HeRO is intended to acquire, store, and report on ECG data collected from infants. HeRO is intended to be used under the direct supervision of a licensed health care practitioner in a hospital neonatal or pediatric ICU environment.

HeRO is intended to be used for the variability in RR intervals (heart rate) and to report measurements of the variability of heart rate data (HRV). The HRV measurements reported by HeRO are specialized in nature, and intended to identify periods of transient decelerations and/or reduced baseline variability in the heart rate.

HeRO is intended to provide only specialized HRV measurements and is not intended to produce any interpretation of those measurements or any kind of diagnosis.

The specialized HRV measurements produced by HeRO have not been approved by the FDA for any specific clinical diagnosis.

HeRO acquires data from a user-supplied ECG monitor, and requires a user-supplied local area network.

Device Description

HeRO Symphony, HeRO solo/duet, and HeRO ES are comprised of off-the-shelf Personal Computers (PC's) and special-purpose hardware capable of acquiring, storing, analyzing, and reporting ECG data from the cardiac monitoring real-time network. Data is acquired either on a special-purpose Data Acquisition Device (DAD) or via the physiological monitoring network. It is stored and analyzed on a HeRO Server or physiological monitor. Results of the analyses are reported on one or more Viewing Stations. The analysis algorithms identify Heart Rate Variability (HRV) patterns that reflect transient decelerations and/or reduced baseline variability.

AI/ML Overview

Here's a breakdown of the acceptance criteria and supporting study details for the HeRO Symphony, HeRO solo/duet, and HeRO ES devices, based on the provided FDA 510(k) summary:

Acceptance Criteria and Device Performance

The provided document does not explicitly list quantitative acceptance criteria for the HeRO Symphony, HeRO solo/duet, and HeRO ES devices. Instead, it asserts that the performance matches the product specifications and is "as safe, as effective, and perform as well as or better than HeRO 3.0" (the predicate device).

This implies that the acceptance criteria are implicitly tied to demonstrating equivalence to the predicate device, HeRO 3.0. The "performance matches product specifications" statement suggests internal verification, but the specifications themselves are not detailed in this document.

Table of Acceptance Criteria and Reported Device Performance (Inferred)

Acceptance Criterion (Inferred from Equivalence Claim)	Reported Device Performance (HeRO Symphony, solo/duet, ES)
Equivalence in ability to acquire, store, analyze, and report ECG data from infants.	Performs equivalently to HeRO 3.0.
Equivalence in heart rate variability (HRV) analysis, specifically identifying transient decelerations and/or reduced baseline variability.	Performs equivalently to HeRO 3.0.
Compliance with product specifications (unstated in document).	Performance matches product specifications.
Safety equivalent to HeRO 3.0.	As safe as HeRO 3.0.
Effectiveness equivalent to HeRO 3.0.	As effective as HeRO 3.0.
General performance (functionality, accuracy of HRV measurements) equivalent to HeRO 3.0.	Performs as well as or better than HeRO 3.0.

Study Information

The document describes non-clinical testing to support the substantial equivalence claim. It does not detail a separate clinical (human-subject) study specifically for HeRO Symphony, HeRO solo/duet, and HeRO ES to establish their individual performance against specific clinical acceptance criteria. Instead, it leverages the established performance and safety of its predicate device, HeRO 3.0.

Here's an analysis based on the provided text:

1. Sample size used for the test set and the data provenance:
- Test Set Size: Not explicitly stated for the current devices. The statement "The nonclinical testing... demonstrate the HeRO Symphony, HeRO solo/duet, and HeRO ES are as safe, as effective, and perform as well as or better than HeRO 3.0" suggests a comparative assessment, likely against HeRO 3.0's capabilities. There's no mention of a separate test set of patient data used to evaluate the new devices' performance independently.
- Data Provenance: Not specified. Given the focus on non-clinical testing and equivalence to a predicate, it's likely this refers to testing of the software and hardware components rather than new patient data.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there's no described clinical test set for these specific devices that would require expert-established ground truth. The devices provide "specialized HRV measurements" and are explicitly stated not to produce interpretations or diagnoses.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as no human-expert adjudicated test set is described for these specific devices.
4. 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 describe an MRMC study. HeRO devices are not explicitly marketed as AI-assisted diagnostic tools with human-in-the-loop improvement metrics. They provide physiological measurements (HRV) that are consumed by clinicians. The references listed pertain to studies on the general concept of heart rate characteristics monitoring in neonates (likely conducted with HeRO 3.0 or similar technology), not a comparative effectiveness study involving the new device iterations and human readers.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Yes, implicitly. The device "acquires, store, analyze, and report on ECG data" and "report measurements of the variability of heart rate data (HRV)." It is explicitly stated: "HeRO is intended to provide only specialized HRV measurements, and is not intended to produce any interpretation of those measurements or any kind of diagnosis." This means its "standalone" performance is its ability to accurately measure and report these HRV metrics based on input ECG data. The non-clinical testing and statement that "performance matches the product specifications" covers this.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the new devices, the ground truth is likely defined implicitly by the performance of the predicate device (HeRO 3.0) and established engineering/physiological standards for ECG data acquisition and HRV calculation. For the underlying science of HRV monitoring (as referenced in the paper list), outcomes data (e.g., neonatal sepsis, neurodevelopmental outcome, necrotizing enterocolitis, mortality) were likely used in the original validation of the HeRO concept, but this applies to the predicate, not a new validation of these specific devices.
7. The sample size for the training set: Not applicable for these specific devices. Their software is stated to be the same as HeRO 3.0. Any "training" (in a machine learning sense, if applicable to the underlying algorithms – which are likely signal processing, not deep learning) would have been done for the HeRO 3.0 development.
8. How the ground truth for the training set was established: Not applicable for these specific devices, as the software is the same as the predicate. The underlying algorithms for HRV analysis are likely based on established physiological principles and signal processing techniques, not machine learning trained on annotated data in the typical sense.

In summary: The submission for HeRO Symphony, HeRO solo/duet, and HeRO ES relies heavily on demonstrating substantial equivalence to its predicate device, HeRO 3.0, and on compliance with non-clinical engineering standards (IEC 60601-1 and IEC 60601-1-2) and the manufacturer's own quality system (21 CFR 820). No new clinical studies with human subjects or expert adjudication for performance evaluation of these specific device iterations are described in this summary.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services seal on the left and the FDA acronym and name on the right. The FDA acronym and name are in blue, with the acronym in a square and the name in a sans-serif font. The logo is simple and professional, and it is easily recognizable.

February 28, 2018

Medical Predictive Science Corporation William King Chief Executive Officer 2246 Ivy Road, Suite 17 Charlottesville, Virginia 22903

Re: K180242

Trade/Device Name: HeRO Symphony, HeRO ES, HeRO solo/duet Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II Product Code: DPS Dated: January 26, 2018 Received: January 29, 2018

Dear William King:

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. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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Page 2 - William King

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

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

M.A. Wilhelm

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

Enclosure

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Indications for Use

510(k) Number (if known) K180242

Device Name HeRO Symphony, HeRO solo/duet, HeRO ES

Indications for Use (Describe)

HeRO is intended to provide only specialized HRV measurements and is not intended to produce any interpretation of those measurements or any kind of diagnosis.

The specialized HRV measurements produced by HeRO have not been approved by the FDA for any specific clinical diagnosis.

HeRO acquires data from a user-supplied ECG monitor, and requires a user-supplied local area network.

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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Section 08: 510(k) Summary

1. Applicant

Owner Name	Medical Predictive Science Corporation
Owner Address	2246 Ivy Rd, Suite 17Charlottesville, VA 22903Tel: (434) 220 0714Fax: (240) 220 6098
Contact	William E King, CEO(434) 220 0714 x113wking@heroscore.com
Date of Preparation	1/25/18

2. Device

Common Name	Electrocardiograph, HRV Analysis System
Trade Names	HeRO SymphonyHeRO solo/duetHeRO ES
Classification Number	21 CFR 870.2340
Classification & Product Code	Class II, DPS

Predicate 3.

Predicate Device	HeRO 3.0
Predicate Device Manufacturer	Medical Predictive Science Corporation
Predicate Device Common Name	Electrocardiograph, HRV Analysis System
Predicate Device Classification Number	21 CFR 870.2340
Predicate Device Classification & ProductCode	Class II, DPS
Predicate Device Premarket Notification #	K111601

4. Description of Devices

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5. Indications for Use

HeRO is intended to acquire, store, analyze, and report on ECG data collected from infants. HeRO is intended to be used by trained operators under the direct supervision of a licensed health care practitioner in a hospital neonatal or pediatric ICU environment.

HeRO is intended to be used for the analysis of the variability in RR Intervals (heart rate) and to report measurements of the variability of heart rate data (HRV). The HRV measurements reported by HeRO are specialized in nature, and intended to identify periods of transient decelerations and/or reduced baseline variability in the heart rate.

HeRO is intended to provide only specialized HRV measurements, and is not intended to produce any interpretation of those measurements or any kind of diagnosis.

The specialized HRV measurements produced by HeRO have not been approved by the FDA for any specific clinical diagnosis.

HeRO acquires data from a user-supplied ECG monitor, and requires a user-supplied local area network.

6. Summary of Technological Characteristics

HeRO Symphony, HeRO solo/duet, and HeRO ES share the same software as HeRO 3.0, and are identical in technological characteristics. HeRO Symphony is the marketing name for networkbased implementations of HeRO, with a separate server and viewing stations. HeRO solo and duet implement the server and viewing station functionality on a single medical-grade PC for one or two beds. HeRO ES implements HeRO on the integrated PC (iPC) of a Philips MX700 or MX800 monitor.

New labeling has been created that is specific to each of these three embodiments. The new instructions for use differ from the previously cleared device in updated (and specific) screenshots, availability of electronic copies of the labeling, references and annotations to new journal articles supporting the intended use 15, simplification of the user interface particularly related to admission, transfer, and discharge, and general edits for clarification.

7. Summary of Supporting Data

HeRO Symphony, HeRO solo/duet, and HeRO ES were developed and are manufactured in accordance with 31 CFR 820 Quality System Regulations. HeRO specific hardware has been third-party tested in accordance with IEC 60601-1 and IEC 60601-1-2. HeRO Symphony, HeRO solo/duet, and HeRO ES performance matches the product specifications.

The nonclinical testing that is part of the processes described above demonstrate the HeRO Symphony, HeRO solo/duet, and HeRO ES are as safe, as effective, and perform as well as or better than HeRO 3.0.

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8. References

² Moorman JR, Delos JB, Flower AA, Cao H, Kovatchev BP, Richman JS, Lake DE. Cardiovascular oscillations at the bedside: early diagnosis of neonatal sepsis using heart rate characteristics. Physiological Measures, 2011.

2 Addison K, Griffin MP, Moorman JR, Lake DE, O'Shea TM. Heart rate characteristics and neurodevelopmental outcome in very low birth weight infants. J Perinatol. 29:750-6, 2009.

3 Stone ML, Tatum PM, Weitkamp JH, Mukherjee AB, Attridge J, McGahren ED, Rodgers BM, Lake DE, Moorman JR, Fairchild KD. Abnormal heart rate characteristics before clinical diagnosis of necrotizing enterocolitis. J Perinatol. (2013) May 30.

් Vergales BD, Zanelli SA, Matsumoto JA, Goodkin HP, Lake DE, Moorman JR, Fairchild KD. Depressed Heart Rate Variability is Associated with Abnormal EEG, MRI, and Death in Neonates with Hypoxic Ischemic Encephalopathy. Am J Perinatol. (2013) Dec 17.

్ Moorman JR, Carlo WA, Kattwinkel J, Schelonka RL, Porcelli PJ, Navarrete CT, Bancalari E, Aschner JL, Walker MW, Perez JA, Palmer C, Wagner DP, Stukenborg GJ, Lake DE, O'Shea TM. Mortality benefit of heart rate characteristics monitoring in very low birth weight infants: a randomized trial. J Pediatr 2011.

ର୍ Heart rate characteristics: novel physiomarkers to predict neonatal infection and death. Griffin MP, Lake DE, Bissonette EA, Harrell FE, O'Shea TM, Moorman JR. Pediatrics 116:1070-4, 2005.

Regulation Number and Section

§ 870.2340 Electrocardiograph.

(a)
Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.(b)
Classification. Class II (performance standards).