Search Results

The purpose and function of the N-3000 Patient Monitor is to:

• noninvasively and continuously monitor functional arterial oxygen saturation and pulse rate (using an accessory SpO2 sensor);
• noninvasively and continuously monitor ECG and heart rate (using accessory ECG leads).
• noninvasively and continuously measure Respiration Rate.

When connected to the N-3200 Display/Printer, the purpose and function of the combined device is expanded to:

• display and print out associated ECG and Plethysmograhic waveforms, SpO2, pulse rate, heart rate and respiration rate.

When further connected to the N-3100 Blood Pressure Monitor, the intended use of the interconnected N-3000/N-3100/N-3200 is also to:

• noninvasively and automatically measure systolic, diastolic and mean arterial blood pressure and to derive pulse rate from these measurements (using accessory blood pressure cuffs); and display and print out systolic, diastolic and mean arterial blood pressure (on the N-3200 display/printer).

The N-3000 Patient Monitor is intended for use in hospital and hospital-type environments as a "standalone" product and when connected to the N-3200 display/printer and/or the N-3100 blood pressure monitor. It is also intended for use during hospital transport when connected to and operating off of the N-3000 and/or N-3200 internal battery, to monitor neonatal, pediatric, or adult patients. The N-3000, N-3200 and N-3100 are for prescription use only.

The device which is the subject of this submission comprises a patient monitor, namely, a Respiration Rate Monitor combined with a Pulse Oximeter and ECG, model N-3000. The submitted device can also be connected to a noninvasive Blood Pressure Monitor, model N-3100 and to an accessory display/printer, model N-3200. Previous 510(k) submissions K945947 and K955642 cleared the N-3100 Blood Pressure Monitor and the related N-3000 Patient Monitor with ECG and SpO2 modalities and N-3200 display/printer for market release in 1995 and 1996, respectively.

The present submission covers software and hardware modifications to the predicate N-3000 patient monitor in order to incorporate a Respiration Rate measurement function and enable the display and printout of Respiration Rate information on the optional N-3200 Display/Printer. No hardware or software changes are required to the N-3100 blood pressure monitor or the N-3200 Display/Printer to accomplish the above.

This submission also covers software changes incorporated in the N-3000, N-3100 and N-3200 to enable data communication between these individual monitors and with the N-3200 display/printer when operating in the connected configuration.

The N-3000 can operate as a standalone monitor or it can be connected to (stacked with) other NELLCOR SYMPHONY instruments, such as the N-3100 Blood Pressure Monitor. The N-3200 Display/Printer accessory is functional only when connected to either the N-3000, N-3100 or both monitors stacked together.

The SpO2 ECG and noninvasive blood pressure functions and algorithms remain unchanged from those described in K955642 and K945947 respectively. The new Respiration Rate feature utilizes the ECG lead set and patient surface ECG electrodes, together with additional electronics processing on the ECG PC board located within the N-3000 housing. Respiration Rate in breaths/minute is displayed numerically on the N-3000 front panel display, when selected by the user. As a standalone device, the N-3000 incorporates alarms for high and low Respiration Rate. SpO2, pulse rate and heart rate.

The N-3200 Display/Printer accessory comprises an electroluminescent. EL or. alternatively, a liquid crystal, LCD graphic display, a User Interface (UIF) PCB, a display driver PCB and a sealed, lead-acid battery. The N-3200 also incorporates a thermal strip printer.

The N-3200 displays and prints Respiration Rate, SpO2 , ECG or NIBP waveforms, graphical and trend data when connected to an N-3000 or to an N-3100 or to both monitors.

The provided text is a 510(k) Summary for the NELLCOR SYMPHONY™ N-3000 Patient Monitor, which focuses on the addition of a Respiration Rate measurement function. The document establishes substantial equivalence to predicate devices and describes the device's technological characteristics and intended use.

However, the summary does not contain the detailed clinical study information required to populate the table and answer the specific questions about acceptance criteria, reported performance, sample sizes, ground truth establishment, expert involvement, or comparative effectiveness studies. The document states that "Safety and effectiveness...have been confirmed by complying with the requirements of the Reviewer Guidance for Premarket Notification Submissions, November 1993, through design, testing and labeling," but it does not provide the specific results or methodology of these tests in a format that allows for the requested analysis.

Therefore, many of the requested fields cannot be filled directly from the provided text.

Here is an attempt to address the questions based on the absence of information where applicable, and any available clues:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance

• Sample Size (Test Set): Not specified in the provided document.
• Data Provenance: Not specified, but generally, medical device premarket notifications in the US would rely on data from testing conducted under relevant industry standards and guidance. It's highly likely to be prospective testing for device verification and validation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• 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. 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

• MRMC Comparative Effectiveness Study: No, this document pertains to a patient monitor (hardware and integrated algorithms) with a respiration rate function, not an AI-assisted diagnostic tool that would involve "human readers" in the sense of interpreting outputs like images. The focus is on the device's direct measurement capability.
• Effect Size of Human Reader Improvement: Not applicable.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Standalone Performance: Yes, the fundamental function of the N-3000 (including the respiration rate algorithm) is designed to operate as a standalone measurement device, providing numerical display of respiration rate. The document states: "Respiration Rate in breaths/minute is displayed numerically on the N-3000 front panel display, when selected by the user. As a standalone device, the N-3000 incorporates alarms for high and low Respiration Rate..." The verification and validation testing for this function would inherently assess its standalone performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Type of Ground Truth: For a respiration rate monitor, the ground truth would most likely be established through:
  • Direct observation/manual counting by trained personnel: A common method for validating respiration rate.
  • Reference standard devices: Comparing the device's output to another highly accurate, independently validated respiration rate measurement system.
  • Physiological models/simulators: For initial testing and calibration.
  • The document does not specify the exact method used for ground truth.

8. The sample size for the training set

• Sample Size (Training Set): Not specified in the provided document. This device pre-dates widespread use of "AI" and "training sets" in the modern sense. The "training" for such an algorithm would typically involve development and refinement using physiological data, but the term "training set" with a specified size is unlikely to be used or reported in this context.

9. How the ground truth for the training set was established

• Ground Truth Establishment (Training Set): Not specified in the provided document. As noted above, the concept of a "training set" for machine learning with a distinct ground truth establishment process is not applicable to technology of this era for a device like a respiration rate monitor. Algorithm development would typically involve engineering and physiological principles validated against established methods.

Ask a specific question about this device