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The Intelwave 1.0 System is intended for use in Heart Rate Variability (HRV) measurements in response to paced respiration and controlled exercises.

The Intelwave 1.0 System is a computer-based system for measurement of Heart Rate Variability (HRV) in response to paced respiration and controlled exercises. The system performs a fully automated quantitative analysis of HRV based on data collected by an FDA-compliant R Wave Trigger device recommended or supplied by Intelwave. The system presents the results to the physician through a computer-based user interface. The system has patient data management capability.

Acceptance Criteria and Study for Intelwave Heart Rate Variability System

The provided document, K062068, for the Intelwave Heart Rate Variability System, primarily discusses substantial equivalence to predicate devices and outlines general performance testing approaches. However, it does not explicitly state numerical acceptance criteria or detail a specific study proving the device meets those criteria in the way typically expected for a detailed performance study.

Instead, the performance section mentions:

• "This product is designed to comply with ANSI/AAMI EC57: 1998/(R) 2003 'Testing and reporting performance results of cardiac rhythm and ST-segment measurement algorithms'."
• Two types of performance evaluations:
  1. "Comparison Performance Evaluation. Testing against the Holter Plus TM system."
  2. "Validation of reliability of HRV assessment by the Intelwave system."

Given this, the acceptance criteria are implicitly tied to demonstrating performance comparable to the predicate device (Holter Plus TM) and compliance with the mentioned ANSI/AAMI standard. The document does not provide specific numerical benchmarks for this comparison.

Based on the provided information, I cannot fill out the table with explicit numerical acceptance criteria and reported device performance, nor can I fully answer all the detailed questions regarding study specifics, as this level of detail is not present in the 510(k) summary.

Here's an attempt to answer the questions based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The 510(k) summary (K062068) does not explicitly define numerical acceptance criteria or present a table of reported device performance metrics against specific benchmarks. The criteria are implicit: compliance with ANSI/AAMI EC57 and performance comparable to the predicate Holter Plus TM system.

2. Sample Size and Data Provenance

The document does not specify the sample size used for the comparison or reliability validation tests, nor does it provide information on the data provenance (e.g., country of origin, retrospective/prospective).

3. Number and Qualifications of Experts for Ground Truth

The document does not mention the use of experts to establish ground truth for the test set, nor does it specify the number or qualifications of any such experts. The comparison appears to be against an existing device (Holter Plus TM system) rather than an expert panel.

4. Adjudication Method

The document does not describe any adjudication method for the test set.

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

The document does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study, nor does it discuss human reader performance with or without AI assistance. The device is for automated analysis.

6. Standalone (Algorithm Only) Performance Study

Yes, the performance evaluations described ("Comparison Performance Evaluation" and "Validation of reliability of HRV assessment by the Intelwave system") appear to be standalone performance tests of the algorithm, as the system performs "fully automated quantitative analysis of HRV."

7. Type of Ground Truth Used

The type of ground truth used implicitly would be the output/measurements from the predicate Holter Plus TM system for the "Comparison Performance Evaluation" and potentially an internal reference standard or established methodology for the "Validation of reliability of HRV assessment." However, the specific nature of this ground truth (e.g., expert consensus, pathology, outcomes data) is not detailed.

8. Sample Size for the Training Set

The document does not provide information on a training set or its sample size.

9. How Ground Truth for the Training Set Was Established

The document does not provide information on how a training set ground truth was established, as no training set is mentioned.

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