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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. 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

Contraindications
AirStrip RPM software is intended for installation on cellular telephones and other wireless devices, and is not intended for use anywhere cellular telephones or wireless devices are prohibited. AirStrip RPM is intended for use by clinicians when they cannot be at the hospital. AirStrip RPM is intended for use by clinicians as a diagnostic aid, and not as a replacement for direct viewing of any of the monitoring devices from which it obtains its data.

The AirStrip RPM InvisionHeart Adapter is a software application that interfaces with the InvisionECG System in hospitals to allow health care professionals the ability to view near real-time patient data remotely. AirStrip RPM works by retrieving patient data from the InvisionECG System monitoring system and providing that data to the end user's device via Wi-Fi or cellular modem over the Internet.

The AirStrip RPM InvisionHeart Adapter is a software application that interfaces with the InvisionECG System to display near real-time patient data remotely to healthcare professionals.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a numerical sample size for a test set in terms of patient data or clinical cases. The performance evaluation primarily focuses on demonstrating substantial equivalence through non-clinical testing of the software's functionality, interoperability, and adherence to standards.

The data provenance for any internal testing is not explicitly mentioned, but the system is designed to interface with the InvisionECG System, which handles patient data. The context implies that the testing involves how the adapter processes and displays data originating from the InvisionECG System, which in turn acquires data from actual patients in a hospital setting. The study is retrospective in the sense that it evaluates the software's ability to display data that has already been generated by other medical devices.

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

This information is not provided in the document. Given that no formal clinical study with human interpretation of results is detailed, there's no mention of experts establishing ground truth for a test set. The evaluation is focused on the technical performance of the software in accurately displaying information from the source system.

4. Adjudication Method for the Test Set

This information is not applicable as there is no mention of a human-centric test set requiring adjudication. The evaluation centers on software verification and validation.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or reported in this submission explicitly. The device's purpose is to display data to clinicians, not to perform interpretations or make diagnoses itself. Therefore, a study to measure human reader improvement with AI assistance (as the device is a medical device data system, not an AI diagnostic tool) is not relevant to its stated function or the type of evaluation presented.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The evaluation conducted is essentially a standalone (algorithm only) performance assessment, though not in the typical sense of a diagnostic algorithm. The device itself is software that transmits and displays data. The "performance" tested is its adherence to technical specifications, cybersecurity, risk management, and the accurate rendering of data (ECG waveforms, other physiological parameters) from a source system. The "algorithm" here refers to the software's logic for data capture, processing, and presentation, rather than a diagnostic algorithm.

7. The Type of Ground Truth Used

The ground truth for the non-clinical tests appears to be the predetermined specifications of the software and the expected output or behavior when interfacing with the InvisionECG System, as well as adherence to relevant standards (e.g., DICOM, ISO 14971). For example, the ground truth for DICOM compliance is the DICOM standard itself. For accurate waveform display, the ground truth would be the waveform as generated by the InvisionECG System.

8. The Sample Size for the Training Set

The document does not mention a training set as this device is a data display and communication system, not a machine learning or AI model that typically requires training data. Its functionality is based on established software engineering principles and interoperability standards.

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

As no training set is mentioned or implied for this type of medical device data system, this point is not applicable.

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This device is intended to be used by clinicians for the following purposes:

• 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

This device 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
• Systolic Blood Pressure Invasive
• Mean Arterial Pressure Invasive
• Diastolic Blood Pressure Invasive
• Systolic Blood Pressure Cuff
• Mean Arterial Pressure Cuff
• Diastolic Blood Pressure Cuff

Not Found

The provided document is a 510(k) premarket notification letter from the FDA for the Airstrip ONE Web Client, a cardiac monitor. This document primarily focuses on FDA's determination of substantial equivalence and does not contain specific details about acceptance criteria for device performance or the study that proves the device meets those criteria.

The information typically found in such a study (acceptance criteria, sample size, ground truth establishment, expert qualifications, etc.) is not present in this regulatory letter. This letter is a formal communication from the FDA stating that the device has been cleared for marketing based on its substantial equivalence to a legally marketed predicate device, and it outlines the regulatory obligations of the manufacturer.

Therefore, I cannot extract the requested information from the provided text.

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AirStrip RPM for LIFENET Consult is an optional data transmission system that provides the capability to receive notifications at a remote location. Data is received from the field and can be used for diagnosis, disposition, and therapy decisions by qualified medical personnel.

Not Found

This looks like a 510(k) clearance letter for the AirStrip Remote Patient Monitoring (RPM) for LIFENET® Consult device. Unfortunately, the provided document does not contain the detailed information required to answer your request about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment.

This type of FDA letter typically confirms that a device is substantially equivalent to a predicate device and is cleared for marketing. It usually does not include the detailed scientific study results that demonstrate how the device meets specific performance acceptance criteria. Such information would typically be found in the original 510(k) submission, which is a much more extensive document.

Therefore, I cannot provide the requested table and study details.

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