The intended use for the iBed™ Wireless (with iBed™ Awareness) is to assist clinical staff to monitor bed parameters on specific Stryker beds. The desired bed parameters will be set by clinicians at the bedside. The iBed™ Wireless software is intended to be used only with specifically enabled Stryker beds that have been verified and validated with the iBed™ Wireless software, and is not intended to provide bed status information for non-Stryker beds. The iBed™ Wireless software is not intended to communicate any patient status information, nor to permanently store any type of data. The iBed™ Wireless with iBed™ Awareness System is not intended to provide automated treatment decisions or as a substitute for professional healthcare judgment. The iBed™ Wireless with iBed™ Awareness System is not a replacement or substitute for vital signs monitoring or alert equipment. All patient medical diagnosis and treatment are to be performed under direct supervision and oversight of an appropriate health care professional.

Device Description

The iBed™ Awareness is used to monitor hospital bed status and to assist the Healthcare Provider in providing patient care. The system is integrated into Stryker hospital bed to monitor bed information such as: iBed™ Awareness status, bed exit status, siderail status, bed brake status, fowler angle, and weight on bed, for example. The Healthcare Professional can set the alerting function (audible and lights) to activate if bed status has changed. The iBed™ Wireless device is a tool that facilitates the wireless transmission of the bed status data using a wireless hardware and software device to the hospital server. The data can be captured by hospital data collection systems (developed and provided by Third Parties; not part of this submission). Through the use of the third party software, the data may be displayed at user-defined locations, such as nursing stations.

AI/ML Overview

This document describes the regulatory submission for the iBed™ Wireless with iBed™ Awareness system, a device that monitors hospital bed status. The provided text, however, does not contain specific acceptance criteria or a detailed study proving the device meets those criteria in the typical format of clinical performance evaluation (e.g., sensitivity, specificity, accuracy against a recognized gold standard).

Instead, the document focuses on demonstrating substantial equivalence to predicate devices and adherence to existing safety and performance standards for similar medical devices.

Here's an analysis based on the provided text, addressing your points where information is available:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria (e.g., minimum accuracy rates for bed status detection) or specific performance metrics in a tabulated format. Instead, it states that the device "meets its functional, performance, safety and efficacy specifications and requirements."

The "performance" is generally described as compliance with established international standards for medical devices and software, rather than a clinical performance study with specific outcomes.

2. Sample Size Used for the Test Set and Data Provenance

The document does not mention a specific "test set" in the context of a clinical performance study with a defined sample size (e.g., number of patients, number of bed events). The testing described is primarily related to product verification and validation, adherence to safety standards, and electromagnetic compatibility.

Test Set Sample Size: Not specified for a clinical performance study.
Data Provenance: Not specified. The testing seems to be internal verification and validation by Stryker Medical.

3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts

This information is not provided. The document does not describe a study involving human experts establishing ground truth for performance evaluation of the device's monitoring capabilities.

4. Adjudication Method for the Test Set

Not applicable, as a study involving expert adjudication for a test set (e.g., clinical images, event logs) is not described.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study is mentioned. The device's purpose is to monitor bed parameters, not to assist human readers in interpretation or diagnosis. Therefore, the concept of "human readers improve with AI vs without AI assistance" does not apply to this device.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance

Yes, the testing described appears to be for the standalone performance of the device's hardware and software. The text states:

"Software testing and hardware testing of each component and of the final device have been conducted extensively."
"The extensive performance testing that has been conducted on the individual components and on the finished system demonstrate that the iBed™ Wireless with iBed™ Awareness are safe and effective, and perform as well or better than the predicate devices."

This implies that the system itself was tested for its ability to accurately detect and transmit bed status information without direct human intervention in the detection process. The device's intended use is to "assist clinical staff to monitor bed parameters," meaning the device provides data, and staff then act upon it.

7. Type of Ground Truth Used

The document does not explicitly define the "ground truth" used for testing the iBed™ Wireless system. Given the nature of the device (monitoring bed parameters like siderail status, brake status, fowler angle, and weight on bed), the ground truth would likely be established through:

Direct physical observation/measurement: For mechanical parameters like siderail position or brake engagement, this would involve physically checking and comparing to the device's report.
Engineered test conditions: For parameters like weight, a known weight placed on the bed would serve as ground truth for calibration and accuracy testing.
Internal reference systems: For angle measurements, an independent reference sensor could be used.

However, the document does not detail these ground truth establishment methods.

8. Sample Size for the Training Set

No training set is mentioned. This device appears to be rule-based or sensor-based, rather than employing machine learning algorithms that would require a "training set" in the conventional sense. The "software testing" refers to verification and validation of its programmed logic and functionality.

9. How Ground Truth for the Training Set Was Established

Not applicable, as no training set is mentioned for this device.

Summary

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Redical

510(k) Summary

DEC 16 2010

Manufacturer and Submitter

Company Name:	Stryker Corporation, Medical Division
Company Address:	3800 E. Centre Ave.Portage, MI 49002phone: 269.324.6689fax: 269.329.2307
Contact Person:	Renata Sila
Date Summary Prepared:	November 4, 2010

Device

Trade/Device Name: Common/Usual Name: Classification Name: Regulation Number: Product Code: Classification Panel: Classification:

iBed™ Wireless with iBed™ Awareness Accessory to AC-Powered Adjustable Hospital Bed AC-Powered Adjustable Hospital Bed 21 CFR 880.5100 FNL General Hospital Class II

Predicate Devices:

Advance Series from Hill-Rom, Hill-Rom (K922352) VivaTRAKTM, Wireless MedCARE, LLC (K101109)

Device Description

Intended Use/Indications for Use

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for non-Stryker beds. The iBed™ Wireless software is not intended to communicate any patient status information, nor to permanently store any type of data. The iBed™ Wireless with iBed™ Awareness System is not intended to provide automated treatment decisions or as a substitute for professional healthcare judgment. The iBed™ Wireless with iBed™ Awareness System is not a replacement or substitute for vital signs monitoring or alert equipment. All patient medical diagnosis and treatment are to be performed under direct supervision and oversight of an appropriate health care professional.

Substantial Equivalence Analysis

The iBed™ Wireless with iBed™ Awareness is similar in technology and intended use to the AC-Powered Hospital bed Advance Series from Hill-Rom, Hill-Rom (K922352), and the VivaTRAKIM, Wireless MedCARE, LLC (K101109), which monitors in-bed activity using wireless technology.

The slight difference in Intended Use statements between the iBed™ Wireless with iBed™ Awareness and the predicates include that the VivaTRAK™ system uses include the Electronic Health Record (EHR) application interface, while iBed Wireless™ system does not, and the type of data transmitted with iBed Wireless includes other bed parameters in addition to the in-bed activity (bed exit status) monitored with VivaTRAKTM. These differences do not impact safety or effectiveness of the device when used as labeled, as the device has been fully tested for use and performance to demonstrate its safe and effective use. Neither the iBed™ Wireless with iBed™ Awareness nor the VivaTRAK™ devices are intended to provide automated treatment decisions or be used as a substitute for professional healthcare judgement.

Non-Clinical Performance Summary

Stryker Medical has verified and validated that the iBed™ Wireless with iBed™ Awareness meets its functional, performance, safety and efficacy specifications and requirements. Software testing and hardware testing of each component and of the final device have been conducted extensively. The device has been tested according to International Standards for compliance with:

Software module and system-wide validation and verification testing according to . ANSI/AAMI/IEC 62304,
י . Electrical safety and life cycle testing according to IEC 60601-1, and IEC 60601-2-38.
. Electromagnetic safety and emissions, and electromagnetic compatibility testing according to IEC 60601-2, and
- t Standards for information technology, IEEE 802.11.

The extensive performance testing that has been conducted on the individual components and on the finished system demonstrate that the iBed™ Wireless with iBed™ Awareness are safe and effective, and perform as well or better than the predicate devices.

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Conclusions

In summary, Stryker Corporation, Medical Division believes that the iBed™ Wireless with iBed™ Awareness is as safe and effective as similar devices currently on the market, and concludes that the iBed™ Wireless with iBed™ Awareness is substantially equivalent to the predicate devices.

iBed™ Wireless with iBed™ Awareness Premarket Notification Application

r : Stryker Corporation, Medical Division Page 3

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

Stryker Corporation C/O Mr. William Sammons Responsible Third Party Official Intertek Testing Services 2307 East Aurora Road, Unit B7 Twinsburg, Ohio 44087

DEC 16 2010

Re: K103536

Trade/Device Name: iBed" Wireless with iBed™ Awareness Regulation Number: 21 CFR 880.5100 Regulation Name: AC-Powered Adjustable Hospital Bed Regulatory Class: II Product Code: FNL Dated: November 30, 2010 Received: December 1, 2010

Dear Mr. Sammons:

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 Eederal Register.

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Page 2- Mr. Sammons

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/CDRH/CDRHOffices/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.goy/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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

for

Anthony D: Watson, B.S., M.S., M.B.A. Director

Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation

Center for Devices and Radiological Health

Enclosure

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Indications for Use

K103536

DEC 1 6 2010

510(k) Number (if known):

Device Name:

iBed™ Wireless with iBed™ Awareness

Indications For Use:

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ruld C. Chapman 12/6/10

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

510(k) Number: _______________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 880.5100 AC-powered adjustable hospital bed.

(a)
Identification. An AC-powered adjustable hospital bed is a device intended for medical purposes that consists of a bed with a built-in electric motor and remote controls that can be operated by the patient to adjust the height and surface contour of the bed. The device includes movable and latchable side rails.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.