The Proteus® Patch is a miniaturized, wearable data-logger for ambulatory recording of physiological and behavioral metrics such as heart rate, activity, body angle relative to gravity, and time-stamped, patient-logged events, including events signaled by swallowing the Ingestible Sensor accessory. The Proteus Patch enables unattended data collection for clinical and research applications. The Proteus Patch may be used in any instance where quantifiable analysis of event-associated physiological and behavioral metrics is desirable.

Device Description

The Proteus Patch is a body-worn sensor that collects physiological and behavioral metrics such as heart rate, activity, body angle relative to gravity, and time-stamped user-logged events generated by swallowing the Proteus Ingestible Sensor. The Ingestible Sensor is embedded inside an inactive tablet (the Pill) for ease of handling and swallowing. Once the Ingestible Sensor reaches the stomach, it activates and communicates its presence and unique identifier to the Patch. The Patch stores and wirelessly sends the physiological, behavioral, event, and ingestion data to a general computing device for display.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state quantitative "acceptance criteria" in the traditional sense (e.g., minimum sensitivity, specificity, or accuracy percentages). Instead, it focuses on validating the functionality of different components. Therefore, the table below reflects the validation methods and what was "proven" or "tested."

Parameter / Acceptance Criteria Category	Reported Device Performance (as tested)
Accelerometer (Motion & Angle)	Validated against a known acceleration applied against each of its three axes. (Implies accurate measurement of motion and angle relative to gravity.)
Biopotential Low-Frequency Amplifier (Heart Rate)	Tested using guidelines set forth in the ANSI/AAMI EC 13 standard to quantify heart rate by measuring R-wave frequency based on a modified Hamilton-Tompkins algorithm. (Implies accurate heart rate measurement.)
Ingestion Sensor (Activation & Lifetime)	Tested for activation time and lifetime after activation. (Implies the sensor activates as intended and performs for a sufficient duration.)

2. Sample Size for the Test Set and Data Provenance

The document does not explicitly state the sample size used for the test set for each validation. It also does not provide details on data provenance (e.g., country of origin, retrospective or prospective nature of the data). The validation efforts appear to be laboratory-based rather than real-world patient data in some cases.

Accelerometer: "validated against a known acceleration applied against each of its three axes." This suggests controlled laboratory testing.
Heart Rate: "tested using guidelines set forth in the ANSI/AAMI EC 13 standard." This standard typically involves using databases or simulators for testing, but details are not provided.
Ingestion Sensor: "tested for activation time and lifetime after activation." This would likely be laboratory testing of the ingestible sensor units.

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

The document does not mention the use of human experts to establish ground truth for the device's performance. The validation appears to be against established physical standards, known inputs, or existing guidelines (like ANSI/AAMI EC 13).

4. Adjudication Method for the Test Set

No adjudication method is mentioned. Given the nature of the "testing" described (validation against known physical inputs and standards), an adjudication process among human experts would not be applicable.

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

No MRMC comparative effectiveness study was done or mentioned. The device, the Proteus Patch Including Ingestible Sensor, is a data-logger and sensor, not an interpretive AI system that assists human readers. Therefore, the concept of human readers improving with or without AI assistance is not applicable to this device.

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

The described performance evaluation is a standalone (algorithm only) evaluation. The validation tests were conducted on the device's sensors and algorithms directly (e.g., accelerometer output, R-wave frequency detection, sensor activation). There is no human-in-the-loop component mentioned in these performance assessments.

7. Type of Ground Truth Used

The ground truth used in the validation studies appears to be:

Known physical inputs/standards: For the accelerometer, "known acceleration applied against each of its three axes."
Standardized guidelines/algorithms: For heart rate, "guidelines set forth in the ANSI/AAMI EC 13 standard" and a "modified Hamilton-Tompkins algorithm."
Intrinsic device characteristics/specifications: For the ingestion sensor, "activation time and lifetime after activation" refers to its expected functional behavior.

There is no mention of expert consensus, pathology, or outcomes data being used as ground truth for these specific performance validations.

8. Sample Size for the Training Set

The document does not specify a "training set" or its sample size. This device is described as a "data-logger" and sensor system. While it contains algorithms (e.g., for R-wave detection), there is no indication that these algorithms were developed using a machine learning approach that would typically involve a distinct training set. The focus is on validation against established engineering and physiological standards.

9. How the Ground Truth for the Training Set was Established

Since no training set and corresponding machine learning approach are explicitly described, the method for establishing ground truth for a training set is not provided.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for Proteus Digital Health. The logo is in black and white and features the word "proteus" in a stylized font. Below the word "proteus" is the phrase "DIGITAL HEALTH" in a smaller font. The logo is simple and clean, and it conveys a sense of innovation and technology.

JUN 2 3 2013

K131524 P1/4

510(k) Summary

Submitted by: Address:

Telephone: Facsimile: Contact Name:

Proteus Digital Health Inc. 2600 Bridge Parkway, Suite 101 Redwood City, CA, 94065 650 - 637 - 6158 650 - 362- 1860 Zahedeh Hatamkhany zhatamkhany(@proteusdh.com

Date Submitted:

May 24, 2013

Name of Device

Trade name: Common name: Classification name: Proteus® Patch Including Ingestible Sensor Ingestible Event Marker Ingestible Event Marker (21 CFR 880.6305, Product Code OZW, DXH)

Unmodified Device

Proteus® Patch Including Ingestible Sensor (K131009) .

General Device Description

Proteus Digital Health, Inc.

6-1

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K131524 P2/4

Intended Use

Physical Characteristics

Parameter	Value
The Patch
Shape	One-piece: ovoid
Size	102mm x 56mm x 10mm
Weight	11g
Battery type	Lithium Manganese (LiMn) CoinCell
Moisture susceptibility	Water-resistant
Memory	4 MB
Storage temperature	Room Temperature
Relative humidity	Ambient
The Pill
Shape	Round
Size	6.5mm x 2.0mm
Weight	80mg

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K131524

P3/4

Technological Characteristics

Parameter	Sensor Technology	Method
Heart rate	Biopotential low-frequency amplifier	Digitized R wave
Activity	Accelerometer	Digitized accelerometer output
Body angle	Accelerometer	Double integration of accelerometer output
Manual event logging	Patient activated button	Digital pulse
Inter-electrode impedance	Biopotential high-frequency amplifier	Digitized impedance from small auxiliary current
Ingestible Event Marker	Bio-galvanically powered ingestible circuit	Volume conduction communication

Summary of Non-Clinical Performance Data

The three-axis accelerometer provided motion and angle relative to gravity data and was validated against a known acceleration applied against each of its three axes.

The biopotential low-frequency amplifier was used to quantify heart rate by measuring Rwave frequency based upon a modified Hamilton-Tompkins algorithm, tested using guidelines set forth in the ANSI/AAMI EC 13 standard.

The Ingestion Sensor was tested for activation time and lifetime after activation.

Summary of Clinical Performance Data

No additional clinical data were required to confirm substantial equivalence to predicate device.

Conclusion

Proteus Digital Health, Inc.

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K131524

P4/4

Based on technological characteristics, risk evaluation, and design verification of the Proteus Patch Including Ingestible Sensor, Proteus Digital Health believes that the product is safe and effective, and is substantially equivalent to predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure with three stylized, flowing lines representing the body and wings.

June 23, 2013

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

Proteus Digital Health. Inc. Mr. Zahedeh Hatamkhany Cmc Regulatory-Combination Products 2600 Bridge Parkway, Suite 101 Redwood City, CA 94065 US

Re: K131224

Trade/Device Name: Proteus Patch including Ingestible Sensor Regulation Number: 21 CFR 880.6305 Regulation Name: Ingestible Event Marker Regulatory Class: Class II Product Code: OZW, DXH Dated: May 24, 2013 Received: May 28, 2013

Dear Mr. Zahedeli Hatamkhany:

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

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Page 2 - Mr. Zahedeh Hatamkhany

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.gov/MedicalDevices/Safety/ReportaProblem/default.htmfor 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,

Bram D.Zuckerman -S

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

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K131524

Indications for Use Statement

510(k) Number (if known)
Proteus® Patch including Ingestible Sensor Device Name

Indications for Use

The Proteus* Patch is a miniaturized, wearable data-logger for ambulatory recording of physiological and behavioral metrics such as heart rate, activity, body angle relative to gravity, and time-stamped, patient-logged events, including events signaled by swallowing the Ingestible Sensor accessory. The Proteus Patch enables unattended data collection for clinical and research applications. The Proteus Patch may be used in any instance where quantifiable analysis of event-associated physiological and behavioral metrics is desirable.

Prescription Use _ X (Per 21 CFR 801.109)

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)

201

Regulation Number and Section

§ 880.6305 Ingestible event marker.

(a)
Identification. An ingestible event marker is a prescription device used to record time-stamped, patient-logged events. The ingestible component links wirelessly through intrabody communication to an external recorder which records the date and time of ingestion as well as the unique serial number of the ingestible device.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The device must be demonstrated to be biocompatible and non-toxic;
(2) Nonclinical, animal, and clinical testing must provide a reasonable assurance of safety and effectiveness, including device performance, durability, compatibility, usability (human factors testing), event recording, and proper excretion of the device;
(3) Appropriate analysis and nonclinical testing must validate electromagnetic compatibility performance, wireless performance, and electrical safety; and
(4) Labeling must include a detailed summary of the nonclinical and clinical testing pertinent to use of the device and the maximum number of daily device ingestions.