FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

•Non-invasive blood pressure determinations acquired concurrently with the ECG parameter will report a determination in the presence of an irregular heart rhythm in the adult/pediatric mode.

Heart/pulse rate, respiration rate, ECG

Oxygen saturation (SpO2) by noninvasive pulse oximetry and

Predictive temperature by resistive thermometry.

The Pro 1000 with SuperStat Monitor also detects alarm limit conditions and is capable of recording up to two waveforms. Using the monitor a clinician can view, record and recall clinical data derived from each parameter.

Device Description

The DINAMAP® Pro 1000 Monitor w/ SuperStat is intended to monitor a single patient's vital signs in the hospital, outpatient surgery and healthcare practitioner facilities. The patient populations include adult, pediatric, and neonatal. The device's networking capabilities include connection to a central station via VHF, 900 MHz or hardwire communication: host communications for use with other devices. In addition, the DINAMAP Pro 1000 Monitor may be operated from internal batteries making the device portable and suitable for intra-hospital transport.

AI/ML Overview

The acceptance criteria for the DINAMAP® Pro 1000 Monitor with SuperStat are tied to its performance in Non-Invasive Blood Pressure (NIBP) measurement, specifically regarding its ability to measure oscillometric NIBP, optimize performance in the presence of artifact, and report NIBP determinations with irregular heart rhythms. The study conducted to demonstrate that the device meets these criteria involved clinical studies following the ANSI/AAMI SP10 Standard.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Able to measure oscillometric non-invasive blood pressure (systolic, diastolic, and mean arterial pressure) in adult, pediatric, and neonate patient populations.	Met: The DINAMAP® Pro 1000 with SuperStat is intended to monitor oscillometric non-invasive blood pressure (systolic, diastolic, and mean arterial pressure) for adult, pediatric and neonate patients.
Will optimize performance in the presence of artifact due to vibration and patient motion.	Met: The device "Will optimize performance in the presence of artifact due to vibration and patient motion."
Non-invasive blood pressure determinations acquired concurrently with the ECG parameter will report a determination in the presence of an irregular heart rhythm in the adult/pediatric mode.	Met: The device "Non-invasive blood pressure determinations acquired concurrently with the ECG parameter will report a determination in the presence of an irregular heart rhythm in the adult/pediatric mode."

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

Sample Size: The document does not specify the exact sample size (number of patients) used for the clinical studies. It only states that "Clinical studies were conducted."
Data Provenance: The document does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. It just refers to "Clinical studies."

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

The document does not provide information on the number of experts used or their qualifications for establishing ground truth for the test set. The standard referenced, ANSI/AAMI SP10, typically involves a comparison to a reference standard (e.g., intra-arterial blood pressure measurements).

4. Adjudication Method for the Test Set

The document does not describe the adjudication method used for the test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size

No, the document does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. The focus is on the device's performance against a standard, not on comparing human readers with and without AI assistance.

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

Yes, the clinical studies describe the performance of the "SuperStat NIBP algorithm" according to the ANSI/AAMI SP10 standard. This implies a standalone evaluation of the algorithm's accuracy in measuring blood pressure, as NIBP devices typically provide automated readings.

7. The Type of Ground Truth Used

The ground truth for the NIBP measurements would typically be established by a reference standard during the clinical studies conducted according to the ANSI/AAMI SP10 standard. This almost certainly involves a direct comparison of the device's NIBP readings to simultaneously obtained, high-fidelity reference blood pressure measurements (e.g., intra-arterial blood pressure measurements performed by a trained professional). The document only states adherence to the standard, not the specific ground truth method.

8. The Sample Size for the Training Set

The document does not provide information on the sample size used for the training set.

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

The document does not provide information on how the ground truth for the training set was established. Given the nature of a 510(k) submission, the primary focus is on the validation of the final algorithm/device, not the specifics of its development or training data.

Summary

Regulation Number and Section

§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).

(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.