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The monitor one nDx® is intended to measure time domain heart rate variability (HRV) in response to a series of standardized, controlled exercises on the patient. While the monitor one nDx® has been shown to be safe and effective for the measurement of heart rate variability, it is not intended to be used as the basis for a specific clinical diagnosis. The clinical significance of HRV should be determined by the physician.

monitor one nDx® is a microprocessor based, real-time, hand-held, battery powered, ECG monitor and respiration pacer. It identifies, classifies, analyzes, stores and retrieves from memory electrocardiographic (ECG) signals for the purpose of measuring and providing statistical analysis of heart rate variability. These signals, along with associated numerical data, are provided to the user in printed or electronic form for over-reading by competent medical professionals. The monitor one nDX ® system consists of a pacing and recording device, a set of skin electrodes with associated cable and an optically coupled interface for transmitting stored data to compatible devices or modems. The hand-held monitor weighs 16 oz. and measures 7.5 x 3.5 x 1.4 inches. It is powered by four AA alkaline batteries. monitor one nDx® senses changes in the electrical potential of the skin caused by successive depolarization and repolarization of the heart as it beats. These electrocardiographic (ECG) signals are picked up by electrodes applied to the skin in three locations representing two poles of the V5 lead (recommended) and a reference or "ground" lead. The resulting signal is fed to a series of operational amplifiers, comprising a precision instrumentation amplifier. The signal is conditioned, by means of filters to minimize the effect of noise and artifact. Protection circuits shunt destructive overvoltage to ground to prevent damage to the circuitry.

This 510(k) submission (K972991) for the Monitor One nDx® ECG monitor and respiration pacer does not contain the detailed acceptance criteria or a study proving the device meets specific performance criteria in the way typically seen for AI/software as a medical device (SaMD) clearances.

Instead, this submission is focused on demonstrating substantial equivalence to an existing predicate device based on its intended use, design, and safety. There is no mention of an algorithm making a diagnosis or providing an interpretation that would require clinical performance metrics like sensitivity, specificity, or AUC. The device is described as measuring "time domain heart rate variability (HRV) in response to a series of standardized, controlled exercises," and providing these signals and numerical data to the user for "over-reading by competent medical professionals." It explicitly states that it "is not intended to be used as the basis for a specific clinical diagnosis" and "does not provide a diagnosis."

Therefore, the requested information regarding acceptance criteria, reported device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are not applicable or available in this document for the reasons explained above.

Here's an analysis of what is available from the provided text, framed against your requested categories, with notes indicating why certain information is absent:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable. This device is cleared through substantial equivalence to a predicate device for its intended use as an ECG monitor and respiration pacer that provides statistical analysis of heart rate variability. It does not provide a diagnosis, and therefore, typical diagnostic performance metrics (e.g., sensitivity, specificity for a particular condition) are not presented as acceptance criteria or reported performance outputs. The safety summary focuses on electrical and mechanical safety, and the device's role as a diagnostic aid that presents information for physician review.

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

Not applicable. No "test set" in the context of evaluating an algorithm's diagnostic performance is described. The submission focuses on the device's technical specifications, safety, and functionality in measuring HRV and presenting data.

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

Not applicable. No clinical "ground truth" or expert consensus for device performance evaluation in a diagnostic capacity is described. The device provides raw data and statistical analysis for "over-reading by competent medical professionals."

4. Adjudication Method for the Test Set

Not applicable. There is no test set performance for adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

Not applicable. This device is not an AI-based diagnostic tool and does not describe any human-in-the-loop assistance features or a comparative effectiveness study.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is not an AI algorithm but rather a device that measures and processes ECG signals to provide statistical analysis of heart rate variability. It explicitly states it "does not provide a diagnosis."

7. The Type of Ground Truth Used

Not applicable. No diagnostic ground truth (pathology, expert consensus, outcomes data) is described in relation to the device's performance because the device itself does not make a diagnosis. It measures HRV for professional interpretation.

8. The Sample Size for the Training Set

Not applicable. This device is not described as using machine learning or AI models that require training sets. It uses embedded programming to process ECG signals and apply statistical analysis.

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

Not applicable. As above, there is no mention of a training set or associated ground truth for this device.

Summary of Device and Approval Context:

The Monitor One nDx® is a hardware device (an ECG monitor and respiration pacer) that performs real-time processing and statistical analysis of heart rate variability. Its clearance (K972991) in 1998 was based on demonstrating substantial equivalence to a predicate device (SpaceLabs Heart Rate Variability Software Option K950779) in terms of its intended use to measure time domain heart rate variability.

The submission emphasizes the device's technical specifications, safety (e.g., electrical isolation, battery operation, non-invasive nature), and the fact that it is a diagnostic aid whose output is for "over-reading by competent medical professionals" and "is not intended to be used as the basis for a specific clinical diagnosis."

Therefore, the detailed performance study data, acceptance criteria, and AI-specific metrics you've requested are not part of this type of 510(k) submission for a device that predates widespread AI/ML software as a medical device (SaMD) and focuses on data capture and statistical processing rather than diagnostic interpretation.

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