the predetermined acceptance criteria.

The testing above also demonstrated comparable safety and effectiveness of InfoSmart™ in comparison to the predicate.

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Clinical Performance Data 5.5

Clinical tests were not required to demonstrate the safety and effectiveness of InfoSmart™. Product functionality has been adequately assessed by non-clinical tests.

5.6 Conclusions

Results obtained from non-clinical testing demonstrate that, InfoSmart™ meets the design and functional requirements providing performance and is as safe and as effective as the predicate device. The differences between the subject and predicate do not raise new issues of safety and effectiveness.

It is therefore concluded that InfoSmart™ is substantially equivalent to the predicate device.

Regulation Number and Section

§ 868.5905 Noncontinuous ventilator (IPPB).

(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).