(203 days)
The purpose and function of the N-3000E Patient Mcnitor 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). 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 and heart rate. When further connected to the N-3100 Blood Pressure Monitor, the intended use of the interconnected N-3000E/N-3100/N-3200 is aiso to: noninvasively and automatically measure systclic, 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 disclay/printer) When the N-3100 is connected to the N-3200 Display/Printer, the purpose and function of the combined device (compared to K945947) is expanded to: display and print out associated. pulse rate and systolic, diastolic and mean . arterial blood pressure. The N-3000E Patient Monitor is intended for use in hospital-type and hospital transport environments as a "standalone" product and when connected to the N-3200 display/printer and/or the N-3100 blocd pressure monitor. It is also intended for use to monitor neonatal, pediatric, or adult patients. The N-3000E. N-3200 and N-3100 are for prescription use only.
Intrinsic electrocardiac signals are collected by conventional patient surface electrodes and conducted via a 3-lead ECG lead set and cable to the N-3000E's ECG processing module. These signals then undergo amplification and noise filtering. A software algorithm operates on the processed ECG signal to identify sequential QRS complexes and, hence, determine heart rate for numerical presentation on the N-3000E's front panel display. The processed ECG signal may also be supplied to the N-3200 Display/Printer for graphical presentation and printout. The ECG module is designed to comply with the AAMI/ANSI EC-13 standard, with the exception of clause 3.2.6.1. Test results confirming compliance with this standard have been included in the 510(k) submission. The technological characteristics of the pulse oximetry function of the N-3000E are identical to those in the predicate N-3000 pulse oximeter. The same algorithm is used in both products. Testing has been conducted to confirm that modification of the N-3000 pulse oximeter to add an ECG function and access to the N-3200 display/printer have not affected the safety or effectiveness of the oximetry function of the N-3000E.
The provided text describes the intended use and technological characteristics of the NELLCOR SYMPHONY™ N-3000E Patient Monitor, but it does not include information about acceptance criteria or specific studies proving the device meets those criteria.
Therefore, I cannot populate the table or answer most of the questions you've provided. The document focuses on establishing substantial equivalence to predicate devices and adherence to relevant standards like AAMI/ANSI EC-13 for ECG.
Here's a breakdown of what I can infer or what is explicitly stated, and what is missing:
Missing Information:
- Acceptance Criteria Table: No specific performance metrics or acceptance thresholds are provided in the document.
- Reported Device Performance: While it states "Test results confirming compliance with this standard have been included in the 510(k) submission," these results are not detailed in this excerpt.
- Sample size used for the test set and the data provenance: Not mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not mentioned.
- 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 mentioned. This type of study is typically for AI-assisted diagnostic devices, which this patient monitor is not.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not explicitly detailed as a separate study. The document mentions the "software algorithm operates on the processed ECG signal to identify sequential QRS complexes and, hence, determine heart rate," implying standalone algorithmic performance for heart rate calculation.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not mentioned for any specific test. For ECG, the ground truth would likely be a reference ECG system.
- The sample size for the training set: Not mentioned.
- How the ground truth for the training set was established: Not mentioned.
What can be extracted from the provided text:
While a formal acceptance criteria table and study details are absent, the document implies that compliance with AAMI/ANSI EC-13 standard for ECG and demonstration of unaffected safety/effectiveness for oximetry following modifications are the key criteria.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| ECG Function: | |
| Compliance with AAMI/ANSI EC-13 standard (with exception of clause 3.2.6.1) | "Test results confirming compliance with this standard have been included in the 510(k) submission." (Specific results not provided in this excerpt) |
| Accurate identification of sequential QRS complexes and heart rate determination | Implied by the algorithm description; specific performance metrics not given. |
| Pulse Oximetry Function: | |
| Safety and effectiveness not affected by modifications (addition of ECG/display) | "Testing has been conducted to confirm that modification... have not affected the safety or effectiveness of the oximetry function of the N-3000E." (Specific results not provided in this excerpt) |
| Overall Device: | |
| Compliance with "Reviewer Guidance for Premarket Notification Submissions, November 1993" | "Safety and effectiveness... have been confirmed by complying with the requirements... through design, testing and labeling." |
| Substantial Equivalence to predicate devices (Datascope PASSPORT, Protocol Systems PROPAQ 104, NELLCOR SYMPHONY™ N-3000, NELLCOR SYMPHONY™ N-3100) | Established through comparison of intended use, environment, patient population, and technological characteristics. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not specified. The document mentions "Test results" for ECG compliance and "Testing has been conducted" for oximetry, but gives no details on sample size or data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not specified.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not specified.
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
- No such study was mentioned or is applicable. This device is a patient monitor, not an AI-assisted diagnostic tool for interpretation by human readers in the way an MRMC study would typically evaluate.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The document implies a standalone algorithmic performance for heart rate determination: "A software algorithm operates on the processed ECG signal to identify sequential QRS complexes and, hence, determine heart rate for numerical presentation on the N-3000E's front panel display." However, specific details of a standalone study are not provided.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not explicitly stated in detail. For ECG compliance with AAMI/ANSI EC-13, the ground truth would typically be derived from a precisely calibrated electrical signal generator or a reference ECG system. For oximetry, it's usually comparison against an arterial blood gas analyzer (co-oximeter).
8. The sample size for the training set
- Not specified. (It's not certain if a "training set" in the machine learning sense was used for this type of traditional monitoring device, or if the algorithm was developed through other engineering methods.)
9. How the ground truth for the training set was established
- Not specified.
§ 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).