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1.) use for long-term monitoring of cardiac rhythm when intermittent arrhythmias are suspected due to patient symptoms such as palpitations, transient attacks (TIA's), syncope (fainting), or other such symptoms as determined by the physician.
2.) Efficacy of Treatment: The NorthEast Monitoring DR180-R/Oxy is indicated for use to determine if current pharmacological treatment of known arrhythmias is effective by measuring the frequency and duration of the arrhythmia compared to the frequency and duration prior to treatment.
3.) evaluate the function of implanted pacemakers to insure that the pacemaker is functioning . within prescribed limits.
4.) Trending of oxygen saturation (SpO2) in the blood for periods of up to 24 hours. If the device is to be used for home monitoring, periods of activity or excessive movement are to be omitted due to the artifact that would be generated.
5.) . The NorthEast Monitoring DR180-R/Oxy is to be used only on the order of a physician.

The DR180-R/Oxy Holter and Pulse Oximetry Recorder is the predicate device (DR180 Holter recorder, 510(k) K960925) with the addition of a Nonin Xpod pulse oximetry probe. The probe cable is attached to the DR180 with the electrode lead wires. ECG and pulse oximetry are recorded simultaneously for periods up to the hours. This data is recorded onto PCMCIA Flashdisk memory storage cards. When recording is complete, the card is removed from the DR180-R/Oxy, inserted into a slot in the analysis system, and the data is downloaded and analyzed as previously. The oximetry data is simply presented to the operator; no manipulation or editing is allowed.

The acceptance criteria and device performance information provided is limited to the pulse oximetry component of the DR180-R/Oxy device, given the focus of the 510(k) summary on the addition of this functionality.

Here's the breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance (for Pulse Oximetry)

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

• Sample Size: Not explicitly stated for the human subjects clinical test conducted by Nonin for the Xpod, nor for the simulator test by NorthEast Monitoring for the DR180-R/Oxy. It only mentions "human subjects" for Nonin's test.
• Data Provenance:
  • Nonin Xpod Clinical Test: Human subjects. No country of origin is mentioned. It is implied to be a prospective clinical study, as it was conducted "by its manufacturer, Nonin."
  • NorthEast Monitoring DR180-R/Oxy Test: Pulse oximetry simulator. This is a bench test, not clinical data provenance.

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

This information is not provided in the document. The clinical testing was conducted by Nonin, the manufacturer of the Xpod. For the simulator test, the "ground truth" would be the known, controlled output of the simulator.

4. Adjudication Method for the Test Set

This information is not provided as the details of the clinical study conducted by Nonin are not given, and for the simulator test, adjudication is not applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not mentioned. The submission focuses on the performance of the device itself and its equivalence to a predicate, not on how human readers' performance improves with or without the device.

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

Yes, a standalone test was performed for the pulse oximetry component.

• Nonin "clinically tested (human subjects)" the Xpod probe.
• NorthEast Monitoring "tested the DR180-R/Oxy using a pulse oximetry simulator."
  In both cases, these appear to be evaluations of the device's accuracy without a human interpreting the results, as the oximetry data is "simply presented to the operator; no manipulation or editing is allowed."

7. The Type of Ground Truth Used

• Nonin Xpod Clinical Test: Implied to be a reference standard for oxygen saturation in human subjects against which the Xpod's measurements were compared to determine the "<2% error." The exact nature (e.g., arterial blood gas analysis) is not stated but standard clinical practice for oximetry validation usually involves these types of measurements.
• NorthEast Monitoring DR180-R/Oxy Test: The ground truth was the known, controlled output of the pulse oximetry simulator.

8. The Sample Size for the Training Set

This information is not provided. The document describes testing, not the development or training of an algorithm (though the device itself is a measurement device, not an AI/ML algorithm in the modern sense).

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

This information is not provided as there is no mention of a "training set" or an algorithm that required specific training data in the context of this traditional medical device submission.

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