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

AirStrip RPM is software capable of displaying physiologic and other patient information. This information is generated by other medical devices and patient information system, and not by AirStrip RPM captures this information from these other systems and displays it for clinicians.

AirStrip RPM is intended to be used by clinicians for the following purposes:

· By using a cellular telephone or other device on which AirStrip RPM is installed, to review physiologic data of a patient when the clinician is not at the hospital

· To view the near real-time waveforms remotely

· To remotely review other standard or critical near real-time patient data from the monitored system

· To provide a request for remote consultation regarding a patient's waveform or other data

The AirStrip RPM software can display the following the physiologic data captured by other medical devices:

· ECG Waveform
· Heart Rate Monitored
· Respiratory Rate
· Oxygen Saturation
· Intracranial Pressure
· Central Venous Pressure
· Pulmonary Capillary Wedge Pressure
· Cardiac Index
· Cardiac Output
· Cerebral Perfusion Pressure
· Urine Output
Urine/Stool Mix Output
· Systolic Blood Pressure Invasive
· Mean Arterial Pressure Invasive
· Diastolic Blood Pressure Invasive
· Systolic Blood Pressure Cuff
· Mean Arterial Pressure Cuff
· Diastolic Blood Pressure Cuff
· Vasoactive Infusions · Antiarrhythmics
· Sedation
· Paralytics
· Laboratory Data including
Blood Gas
Chemistry
Hematology
Coagulation
· Allergies
· Medications

Device Description

AI/ML Overview

The provided text is a 510(k) summary from the FDA for the AirStrip RPM device. It largely focuses on regulatory approval, intended use, and general controls. It does not contain the detailed information necessary to answer most of the questions about acceptance criteria and the specific study that proves the device meets those criteria.

However, based on the information provided, here's what can be inferred and what is missing:

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

Acceptance Criteria: The document does not explicitly state specific quantitative acceptance criteria for the device's performance (e.g., accuracy percentages, latency thresholds). The focus is on the device's ability to display physiological and patient information generated by other medical devices. The "Indications for Use" section outlines what the device does (e.g., "to review physiologic data," "to view near real-time waveforms remotely"). Implicitly, acceptance criteria would likely revolve around the reliable and accurate display of this data, without introducing errors or significant delays.
Reported Device Performance: Similarly, the document does not provide specific quantitative performance metrics (e.g., "the device displayed data with 99.5% accuracy compared to the source"). It states that the device is "capable of displaying physiologic and other patient information."

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

This information is not provided in the document.

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)

This information is not provided in the document. The device primarily displays data from other medical devices, so "ground truth" might refer to the data from the source devices, rather than a subjective expert assessment of the RPM's output.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This information is not provided in the 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

This information is not provided in the document. The AirStrip RPM is described as a display and remote viewing tool for existing data, not an AI-assisted diagnostic tool that would typically undergo an MRMC study to compare human performance with and without AI.

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

The document implies that the device is standalone in its function of displaying data. Its performance would be assessed on its ability to accurately and reliably receive and display information from other devices. However, no specific standalone performance metrics are provided. The "human-in-the-loop" aspect is the clinician interpreting the displayed data, not the device performing an algorithmic diagnosis.

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

The implicit "ground truth" for this device would be the data as generated by the original medical devices or patient information systems from which AirStrip RPM obtains its data. The device's performance would be evaluated on how faithfully and accurately it replicates and displays this source data. There's no mention of expert consensus, pathology, or outcomes data as a ground truth for the AirStrip RPM itself.

8. The sample size for the training set

This information is not provided in the document. This type of device (a display and communication tool) typically doesn't have a "training set" in the sense that an AI or machine learning model would. Its development would involve software engineering and testing for data integration, transmission, and display accuracy.

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

As above, the concept of a "training set" with ground truth in the AI/ML sense is not applicable to the description of this device. Development would involve testing against known valid data outputs from the source medical devices to ensure correct display.

Summary

Regulation Number and Section

§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).

(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).