Search Results

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.

Ask a specific question about this device

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 Version 2.0 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 devices. Data is acquired on a special-purpose Data Acquisition Device (DAD). It is stored and analyzed on a server, also called the Central Monitoring Station (CMS), located in a data closet or other suitable location. Results of the analyses are reported on a viewing station, or Remote Monitoring Station (RMS). The analysis algorithms identify Heart Rate Variability (HRV) patterns that reflect transient decelerations and/or reduced baseline variability.

Acceptance Criteria and Device Performance Study for HeRO Version 2.0

This submission describes the HeRO Version 2.0 HRV Analysis System, which is a substantial equivalence determination for an updated version of a previously approved device (HeRO, K021230). The focus of this 510(k) is on demonstrating the updated device maintains the same intended use, technology, and safety/efficacy profile as its predicate, rather than establishing new clinical performance metrics. Therefore, explicit "acceptance criteria" for novel clinical performance and a specific "study" proving these criteria are met are not presented in the traditional sense of a de novo device. Instead, the submission focuses on demonstrating equivalency to the predicate.

Here's an analysis of the provided text in relation to your request:

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of this 510(k) (Special 510(k) for an updated device), the "acceptance criteria" are primarily centered around maintaining the performance, safety, and intended use of the predicate device. The "reported device performance" is then the assertion that HeRO Version 2.0 achieves this equivalence.

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

The provided document does not detail any specific test set, its sample size, or data provenance used for a clinical performance study demonstrating the device's accuracy or effectiveness with patient data. This is typical for a Special 510(k) where the device is an update to an existing one, and the focus is on engineering changes and maintained performance, rather than new clinical claims. The "Test Summary" section refers to third-party testing for electrical safety and electromagnetic compatibility (UL 60601-1 and IEC 60601-1-2), not clinical performance with a patient data test set.

3. Number of Experts Used to Establish Ground Truth and Qualifications

As no clinical performance study with a test set of patient data is described, there is no information provided on experts or ground truth establishment for such a dataset.

4. Adjudication Method

Since no clinical performance study involving expert review of a test set is described, there is no adjudication method mentioned.

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

There is no mention of an MRMC comparative effectiveness study where human readers' performance with and without AI assistance was evaluated. The HeRO device is described as an "HRV Analysis System" that provides "specialized HRV measurements" and is not intended to "produce any interpretation of those measurements or any kind of diagnosis." This indicates it's an analytical tool, not a diagnostic aid requiring human interpretation in a comparative effectiveness study as typically understood for AI-assisted diagnostics.

6. Standalone (Algorithm Only) Performance Study

The document does not describe a standalone performance study in terms of diagnostic accuracy or clinical utility using patient data. The device's function is to "acquire, store, analyze, and report on ECG data" by identifying "HRV patterns." The performance being demonstrated here is primarily related to its technical ability to compute these HRV measurements and its safety, not its standalone diagnostic accuracy for a specific condition.

7. Type of Ground Truth Used

As no clinical performance study on patient data is detailed, no specific type of ground truth (e.g., expert consensus, pathology, outcomes data) is mentioned for establishing the accuracy of the device's HRV measurements in a clinical context.

8. Sample Size for the Training Set

The document does not provide any information regarding a training set sample size. This is consistent with the nature of the submission not detailing a new algorithm development or extensive clinical validation study. The algorithm likely evolved from previous versions or established HRV analysis techniques, rather than being a de novo algorithm from a large training dataset for this specific submission.

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

As no training set is mentioned, there is no information provided on how its ground truth might have been established.

Ask a specific question about this device