The mini-Medic™ system is comprised of a minimum of one Forehead Sensor Unit and one Handheld Display Unit, and is intended for use on patients who are eighteen (18) years and over.

The mini-Medic™ system is indicated as a single or multi-parameter vital signs monitor for SpO2 and pulse rate via an integrated SpO2 forehead sensor, and/or heart rate from ECG electrodes, and forehead skin surface temperature from an infrared temperature sensor. Pulse wave transit time (PWTT) is obtained utilizing pulse measurements from the integrated SpO2 forehead sensor and ECG electrodes placed on the upper chest. Pulse wave transit time (PWTT) is used to track changes in blood pressure. Skin temperature is used as an adjunct to other clinical diagnostic procedures in the diagnosis, quantifying, and screening of relative skin surface temperature for hyperthermia and hypothermia conditions.

Patient data may be entered on the Handheld Display Unit. The mini-Medic™ system provides vital parameter alarms and a patient composite/summary alarm.

Patient information and system commands are transmitted using wireless radio communications between the Forehead Sensor Unit and the Handheld Display Unit. Stored patient data may be output, printed, downloaded and saved via a dedicated mini-Medic™ PC Software application.

Typical locations for the use of the mini-Medic™ system are: pre-hospital (i.e., at the point of injury or trauma scene), hospital, healthcare facility, emergency medical application, and during ground or air transport. The monitor is intended to be used by trained healthcare providers in military and civilian roles including doctors, nurses, combat medics, combat lifesavers, EMT's, and paramedics.

Device Description

The Athena GTX mini-Medic™ wireless vital signs monitor system is a small, lightweight, rugged, and highly portable patient monitor designed to measure SpO₂, cardiotachometer, skin temperature and pulse wave transit time (PWTT). Vital signs are displayed directly on the forehead sensor and transmitted wirelessly to a handheld display unit. Reports and data file saving is done via wireless download to a PC.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the mini-Medic™ device:

The provided document, K113165 P1/3, is a 510(k) Summary of Safety and Effectiveness for the Athena GTX mini-Medic™ wireless vital signs monitor. It describes the device, its intended use, and states that testing was completed to verify compliance with standards, concluding that the device is safe, effective, and substantially equivalent to listed predicate devices. However, it does not explicitly detail specific acceptance criteria or the numerical results of studies demonstrating performance against such criteria. The document focuses on regulatory compliance and substantial equivalence, rather than a detailed performance study report with acceptance criteria and their fulfillment.

Therefore, much of the requested information regarding specific acceptance criteria, reported performance, sample sizes for test/training sets, ground truth establishment, expert qualifications, and detailed study methodologies is not present in the provided text.

Here's what can be extracted and what is missing:

Description of Acceptance Criteria and Device Performance Studies

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: Not explicitly stated in the provided document. The document indicates that testing was completed "to verify compliance with recognized national and international standards for safety and performance for medical devices, and particular requirements applicable to this device." However, the specific numerical or qualitative acceptance criteria derived from these standards are not detailed.
Reported Device Performance: Not explicitly reported in numerical or quantitative terms for individual vital signs measurements. The document states that the mini-Medic™ is "capable of the same heart rate, functional oxygen saturation, pulse rate, pulse wave transit time and IR temperature measurements as have been provided by the combination of predicate devices referenced above." This implies performance is comparable to the predicate devices, but no concrete metrics are given.

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

Sample Size for Test Set: Not specified.
Data Provenance: Not specified.

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)

Number of Experts: Not specified.
Qualifications of Experts: Not specified.

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

Adjudication Method: Not specified.

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

MRMC Study: Not applicable. This device is a physiological monitor, not an AI-assisted diagnostic imaging device requiring human reader interpretation in the context of an MRMC study. The concept of "human readers improve with AI" does not align with the nature of this device.

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

Standalone Performance: The core function of the mini-Medic™ is to measure and display vital signs automatically. The 'testing' mentioned in the summary would inherently assess the standalone performance of these measurement capabilities against established standards (e.g., accuracy of SpO2, heart rate, temperature). While not detailed as an "algorithm only" study, the validation of such a device's measurements is by definition a standalone assessment of its sensory and processing capabilities. However, actual performance metrics are not provided.

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

Type of Ground Truth: Not specified. For physiological monitors, ground truth typically comes from reference gold-standard devices or established clinical methods (e.g., arterial blood gas analysis for SpO2, EKG for heart rate, calibrated thermometers for temperature). The document only states "compliance with recognized national and international standards for safety and performance."

8. The sample size for the training set

Sample Size for Training Set: Not applicable/Not specified. This device is a physiological monitor, not an AI/Machine Learning algorithm that typically requires a distinct "training set" in the same sense as image recognition or predictive models. Its parameters are likely based on established physiological principles and sensor calibration, not learned from a large dataset.

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

How Ground Truth for Training Set was Established: Not applicable/Not specified, for the reasons stated above.

Summary of what the document does indicate:

The mini-Medic™ is a standalone physiological monitor designed to measure SpO₂, cardiotachometer (heart rate), skin temperature, and pulse wave transit time (PWTT).
It is intended for use on patients 18 years and over by trained healthcare providers in various settings (pre-hospital, hospital, emergency medical, transport).
The manufacturer states that "testing on the mini-Medic™ has been completed to verify compliance with recognized national and international standards for safety and performance for medical devices," and that it is "substantially equivalent" to listed predicate devices in its capabilities.
The 510(k) clearance by the FDA indicates that the agency found the device to be substantially equivalent to legally marketed predicate devices, implying that its safety and effectiveness profiles are similar.

Conclusion:

The provided 510(k) summary (K113165) gives a high-level overview of the mini-Medic™ device and the regulatory determination of its substantial equivalence. However, it does not contain the detailed data for specific acceptance criteria and study results in the quantitative format requested. Such detailed performance data is typically found in the full 510(k) submission, which is not publicly available in this format, or in associated scientific publications or internal company reports.

Summary

{0}------------------------------------------------

K113165 P1/3

FEB - 2 2012

ﺐ ﻟﻤ

Section 5 – Summary of Safety and Effectiveness

Submission Date:	October 21, 2011
510(k) Submitter/Holder:	Athena GTX3620 SW 61st Street, Suite 395Des Moines, lowa 50321Ph: 515.288.3360 Fax: 515.288.3394
Company Contact:	Sean Mahoney (Chief Technical Officer)Office Phone Number: 515.288.3360Email: smahoney@athenagtx.com
Trade Name:	mini-Medic ™
Common Name:	Patient Physiological Monitor
Classification Name:	Patient Physiological Monitor (Refer to 21 CFR 870.2300)Cardiac Monitor (Including cardio tachometer and ratealarm) (Refer to 21 CFR 870.2300)Clinical Electronic Thermometer(Refer to 21 CFR 880.2910)Oximeter (Refer to 21 CFR 870.2700)Radiofrequency Physiological Signal Transmitter andReceiver (Refer to 21 CFR 870.2910)
ClassificationRegulation:	Class II
Basis for Submission:	New device design
Legally Marketed(Predicate) Devices:	Athena GTX Wireless Vital Signs Monitor (WVSM) K101674Envitec-Wismar GmbH OxiPen Pulse Oximeter K070193Exergen Temporal Scanner Thermometer K011291Nihon Kohden BSM-2300 Series Bedside Monitors K011918Nonin 8000R Reflectance Sensor (specified accessory inNonin 2500A monitor) K050056

510(k) Summary of Safety and Effectiveness

{1}------------------------------------------------

Section 5 – Summary of Safety and Effectiveness

Device Description:	The Athena GTX mini-Medic™ wireless vital signs monitorsystem is a small, lightweight, rugged, and highly portablepatient monitor designed to measure SpO₂, cardiotachometer, skin temperature and pulse wave transittime (PWTT). Vital signs are displayed directly on theforehead sensor and transmitted wirelessly to a handhelddisplay unit. Reports and data file saving is done via wirelessdownload to a PC.
Predicate DeviceOverview:	The mini-Medic™ is designed for the same application andintended use as the combination of listed predicate devices.The mini-Medic™ is capable of the same heart rate,functional oxygen saturation, pulse rate, pulse wave transittime and IR temperature measurements as have beenprovided by the combination of predicate devices referencedabove.
Intended Use:	The mini-Medic™ system is comprised of a minimum of oneForehead Sensor Unit and one Handheld Display Unit, andis intended for use on patients who are eighteen (18) yearsand over.The mini-Medic™ system is indicated as a single or multi-parameter vital signs monitor for SpO₂ and pulse rate via anintegrated SpO₂ forehead sensor, and/or heart rate fromECG electrodes, and forehead skin surface temperaturefrom an infrared temperature sensor. Pulse wave transit time(PWTT) is obtained utilizing pulse measurements from theintegrated SpO₂ forehead sensor and ECG electrodesplaced on the upper chest. Pulse wave transit time (PWTT)is used to track changes in blood pressure. Skintemperature is used as an adjunct to other clinical diagnosticprocedures in the diagnosis, quantifying, and screening ofrelative skin surface temperature for hyperthermia andhypothermia conditions.Patient data may be entered on the Handheld Display Unit.The mini-Medic™ system provides vital parameter alarmsand a patient composite/summary alarm.Patient information and system commands are transmittedusing wireless radio communications between the ForeheadSensor Unit and the Handheld Display Unit. Stored patient
	data may be output, printed, downloaded and saved via adedicated mini-Medic™ PC Software application.
	Typical locations for the use of the mini-Medic™ system are:pre-hospital (i.e., at the point of injury or trauma scene),hospital, healthcare facility, emergency medical application,and during ground or air transport. The monitor is intendedto be used by trained healthcare providers in military andcivilian roles including doctors, nurses, combat medics,combat lifesavers, EMT's, and paramedics.
Summary ofTesting:	Testing on the mini-Medic™ has been completed to verifycompliance with recognized national and internationalstandards for safety and performance for medical devices,and particular requirements applicable to this device.
Conclusion:	Based on the results for all safety and compliance testingperformed, it is the opinion of Athena GTX the mini-Medic™wireless vital signs monitor system is safe and effective, andis substantially equivalent to the above listed predicatedevices.

{2}------------------------------------------------

Section 5 – Summary of Safety and Effectiveness

{3}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is a stylized symbol that resembles an eagle or bird-like figure, with its wings spread. The logo is black and white.

Public Health Service

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

FEB - 2 2012

Athena GTX c/o Mr. Sean Mahoney Chief Technical Officer 3620 SW 61st Street, Suite 395 Des Moines. Iowa 50321

Re: K113165

Trade/Device Name: mini-Medic™ Wireless Vital Signs Monitor System Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (including cardiotachometer and rate alarm) Regulatory Class: Class II (two) Product Codes: MWI, DQA, FLL, DRT. DRG Dated: January 10, 2012 Received: January 11, 2012

Dear Mr. Mahoney:

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.

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

{4}------------------------------------------------

Page 2 - Mr. Sean Mahoney

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.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,

Bran D. Zuckerman, M.D.
Director

Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

Section 4 - Indications for Use Statement

Indications for Use Statement

510(k) Number: KIJ 3165

Device Name: mini-Medic™ System

Indications for Use:

The mini-Medic™ system is comprised of a minimum of one Forehead Sensor Unit and one Handheld Display Unit, and is intended for use on patients who are eighteen (18) years and over.

The mini-Medic™ system is indicated as a single or multi-parameter vital signs monitor for SpO2 and pulse rate via an integrated SpO2 forehead sensor, and/or heart rate from ECG electrodes. and forehead skin surface temperature from an infrared temperature sensor. Pulse wave transit time (PWTT) is obtained utilizing pulse measurements from the integrated SpO2 forehead sensor and ECG electrodes placed on the upper chest. Pulse wave transit time (PWTT) is used to track changes in blood pressure. Skin temperature is used as an adjunct to other clinical diagnostic procedures in the diagnosis, quantifying, and screening of relative skin surface temperature for hyperthermia and hypothermia conditions.

Patient data may be entered on the Handheld Display Unit. The mini-Medic™ system provides vital parameter alarms and a patient composite/summary alarm.

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)

(Division Sign-Off)
Division of Cardiovascular Devices

510(k) Number	K113165
---------------	---------

{ 4 - 1 }

Regulation Number and Section

§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).

(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).