The AITRICS-VC is stand-alone software intended to analyze patient data sourced from an EHR (Electronic Health Record) system and display data of in-hospital patient data whose vital signs, blood test results, or conventional early warning scores such as MEWS, and qSOFA exceed predefined thresholds. It is not intended to replace bedside patient monitors or clinical decision-making. It is not indicated for use in high-acuity environments like the ICU or operating rooms for acutely or critically ill patients. It may be used by clinicians to aid in understanding a patient's current condition and changes over time. The AITRICS-VC is solely indicated for use in the general ward of a hospital environment.

Device Description

AITRICS-VC is a clinical decision support software that receives in-hospital patient information, including physiological parameters such as vital signs and blood test results from EHR and conducts rule-based calculations for conventional early warning scores, which include NEWS (National Early Warning Score), MEWS (Modified Early Warning Score), and qSOFA (quickSOFA).

The AITRICS-VC screens patients who meet predefined criteria based on single values of physiological parameters and early warning scores. It displays a multi-patient dashboard and detailed pages for individual patients via a web browser on clinicians' PCs.

AI/ML Overview

Here's an analysis of the AITRICS-VC device based on the provided FDA 510(k) summary, structured to address your specific questions.

Currently, this document lacks specific details on the acceptance criteria and performance of the AITRICS-VC, as well as the specifics of any studies conducted to validate its performance. The document focuses on regulatory approval based on substantial equivalence to a predicate device and adherence to harmonized non-clinical standards.

Therefore, many sections of your request cannot be fully answered with the provided information. However, I will extract and present all available relevant information and note where data is missing.

Description of Acceptance Criteria and Device Performance

The provided document describes the AITRICS-VC as a standalone software intended to analyze patient data from an EHR and display data when vital signs, blood test results, or conventional early warning scores (MEWS, NEWS, qSOFA) exceed predefined thresholds.

Crucially, the document explicitly states: "No new issues of safety or effectiveness are introduced as a result of using this device. This device does not require clinical data." This indicates that a detailed clinical performance study with acceptance criteria and reported performance metrics was not deemed necessary by the FDA for this 510(k) clearance, as the device's function is primarily to aggregate and display data based on predefined thresholds, not to make diagnostic or treatment recommendations or to generate novel risk scores.

Given this, the "acceptance criteria" primarily relate to the software's functionality, safety, and adherence to specified standards, rather than direct clinical efficacy metrics.

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided document, specific quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy) and corresponding reported device performance metrics from a clinical study are NOT available. The document focuses on non-clinical performance data and substantial equivalence to a predicate device.

Acceptance Criteria Category	Specific Criteria (as inferred from document)	Reported Device Performance (as inferred from document)
Software Life Cycle	Compliance with IEC 62304 Ed 1.1 2015-06	Passed non-clinical tests
Usability Engineering	Compliance with IEC 62366-1 Ed 1.1 2020-06	Passed non-clinical tests
Alarm Systems (if applicable)	Compliance with IEC 60601-1-8 Ed 2.2 2020-07	Passed non-clinical tests
Functional Performance	Accurately analyze and display patient data when vital signs, blood test results, or conventional early warning scores exceed predefined thresholds.	Implied to function as intended based on non-clinical testing and regulatory clearance. Specific performance metrics are not provided.
Safety and Effectiveness	No new issues of safety or effectiveness compared to predicate device.	Demonstrated substantial equivalence and adherence to standards.

2. Sample size used for the test set and the data provenance

The document states, "This device does not require clinical data." Therefore, there is no mention of a clinical "test set" in terms of patient data used for performance evaluation in a hypothesis-driven study.

The "tests" mentioned are non-clinical and relate to software engineering, usability, and alarm systems. No sample size for a patient-based test set is provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. As no clinical "test set" and corresponding performance study are described, there is no mention of experts establishing ground truth for such a set. The device operates on predefined thresholds for existing clinical scores and vital signs, not on novel diagnostic interpretations requiring expert consensus.

4. Adjudication method for the test set

Not applicable. No clinical test set or adjudication process is mentioned.

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

No. The document does not mention any MRMC comparative effectiveness study. The AITRICS-VC is described as a display tool that aids clinicians in understanding a patient's condition, not as an AI that directly assists in diagnosis or interpretation to improve human reader performance in a quantifiable way.

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

The device is inherently "standalone" in that it is software only ("AITRICS-VC is stand-alone software"). However, its intended use is to "display data" for clinicians "to aid in understanding a patient's current condition." It is explicitly stated that it is "not intended to replace bedside patient monitors or clinicians' clinical decision-making."

Therefore, its performance is as an information display system based on predefined rules/thresholds, rather than a diagnostic algorithm generating an output that would typically undergo standalone performance evaluation like sensitivity and specificity. The non-clinical tests confirm that the software "performs as intended," which implies standalone functionality as designed.

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

Not applicable in the context of a clinical performance study. The "ground truth" for the device's function is the predefined thresholds for vital signs, blood test results, and conventional early warning scores (MEWS, NEWS, qSOFA). The software's "truth" is whether it correctly identifies and displays patients whose data meet these established clinical thresholds.

8. The sample size for the training set

Not explicitly mentioned in the document for the AITRICS-VC's core functionality. The AITRICS-VC identifies patients where "vital signs, blood test results, or conventional early warning scores such as MEWS, NEWS, and qSOFA exceed predefined thresholds." These scores (MEWS, NEWS, qSOFA) are established clinical tools, and their underlying models (if any) would have been "trained" on historical data as part of their initial development, separate from the AITRICS-VC software. The AITRICS-VC itself seems to implement these existing rule-based calculations.

If there is any machine learning component beyond rule-based calculations that involved training, the document does not elaborate on it or provide a training set size.

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

Not applicable/Not mentioned. Similar to the training set size, the "ground truth" for the existing conventional early warning scores (MEWS, NEWS, qSOFA) would have been established during their development. The AITRICS-VC's function is to apply these scores and thresholds, not to develop new ones.

Summary

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July 23, 2024

AITRICS Co.,Ltd. Dongyeop Kim RA/QA manager 13F, 218, Teheran-ro, Gangnam-gu Seoul. 06221 Korea, South

Re: K240756

Trade/Device Name: AITRICS-VC Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer And Rate Alarm) Regulatory Class: Class II Product Code: PLB Dated: March 18, 2024 Received: March 20, 2024

Dear Dongyeop Kim:

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 (the 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 available 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.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

for

Robert T. Kazmierski -S

LCDR Stephen Browning Assistant Director DHT2A: Division of Cardiac Electrophysiology, Diagnostics

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and Monitoring Devices OHT2: 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) K240756

Device Name AITRICS-VC

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

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

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Image /page/4/Picture/0 description: The image shows the logo for AI TRICS. The logo is green and features the letters "AI" inside of a rounded square. To the right of the square are the letters "TRICS".

510(k) Summary

This summary of safety and effectiveness information is prepared in accordance with the requirements of 21 CFR 807.92.

Date Prepared: March 20, 2024

l. Submitter

Applicant: AITRICS Co.,Ltd. 13F, 218, Teheran-ro, Gangnam-gu, Seoul, Republic of Korea (06221) Phone: +82 2 569 5507

Contact Person: Dongyeop Kim RA/QA Manager

Prepared by: Dongyeop Kim, RA/QA Manager Sojeong Kim, RA manager Sangjun Lee, RA Manager Sun Young Kim, RA Manager

II. Device

Device Name: AITRICS-VC Common Name: Cardiac monitor (including cardiotachometer and rate alarm) Classification Name: Multivariate Vital Signs Index Regulation Number: 870.2300 Product Code: PLB

III. Predicate Device

510(k) No.: K213335 Device Name: Capsule Surveillance System Product Code: MWI

IV. Device Description

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V. Intended Use / Indications for Use

The AITRICS-VC is stand-alone software intended to analyze patient data sourced from an EHR (Electronic Health Record) system and display data of in-hospital patients. It displays patient data whose vital signs, blood test results, or conventional early warning scores such as MEWS, NEWS, and qSOFA exceed predefined thresholds. It is not intended to replace bedside patient monitors or clinicians' clinical decision-making. It is not indicated for use in high-acuity environments like the ICU or operating rooms for acutely or critically ill patients. It may be used by clinicians to aid in understanding a patient's current condition and changes over time. The AITRICS-VC is solely indicated for use in the general ward of a hospital environment.

[Comparison of Intended Use with Predicate Device]

Operational and technological characteristics for the determination of substantial equivalence of the subject device with the predicate device. The difference of technological characteristics does not raise new questions of safety and effectiveness and both devices have same intended use.

VI. Comparison of Technology Characteristics

The subject device and the predicate device are substantially equivalent in most technical characteristics. Both devices are used by clinicians and are utilized for analyzing and displaying patient data from EHR system in hospital settings. While there is a different technical characteristic for the output, the output of the subject device aligns with methods commonly used by clinicians, being encompassed by the methods of the predicate device, which are described as "clinical practices, protocols, and policies." Therefore, this difference raises no new questions of safety and effectiveness.

Attribute	Subject Device (AITRICS-VC)	Predicate Device
ProductCode	PLB: Multivariate Vital Signs Index	MWI: Physiological Patient Monitor(without arrhythmia detection oralarms)
Indicationsfor Use	The AITRICS-VC is stand-alonesoftware intended to analyze patientdata sourced from an EHR (ElectronicHealth Record) system and displaydata of in-hospital patients.It displays patient data whose vitalsigns, blood test results, orconventional early warning scoressuch as MEWS, NEWS, and qSOFAexceed predefined thresholds.It is not intended to replace bedsidepatient monitors or clinicians' clinical	The Capsule Surveillance is a clinicaldecision support device thatintegrates, analyzes, and displays datafrom multiple sources includingmedical devices and healthcareinformation systems.It uses standardized rules that arebased on customers approved clinicalpractices, protocols, and policies tocreate clinically relevant alerts inhealth care facilities when used byclinical physicians or appropriate
Attribute	Subject Device (AITRICS-VC)	Predicate Device
	decision-making.It is not indicated for use in high-acuity environments like the ICU oroperating rooms for acutely orcritically ill patients.It may be used by clinicians to aid inunderstanding a patient's currentcondition and changes over time.The AITRICS-VC is solely indicated foruse in the general ward of a hospitalenvironment.	medical staff under the direction ofphysicians.It is not intended to replace clinicians'judgment, but rather to assistclinicians in making timely, informed,higher quality decisions.Capsule Surveillance may beconfigured for secondary monitoringand alerting intended to be reliedupon in deciding to take immediateclinical action.Capsule Surveillance may also beconfigured for remote display ofphysiological data and alerts notintended to be relied upon in decidingto take immediate clinical action.
IntendedUser	Clinicians	Clinicians
TargetPatients/Environmentof Use	Patients at general ward in hospitalsetting	Patients in hospital setting
ApplicationType	Remote display via a web browser	Two types; The workstation usedexclusively in kiosk mode and theremote display via a web browser
ApplicationViews	Two types; multi-patientsimultaneous monitoring and detailedviews/monitoring of single patients	Two types; multi-patientsimultaneous monitoring and detailedviews/monitoring of single patients
Data Input	EHR system via HL7 feed	EHR systems as well as medicaldevices via HL7 feed
Output	Patient information is displayed whenpatient data whose vital signs, bloodtest results, or conventional earlywarning scores exceed predefinedthresholds.	Clinically relevant alerts are createdby standardized rules that are basedon customers approved clinicalpractices, protocols, and policies.
Performancedata	Tests according to harmonizedstandards below.IEC 62304:2006/A1:2016IEC 62366- 1:2015+AMDI:2020IEC 60601-1-8	Tests according to harmonizedstandards below.IEC 62304:2006/A1:2016IEC 62366- 1:2015+AMDI:2020IEC 60601-1-8
Clinical data	Not require clinical data	Not require clinical data

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VII. Performance Data

The AITRICS-VC has passed all non-clinical tests for demonstrated compliance with the harmonized standards below.

. IEC 62304 Ed 1.1 2015-06 | Medical device software – Software life cycle processes
IEC 62366-1 Ed 1.1 2020-06 | Medical devices – Part 1 Application of usability engineering to medical devices
. IEC 60601-1-8 Ed 2.2 2020-07 | Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems

No new issues of safety or effectiveness are introduced as a result of using this device.

This device does not require clinical data.

VIII. Conclusions

The results of the substantial equivalence discussion including non-clinical tests demonstrate that the AITRICS-VC does not raise new questions of safety and effectiveness, performs as intended are substantially equivalent to the predicate device.

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).