The ARC System is an intensive care information system indicated for aggregating, displaying, and managing physiology and other patient information. The system collects and displays data from FDA-cleared patient bedside medical devices and patient information systems. The Arc System allows healthcare professionals to define rule-based algorithms to receive notifications for patient prioritization and continuous patient monitoring.

The ARC System software is intended to be used by healthcare professionals for the following purposes:

· To remotely consult, regarding a patient's status
· To remotely review other standard or critical near real-time patient data, waveforms, and alarms in order to utilize this information to aid in clinical decisions and deliver patient care
· To create and manage Patient Prioritization Rules
· To access Patient Prioritization information

WARNING:

Rx Only.
· Do not use the ARC System as an active patient monitoring.
· Do not use the ARC System to replace any part of the hospital's device monitoring.
· Do not rely on the ARC System software as the sole source of patient status information.

Device Description

The ARC ICU Information System is intended to provide the Intensive Care Unit (ICU) with clinical decision support, workflow management, interoperability and device connectivity. The system receives near real-time data from medical devices in the ICU and presents them on a single dashboard to provide secondary clinical decision support. Patient vitals from ventilators, monitors, pumps, smart beds, IoT sensors etc. are connected to the ARC Box. From the ARC Box, data is propagated through the ARC software, and displayed on a central monitoring system, the ARC DS. The data is available on remote monitoring devices, such as a mobile device or physician tablet. The ARC System is composed of a physical hardware component (ARC Box), which interfaces with the ICU medical devices, and the ARC System Software components.

Decision support algorithms, treatment protocols and applications used within ARC System do not come with a predefined procedure or standard. A skilled health care professional can use ARC System to create and define a healthcare workflow dynamically on the basis of an individual hospital, clinic or physician. ARC ICIS is a Web-based and Cloud Ready system that is built on IoMT and BigData technologies. It is intended to provide reliable and secure access to patient information.

ARC Box is a vendor-neutral connectivity solution that retrieves patient data from different device makers and transfers this data, via serial ports and/or ethernet ports, to a central dashboard. It is built on IoT for secure and quick communication between medical devices while gathering rich data. It temporarily stores data in the event of unexpected circumstances such as power outage or server failure and transfers saved data to ARC ICIS to be visualized for Clinical Decision Support.

AI/ML Overview

This document is a 510(k) Premarket Notification from Ordinatrum Solutions to the FDA for their ARC Intensive Care Information System (ARC System). It aims to demonstrate substantial equivalence to a predicate device (K142106 - Decision Health Patient Dashboard).

However, the provided text does not contain the specific details required to answer all parts of your request regarding acceptance criteria and a study proving the device meets those criteria. Specifically, it mentions "Performance testing to demonstrate substantial equivalence" and "Unit, integration, security, vulnerability and system level testing demonstrated that the ARC System meets its specifications," but it does not provide a table of acceptance criteria, the reported device performance against those criteria, or a detailed breakdown of methodology (sample sizes, expert involvement, ground truth establishment, or an MRMC study). The human factors usability study is mentioned, but it is not framed as a study to prove the device meets specific functional or performance acceptance criteria for, for example, patient prioritization rule accuracy or remote data review.

Therefore, I can only extract limited information from the provided text based on your request.

Here's what can be gathered:

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

This information is not provided in the document. The document states that "Performance testing... demonstrated that the ARC System meets its specifications" but does not list these specifications as explicit acceptance criteria with corresponding performance data.

2. Sample sizes used for the test set and the data provenance:

Test set sample size: Not explicitly stated for performance testing.
A human factors usability study was conducted with "30 typical users (15 intensivists and 15 critical care nurses)." This is a sample size for a usability study, not for a core performance test (e.g., accuracy of rule-based algorithms).
Data provenance: Not specified.

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

This information is not provided. The document does not describe the establishment of a "ground truth" for evaluating the performance of its rule-based algorithms or data display. The human factors study involved "typical users" (intensivists and critical care nurses), but their role was in a usability study, not in establishing a ground truth for algorithm performance.

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

This information is not provided.

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:

An MRMC study is not mentioned or implied. The device is an "intensive care information system" for aggregating, displaying, and managing patient information, and allowing healthcare professionals to define rule-based algorithms for notifications. It is not an AI-assisted diagnostic imaging tool where an MRMC study would typically be conducted to assess reader improvement. The warning explicitly states: "Do not use the ARC System as an active patient monitoring. Do not use the ARC System to replace any part of the hospital's device monitoring. Do not rely on the ARC System software as the sole source of patient status information." This suggests its role is primarily data aggregation and rule-based notification, not AI-driven diagnostic assistance.

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

The document states, "Unit, integration, security, vulnerability and system level testing demonstrated that the ARC System meets its specifications." This implies that various technical tests were performed without direct human-in-the-loop interaction for the specific functions being tested (e.g., data connectivity, data propagation), but it doesn't specify an "algorithm only" performance study in the context of diagnostic accuracy. Given the device's function (rule-based algorithms defined by healthcare professionals, not pre-defined AI algorithms for diagnosis), a standalone "algorithm only" performance evaluation in the typical sense (e.g., for diagnostic accuracy) is not detailed.

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

This information is not provided.

8. The sample size for the training set:

The document does not mention a training set. The ARC System appears to be a rule-based system where healthcare professionals define the rules, rather than a machine learning/AI system that would require a distinct training set.

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

Since a training set is not mentioned, the method for establishing its ground truth is also not applicable or provided.

Summary of Device and Performance Information Mentioned (but lacking specific detail on meeting acceptance criteria):

Device Name: ARC Intensive Care Information System (ARC System)
Intended Use: Aggregating, displaying, and managing physiology and other patient information. Collects and displays data from FDA-cleared patient bedside medical devices and patient information systems. Allows healthcare professionals to define rule-based algorithms to receive notifications for patient prioritization and continuous patient monitoring.
Purposes for Healthcare Professionals: Remotely consult on patient status; remotely review near real-time patient data, waveforms, and alarms to aid clinical decisions; create and manage Patient Prioritization Rules; access Patient Prioritization information.
Testing Conducted:
- Performance testing to demonstrate substantial equivalence.
- Unit, integration, security, vulnerability, and system level testing (stated to have demonstrated that the ARC System meets its specifications).
- Human factors usability study (30 typical users: 15 intensivists, 15 critical care nurses).
Conclusion: The manufacturer asserts that the testing demonstrated substantial equivalence to the predicate device and that differences do not raise significant new questions of safety or effectiveness.

To reiterate, the provided text is a standard FDA 510(k) summary focusing on substantial equivalence to a predicate device. It highlights that testing was done to meet specifications but does not provide the granular detail about set acceptance criteria and the results of specific performance evaluations against those criteria, which you requested.

Summary

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June 6, 2023

Ordinatrum Solutions % H. Semih Oktay, Ph.D. President CardioMed Device Consultants, LLC. 3168 Braverton Street Suite 200 Edgewater, MD 21037

Re: K220117

Trade/Device Name: ARC Intensive Care Information System (ARC System) Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer And Rate Alarm) Regulatory Class: Class II Product Code: MWI, OUG Dated: May 5, 2023 Received: May 5, 2023

Dear Semih Oktay:

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.

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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 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.

Robert T. Kazmierski -S

for

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) K220177

Device Name ARC System

Indications for Use (Describe)

The ARC System software is intended to be used by healthcare professionals for the following purposes:

· To remotely consult, regarding a patient's status
· To remotely review other standard or critical near real-time patient data, waveforms, and alarms in order to utilize this information to aid in clinical decisions and deliver patient care
· To create and manage Patient Prioritization Rules
· To access Patient Prioritization information

WARNING:

Rx Only.
· Do not use the ARC System as an active patient monitoring.
· Do not use the ARC System to replace any part of the hospital's device monitoring.
· Do not rely on the ARC System software 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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K220117

1. 510(k) Summary

In accordance with 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence.

Applicant:

Submitter name:	Ordinatrum Solutions
Responsible person:	Ali Yasin Ozturk
Phone:	(858) 537-7065
E-mail:	aozturk@ordinatrumsolutions.com

Official Correspondent:

Contact person:	Semih Oktay, Ph.D.
Phone:	(410)271-2088
E-Mail:	soktay@cardiomedllc.com
Date prepared:	June 6th, 2023

Device Name:

Proprietary name:	ARC Intensive Care Information System (ARC System)
510(k) number:	K220117
Common name:	Physiological Patient Monitor (without arrhythmia detection or alarms)
Classification name:	Class II, 21 CFR§870.2300, Cardiac monitor (including cardiotachometer and rate alarm)
Product code:	MWI

Indications for Use:

The ARC System is an intensive care information system indicated for aggregating, displaying, and managing physiologic and other patient information. The system collects and displays data from FDA-cleared patient bedside medical devices and patient information systems. The Arc System allows healthcare professionals to define rule-based algorithms to receive notifications for patient prioritization and continuous patient monitoring.

The ARC System software is intended to be used by healthcare professionals for the following purposes:

To remotely consult, regarding a patient's status .
. To remotely review other standard or critical near real-time patient data, waveforms, and alarms in order to utilize this information to aid in clinical decisions and deliver patient care
To create and manage Patient Prioritization Rules ●
To access Patient Prioritization information ●

WARNING:

Rx Only. ●
Do not use the ARC System as an active patient monitoring. ●
Do not use the ARC System to replace any part of the hospital's device monitoring. ●
Do not rely on the ARC System software as the sole source of patient status information. ●

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K220117

Device Description:

This medical device product has functions subject to FDA premarket review as well as functions that are not subject to FDA premarket review. For this application, if the product has functions that are not subject to FDA premarket review, FDA assessed those functions only to the extent that they either could adversely impact the safety and effectiveness of the functions subject to FDA premarket review or they are included as a labeled positive impact that was considered in the assessment of the functions subject to FDA premarket review.

Predicate Device:

Substantial Equivalence is claimed with the device, K141206 - Decision Health Patient Dashboard manufactured by Decision Health, Inc. on the basis of equivalent intended use / indications for use, technological characteristics and principle of operation.

Comparison of Technological Characteristics:

The table below provides a comparison of the predominant technical characteristics of the new device and the legally marketed predicate device.

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System Information	ARC ICU Information System	Predicate Device
510(k) Number	K220177	K142106
Device Trade Name	ARC System	Decisio Health PatientDashboard
ClassificationRegulation	Class II, 870.2300	Same
Product Code(s)	MWI, Monitor, Physiological, Patient (WithoutArrhythmia Detection or Alarms)	Same
Indications for Use	The ARC System is an intensive care informationsystem indicated for aggregating, displaying, andmanaging physiologic and other patientinformation. The system collects and displaysdata from FDA-cleared patient bedside medicaldevices and patient information systems. The ArcSystem allows healthcare professionals to definerule-based algorithms to receive notifications forpatient prioritization and continuous patientmonitoring.The ARC System software is intended to be usedby healthcare professionals for the followingpurposes:To remotely consult, regarding apatient's status To remotely review other standard orcritical near real-time patient data,waveforms, and alarms in order to utilizethis information to aid in clinicaldecisions and deliver patient care To create and manage PatientPrioritization Rules To access Patient Prioritizationinformation WARNING:Rx Only. Do not use the ARC System as an activepatient monitoring. Do not use the ARC System to replaceany part of the hospital's devicemonitoring. Do not rely on the ARC System softwareas the sole source of patient statusinformation.	The Decisio Health PatientDashboard is a decision supportdevice indicated for aggregating,displaying, and managingphysiologic and other patientinformation. This information isgenerated by third party medicaldevices and patient informationsystems. The device performsautomated calculations on patientdata collected by third partydevices based on approvedclinical protocols at patient carefacilities.The Decisio Health PatientDashboard is intended for use byclinicians in healthcare facilities.
Intended Use	The ARC System is intended to provideIntensive Care Unit (ICU) clinical staff decisionsupport, workflow management, interoperabilityand device connectivity.	Same
Target patientpopulation	Adults	Same

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System Information	ARC ICU Information System	Predicate Device
Intended User	Clinicians in healthcare facilities;Administrators; Physicians: Nurses	Same
Display Features	Computer or Mobile device (app)	Patient monitor, computer, or amobile device
Connectivity	Web-based	Same
Inputs	FDA Cleared Devices:EMRVital signs monitorsVentilatorsIV PumpsFoley Catheters	Same
HardwareSpecifications	Ports: Serial (rs-232) port, Ethernet (tcp) port,HTTPS portsProtocols: Tcp, Https (443,8080)	Similar
Use Environments	Intensive Care Unit	Same
Alarms	Yes	N/A
Supportive Testing	Software Validation; Cybersecurity; humanfactors; Unit, integration and system leveltesting, IEC 60601-1-8	Similar
Software Level ofConcern	Moderate	Similar
Sterilization	Non-sterile	Same
Shelf Life	Not likely to be susceptible to degradation	Same
Biocompatibility	No direct nor indirect tissue-contactingcomponents	Same

The ARC ICU Information System has the same intended use and similar technological characteristics as the predicate device. Although there are some differences in indications for use specificity, this level of clarity aligns with other ICIS-type software under product code MWI.

The ARC system is different from the predicate device with regards to the difference in what platform patient data is displayed on. The ARC system does not include display features on the patient monitor. The Arc System allows healthcare professionals to define rule-based algorithms to receive notifications for patient prioritization and continuous patient monitoring, including receiving pass-through alarms. Testing has demonstrated that differences in the technological characteristics will have no impact on safety or effectiveness.

Summary of Testing:

Performance testing to demonstrate substantial equivalence and ensure that the ARC System performs as intended has been conducted. Unit, integration, security, vulnerability and system level testing demonstrated that the ARC System meets its specifications. A human factors usability study has been completed evaluating 30 typical users (15 intensivists and 15 critical care nurses).

Conclusion:

The information included in this submission demonstrates that the ARC System is substantially equivalent to the predicate device (K142106). Although there are minor differences noted between the proposed system and the predicate device, these differences do not raise significant new questions of safety or effectiveness.

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).