The Intel® Health Guide PHS6000 is a communication tool that allows caregivers to remotely access vital sign measurements of patients at home. It collects measurements captured on commercially available wireless or tethered medical devices designed for home use, stores and displays the collected information on the LCD screen, and transmits the information to a secure host server. Caregivers can review the transmitted information and select education and reminders for patients using a caregiver software interface to the host server. Patients can review the stored vital sign measurement information and receive educational and motivational content from caregivers. Patients can also optionally engage in video conferences with caregivers and answer the caregivers' questions by participating in surveys.

The Intel® Health Guide PHS6000 is not intended for diagnosis or as a substitute for medical care, and it is not intended to provide real time data. It is made available to patients when time-critical care is not required. It is contraindicated for patients requiring direct medical supervision or emergency intervention. It is intended for patients who are willing and capable of managing its use. Clinical judgment and experience by a caregiver are required to check and interpret the information delivered.

Device Description

The Intel® Health Guide PHS6000 system consists of the:

Intel® Health Guide PHS6000 hardware: The physical component is an electronic device with a touch screen, video camera with privacy screen, microphones, speakers and a reminder light. It has a power socket, headphone socket, Broadband internet socket, medical device sockets, and optionally a phone socket.
Intel® Health Guide software application: Captures, stores, and transmits information to a secure website.
Intel® Care Management Suite software application: Allows caregivers to review patient vital signs on the secure website and set limits for alerts.
Processor software application: Manages the interface between the Intel® Health Guide PHS6000 software application and the secure website.

The Intel® Health Guide PHS6000 is not intended for diagnosis or as a substitute for medical care, and it is not intended to provide real time data. It is made available to patients when time-critical care is not required. The device is contraindicated for patients requiring direct medical supervision or emergency intervention. The device is intended for patients who are willing and capable of managing its use. Clinical judgment and experience by a caregiver are required to check and interpret the information delivered.

AI/ML Overview

The provided text describes a 510(k) Notification Submission for a modification to the Intel® Health Guide PHS6000. However, it explicitly states that clinical performance data was not used to demonstrate safety and efficacy.

Therefore, I cannot provide information on acceptance criteria or a study proving the device meets those criteria from the given text.

Here's why and what the document does say:

A table of acceptance criteria and the reported device performance: This information is not present. The document focuses on demonstrating substantial equivalence to a predicate device, not on specific performance metrics or acceptance criteria for the modified device.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable, as no clinical study or test set data is mentioned.
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): Not applicable, as no clinical study or ground truth establishment is mentioned.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as no clinical study or adjudication is mentioned.
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. The device is a "Remote Patient Monitoring System" and is not an AI-assisted diagnostic tool for human readers. No MRMC study is mentioned.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. The document states: "The Intel® Health Guide PHS6000 is not intended for diagnosis or as a substitute for medical care, and it is not intended to provide real time data." and "Clinical judgment and experience by a caregiver are required to check and interpret the information delivered." This indicates a human-in-the-loop system, but not one that evaluated "algorithm only" performance. Furthermore, no performance study of any type is detailed.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as no clinical study or ground truth establishment is mentioned.
The sample size for the training set: Not applicable, as no machine learning algorithm training is described within the context of a clinical study.
How the ground truth for the training set was established: Not applicable, as no machine learning algorithm training with ground truth is described.

What the document states regarding safety and efficacy:

The document explicitly states in "Safety and Efficacy":
"The Intel® Health Guide PHS6000 does not rely on an assessment of clinical performance data. The device conforms to FDA's recognized consensus standards and relies on its conformity to demonstrate the safety and efficacy. The device introduces no new questions concerning the safety or efficacy and is, therefore, substantially equivalent to the predicate device."

This indicates that the regulatory clearance for this modification was based on demonstrating substantial equivalence to an existing predicate device (Intel® Health Guide PHS6000, K080798) and adherence to recognized consensus standards, rather than through a clinical study with specific acceptance criteria and performance data.

Summary

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510(k) Notification Submission - Special 510(k) Modification to Intel® Health Guide PHS6000

510(k) Summarv As required by 21 CFR §807.92(c)

NOV 2 6 2008

Submitter

510(k) Owner:	Intel Corporation
Address:	1900 Prairie City Road, FM7-197, Folsom, CA 95630
Telephone:	(408) 765-2060
Contact Person:	Tae-Woong Koo
Date Prepared:	October 20, 2008

Device Information

Trade Name:	Modification to Intel® Health Guide PHS6000
Common Name:	Remote Patient Monitoring System
Classification Name:	Transmitters and Receivers, Physiological Signal, Radiofrequency (21 CFR 870.2910, Product Code DRG)

Substantial Equivalence is claimed to the following device: Intel Corporation's Intel® Health Guide PHS6000 (K080798)

Device Description

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510(k) Notification Submission - Special 510(k) Modification to Intel® Health Guide PHS6000

The Intel® Health Guide PHS6000 system consists of the:

Intel® Health Guide PHS6000 hardware: (1)
The physical component of the Intel® Health Guide PHS6000 is an electronic device contained in a plastic enclosure with a touch screen, video camera with privacy screen, microphones, speakers and a reminder light which is mounted into the top of the case. On the back of the device is a power socket, a headphone socket, a Broadband (high-speed) internet socket for connection to a broadband network. The device has medical device sockets for connection to specific physiological monitors, and may optionally have a phone socket for modem connection to a standard phone line.
Intel® Health Guide software application: (2)
The software application captures, stores, and transmits information to a secure website via a standard telephone line or a LAN/WAN connection.
Intel® Care Management Suite software application: (3)
The application allows caregivers to review patient vital signs on the secure website. The Intel® Care Management Suite allows for predefining upper and lower limits and, when either limit is exceeded, the system emails and/or pages the caregiver.
(4) Processor software application:
The processor software application manages the interface between the Intel® Health Guide PHS6000 software application and the secure website.

The Intel® Health Guide PHS6000 is not intended for diagnosis or as a substitute for medical care, and it is not intended to provide real time data. It is made available to patients when time-critical care is not required. The device is contraindicated for patients requiring direct medical supervision or emergency intervention. The device is intended for patients who are willing and capable of managing its use. Clinical judgment and experience by a caregiver are required to check and interpret the information delivered.

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510(k) Notification Submission - Special 510(k) Modification to Intel® Health Guide PHS6000

Indications for Use

Technological Characteristics

The Intel® Health Guide PHS6000 is substantially equivalent to the predicate device in terms of data collection software functionality, operating system for the patient device, communication method of patient device with central server. types of sensors which can be interfaced to the patient device, implementation method of collecting data from sensors, sensor software, connectivity, communication protocol, power source, and display method.

Safety and Efficacy

The Intel® Health Guide PHS6000 does not rely on an assessment of clinical performance data. The device conforms to FDA's recognized consensus standards and relies on its conformity to demonstrate the safety and efficacy. The device introduces no new questions concerning the safety or efficacy and is, therefore, substantially equivalent to the predicate device.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 6 2008

Intel Corporation c/o Mr. Tae-Woong Koo, Ph.D. Manager of Medical Regulatory Affairs Digital Health Group 1900 Prairie City Road, FM7-197 Folsom, CA 95630

Re: K083115

Trade/Device Name: Intel® Health Guide PHS6000 Regulation Number: 21 CFR 870.2910 Regulation Name: Physiological Signal Radiofrequency Transmitters and Receivers Regulatory Class: Class II Product Codes: DRG, LFR, CGA Dated: November 18, 2008 Received: November 20, 2008

Dear Dr. Koo:

Wc 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 regurrements of the Act

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Page 2 - Tae-Woong Koo, Ph.D.

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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

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

Enclosure

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Indications for Use:

510(k) Number:

KO83115

Device Name:

Modification to Intel® Health Guide PHS6000

Indications for Use:

The Intel® Health Guide PHS6000 is a communication tool that allows caregivers to remotely access vital sign measurements of patients at home. It collects measurements cantured on commercially available wireless or tethered medical devices designed for home use, stores and displays the collected information on the LCD screen, and transmits the information to a secure host server. Caregivers can review the transmitted information and select education and reminders for patients using a caregiver software interface to the host server. Patients can review the stored vital sign measurement information and receive educational and motivational content from caregivers. Patients can also optionally engage in video conferences with caregivers and answer the caregivers' questions by participating in surveys.

Prescription Use X (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 CD of Device Evaluation (ODE) (Division Sian-Off) 11/26/05 Division of Cardiovascular Devices 083115 510(k) Number_

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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).