The RhythmView™ Workstation is a computerized system that assists in the diagnosis of complex cardiac arrhythmias. The RhythmView™M Workstation is used to analyze electrogram and electrocardiogram signals and display them in a visual format.

Device Description

The RhythmView is comprised of these major components,

RhythmView hardware – Computer, monitor, keyboard, and mouse
RhythmView Software – Software pre-installed

The RhythmView Workstation takes electrical signals collected from multi-polar electrophysiology catheters and outputs a graphic display that assists in the diagnosis of cardiac arrhythmias.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the RhythmView Workstation:

The provided document does not contain explicit stated acceptance criteria in terms of specific performance metrics (e.g., sensitivity, specificity, accuracy, or quantitative thresholds for signal processing or display characteristics). Instead, it states that the system "passed all verification and validation tests in accordance with predetermined specifications and appropriate test criteria." It primarily demonstrates substantial equivalence to predicate devices based on technological characteristics and overall safety and effectiveness.

Therefore, the following table and subsequent sections will reflect the information available in the document, highlighting what is stated and what is not.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (as described/implied)	Reported Device Performance
Safety and Effectiveness	- "Passed all verification and validation tests"
	- "Demonstrate that it was as safe and as effective as the predicate devices."
	- "Results demonstrate that the RhythmView is safe and effective when used in accordance with its intended use and labeling."
Technological Characteristics - Signal Processing	Yes (matches predicate devices)
Technological Characteristics - Post processing display - propagation map	Yes (matches one predicate, different from another)
Technological Characteristics - Grid display of electrode signals	Yes (matches one predicate, different from another)
Compliance with Predetermined Specifications and Test Criteria	"Passed all verification and validation tests in accordance with predetermined specifications and appropriate test criteria."
No New Questions of Safety and Effectiveness	"There were no new questions of safety and effectiveness raised."

Note: The document does not provide specific numerical performance metrics (e.g., accuracy, precision) for the device's diagnostic assistance capabilities. The "acceptance criteria" are broadly defined as passing verification and validation tests and demonstrating equivalence to predicate devices in safety and effectiveness.

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

Sample Size for Test Set: The document states that the RhythmView System underwent "extensive bench testing, including a data wide variety of cardiac electrogram data." However, no specific numerical sample size (number of cases or electrogram recordings) for the test set is provided.
Data Provenance: The document mentions "a data wide variety of cardiac electrogram data." The country of origin for this data is not specified. The document does not explicitly state whether the data was retrospective or prospective. Given the context of "bench testing" and "variety of cardiac electrogram data," it implies existing data sources were used.

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

Number of Experts: Not specified.
Qualifications of Experts: Not specified. The document does not mention the involvement of experts in establishing ground truth for the test data.

4. Adjudication method for the test set

Adjudication Method: Not specified. The document does not describe any adjudication process for interpreting the test data or establishing ground truth.

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

MRMC Comparative Effectiveness Study: No, an MRMC comparative effectiveness study was not done (or at least not reported in this summary). The document focuses on the device's performance in isolation ("bench testing") and its substantial equivalence to predicate devices based on technological characteristics and overall safety/effectiveness, not on human reader performance with or without the device.
Effect Size of Improvement: Not applicable, as no such study was reported.

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

Standalone Performance Study: Yes, in essence, the "extensive bench testing" of the RhythmView System, where it "passed all verification and validation tests," represents a standalone evaluation of the algorithm and system's performance. The device is described as "assists in the diagnosis," implying it's a tool, but the testing described focuses on the system itself, not its impact on a human reader's performance.

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

Type of Ground Truth: The document refers to "cardiac electrogram data" and the device assisting in the "diagnosis of complex cardiac arrhythmias." This implies that the ground truth for the test data would be the actual presence or absence, and specific type, of cardiac arrhythmias as determined by established clinical or electrophysiological standards, which often involves expert interpretation of electrograms and clinical correlation. However, the specific method (e.g., expert consensus, comparison to gold standard recordings) for establishing this ground truth is not explicitly stated.

8. The sample size for the training set

Sample Size for Training Set: Not specified. The document does not partition data into training and test sets or mention details about a training set. This suggests that the device's development and validation might have relied on a traditional engineering V&V process rather than a machine learning model requiring a distinct training set in the current common understanding.

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

How Ground Truth for Training Set was Established: Not specified. As the document doesn't explicitly mention a training set, details on its ground truth establishment are also absent.

Summary

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Appendix 4 — 510(k) Summary

510(k) Summary of Safety and Effectiveness

SEP 2 3 2011

Submitter'sinformation	Topera, Inc.Contact: Ruchir Sehra, MDPhone: 858 367-339503/22/2011
Device/classificationname	Device Name:• RhythmView WorkstationClassification/Common name:• Programmable diagnostic computerThe marketed device(s) to which substantial equivalence is claimed:• Astronomer + (K003362)• CARTO XP Mapping System (K013083)
Devicedescription	The RhythmView is comprised of these major components,1. RhythmView hardware – Computer, monitor, keyboard, and mouse2. RhythmView Software – Software pre-installedThe RhythmView Workstation takes electrical signals collected from multi-polar electrophysiology catheters and outputs a graphic display that assists inthe diagnosis of cardiac arrhythmias.
Indications foruse	The RhythmView™ Workstation is a computerized system that assists in thediagnosis of complex cardiac arrhythmias. The RhythmView™ Workstationis used to analyze electrogram and electrocardiogram signals and displaythem in a visual format.
	Continued on next page

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510(k) Summary of Safety and Effectiveness, Continued

Technological The table below lists the technological characteristics for both the new and characteristics predicate devices

Device Characteristic	New DeviceRhythm ViewTM	Predicate DeviceAstronomer +	Predicate DeviceCARTO XP
Signal capture	No	Yes	Yes
Signal processing	Yes	Yes	Yes
Location capability	No	Yes	Yes
Post processing display -propagation map	Yes	No	Yes
Grid display of electrodesignals	Yes	Yes	No

Performance The RhythmView System underwent extensive bench testing, including a data wide variety of cardiac electrogram data, to demonstrate that it was as safe and as effective as the predicate devices.

The Rhythm View System passed all verification and validation tests in accordance with predetermined specifications and appropriate test criteria. There were no new questions of safety and effectiveness raised.

Conclusion Verification and validation testing were conducted to establish the performance characteristics of the RhythmView System. The results demonstrate that the Rhythm View is safe and effective when used in accordance with its intended use and labeling.

K110878

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services (HHS). The logo features a stylized caduceus, which is a symbol often associated with healthcare. The caduceus is depicted with three lines forming a shape resembling a bird or abstract human figure. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the caduceus.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WC066-G609 Silver Spring, MD 20993-0002

Topera, Inc. c/o Dr. Ruchir Schra 11445 E. Via Linda Suite 2 P.O. Box 224 Scousdale. AZ 85259

SEP 2 3 201

Re: K110878

Trade/Device Name: RhythmView Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DQK Dated: September 8, 2011 Received: September 12, 2011

Dear Dr. Sehra:

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 interestate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendonants, or 10 devices that have been reclassified in accordance with the provisions of the Federal Food, youg, 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 The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbaranding and adulteration. Please note: CDRH does not evaluate information related to contractly antity 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

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Page 2 - Dr. Ruchir Schra

found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register,

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050,

If you desire specific advice for your device on our labeling regulation (21 CFR Pari 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

uckerman, M.D. Bram D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Appendix 3 - Indications for Use

Indications for Use Statement

Statement The Indications for Use Statement:

510(k) Number: K110878

Device Name: RhythmView Workstation

Prescription Use X -AND/OR (Part 21 CFR 801 Subpart D)

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number	K110878

Topera, Inc.

Regulation Number and Section

§ 870.1425 Programmable diagnostic computer.

(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).