(276 days)
The VORTRAN Airway Pressure Monitor (VAPM) is to be used by properly trained personnel to monitor the delivery of emergency, short term, ventilatory support to adult (using VAPM-3900 Adult Model) and/or pediatric (using VAPM-3800 Pediatric Model).
The VAPM is a battery (9 VDC) operated, portable, self-contained device that is connected to the patient via the connection tubing for monitoring cycling conditions of resuscitators such as the VORTRAN® Automatic Resuscitator.
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Table of Acceptance Criteria and Reported Device Performance:
The provided document describes the VORTRAN Airway Pressure Monitor (VAPM) and states that "The VAPM passed all required tests and demonstrated that it meets all predetermined acceptance criteria for applicable standards." However, the document does not explicitly list the specific numerical acceptance criteria for each measured parameter (e.g., accuracy for Peak Inspiratory Pressure, PEEP, Respiratory Rate, etc.) nor does it provide a table of the device's reported performance against these criteria.
Instead, it lists the performance standards with which the VAPM complies:
- IEC/UL-60601-1: General Requirements for Safety
- IEC 60601-1-8: Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
- IEC 60601-1-2: Collateral standard: Electromagnetic compatibility - Requirements and tests
Without specific performance criteria (e.g., "PIP accuracy ±X cm-H2O") and corresponding reported performance, a table cannot be fully generated from this document. The document only offers a general statement of compliance.
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Sample Size Used for the Test Set and Data Provenance:
- Sample Size: This information is not provided in the document.
- Data Provenance: This information is not provided in the document.
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Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- This information is not provided in the document. As this is a medical device for monitoring physiological parameters, the "ground truth" would typically come from calibrated reference instruments or established methodologies rather than expert consensus on interpretive data like images.
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Adjudication Method for the Test Set:
- Not applicable as the document does not describe a test set requiring adjudication in the context of interpretation (e.g., image reading). Testing for this device would involve comparing its measurements against reference standards.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study was not done. The device is an objective measurement tool, not an interpretive AI system that assists human readers.
- The document states "Clinical Tests: None."
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Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance):
- The relevant "standalone performance" for this type of device would be its accuracy and reliability in measuring airway pressure and related parameters. While the document states "The VAPM passed all required tests," detailed information about the specific standalone performance study (e.g., protocols, results of accuracy tests for PIP, PEEP, respiratory rate, alarm activation thresholds, and timing) is not provided. The document indicates compliance with international performance standards, implying such tests were conducted.
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Type of Ground Truth Used:
- The document implies that the ground truth for validation would be derived from calibrated reference standards or established measurement methodologies for airway pressure and respiratory parameters as per the IEC/UL standards it complies with. Specific details are not given, but for devices measuring physical quantities, this is the standard approach (e.g., a highly accurate pressure transducer for pressure measurements, a timer for rate measurements, etc.).
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Sample Size for the Training Set:
- Not applicable. This device is a hardware-based monitor, not an AI/ML algorithm that requires a "training set" in the conventional sense.
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How the Ground Truth for the Training Set Was Established:
- Not applicable as there is no training set for this type of device.
§ 868.2600 Airway pressure monitor.
(a)
Identification. An airway pressure monitor is a device used to measure the pressure in a patient's upper airway. The device may include a pressure gauge and an alarm.(b)
Classification. Class II (performance standards).