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HeRO is intended to acquire, store, analyze, 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 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.

HeRO 3.0 is 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.

The provided text describes the HeRO 3.0 device and its regulatory submission, but it does not contain the acceptance criteria or a study that proves the device meets specific acceptance criteria related to its performance.

The document focuses on:

• Device Description: What HeRO 3.0 is and how it functions (acquiring, storing, analyzing ECG data to report Heart Rate Variability (HRV) patterns).
• Indications for Use: The intended purpose of the device (analysis of HRV to identify transient decelerations and/or reduced baseline variability in heart rate in infants in NICU/PICU, under supervision). It explicitly states it's not for interpretation or diagnosis.
• Comparison to Predicate Device (HeRO 2.0): It highlights that HeRO 3.0 is identical in intended use, indications, technology, and algorithm. The differences are in graphical interface languages, display options, and digital input acceptance, and these changes are stated not to raise new safety/effectiveness questions.
• Regulatory Compliance: Mentioning compliance with 21CFR820 Quality System Regulations and third-party testing according to IEC 60601-1 and IEC 60601-1-2 for the hardware. It states, "The HeRO 3.0 System performance matches its product specifications." However, specific product specifications or performance criteria are not detailed.
• FDA Clearance: The letter from the FDA confirms substantial equivalence to a predicate device, which is a regulatory finding primarily based on the comparison to the existing device and not typically a detailed performance study against specific, quantified acceptance criteria in the way a clinical trial or algorithm validation study would present them.

Therefore, I cannot populate the requested table or answer the specific questions about sample size, expert ground truth, adjudication methods, MRMC studies, or standalone performance, as this information is not present in the provided text. The document describes a 510(k) submission, which often relies on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting new, extensive performance data against predefined acceptance criteria for the new device's core functionality.

Missing Information:

• Acceptance Criteria for Device Performance: The document states "The HeRO 3.0 System performance matches its product specifications," but it does not list these specifications or criteria.
• Specific Study Details: There is no description of a scientific study (either clinical or algorithmic validation) that tested HeRO 3.0 against specific performance metrics. The comparison is primarily to the predicate device HeRO 2.0.
• Quantitative Performance Data: No numbers for sensitivity, specificity, accuracy, or any other performance metric are provided.
• Sample Sizes (Training/Test), Data Provenance, Ground Truth Establishment: These details are entirely absent.
• Expert Review/Adjudication: Not mentioned.
• MRMC or Standalone Performance: No information on these types of studies.

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