CER-S is intended for use in clinical and hospital settings only by qualified medical personnel or adequately trained professional personnel working under the supervision and responsibility of a clinician. Users must undergo a thorough software training before using the medical device.

The device provides the clinician an additional tool to aid in the interpretation of ECG data for diagnosis of heart rhythm disorders in adult and pediatric patients.

Note: This device does not provide an automated interpretation and is not intended for use as the only diagnostic tool.

CER-S analysis provides indications for, but not limited to, evaluation of:

Patients with rhythm disturbances (cardiac arrhythmias),
Patients with transient myocardial ischemia,
Patients with pacemaker (only if pacing detection is available from the input recording),
Patients needing HRV evaluation,
Newborn patients limited to QRS detection.

Device Description

CER-S is a tool, designed to offer a framework for the interaction of different software-modules, providing advanced solutions for Continuous ECG Recording (CER).
Different modules provide:
ECG Beat detection and classification Analysis of ECG rhythm, arrhythmia detection interactive Viewer and set of tools to perform editing of ECG beats, Rhythm annotations and noise Windows interactive Continuous ECG Viewer interactive display/management of ECG Templates Holter-like report for analyzed Continuous ECG records, record exportation, in ISHNE format generation of aECG FDA HL7 XML (v. 2), for the submission of continuous ECG recording to the FDA ECG Warehouse.
Note: The automatic analysis is limited to data acquired from electrodes with conductive paste/gel (dry and dry/metal electrodes are not intended to be used) placed on standard location in compatible formats from any device used for the arrhythmia diagnostics such as Holter, event recorder, 12-lead ambulatory ECG devices when assessment of the rhythm is necessary.
Moreover, CER-S allows the automatic analysis for the following patch location:
two-electrode patches positioned in the left upper chest area at a roughly inclined angle three-electrode triangular shape patches positioned on the patient's left upper chest area below the 1st rib, at an inclined angle three-electrode T-shaped patches positioned in the center-thoracic position between the upper part of the chest (manubrium) and the sternum
In all cases, patch placement must strictly follow the indication provided by the manufacturer of the certified-patch device.

AI/ML Overview

The provided text does not contain the detailed information required to fill out all sections of your request regarding acceptance criteria and a study proving device performance. The document is a 510(k) summary for the CER-S device, which outlines its purpose, regulatory information, and a high-level overview of some testing. However, it explicitly states: "No clinical tests were performed to demonstrate safety and effectiveness of CER-S". This means there was no clinical study with human participants to measure the device's performance against specific acceptance criteria in a real-world setting.

Instead, the submission relies on non-clinical tests (performance testing against existing standards and software development life cycle adherence) and substantial equivalence to a predicate device.

Therefore, I can only provide information based on what is available in the text. Many of your requested points will be answered with "Not applicable" or "Information not provided in the document."

Here is the breakdown based on the provided text:

Acceptance Criteria and Device Performance Study (CER-S)

As stated in the 510(k) Summary, no clinical tests were performed to demonstrate the safety and effectiveness of CER-S. The submission relies on non-clinical performance testing and software development life cycle adherence to established standards, as well as arguments for substantial equivalence to a predicate device. Therefore, a study demonstrating the device meets performance acceptance criteria via a clinical trial with human-in-the-loop or standalone AI performance metrics is not detailed in this document.

The document mentions compliance with several non-clinical standards for ECG performance and software development. These standards inherently have their own acceptance criteria, but the specific performance results against these criteria are not numerical values reported in a table within this summary.

1. Table of Acceptance Criteria and Reported Device Performance

Given that no clinical study measuring specific performance metrics against clinical acceptance criteria was conducted and detailed in this summary, a table of this nature cannot be generated from the provided text. The document states:

"The following non-clinical tests have been conducted on the Subject Device:
- ECG performance testing, according to: ANSI/AAMI EC57:1998/(R)2003 and IEC 60601-2-47:2012 (Recognition Number 3-155) IEC 60601-2-25:2011 (Recognition Number 3-105)
- Software development life cycle, according to: ANSI AAMI IEC 62304:2006 (Recognition Number 13-32)
- Usability engineering process, according to: IEC 62366:2007"
"The testing demonstrated that CER-S is safe and effectiveness for the propose intended use."

While these standards contain acceptance criteria for the device's functions (e.g., ECG signal processing accuracy, software robustness), the specific quantitative results are not reported in this summary.

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

Sample Size (Test Set): Not applicable, as no clinical test set/study is detailed. The non-clinical tests would have used synthetic or recorded ECG data, but the "sample size" of such data is not specified.
Data Provenance: Not applicable for a clinical test set. The document refers to "data acquired from electrodes with conductive paste/gel... from any device used for the arrhythmia diagnostics." The origin (country, retrospective/prospective) of this data, if used for internal validation, is not specified.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Number of Experts: Not applicable, as no clinical test set/study requiring expert ground truth is detailed.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable, as no clinical test set/study is detailed.

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

MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed or detailed for AI assistance versus human-alone performance. The device is described as an "additional tool to aid in the interpretation of ECG data" and explicitly states it "does not provide an automated interpretation and is not intended for use as the only diagnostic tool." This suggests it's an analysis and review tool, not a standalone AI diagnostic.
Effect Size: Not applicable.

6. Standalone Performance (Algorithm Only Without Human-in-the-Loop)

Standalone Performance Study: No, a standalone (algorithm only) performance study in the sense of an AI diagnostic evaluating cases without human intervention is not described. The device is a software suite for analyzing, editing, reviewing, and reporting, implying human interaction. It also explicitly states it "does not provide an automated interpretation."

7. Type of Ground Truth Used

Type of Ground Truth: Not applicable for a clinical study. For the non-clinical ECG performance testing, the ground truth would be defined by the known characteristics of the ECG signals and simulated arrhythmias as per the testing standards (e.g., ANSI/AAMI EC57).

8. Sample Size for the Training Set

Sample Size (Training Set): Not provided. The document describes the device as a "tool, designed to offer a framework for the interaction of different software-modules," some of which perform "ECG Beat detection and classification Analysis of ECG rhythm, arrhythmia detection." While these functions imply some form of algorithm or model development, the document does not specify if or how an explicit "training set" (in the machine learning sense) was used, nor its size.

9. How the Ground Truth for the Training Set Was Established

Ground Truth Establishment (Training Set): Not provided. If algorithms within the software were developed using training data, the method for establishing ground truth for such data is not described in this summary.

Summary

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

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION".

August 26, 2020

CardioCalm Fabio Badilini President & Legal Representative Corso Martiri della Libertà, nr. 40 Montichiari, 25018, Italy

Re: K193177

Trade/Device Name: CER-S Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DQK Dated: July 17, 2020 Received: July 27, 2020

Dear Fabio Badilini:

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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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

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 (OS) 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 medical devices and radiation-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

Jennifer Shih Assistant Director DHT2A: Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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

Indications for Use

Device Name CER-S

Indications for Use (Describe)

CER-S is a stand-alone software medical device intended to analyze, edit, review and report digital continuous ECG recordings.

The device provides the clinician an additional tool to aid in the interpretation of ECG data for diagnosis of heart rhythm disorders in adult and pediatric patients.

Note: This device does not provide an automated interpretation and is not intended for use as the only diagnostic tool.

CER-S analysis provides indications for, but not limited to, evaluation of:

· Patients with rhythm disturbances (cardiac arrhythmias),
· Patients with transient myocardial ischemia,
· Patients with pacemaker (only if pacing detection is available from the input recording),
· Patients needing HRV evaluation,
· Newborn patients limited to QRS detection.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Druq Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

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

510(k) Summary (as required by 21 CFR 807.92)

Submitter	CardioCalmCorso Martiri della Libertà, nr. 4025018 Montichiari (BS)
Telephone	+39 030 9650782
Fax	+39 030 9650572
Contact Person	Fabio BadiliniPresident & Legal Representative
Address	Corso Martiri della Libertà, nr. 40
Telephone	+39 030 9650782
Fax	+39 030 9650572
Email	badilini@cardiocalm.com
Date Prepared	10/29/2019
Trade Name	CER-S
Common Name	Continuous ECG Recording - Suite
Panel Code	Cardiovascular/74
Classification Name	Computer diagnostic, programmable
Class	Class II
Regulation Number	21 CFR 870.1425
Regulation Description	Programmable diagnostic computer
Product Code	DQK
Name of Predicate Device	510(k) #	Manufacturer
SyneScopeTM, EasyScopeTM, SyneComTMHolterReader	K042002	Sorin Group(Ela Medical, Inc)
Reason for Submission	Pre-market notification for CER-S, a new Device, seeking authority to market the product underSection 510(k), as substantially equivalent to the Predicate Devices listed above, legally marketedon US territory.
Device Description	CER-S is a tool, designed to offer a framework for the interaction of different software-modules,providing advanced solutions for Continuous ECG Recording (CER).Different modules provide:ECG Beat detection and classification Analysis of ECG rhythm, arrhythmia detection interactive Viewer and set of tools to perform editing of ECG beats, Rhythm annotations and noise Windows interactive Continuous ECG Viewer interactive display/management of ECG Templates Holter-like report for analyzed Continuous ECG records, record exportation, in ISHNE format generation of aECG FDA HL7 XML (v. 2), for the submission of continuous ECG recording to the FDA ECG Warehouse. Note: The automatic analysis is limited to data acquired from electrodes with conductive paste/gel(dry and dry/metal electrodes are not intended to be used) placed on standard location incompatible formats from any device used for the arrhythmia diagnostics such as Holter, eventrecorder, 12-lead ambulatory ECG devices when assessment of the rhythm is necessary.Moreover, CER-S allows the automatic analysis for the following patch location:two-electrode patches positioned in the left upper chest area at a roughly inclined angle three-electrode triangular shape patches positioned on the patient's left upper chest area below the 1st rib, at an inclined angle three-electrode T-shaped patches positioned in the center-thoracic position between the upper part of the chest (manubrium) and the sternum In all cases, patch placement must strictly follow the indication provided by the manufacturer of the certified-patch device.
Indications foruse	CER-S is a stand-alone software medical device intended to analyze, edit, review and report digitalcontinuous ECG recordings.CER-S is intended for use in clinical and hospital settings only by qualified medical personnel oradequately trained professional personnel working under the supervision and responsibility of aclinician. Users must undergo a thorough software training before using the medical device.The device provides the clinician an additional tool to aid in the interpretation of ECG data fordiagnosis of heart rhythm disorders in adult and pediatric patients.Note: This device does not provide an automated interpretation and is not intended for use as theonly diagnostic tool.CER-S analysis provides indications for, but not limited to, evaluation of:Patients with rhythm disturbances (cardiac arrhythmias), Patients with transient myocardial ischemia, Patients with pacemaker (only if pacing detection is available from the input recording), Patients needing HRV evaluation, Newborn patients limited to QRS detection.
TechnologicalCharacteristicsandSubstantialEquivalence	The fundamental scientific principles and technological characteristic, including the indications for useand general design are equivalent to the predicate device, as summarized hereafter:Software type, Holter Analyzer, working in Windows OperativeSystem, as the predicate; Patient population, adults and pediatrics; User groups: trained operators under the direct supervision of alicensed healthcare practitioner, equivalent to predicate device; Indications for use, equivalent to the predicate; Environmental use, equivalent to the predicate.
	The technological characteristics of the subject device and the predicate device are substantially equivalent to the predicate.
	As for the predicate device described below, the Subject device is a PC based SaMD, working in Windows Operative System
PerformanceData	The following non-clinical tests have been conducted on the Subject Device:ECG performance testing, according to: ANSI/AAMI EC57:1998/(R)2003 and IEC 60601-2-47:2012 (RecognitionNumber 3-155) IEC 60601-2-25:2011 (Recognition Number 3-105) Software development life cycle, according to: ANSI AAMI IEC 62304:2006 (Recognition Number 13-32) Usability engineering process, according to: IEC 62366:2007
	Any potential hazards have been evaluated and controlled through Risk Management activities.The testing demonstrated that CER-S is safe and effectiveness for the propose intended use.No clinical tests were performed to demonstrate safety and effectiveness of CER-S
Conclusion	Based on the indications for use, technological characteristics, and comparison to predicatedevices, the Subject device CER-S has been shown to be substantially equivalent to the legallymarketed predicate devices and is safe and effective for its intended use.

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

Traditional 510(k) Premarket Notification

CER-S

Regulation Number and Section

§ 870.2800 Medical magnetic tape recorder.

(a)
Identification. A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers.(b)
Classification. Class II (performance standards).