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The Vicor PD2i Analyzer is intended to display and analyze electrocardiographic information and to measure heart rate variability (HRV) at rest and in response to controlled exercise and paced respiration in patients undergoing cardiovascular disease testing. The results are to be interpreted by a qualified healthcare practitioner. These and other measurements are not intended for any specific clinical diagnosis. The clinical significance of HRV and other parameters must be determined by the physician.

The Vicor PD2i Analyzer is a software algorithm for measuring heart rate variability (HRV) using the Point Correlation Dimension Algorithm (PD2i).

Here's an analysis of the provided text regarding the Vicor PD2i Analyzer:

Important Note: The provided document (K101867) is a 510(k) summary for a modification to an existing device (Vicor PD2i Analyzer, predicate K082709). The primary claim of this 510(k) is that the changes (user interface, transmission method, display of additional parameters) do not alter the underlying PD2i algorithm and thus do not raise new questions of safety or effectiveness. Therefore, this document does not contain a new study to prove the device meets acceptance criteria for its core functionality. Instead, it relies on the previous clearance (K082709) for the algorithm's performance and focuses on demonstrating that the changes are substantially equivalent.

Because the document states: "This 510(k) notification presents changes to the user interface of the PD2i Analyzer software without change in the PD2i algorithm," and "The software algorithm for calculating the HRV is unchanged," there is no performance data or acceptance criteria provided in this specific 510(k) document relating to the accuracy or clinical performance of the PD2i algorithm itself. The information requested below regarding acceptance criteria and a study to prove its performance would likely be found in the original 510(k) for the predicate device (K082709) or subsequent clinical studies if they were performed.

However, based on the information available in this K101867 document, here's what can be inferred or stated about the device and its regulatory pathway:

Acceptance Criteria and Device Performance Study (Based on K101867)

1. Table of Acceptance Criteria and Reported Device Performance:

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

• No specific test set or sample size is mentioned in this 510(k) document for directly proving the PD2i algorithm's performance. The submission primarily focuses on the unchanged nature of the algorithm and the equivalence of new features.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

• Not applicable for this 510(k) document. No new test set requiring expert ground truth establishment for the PD2i algorithm's core function is described.

4. Adjudication Method for the Test Set:

• Not applicable for this 510(k) document. No new test set requiring adjudication is described.

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

• No MRMC study is mentioned in this 510(k) document. This submission is for modifications to a previously cleared device, not a new clinical effectiveness study.

6. Standalone (Algorithm Only) Performance Study:

• No standalone performance study is directly described in this K101867 document. This 510(k) relies on the previous clearance of the PD2i algorithm as part of the predicate device (K082709). The initial standalone performance of the algorithm would have been part of that submission.

7. Type of Ground Truth Used:

• Not described in this K101867 document. The nature of the ground truth used to validate the original PD2i algorithm (in K082709) is not detailed here.

8. Sample Size for the Training Set:

• Not applicable / not provided in this K101867 document. This submission does not describe the training of the PD2i algorithm, as the algorithm itself is stated to be unchanged from the predicate device.

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

• Not applicable / not provided in this K101867 document. As above, the document does not describe the training or ground truth establishment for the PD2i algorithm.

Summary of this 510(k) Document (K101867):

This 510(k) is a "Special 510(k)" or similar modification submission. It seeks clearance for changes to the Vicor PD2i Analyzer that primarily involve the user interface, data transmission methods, and the display of additional physiological parameters (blood pressure, Ewing ratio). The crucial point for this submission is that the core algorithm (PD2i) for calculating Heart Rate Variability (HRV) remains unchanged from its predicate device (K082709). Therefore, the document asserts substantial equivalence by demonstrating that these modifications do not introduce new questions of safety or effectiveness, rather than by presenting new performance data for the algorithm itself. To find the detailed performance validation of the PD2i algorithm, one would need to consult the original 510(k) submission for the predicate device, K082709.

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The Vicor PD2i Analyzer is intended to display and analyze electrocardiographic information and to measure heart rate variability (HRV). These and other measurements are not intended for any specific clinical diagnosis. The clinical significance of HRV and other parameters must be determined by the physician.

The Vicor PD2i Analyzer is a software algorithm for recording heart rate variability (HRV) using the Point Correlation Dimension Algorithm (PD2i).

Here's an analysis of the provided text regarding the Vicor PD2i Analyzer, focusing on acceptance criteria and the study details:

Missing Information:

It's important to note that the provided text is a 510(k) summary and letter from the FDA. While it discusses the device's intended use and substantial equivalence to a predicate, it does not contain the details of specific acceptance criteria or a study outlining the device's performance against those criteria. Such information would typically be detailed in a separate technical report or validation study submitted as part of the 510(k) application, but not usually fully reproduced in the summary letter itself.

Therefore, the following answers are based on the absence of this information in the provided document and general understanding of 510(k) submissions for similar devices where performance data is crucial.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not specified in the provided document.
• Data Provenance: Not specified in the provided document (e.g., country of origin, retrospective or prospective).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Number of Experts: Not specified in the provided document.
• Qualifications of Experts: Not specified in the provided document.

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified in the provided document.

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

• Was an MRMC study done? Not specified in the provided document.
• Effect Size of Human Reader Improvement: Not applicable, as no MRMC study details are provided. This type of study comparing human readers with and without AI assistance is more common for diagnostic imaging AI devices, rather than a device primarily for heart rate variability measurement/analysis as described here.

6. Standalone (Algorithm Only) Performance Study

• Was a standalone study done? The Description of Device states, "The Vicor PD2i Analyzer is a software algorithm for recording heart rate variability (HRV) using the Point Correlation Dimension Algorithm (PD2i)." The Intended Use also describes it as displaying and analyzing ECG information and measuring HRV. This strongly implies that the device is the algorithm, and any performance study would inherently be a standalone evaluation of this algorithm's ability to measure HRV from ECG data. However, the specific details or results of such a standalone study are not provided in the document.

7. Type of Ground Truth Used (for the Test Set, if applicable)

• Type of Ground Truth: Not specified in the provided document. For an HRV measurement device, ground truth would likely be established through a reference standard for ECG acquisition and calculation of HRV parameters, possibly validated against expert manual analysis or established physiological measurement techniques.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not specified in the provided document.

9. How Ground Truth for the Training Set Was Established

• How Ground Truth Was Established: Not specified in the provided document.

Summary of Device and Regulatory Context (from the provided text):

The Vicor PD2i Analyzer is a software algorithm (using the Point Correlation Dimension Algorithm - PD2i) intended to display and analyze electrocardiographic information and measure heart rate variability (HRV). It is classified as an Electrocardiograph (21 CFR 870.2340, Product Code DPS) and is a Class II device. The FDA found it substantially equivalent to the predicate device, "The Portable ANSiscope ECG Monitoring System (K071168)," meaning it has the same intended use.

Key takeaway: The provided 510(k) summary and FDA letter confirm the device's regulatory clearance and its intended use, but they do not delve into the detailed performance study data, acceptance criteria, or methodological specifics that would typically be found in accompanying technical documentation.

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