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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.

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.

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)

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.

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