(104 days)
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
| Acceptance Criterion | Reported Device Performance | Comments |
|---|---|---|
| Not specified in the provided document. | Not specified in the provided document. | The 510(k) summary and FDA letter focus on intended use and substantial equivalence to a predicate, but do not detail specific performance metrics or thresholds for the Vicor PD2i Analyzer. For an electrocardiograph and HRV measurement device, typical criteria would involve accuracy, precision, and agreement with the predicate device for various HRV parameters. |
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.
§ 870.2340 Electrocardiograph.
(a)
Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.(b)
Classification. Class II (performance standards).