The T3 Platform™ software features the T3 Data Aggregation & Visualization software module version 5.0 and the T3 Risk Analytics Engine software module version 8.0.

The T3 Data Aggregation & Visualization software module is intended for the recording and display of multiple physiological parameters of the adult, pediatric, and neonatal patients from supported bedside devices. The software module 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. The software module 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.

The T3 Data Aggregation & Visualization software module 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)

The T3 Data Aggregation & Visualization software module can display laboratory measurements including arterial and venous blood gases, complete blood count, and lactic acid. T3 Data Aggregation & Visualization software module can display information captured by the T3 Risk Analytics Engine software module,

The T3 Risk Analytics Engine software module calculates four indices: the IDO2 Index™ for inadequate delivery of oxygen, the IVCO2 Index™ for inadequate ventilation of carbon dioxide, the ACD Index™ for acidemia, and the HLA Index™ for hyperlactatemia.

The IDO2 Index™ is indicated for use by health care professionals with post-surgical patients 0 to 12 years of age and weighing 2 kg or more under intensive care. The IDO2 Index™ is derived by mathematical manipulations of the physiologic data and laboratory measurements received by the T3 Data Aggregation & Visualization software module. When the IDO2 Index™ is increasing, it means that there is an increasing risk of inadequate oxygen delivery and attention should be brought to the patient. The IDO2 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.

The IVCO2 Index™ is indicated for use by health care professionals with invasively ventilated patients 0 to 12 years of age and weighing 2 kg or more under intensive care. The IVCO2 Index™ is derived by mathematical manipulations of the physiologic data and laboratory measurements received by the T3 Data Aggregation and Visualization software module. When the IVCO2 Index™ is increasing, it means that there is an increasing risk of inadequate carbon dioxide ventilation and attention should be brought to the IVCO2 Index™ presents partial quantitative information about the patient's respiratory condition, and no therapy or drugs can be administered based solely on the internets.

The ACD Index™ is indicated for use by health care professionals with invasively ventilated patients 0 to 12 years of age and weighing 2 kg or more under intensive care. The ACD Index™ is derived by mathematical manipulations of the physiologic data and laboratory measurements received by the T3 Data Aggregation and Visualization software module. When the ACD Index™ is increasing, it means that there is an increasing risk of acidemia and attention should be brought to the patient. The ACD Index™ presents partial quantitative information about the patient's respiratory condition, and no therapy or drugs can be administered based solely on the interpretation statements.

The HLA Index™ is indicated for use by health care professionals with post-surgical patients 0 to 12 years of age and weighing 2 kg or more under intensive care. The HLA Index™ is derived by mathematical manipulations of the physiologic data and laboratory measurements received by the T3 Data Aggregation & Visualization software module. When the HLA Index™ is increasing, it means that there is an increasing risk of hyperlactaternia and attention should be brought to the patient. The HLA 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.

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. System features include:

Adjunctive status indicators
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

AI/ML Overview

Here's an analysis of the acceptance criteria and study proving the device meets those criteria, based on the provided text:

Device: T3 Platform™ software (specifically the T3 Risk Analytics Engine software module version 8.0, which calculates the IDO2 Index™, IVCO2 Index™, ACD Index™, and HLA Index™).

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are broadly defined as "discriminatory power, range utilization, resolution/limitation, and robustness." While specific numerical thresholds for these criteria are not provided in the document, the conclusion states that "All results met acceptance criteria for discriminatory power, range utilization, resolution/limitation, and robustness."

Acceptance Criteria	Reported Device Performance
Discriminatory Power	Met acceptance criteria (all indices)
Range Utilization	Met acceptance criteria (all indices)
Resolution/Limitation	Met acceptance criteria (all indices)
Robustness	Met acceptance criteria (all indices)

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

The document provides sample sizes for the validation of the new indices (ACD and HLA Indexes):

HLA Index Validation: 58,168 whole blood lactate measurements from 3,496 patients.
ACD Index Validation: 24,431 arterial blood pH measurements from 1,858 patients.

Data Provenance:

Country of Origin: United States (data from eleven different clinical sites in the US).
Retrospective or Prospective: Retrospectively computed on all de-identified patients.

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

The document does not specify the number of experts or their qualifications used to establish the ground truth for the test set. It states that the indices are "derived by mathematical manipulations of the physiologic data and laboratory measurements" and that the "underlying physiology model" for the indices has been updated. The ground truth for the ACD Index is defined as "arterial pH less than 7.25" and for the HLA Index as "whole blood lactate level concentration above 4 mmol / L." These appear to be objective thresholds based on laboratory measurements rather than expert consensus on interpretations of images or complex clinical states.

4. Adjudication Method for the Test Set

No adjudication method (e.g., 2+1, 3+1) is mentioned or appears to be relevant given the nature of the ground truth (objective laboratory measurements).

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

No MRMC study was done, as the device is a risk analytics engine providing calculated indices, not an imaging AI designed to assist human readers in interpreting medical images. The primary use is for "remotely consult regarding a patient's status" and "remotely review other standard or critical near real-time patient data in order to aid in clinical decisions and deliver patient care." The indices provide "partial quantitative information" and "no therapy or drugs can be administered based solely on the interpretation statements." Furthermore, the warnings state: "Do not rely on the T3 Platform software as the sole source of patient status information." This indicates an adjunctive role rather than one where human interpretation is directly assisted in a comparative effectiveness study.

6. Standalone (Algorithm Only) Performance Study

Yes, the validation of the ACD Index and HLA Index appears to be a standalone (algorithm only) performance study against objective ground truth derived from laboratory measurements. The indices were "retrospectively computed on all de-identified patients" and evaluated against the defined acceptance criteria.

7. Type of Ground Truth Used

The ground truth used is primarily outcomes data / objective laboratory measurements.

For the ACD Index: Arterial blood pH measurements, with acidemia defined as arterial pH less than 7.25.
For the HLA Index: Whole blood lactate measurements, with hyperlactatemia defined as whole blood lactate level concentration above 4 mmol/L.

8. Sample Size for the Training Set

The document does not explicitly state the sample size for a dedicated "training set." It mentions that the "approach is designed based on principles of physiology, and parameters are chosen to reflect those specified in the medical literature and employed development testing data sets and validation sets." It distinguishes between "Development testing sets" (used to evaluate impact of changes during development) and "Validation sets" (used after development is complete). The sample sizes provided (3,496 patients for HLA, 1,858 patients for ACD) are for the validation sets. The size of the "development testing sets" is not specified.

9. How Ground Truth for the Training Set Was Established

The document implies that the model's development and parameter choices were guided by "principles of physiology" and "medical literature," which would have formed the basis for the ground truth during the development ("training") phase. For the actual performance testing, the ground truth was established by objective laboratory measurements (arterial pH and whole blood lactate levels) with pre-defined thresholds for acidemia and hyperlactatemia. The details of how ground truth was precisely established for the "development testing data sets" are not explicitly detailed, but it would logically follow the same principles of using objective physiological and laboratory data.

Summary

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June 22, 2022

Etiometry, Inc. Tim Hanson VP of RA/QA 280 Summer St, 4th Floor Boston, Massachusetts 02210

Re: K213230

Trade/Device Name: T3 Platform Software Regulation Number: 21 CFR 870.2200 Regulation Name: Adjunctive Cardiovascular Status Indicator Regulatory Class: Class II Product Code: PPW Dated: September 27, 2021 Received: September 29, 2021

Dear Tim Hanson:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

LCDR Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K213230

Device Name T3 Platform™ software

Indications for Use (Describe)

The T3 Platform™ software features the T3 Data Aggregation & Visualization software module version 5.0 and the T3 Risk Analytics Engine software module version 8.0.

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.

The T3 Data Aggregation & Visualization software module 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)

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WARNINGS:

· Do not use the T3 Platform software as an active patient monitoring system.
· Do not use the T3 Platform software to replace any part of the hospital's device monitoring.
· Do not rely on the T3 Platform software as the sole source of patient status information.
· Do not use any of the T3 Platform indices as a substitute for taking blood samples.
· The indices present qualitative and potentially imperfect information of the patient's condition and in certain scenarios, the indices may contradict each other. The primary data should be reviewed as part of standard patient evaluations and no decisions should be solely based on the indices.

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Blank space

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

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May 13, 2022

This 510(k) summary has been prepared in accordance with Title 21 CFR §807.92 and FDA's guidance document, "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications 510(k)" July 28, 2014

9.1 510(k) Submitter

Timothy Hanson, VP of Regulatory Affairs and Quality Assurance 280 Summer St., 4th Floor Boston, MA 02210 Tel: 857.366.9333 ext. 2020 Email: THanson@etiometry.com

9.2 Device

Item	Description
Device Trade Name	T3 Platform™ software
Device Common/Usual Name	Clinical Decision Support Software (without alarms)
Classification Name	Adjunctive cardiovascular status indicator
Classification Number	870.2200
Regulatory Class	Class II with special controls - the primary code is PPW: The adjunctivecardiovascular status indicator is a prescription device based on sensortechnology for the measurement of a physical parameter(s). This device isintended for adjunctive use with other physical vital sign parameters andpatient information and is not intended to independently direct therapy.

Table 97: Device Information

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9.3 Predicate Devices

The primary predicate device is the CipherOx CRI, cleared under DEN160020, and the supportive predicate device is the T3 Platform™ software featuring the T3 Data Aggregation & Visualization software module version 5.0 and the T3 Risk Analytics Engine software module version 6.0, cleared under K202306. These predicates have not been subject to a design-related recall. No reference devices were used in this submission.

9.4 Device Description

Adjunctive status indicators
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

9.5 Indications for Use

The T3 Platform™ software features the T3 Data Aggregation & Visualization software module version 5.0 and the T3 Risk Analytics Engine software module version 8.0.

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.

The T3 Data Aggregation & Visualization software module 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

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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)

The T3 Data Aggregation & Visualization software module can display laboratory measurements including arterial and venous blood gases, complete blood count, and lactic acid.

The T3 Data Aggregation & Visualization software module can display information captured by the T3 Risk Analytics Engine software module.

The IVCO2 Index™ is indicated for use by health care professionals with invasively ventilated patients 0 to 12 years of age and weighing 2 kg or more under intensive care. The IVCO2 Index™ is derived by mathematical manipulations of the physiologic data and laboratory measurements received by the T3 Data Aggregation and Visualization software module. When the IVCO2 Index™ is increasing, it means that there is an increasing risk of inadequate carbon dioxide ventilation and attention should be brought to the patient. The IVCO2 Index™ presents partial quantitative information about the patient's respiratory condition, and no therapy or drugs can be administered based solely on the interpretation statements.

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manipulations of the physiologic data and laboratory measurements received by the T3 Data Aggregation & Visualization software module. When the HLA Index™ is increasing, it means that there is an increasing risk of hyperlactatemia and attention should be brought to the patient. The HLA 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.

WARNINGS:

Do not use the T3 Platform™ software as an active patient monitoring system. ●
Do not use the T3 Platform™ software to replace any part of the hospital's device ● monitoring.
Do not rely on the T3 Platform™ software as the sole source of patient status information.
Do not use any of the T3 Platform™ indices as a substitute for taking blood samples.
The indices present qualitative and potentially imperfect information of the patient's condition and in certain scenarios, the indices may contradict each other. The primary data should be reviewed as part of standard patient evaluations and no decisions should be solely based on the indices.

9.6 Comparison of Technological Characteristics with the Predicate Device

The primary predicate device, having the product code PPW, is intended for use as a multiparameter monitor that uses sensor technology to measure a specific parameter. The devices that fall under this regulation product code (Adjunctive cardiovascular status indicator 21 CFR 870.2200) do not have alarms and do not have a set decision point, matching the functionalities of the subject device. The regulation product code of the primary predicate device includes special controls that were applied to the subject T3 Platform™ software. The regulation product codes between the subject T3 Platform™ software and supportive predicate T3 Platform™ software were unchanged. The subject T3 Platform™ software and supportive predicate T3 Platform™ software have the same Intended Use adding the ACD and HLA Indices.

Feature/Improvement	Description
ACD Index	The underlying physiology model of the Risk Analytics Engine (version8.0) has been updated to afford the computation of a new index whichis a measure of the likelihood that an arterial blood gas will indicateacidemia defined as arterial pH less than 7.25. The new index has beensubject to the same performance testing as the predicate IDO2 andIVCO2 indices. Specifically, the enclosed 510(k) application includesperformance test results using clinical data, covering the indicatedpatient age range: 0 to 12 years of age.
Feature/Improvement	Description
HLA Index	Additional changes to the underlying physiology model of the RiskAnalytics Engine (version 8.0) enable the computation of a second newindex which is a measure of the likelihood that a laboratory result willindicate hyperlactatemia defined as whole blood lactate levelconcentration above 4 mmol / L. The new index has been subject to thesame performance testing as the predicate IDO2 and IVCO2 indices.Specifically, the enclosed 510(k) application includes performance testresults using clinical data, covering the indicated patient age range: 0 to12 years of age.
Tidal Volume to Minute Ventilation InputChange	The Risk Analytics Engine (version 8.0) employs direct measurements ofminute ventilation provided by the ventilator instead of relying on theindirect calculation of minute ventilation accomplished by multiplyingtidal volume and respiratory rate.
Removal of EtCO2 as required input forIVCO2	The IVCO2 Index included as part of the Risk Analytics Engine (version8.0) no longer requires EtCO2 to be available as part of the minimumdata. More specifically, the software utilizes blood gas measurements,arterial or venous pCO2 collected at a minimum of once every 12 hours,interchangeably with EtCO2 measurements. When blood gases are notavailable, the software processes available EtCO2 measurements tosatisfy the minimum data set required as was the case in previouscleared releases.
Continuous Performance Assessment	In order to continually monitor the performance of the Risk Indices indifferent operating environments and clinical settings, the ContinuousPerformance Assessment module (CPA) was developed, whichperiodically computes all critical performance metrics for a site andreports these metrics via email to the Etiometry Support team. If theCPA tool indicates that the performance of the Risk indices at aparticular site is out of specification, the support team can use thisinformation to take action, investigate the root cause, and applymitigation measures as needed.
Repair to the Risk Algorithm Engine responseto Reinitialization	As part of the required behavior, when a Risk index is initialized on anindividual patient, the index is not reported before the minimum dataset is achieved and the index is calibrated (5 minutes post initialization).This behavior was not propagated to the rare instances of algorithmreinitialization, which did not match the original requirement. The RiskAnalytics Engine (version 8.0) provides a repair that satisfies the originalrequirement.
Feature/Improvement	Description
IVCO2 Index patient population	The patient population in the indications for use was expanded from 29days to 12 years of age to 0 to 12 years of age for the IVCO2 Index inthe Risk Analytics Engine (version 8.0).

The subject and predicate devices differ with respect to several technological features. (see Table 98).

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rable 98: Summary of Changes

9.7 Summary of Non-Clinical Performance Testing

Software documentation was provided in accordance with the 2017 FDA guidance document Software as a Medical Device (SAMD): Clinical Evaluation section 5.3 Analytical Validation of a SaMD to support device software with a moderate level of concern and to confirm and provide objective evidence that the software was correctly constructed.

Cybersecurity information was provided in accordance with the 2014 FDA guidance document Content of Premarket Submissions for Management of Cybersecurity in Medical Devices.

Additional summative evaluations were completed to demonstrate the consistency of the output, representative of the range of data sources and data quality, likely to be encountered.

Human factors testing was used to support that device users could safely use the device.

9.8 Summary of Clinical Performance Testing

All of the four indices are a product of a model-based approach to risk estimation. The approach is designed based on principles of physiology, and parameters are chosen to reflect those specified in the medical literature and employed development testing data sets and validation sets. Development testing sets are used to evaluate the impact of the development changes during the development process. Validation sets are then used after all development is complete to validate that performance holds on an independent data set.

The four indices were validated utilizing validation sets that included data from eleven different clinical sites in the US. The clinical study data were obtained by the T3 Platform software. No adverse effects and complications were noted. The indices were retrospectively computed on all de-identified patients. The new indices were evaluated against the same acceptance criteria as the supportive predicate device, being discriminatory power, range utilization, resolution/limitation, and robustness.

A patient cohort was used to validate the HLA Index. The distribution of the points included in the HLA study among the participating centers totaling 58,168 whole blood lactate measurements from 3,496 patients was included in that validation data set. The demographics were 31% infants, and 33% children.

A patient cohort was used to validate the ACD Index. The distribution of the points included in the ACD study among the participating centers totaling 24,431 arterial blood pH measurements from 1,858 patients was included in the validation data set. The demographics were 40% infants, and 26% children.

Additionally, subpopulations studies (neonates, infants, and children) under each of the HLA study and ACD study were completed.

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All results met acceptance criteria for discriminatory power, range utilization, resolution/limitation, and robustness.

Software documentation was provided in accordance with the 2017 FDA guidance document Software as a Medical Device (SAMD): Clinical Evaluation section 5.3 Analytical Validation of a SaMD to support device software with a moderate level of concern and to yield a clinically meaningful output associated to the target use of the output in the target health care situation identified in the definition statement.

9.9 Summary

Based on the clinical performance, the T3 Platform™ software was found to have a safety and effectiveness profile that is similar to the predicate devices.

9.10 Conclusions

Substantial equivalence of the T3 Platform™ software is demonstrated through performance testing and clinical evaluation and through the special controls of the PPW product code of the primary predicate device. The T3 Platform™ software has the equivalent design, features, and functionality as the supportive predicate T3 Platform™ software with few exceptions. 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 devices. The software verification demonstrates that the T3 Platform™ software performs as intended in the specified use conditions. The clinical evaluation demonstrates that the T3 Platform™ software performs comparably to the predicate devices that are currently marketed for the same intended use.

Regulation Number and Section

§ 870.2200 Adjunctive cardiovascular status indicator.

(a)
Identification. The adjunctive cardiovascular status indicator is a prescription device based on sensor technology for the measurement of a physical parameter(s). This device is intended for adjunctive use with other physical vital sign parameters and patient information and is not intended to independently direct therapy.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Software description, verification, and validation based on comprehensive hazard analysis must be provided, including:
(i) Full characterization of technical parameters of the software, including any proprietary algorithm(s);
(ii) Description of the expected impact of all applicable sensor acquisition hardware characteristics on performance and any associated hardware specifications;
(iii) Specification of acceptable incoming sensor data quality control measures; and
(iv) Mitigation of impact of user error or failure of any subsystem components (signal detection and analysis, data display, and storage) on accuracy of patient reports.
(2) Scientific justification for the validity of the status indicator algorithm(s) must be provided. Verification of algorithm calculations and validation testing of the algorithm using a data set separate from the training data must demonstrate the validity of modeling.
(3) Usability assessment must be provided to demonstrate that risk of misinterpretation of the status indicator is appropriately mitigated.
(4) Clinical data must be provided in support of the intended use and include the following:
(i) Output measure(s) must be compared to an acceptable reference method to demonstrate that the output measure(s) represent(s) the predictive measure(s) that the device provides in an accurate and reproducible manner;
(ii) The data set must be representative of the intended use population for the device. Any selection criteria or limitations of the samples must be fully described and justified;
(iii) Agreement of the measure(s) with the reference measure(s) must be assessed across the full measurement range; and
(iv) Data must be provided within the clinical validation study or using equivalent datasets to demonstrate the consistency of the output and be representative of the range of data sources and data quality likely to be encountered in the intended use population and relevant use conditions in the intended use environment.
(5) Labeling must include the following:
(i) The type of sensor data used, including specification of compatible sensors for data acquisition;
(ii) A description of what the device measures and outputs to the user;
(iii) Warnings identifying sensor reading acquisition factors that may impact measurement results;
(iv) Guidance for interpretation of the measurements, including warning(s) specifying adjunctive use of the measurements;
(v) Key assumptions made in the calculation and determination of measurements;
(vi) The measurement performance of the device for all presented parameters, with appropriate confidence intervals, and the supporting evidence for this performance; and
(vii) A detailed description of the patients studied in the clinical validation (
e.g., age, gender, race/ethnicity, clinical stability) as well as procedural details of the clinical study.