(270 days)
When used in NIV mode:
The Airvo 3 NV provides non-invasive ventilator support for non-ventilator dependent, spontaneously breathing adult patients (66 lb/30 kg and above) with respiratory insufficiency. It is intended to be used in hospitals. It is not intended for life support.
When used in High Flow mode:
The Airvo 3 NIV is intended to provide high flow warmed and humidified respiratory gases for administration to spontaneously breathing infant, child, adolescent and adult patients in hospitals. It adds heat and moisture to the flow of air, or blended air/medical oxygen mixture, and assures the user of the air/oxygen mixture using an integrated oxygen analyzer and visual display. The flow may be from 2 to 70 L/min depending on the patient interface. The Airvo 3 NVV provides high flow gases with simultaneous oxygen delivery to spontaneously breathing patients with or without bypassed upper airways in hospitals.
The Airvo 3 NIV provides high flow gases with simultaneous oxygen delivery through nasal cannula interfaces to augment the breathing of spontaneously breathing patients suffering from respiratory distress and/or hypoxemia in the hospital setting. The Airvo 3 NIV is not intended to provide total ventilatory requirements and is not intended for use during field transport.
AirSpiral NIV tube and chamber kit (900PT573):
For use with noninvasive ventilator support for non-ventilator dependent, spontaneously breathing adult patients (66 lbs./30 kg and above) with respiratory insufficiency. It is intended to be used in hospitals. It is not intended for life support.
The subject device, F&P Airvo 3 NIV is a respiratory support device for the delivery of High Flow and NIV (Non-Invasive Ventilation) therapy intended to treat spontaneously breathing patients who would benefit from receiving High Flow or respiratory pressure support. The Airvo 3 NIV is NOT to be used for life-supporting or life-sustaining purposes.
The Airvo 3 NIV is a non-implantable, prescription-only device, provided in a non-sterile state, and intended to be used by healthcare professionals, namely respiratory therapists, doctors and nurses in hospitals. When used in High Flow mode, the Airvo 3 NIV delivers gas at flow rates of between 2-70 L/min. The Airvo 3 NIV also has three non-invasive ventilation therapy modes: CPAP, Bi-Level S/T and Bi-Level PCV.
The AirSpiral NIV Tube and Chamber Kit is a single limb circuit kit designed for use with the Airvo 3 NIV device, for non- ventilator dependent, spontaneously breathing adult patients with respiratory insufficiency.
The provided text is a 510(k) Summary for the F&P Airvo 3 NIV device. It focuses on demonstrating substantial equivalence to predicate devices, rather than a detailed study proving the device meets specific acceptance criteria in the context of an AI/ML algorithm.
Therefore, many of the requested items (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set size, ground truth for training set) are not applicable to this document as it does not describe an AI/ML device or a study of its clinical performance against specific acceptance criteria for such an algorithm.
However, I can extract information related to performance testing from the "PERFORMANCE DATA VII." section, which includes "Bench / Performance Testing."
Here's an attempt to answer your request based on the provided document, noting the limitations due to the nature of the submission:
Acceptance Criteria and Study for F&P Airvo 3 NIV (K233643)
The F&P Airvo 3 NIV is a respiratory support device and not an AI/ML driven diagnostic or therapeutic device. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the non-clinical testing performed to establish substantial equivalence to predicate devices and ensure general safety and effectiveness in line with recognized medical device standards.
1. Table of Acceptance Criteria and Reported Device Performance
The document lists performance testing conducted but does not explicitly state numerical acceptance criteria or reported device performance values in a table format. Instead, it states that the testing "demonstrated the appropriate electrical safety and electromagnetic compatibility profile for the device" and that "The testing demonstrated the appropriate biocompatibility profile for the device" and "The system complies with ANSI AAMI ES 60601-1:2005/(R)2012 and A1:2012, IEC 60601-1-2:2014 and AIM Standard 7351731 Rev. 3.00 2017-02-23" as well as "Alarms testing was performed in accordance with ANSI AAMI IEC 60601-1-8:2006 and A1:2012." For reprocessing, "The acceptance criteria and endpoints used are based on the following standard: AAMI TIR30:2011". For comparative performance, it states "Comparative performance testing was performed to demonstrate substantial equivalence."
Given the information, a table with specific numerical acceptance criteria and performance values cannot be fully populated as requested for items like blending accuracy, flow rate accuracy, etc. The document implies compliance with relevant standards as the "acceptance criteria."
| Acceptance Criteria Category | Specific Acceptance Criteria (Implied by standard compliance) | Reported Device Performance (Implied by positive statement) |
|---|---|---|
| Biocompatibility | Compliance with ISO 10993-1 and ISO 18562-1 (FDA recognized standards). | "Testing of the Airvo 3 System demonstrates an appropriate biocompatibility profile for the device." |
| Electrical Safety, EMC, Alarms | Compliance with ANSI AAMI ES 60601-1, IEC 60601-1-2, AIM Standard 7351731, and ANSI AAMI IEC 60601-1-8. | "The system complies with ANSI AAMI ES 60601-1:2005/(R)2012 and A1:2012, IEC 60601-1-2:2014 and AIM Standard 7351731 Rev. 3.00 2017-02-23. The testing demonstrated the appropriate electrical safety and electromagnetic compatibility profile for the device. Alarms testing was performed in accordance with ANSI AAMI IEC 60601-1-8:2006 and A1:2012." |
| Software V&V | Compliance with FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Device Software Functions." | "Software verification, validation and hazard analysis was conducted, and documentation was provided as recommended by FDA's Guidance..." (implies successful completion). |
| Cleaning/Reprocessing | Compliance with AAMI TIR30:2011 ("A compendium of Processes, Materials, Test Methods, And Acceptance Criteria for Cleaning Reusable Medical Devices"). | "The acceptance criteria and endpoints used are based on the following standard: AAMI TIR30:2011..." (implies successful validation for semi-critical device reprocessing). |
| Bench/Performance Testing | Demonstration of "substantial equivalence" for parameters like blending accuracy, flow rate accuracy, continuous use thermal stability, pressure waveform analysis, humidification output. (Specific numerical criteria not provided). | "Comparative performance testing was performed to demonstrate substantial equivalence" (implies successful demonstration against predicate devices' performance characteristics). |
2. Sample size used for the test set and the data provenance:
- Not applicable for an AI/ML context. This device is hardware with embedded software, thus performance testing involves engineering verification and validation, not a test set of patient data for an algorithm. The testing described focuses on functional aspects of the device, not an algorithm's performance on a dataset.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable for an AI/ML context. Ground truth, in the sense of clinical expert assessment of data, is not mentioned in relation to the device's technical performance testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable for an AI/ML context. This type of adjudication is relevant for resolving discrepancies in expert interpretations of clinical data, which is not described here.
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:
- Not applicable. This device is not an AI-assisted tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device does not feature a standalone algorithm performing a diagnostic or therapeutic task.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For engineering and performance testing described (electrical safety, EMC, flow rate accuracy, etc.), the "ground truth" would be established physical and engineering principles, international standards, and measurements from calibrated reference instruments. It is not clinical "ground truth" as typically defined for AI/ML performance.
8. The sample size for the training set:
- Not applicable. There is no mention of an AI/ML training set. Software verification and validation refer to standard software engineering practices.
9. How the ground truth for the training set was established:
- Not applicable. There is no mention of an AI/ML training set or its associated ground truth establishment.
§ 868.5895 Continuous ventilator.
(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).