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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 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/Stoo! 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
• Coaqulation
• · Allergies
• · Medications

Counter-Indications

Ocamer manageno intended for use anywhere cellular telephones or wireless devices are prohibited. AirStrip RPM is intended for use the hour 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.

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.

This document is a 510(k) clearance letter for the AirStrip Remote Patient Monitoring (RPM) Remote Data Viewing software. It informs AirStrip Technologies, LP that their device has been found substantially equivalent to legally marketed predicate devices and can be marketed.

However, this document does not contain information about:

1. Acceptance criteria or reported device performance
2. Sample sizes or data provenance for test sets
3. Number or qualifications of experts for ground truth
4. Adjudication method
5. Multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes
6. Standalone (algorithm-only) performance studies
7. Type of ground truth used
8. Training set sample size
9. How ground truth for the training set was established

The letter focuses on regulatory approval and specifies the intended use of the device, which is to display physiological and other patient information from existing medical devices and patient information systems to clinicians remotely. It clarifies that AirStrip RPM is a diagnostic aid, not a replacement for direct viewing of monitoring devices.

Therefore, I cannot provide a table of acceptance criteria or details of a study that proves the device meets specific performance criteria based on the provided text. The document is a regulatory approval, not a scientific study report.

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AirStrip RPM is software capable of displaying physiologic and not by AirStrip RPM. AirStrip RPM. AirStrip RPM generated by other medical devices and patential 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 phy 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 payafam as ather deta
• To remotely review other standard of entilour roar time patient's waveform or other data

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

• 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
• Coaqulation
  • Alleraies
  • Medications

AirStrip Remote Patient Monitoring (RPM) Remote Data Viewing software

I am sorry, but the provided text ({0} to {2}) does not contain information about the acceptance criteria, specific studies, or performance metrics for the AirStrip Remote Patient Monitoring (RPM) Remote Data Viewing software.

The document is a US FDA 510(k) clearance letter, which primarily states that the FDA has reviewed the premarket notification and determined the device is substantially equivalent to legally marketed predicate devices. It also lists the "Indications for Use" for the device.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text.

Ask a specific question about this device

AirStrip RPM is software capable of displaying physiologic and other patient 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-lime 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 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
• · Antiarrhvthmics
• · Sedation
• · Paralvtics
• · Laboratory Data including
• Blood Gas
• Chemistry
• Hematology
• Coagulation
• · Allergies
• · Medications

AirStrip RPM is software capable of displaying physiologic and other patient 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.

Based on the provided document, the device is the AirStrip Remote Patient Monitor (RPM) Remote Data Viewing software (K112235). The document is an FDA 510(k) clearance letter, which primarily focuses on substantial equivalence to a predicate device rather than detailing extensive clinical trials with acceptance criteria and performance metrics described as one might find for a PMA.

Therefore, much of the requested information regarding specific acceptance criteria and detailed study results as typically presented for AI/ML device performance is not available in this document. The FDA 510(k) summary for this type of device typically relies on verification and validation testing to demonstrate functional equivalence and safety, rather than a clinical effectiveness study with performance metrics like sensitivity/specificity against ground truth.

However, I can extract the available relevant information:

1. Table of acceptance criteria and the reported device performance:

This document does not explicitly state specific quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) or provide a table of reported device performance metrics against such criteria. The FDA 510(k) typically relies on a comparison to a predicate device and verification/validation testing to demonstrate proper functionality.

The "performance" described here is functional: the ability to accurately display various types of patient data from other medical devices.

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. The document refers to the data as being generated by "other medical devices and patient information system" and "captured from these other systems."

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. Given the nature of the device (a remote viewing software for existing patient data), the "ground truth" would likely be the data as presented by the original monitoring devices. Testing would focus on the fidelity of the data display.

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 device is a "Remote Data Viewing software" and is explicitly described as a "diagnostic aid, and not as a replacement for direct viewing of any of the monitoring devices from which it obtains its data." It is not an AI-assisted diagnostic tool in the sense of providing automated interpretations or improving human reader performance, but rather a system for displaying existing patient data remotely.

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

The device itself is essentially "standalone" in its function of data display, as it presents data from other systems. However, its stated "Indications for Use" clearly state it is "intended to be used by clinicians" and "by clinicians as a diagnostic aid." Therefore, while the software performs its display function independently, its intended use always involves a human clinician in the loop. The document does not describe "standalone" performance in the context of an algorithm providing a definitive diagnosis or interpretation without human oversight.

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

The implied "ground truth" for this device would be the accurate and faithful representation of the data generated by the original medical devices (e.g., ECG monitors, blood pressure cuffs, laboratory systems). The software's performance would be assessed on its ability to correctly transmit and display this data without alteration or corruption, not against an independent clinical ground truth like pathology or patient outcomes.

8. The sample size for the training set:

This information is not provided in the document. The device is a data display software, not a machine learning algorithm that typically requires a "training set" in the conventional sense.

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

This information is not provided in the document. As mentioned, the concept of a "training set" and its associated ground truth establishment is not directly applicable to this type of device based on the provided clearance letter.

Ask a specific question about this device

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
• Blood Pressure Waveform
• 02 Waveform
• CO2 Waveform
• Heart Rate
• 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

AirStrip RPM is software that runs on devices capable of running Apple iPhone OS. It interfaces with third-party centralized monitoring systems that in turn gather data from patient monitors and other devices in the hospital. AirStrip RPM gives health care providers the ability to view near-real-time patient physiological data remotely.

The provided 510(k) summary for the AirStrip RPM device does not include acceptance criteria or the specifics of a study proving the device meets acceptance criteria in the format typically found in clinical validation studies.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices through technical and functional comparisons, and describes internal verification and non-clinical testing.

Here's an analysis based on the information provided, addressing the requested points where possible, and noting where information is absent:

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

The document does not explicitly define acceptance criteria in terms of numerical thresholds for performance metrics (e.g., accuracy, sensitivity, specificity).

However, it states: "AirStrip Technologies conducted verification testing of all data points listed. In this test, known datasets were gathered from Cerner iBus and displayed on AirStrip RPM. These datasets included all data points proposed in AirStrip RPM; all monitored data, all manual data, including patient demographics. In all cases, AirStrip RPM was able to display data points with complete accuracy."

Based on this, we can infer the following:

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

• Sample Size for Test Set: Not specified. The document uses the general term "known datasets" without indicating the number of datasets or cases.
• Data Provenance: The "known datasets" were "gathered from Cerner iBus." While Cerner iBus is an FDA-cleared system, the origin (e.g., country, specific hospital, patient demographics) of the data within these datasets is not provided.
• Retrospective or Prospective: Not explicitly stated, but "known datasets were gathered" suggests a retrospective approach using pre-existing data.

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

This information is not provided. The document states "known datasets were gathered from Cerner iBus," implying that the data from the Cerner iBus itself served as the ground truth, rather than requiring independent expert adjudication of the same data.

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

This information is not provided. Given that the Cerner iBus data was considered the "known dataset," no explicit adjudication method for establishing ground truth for the test set is described.

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, a multi-reader multi-case comparative effectiveness study was not done. The device (AirStrip RPM) is a secure remote viewing software, not an AI-powered diagnostic or assistive tool designed to improve human reader performance in interpreting medical images or data. Its primary function is to display data from other systems.

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

The verification testing described ("AirStrip Technologies conducted verification testing of all data points listed... In all cases, AirStrip RPM was able to display data points with complete accuracy") represents a standalone performance assessment of the device's ability to accurately display data. It's a test of the algorithm's output fidelity compared to the known input, without involving human interpretation of the AirStrip RPM output for diagnostic purposes.

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

The ground truth used was the data as provided by the FDA-cleared Cerner iBus system. The AirStrip RPM's performance was evaluated by directly comparing its displayed data against these "known datasets" from the iBus system.

8. The sample size for the training set

This information is not applicable/provided. AirStrip RPM is a data display and communication software, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. The software's functionality is based on established communication protocols and display logic.

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

This information is not applicable/provided for the same reason as point 8. The device's functionality does not involve a training set with associated ground truth for learning purposes.

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