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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."

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.

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The Philips Respironics Reusable Heated Tubing is a heated wire breathing tube intended to provide warmed and/or humidified breathing gases before they enter a patient's airway. It is indicated for single-patient reuse in the home and multi-patient use in clinical settings, such as hospitals, institutions, sleep laboratories, and sub-acute care facilities. It may be used with non-invasive ventilation for patients weighing over 10 kg (22lbs). It is compatible with the Philips Respironics System One Heated Humidifier and Philips Respironics A-Series System One Heated Humidifier.

The Philips Respironics Reusable Heated Tubing warms air, or breathable gas, as it travels to and from the respiratory patient along the breathing circuit of a respiratory system. It reduces condensation that can form in breathing circuit. The Philips Respironics Reusable Heated Tubing is disinfected between patients through one of the following chemical methods: Cidex. or Cidex OPA. It is alternatively disinfected through the following thermal method: 75 °C for 30 minutes. The Philips Respironics Reusable Heated Tubing has a proprietary connector with two locking tabs (unchanged) that makes it compatible with the Philips Respironics System One Humidifier (K113068) and Philips Respironics A-Series System One Heated Humidifier (K121623).

This is a 510(k) premarket notification for a medical device, which focuses on demonstrating substantial equivalence to a predicate device rather than conducting a full clinical study with specific acceptance criteria in the same way one would for a novel algorithm.

Based on the provided text, here's an analysis of the acceptance criteria and supporting studies, formatted as requested:

1. Table of Acceptance Criteria and Reported Device Performance

For this device (Philips Respironics Reusable Heated Tubing), the acceptance criteria are not presented as numerical thresholds for an AI algorithm's performance (e.g., sensitivity, specificity). Instead, they are related to meeting established medical device standards and demonstrating functionality and safety after reuse and disinfection processes. The "reported device performance" is framed as successfully meeting these standards and maintaining function.

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

• Sample Size: The document does not specify a numerical sample size for "test sets" in the conventional sense of an AI or diagnostic device evaluation. Instead, it refers to "extensive performance testing" and testing under "worst-case conditions" for cleaning, disinfection, and residue removal. These are bench tests, not patient studies with a data cohort.
• Data Provenance: The data is generated from bench testing within a laboratory setting, not from human patient data. There is no mention of country of origin of data or whether it is retrospective/prospective, as it is a non-clinical, in-vitro (simulated) evaluation.

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

Not applicable. This is a medical device (heated tubing) seeking 510(k) clearance, not an AI or diagnostic algorithm requiring expert-established ground truth from images or clinical data. The "ground truth" (i.e., whether the device performs as intended and is safe) is established through adherence to engineering standards, performance metrics, and successful completion of cleaning/disinfection validation.

4. Adjudication Method for the Test Set

Not applicable. As described above, there's no "test set" in the context of human data requiring expert adjudication. Performance is measured against physical and chemical standards.

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 is not an AI diagnostic or assistive device, and therefore, no MRMC study or AI-assisted human reader improvement assessment was conducted.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's safety and effectiveness is established through:

• Adherence to recognized industry standards: ISO 8185, IEC 60601-1, IEC 60601-1-2.
• Bench testing results: Demonstrating that the device maintains its mechanical, electrical, temperature control, and humidity control functionality after repeated cleaning and disinfection cycles.
• Validation of cleaning and disinfection processes: Showing that the specified methods effectively clean and disinfect the device, and that harmful residues are removed, according to AAMI TIR, ASTM, and ISO 10993 guidelines, and FDA guidance.
• Prior FDA clearance of materials: Patient-contacting materials were already deemed safe.

8. The Sample Size for the Training Set

Not applicable. This is not an AI or machine learning device that requires a training set.

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

Not applicable. As this is not an AI or machine learning device, there is no training set or ground truth establishment method for such a set.

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