The T3 Software is intended for the recording and display of multiple physiological parameters of adult, pediatric and neonatal patients from supported bedside devices. T3 is not intended for alarm notification or waveform display, nor is it intended to control any of the independent bedside devices to which it is connected. T3 is intended to be used by healthcare professionals for the following purposes:

To remotely consult regarding a patient's status, and
To remotely review other standard or critical near real-time patient data in order to aid in clinical decisions and deliver patient care in a timely manner.
T3 can display numeric physiologic data captured by other medical devices:
Airway flow, volume and pressure
Arterial blood pressure (invasive and non-invasive, systolic, diastolic, and mean)
Bispectral index (BIS, signal quality index, suppression ratio)
Cardiac Index
Cardiac output
Central venous pressure
Cerebral perfusion pressure
End-tidal CO2
Heart rate
Heart rate variability
Intracranial pressure
Left atrium pressure
Oxygen saturation (intravascular, regional, SpO2)
Premature ventricular counted beats
Pulmonary artery pressure (systolic, diastolic, and mean)
Pulse pressure variation
Pulse Rate
Respiratory rate
Right atrium pressure
Temperature (rectal, esophageal, tympanic, blood, core, nasopharyngeal, skin)
Umbilical arterial pressure (systolic, diastolic, and mean)
It can also display laboratory measurements including arterial and venous blood count, and lactic acid.
T3 includes a Patient Risk Analytics Engine that calculates an index (the Inadequate Oxygen Delivery Index) that is indicated for use by health care professionals with post-surgical neonatal patients weighing 2 kg or more under intensive care. The Inadequate Oxygen Delivery Index is derived by mathematical manipulations of the physiologic data and laboratory measurements received by T3. When the index is elevated, it means that there is increased risk of inadequate oxygen delivery and attention should be brought to the index presents partial quantitative information about the patient's cardiovascular condition, and no therapy or drugs can be administered based solely on the interpretation statements.
WARNING: T3 Software is not an active patient monitoring system. It is intended to supplement and not replace any part of the hospital's device monitoring. Do not rely on the T3 Software Solution as the sole source of patient status information.

Device Description

The Tracking, Trajectory, Trigger (T3) intensive care unit software solution allows clinicians and quality improvement teams in the ICU to aggregate data from multiple sources, store it in a database for analysis, and view the streaming data in real-time. System features include:

Customizable display of physiologic parameters over entire patient stay.
Configurable annotation
Web-based visualization that may be used on any standard browser
Minimal IT footprint
Software-only solution no new bedside hardware required
Highly reliable and robust operation.
Auditable data storage.
The subject device is a modification of the T3 Software that includes Risk Analytics Engine that computes an Inadequate Oxygen Delivery Index (IDO2). The IDO2 Index is derived by mathematical manipulations of the physiologic data and laboratory measurements received by T3. This index provides an interpretation of how different the patient's physiologic measures are from normality.

AI/ML Overview

The provided text describes the T3 Software, version 2.0.1, which includes a Patient Risk Analytics Engine calculating an Inadequate Oxygen Delivery Index (IDO2). The document is a 510(k) summary, making it a submission to the FDA for market clearance, stating that the new version is substantially equivalent to previous versions and other predicate devices.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based only on the provided text:

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

The document does not explicitly present specific, quantitative acceptance criteria for the IDO2 Index. Instead, it relies on demonstrating that the device's software functions as intended and that the IDO2 Index correlates with changes in physical status, similar to a predicate device.

Acceptance Criteria (Implicit from document)	Reported Device Performance
Software Functionality: The software records and displays multiple physiological parameters accurately from supported bedside devices.	"Software verification and validation testing was conducted for the subject device... The results of this testing demonstrate the safety and effectiveness of the subject T3 software product (Ver. 2.0.1) is comparable to that of the predicate T3 software products (Ver. 1.9)." (Implies successful operation and comparable accuracy to predicate for data display and recording)
IDO2 Index Calculation & Interpretation: The Patient Risk Analytics Engine calculates the IDO2 Index correctly based on mathematical manipulations, and when elevated, indicates an "increased risk of inadequate oxygen delivery." (Accuracy of calculation and qualitative interpretation)	"The Inadequate Oxygen Delivery Index is derived by mathematical manipulations of the physiologic data and laboratory measurements received by T3. When the index is elevated, it means that there is increased risk of inadequate oxygen delivery..." (The document states how it's derived and what an elevated index means, implying it performs this function as designed.)
Clinical Correlation of IDO2 Index: The IDO2 Index correlates with changes in the patient's physical status.	"Additionally, validation study results using clinical data gathered in the intended patient population demonstrate the IDO2 Index included in the subject device correlates with changes in the patient's physical status, as does the Visensia Index." (Directly states correlation observed in a validation study.)
Safety and Effectiveness: The device is safe and effective and raises no new questions of safety or effectiveness compared to predicate devices.	"The results of this testing demonstrate the safety and effectiveness of the subject T3 software product (Ver. 2.0.1) is comparable to that of the predicate T3 software products (Ver. 1.9) and the Visensia device." and "No new questions of safety or effectiveness are raised as a result of the differences when compared to the predicate device and the data provided in the submission show that the subject device is substantially equivalent to the legally-marketed predicate devices."

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 states: "Additionally, validation study results using clinical data gathered in the intended patient population demonstrate the IDO2 Index included in the subject device correlates with changes in the patient's physical status, as does the Visensia Index."

Sample Size: The sample size for the "validation study" is not specified in the provided text.
Data Provenance: The country of origin of the data is not specified. The text only mentions "clinical data gathered in the intended patient population." It is also not specified if the data was retrospective or 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)

The document does not provide any information regarding the number of experts used or their qualifications for establishing ground truth in the validation study. The ground truth refers to "changes in the patient's physical status," but how this was determined by experts is not detailed.

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

The document does not specify any adjudication method used for the test set.

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

The document does not describe a multi-reader multi-case (MRMC) comparative effectiveness study. The study focused on the correlation of the IDO2 Index with patient physical status. There is no mention of human readers or their improvement with or without AI assistance. The device is intended to aid clinical decisions and provide quantitative information, but not in a comparative effectiveness study involving human interpretation.

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

Yes, the validation study appears to be a standalone performance study of the algorithm. The statement "validation study results... demonstrate the IDO2 Index... correlates with changes in the patient's physical status" indicates an evaluation of the algorithm's output (the IDO2 Index) against an independent measure of patient status, without involving human-in-the-loop performance measurement.

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

The ground truth used is "changes in the patient's physical status." The specific method for determining "changes in the patient's physical status" (e.g., expert consensus, specific clinical criteria, or other outcomes data) is not detailed in the provided text.

8. The sample size for the training set

The document does not specify a separate "training set" or its sample size. The description focuses on the validation of the IDO2 Index, which implies the algorithm's parameters were already established.

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

Since a "training set" is not mentioned, the document does not provide information on how ground truth for any training set was established. The IDO2 Index is described as being "derived by mathematical manipulations of the physiologic data and laboratory measurements," suggesting a formulaic or rule-based derivation rather than a machine learning model trained on labeled data in the context usually implied by "training set ground truth."

Summary

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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and features the department's name around the perimeter. In the center is an abstract symbol resembling an eagle or bird in flight, composed of three stylized human profiles facing right. The logo is black and white.

Public Health Service

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

March 31, 2016

Etiometry, Inc. % Richard Galgon Independent Consulting Associate Quintiles 5846 Cobblestone Lane Waunakee, Wisconsin 53597

Re: K152258

Trade/Device Name: T3 Software Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer And Rate Alarm) Regulatory Class: Class II Product Code: PLB, MWI Dated: February 19, 2016 Received: February 24, 2016

Dear Richard Galgon:

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 device

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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 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.

Mitchell Stein

for 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K152258

Device Name T3 Software Version 2.0.1

Indications for Use (Describe)

· To remotely consult regarding a patient's status, and
· To remotely review other standard or critical near real-time patient data in order to aid in clinical decisions and deliver patient care in a timely manner.

T3 can display numeric physiologic data captured by other medical devices:

· Airway flow, volume and pressure
· Arterial blood pressure (invasive and non-invasive, systolic, diastolic, and mean)
· Bispectral index (BIS, signal quality index, suppression ratio)
Cardiac Index
Cardiac output
Central venous pressure
· Cerebral perfusion pressure
· End-tidal CO2
· Heart rate
· Heart rate variability
Intracranial pressure
· Left atrium pressure
· Oxygen saturation (intravascular, regional, SpO2)
· Premature ventricular counted beats
· Pulmonary artery pressure (systolic, diastolic, and mean)
· Pulse pressure variation
Pulse Rate
· Respiratory rate
· Right atrium pressure
· Temperature (rectal, esophageal, tympanic, blood, core, nasopharyngeal, skin)
· Umbilical arterial pressure (systolic, diastolic, and mean)

It can also display laboratory measurements including arterial and venous blood count, and lactic acid.

T3 includes a Patient Risk Analytics Engine that calculates an index (the Inadequate Oxygen Delivery Index) that is indicated for use by health care professionals with post-surgical neonatal patients weighing 2 kg or more under intensive care. The Inadequate Oxygen Delivery Index is derived by mathematical manipulations of the physiologic data and laboratory measurements received by T3. When the index is elevated, it means that there is increased risk of inadequate oxygen delivery and attention should be brought to the index presents partial quantitative information about the patient's cardiovascular condition, and no therapy or drugs can be administered based solely on the interpretation statements.

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WARNING: T3 Software is not an active patient monitoring system. It is intended to supplement and not replace any part of the hospital's device monitoring. Do not rely on the T3 Software Solution as the sole source of patient status information.

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary

510(k) Number K152258

I. 510(k) Submitter

Company Name and Address:

Etiometry, Inc. 119 Braintree Street Boston, MA 02134

Company Contact: Dimitar Baronov, PhD Chief Technology Officer Phone: 857.366.9333 ext. 2005 E-mail: baronov@etiometry.com

Date Prepared: March 30, 2016

II. Device

Device Trade Name: T3 Software (Version 2.0.1)

Device Common/Usual Name: Data Management Software (without alarms)

Classification Name: Cardiac monitor (including cardiotachometer and rate alarm)

Classification Number: 870.2300

Regulatory Class: II

Product Code: PLB: Automated calculation of a summary index (or indices) based on several individual measured vital sign inputs. Secondary code is MWI; monitor, physiological, patient (without arrhythmia detection or alarms)

III. Predicate Device

T3 Software (Version 1.9) cleared under K142732 and K151715. 1.
Visensia cleared under K081140 and K110953. 2.

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IV. Device Description

The Tracking, Trajectory, Trigger (73) intensive care unit software solution allows clinicians and quality improvement teams in the ICU to aggregate data from multiple sources, store it in a database for analysis, and view the streaming data in real-time. System features include:

Customizable display of physiologic parameters over entire patient stay .
Configurable annotation ●
Web-based visualization that may be used on any standard browser ●
Minimal IT footprint ●
Software-only solution no new bedside hardware required ●
Highly reliable and robust operation .
Auditable data storage .

The subject device is a modification of the T3 Software that includes Risk Analytics Engine that computes an Inadequate Oxygen Delivery Index (IDO2). The IDO2 Index is derived by mathematical manipulations of the physiologic data and laboratory measurements received by T3. This index provides an interpretation of how different the patient's physiologic measures are from normality.

Indications for Use

To remotely consult regarding a patient's status, and
. To remotely review other standard or critical near real-time patient data in order to utilize this information to aid in clinical decisions and deliver patient care in a timely manner.

T3 can display numeric physiologic data captured by other medical devices:

Airway flow, volume and pressure
Arterial blood pressure (invasive and non-invasive, systolic, diastolic, and mean) .
. Bispectral index (BIS, signal quality index, suppression ratio)
. Cardiac Index
Cardiac output
Central venous pressure
Cerebral perfusion pressure
. End-tidal CO2
Heart rate
Heart rate variability .
Intracranial pressure

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. Left atrium pressure
Oxygen saturation (intravascular, regional, SpO2) ●
. Premature ventricular counted beats
Pulmonary artery pressure (systolic, diastolic, and mean)
. Pulse pressure variation
Pulse Rate
Respiratory rate
Right atrium pressure
Temperature (rectal, esophageal, tympanic, blood, core, nasopharyngeal, skin)
. Umbilical arterial pressure (systolic, diastolic, and mean)

It can also display laboratory measurements including arterial and venous blood gases, complete blood count, and lactic acid.

T3 includes a Patient Risk Analytics Engine that calculates an index (the Inadequate Oxygen Delivery Index) that is indicated for use by health care professionals with postsurgical neonatal patients weighing 2 kg or more under intensive care. The Inadequate Oxygen Delivery Index is derived by mathematical manipulations of the physiologic data and laboratory measurements received by T3. When the index is elevated, it means that there is increased risk of inadequate oxygen delivery and attention should be brought to the patient. The index presents partial quantitative information about the patient's cardiovascular condition, and no therapy or drugs can be administered based solely on the interpretation statements.

V. Comparison of Technological Characteristics with the Predicate Device

The subject and predicate T3 Software systems are web based and designed to acquire data from the network source and display the information remotely for clinicians to use in the care of their patients. The subject T3 software is designed for future scalability and requires a second server where the Risk Analytics Engine runs.

The subject T3 and predicate Visensia software are designed to acquire data from the network source and display the information remotely for clinicians to use in the care of their patients, alongside a derived index. The subject T3 software differs from the predicate Visensia device in requiring a more powerful CPU, more RAM, and a bigger hard drive. Also the subject T3 software runs on Red Hat Enterprise Linux while the predicate Visensia device runs on Microsoft Windows

VI. Performance Data

Software verification and validation testing was conducted for the subject device and documentation was provided in accordance with FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices", May 11, 2005. The

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results of this testing demonstrate the safety and effectiveness of the subject T3 software product (Ver. 2.0.1) is comparable to that of the predicate T3 software products (Ver. 1.9) and the Visensia device.

Additionally, validation study results using clinical data gathered in the intended patient population demonstrate the IDO2 Index included in the subject device correlates with changes in the patient's physical status, as does the Visensia Index.

VII. Conclusions

Substantial equivalence of the T3 Software is demonstrated through performance testing. The T3 Software has equivalent design, features and functionality as the predicate T3 Software with few exceptions and these exceptions do not affect the safety or effectiveness of the system.

No new questions of safety or effectiveness are raised as a result of the differences when compared to the predicate device and the data provided in the submission show that the subject device is substantially equivalent to the legally-marketed predicate devices.

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).