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The BONHAWA Respiratory Humidifier is intended to provide high flow warmed and humidified respiratory gases for administration to spontaneously breathing patients 20 kg and up, child to adults in hospitals. It adds heat and moisture to the flow of gases. The flow may be from 2 to 70 L/min depending on the patient interface.

The BONHAWA Respiratory Humidifier provides high flow gases with simultaneous oxygen delivery to spontaneously breathing patients without bypassed upper airways in hospitals.

The BONHAWA Respiratory Humidifier is a heated humidifier with integrated blower, heater plate and heated breathing circuit that delivers warm and humidified respiratory gas to a patient via nasal cannula. A blower inside the device blends the externally provided oxygen with entrained filtered air and controls the gas flow rate delivered to the patient per the professional user established setting. An internal oxygen sensor monitors and reports the delivered oxygen concentration. The patient interface, heated breathing circuit chamber and chamber adapter are single use.

The provided text is a 510(k) Premarket Notification for the BONHAWA Respiratory Humidifier. It focuses on demonstrating substantial equivalence to a predicate device (Airvo 2 Humidifier series) and a reference device (Airvo 3 High Flow Humidified Oxygen Delivery Device) based on technical characteristics and performance testing against recognized consensus standards.

However, the document does not contain information about acceptance criteria and a study that proves the device meets those criteria in the context of an AI/ML medical device. The device described is a physical medical device (a respiratory humidifier), not an AI/ML-driven diagnostic or therapeutic software. Therefore, the specific questions related to AI/ML device performance metrics (e.g., sample size for test sets, data provenance, expert ground truth, MRMC study, standalone performance, training set details) are not applicable and are not addressed in this filing.

The "Performance Testing" section (Page 11) states that substantial equivalence is based on:

• Product validation and risk mitigation verification testing.
• Meeting pertinent recognized consensus standards:
  • ISO 80601-2-74:2017 (Respiratory humidifying equipment)
  • IEC 60601-1:2005+AMD1:2012 (General requirements for basic safety and essential performance)
  • IEC 60601-1-2:2014 +A1:2020 (Electromagnetic disturbances)
  • IEC 60601-1-8 (Alarm systems)
  • ISO 10993-1 (Biocompatibility)
  • ISO 18562-1 (Biocompatibility of breathing gas pathways).

The table "Comparison of Technological Characteristics" (Pages 6, 7, 8, 9) effectively serves as the "acceptance criteria" through a direct comparison to the predicate and reference devices, demonstrating that the subject device's specifications are either identical or offer non-inferior performance without raising new safety or effectiveness concerns.

Given the nature of the device, the following points address the relevant aspects of your request based on the provided text:

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

The acceptance criteria are implicitly defined by the substantial equivalence comparison to the predicate and reference devices, and adherence to relevant consensus standards. The "reported device performance" is presented through direct specifications and the claim of meeting the standards.

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The Airvo 3 is intended to provide high flow warmed and humidified respiratory gases for administration to spontaneously breathing infant, child, adolescent and adult patients in hospitals and sub-acute facilities. 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 provides high flow gases with simultaneous oxygen delivery to spontaneously breathing patients with or without bypassed upper airways in hospitals and sub-acute facilities.

The Airvo 3 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 is not intended to provide total ventilatory requirements and is not for use during field transport.

The F&P Airvo 3 is a high-flow device comprised of heated humidifier with integrated flow source, intended to treat spontaneously breathing patients, pediatrics and adults, who would benefit from receiving high flow, warmed and humidified entrained air and oxygen (if required).

The F&P Airvo 3 can be reprocessed for use on multiple patient interfaces, heated breathing tube, and water chambers are disposable and are for single patient use only, however, the internal outlet elbow is high-level-disinfected for multi-patient use.

The F&P Airvo 3 is comprised of two main connected functional units: the blower and the humidifier.

The blower is a motorized fan assembly that provides air flow. The flow is adjustable, where a separate source of oxygen independently controlled can be input and mixed with the entrained air. The blower assembly output connects directly to a humidification chamber at the front of the device.

The second functional unit of the F&P Airvo 3 is a heated passover humidifier. The water is contained in a humidification chamber positioned on a heater plate at the front of the unit. The gas is warmed and humidified in the chamber to the dew point set temperature, transported through the heated breathing tube and delivered to the patient through the selected interface.

The provided text pertains to the FDA 510(k) clearance of the F&P Airvo 3 device, a high flow humidified oxygen delivery device. It outlines the regulatory process and demonstrates substantial equivalence to predicate devices, focusing on non-clinical performance data and adherence to recognized standards.

However, the document does not contain information regarding:

• Specific acceptance criteria values and reported device performance in a table for each performance test.
• Sample sizes used for test sets, their data provenance (country, retrospective/prospective).
• Number and qualifications of experts for ground truth establishment.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance studies.
• The specific type of ground truth used (e.g., pathology, outcomes data), if applicable to this type of device.
• Sample size for training sets.
• How ground truth for the training set was established.

The document primarily focuses on non-clinical (bench) testing and adherence to recognized standards to demonstrate substantial equivalence, rather than clinical study results with human participants or AI performance metrics.

Therefore, I can provide the available information from the document, but many of your requested points cannot be answered based on the input.

Available Information from the Document:

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

The document states that comparative performance testing was performed to demonstrate substantial equivalence and to meet the Special Controls requirements of 21 CFR 868.5454. It lists the categories of performance testing but does not provide a table with specific quantitative acceptance criteria or detailed reported device performance values for each.

2. Sample sized 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 performance data summarized relates to non-clinical (bench) tests rather than human clinical studies.

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. The device is a medical equipment (high flow humidified oxygen delivery device), not an imaging or diagnostic AI device that typically relies on expert ground truth for interpretation.

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 F&P Airvo 3 is a medical device, not an AI-assisted diagnostic or interpretation tool for human readers.

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

This information is not provided in the document. This is not an AI algorithm but a physical medical device.

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

This information is not explicitly stated in detail. For physical performance tests (like blending accuracy, flow rate accuracy, thermal stability, humidification output), the "ground truth" would implicitly be defined by the measurement standards and calibrated reference equipment used during bench testing. For biocompatibility, it's adherence to ISO standards; for electrical safety, adherence to IEC/ANSI AAMI standards.

8. The sample size for the training set

This information is not provided in the document. This device does not appear to involve machine learning or AI models with "training sets" in the conventional sense.

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

This information is not provided in the document. As noted above, this type of device does not typically have "training sets" or "ground truth" established in this manner.

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The HVT 2.0 system provides high velocity nasal insufflation (HVNI) with simultaneous warmed and humidified respiratory gas delivery to augment breathing of spontaneously breathing adult and pediatric patients (5 kg and up) suffering from respiratory distress and/or hypoxemia in the hospital setting, via a small bore nasal cannula. HVT 2.0 is not intended to provide total ventilatory requirements of the patient and not for use during field transport. The flow rates may be from 5 to 45 liters per minute (BTPS).

The HVT 2.0 System is comprised of hardware containing software, and single use disposables that are designed to deliver the same High Velocity Nasal Insufflation (HVNI) as the Vapotherm Precision Flow HVNI.

The HVT 2.0 system consists of the HVT 2.0 hardware containing software, a Disposable Patient Circuit (DPC), and a patient interface (nasal cannula). The HVT 2.0 system utilizes an integrated internal blower to deliver warmed and humidified breathing gas at flows 5 to 45 L/min (BTPS) to spontaneously breathing patients, without the need of wall air or any pressurized air source. The addition of an external oxygen source (wall or tank for QAV indication) enables FiO2 delivery from 21% to 100%. The device incorporates a blender and flow sensors that allow the oxygen percentage and total gas flow to be set independently.

The HVT 2.0 main hardware device contains all the electrical and electronic components including the electronic blender and flow controllers, and sensors to monitor the disposable patient circuit. The main hardware device has no water pathways and the gas pathway only contains dry gas at room temperature, and therefore does not require internal cleaning or disinfection.

The available text does not describe an acceptance criteria and a study proving the device meets said criteria in the format requested. The document is a 510(k) summary for the HVT 2.0 device, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study against predefined acceptance criteria for AI or automated system performance.

Here's why the requested information cannot be extracted and what is provided instead:

• 1. A table of acceptance criteria and the reported device performance: This is not present. The document includes a comparison table between the predicate and subject device (HVT 2.0) for various characteristics like Indications for Use, Patient Population, Flow Range, etc. While it lists "Temperature Accuracy" as "±2°C" and "Oxygen Accuracy" as "±2%", these are device specifications and not explicitly presented as "acceptance criteria" for a study in the context of an AI/algorithm performance. It then states "SAME" for the subject device, implying it meets these for equivalence.
• 2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. The document discusses "bench / performance testing" and "comparative performance testing" but does not detail sample sizes for these tests in a way that would be relevant to a "test set" for an algorithm. There is no mention of data provenance (e.g., country of origin, retrospective/prospective).
• 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): Not applicable. This document does not describe the use of experts to establish a "ground truth" for a test set, as it does not involve the evaluation of an algorithm's diagnostic or predictive performance.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for the same reasons as point 3.
• 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 summary does not describe any MRMC studies or AI assistance for human readers. The device (HVT 2.0) is a high-flow humidified oxygen delivery device, a physical medical device, not an AI or software-as-a-medical-device (SaMD) that typically undergoes such evaluations.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device is not an algorithm. Its software is mentioned for verification and validation but not as a standalone performance entity.
• 7. The type of ground truth used (expert concensus, pathology, outcomes data, etc.): Not applicable.
• 8. The sample size for the training set: Not applicable, as there is no mention of a training set for an algorithm.
• 9. How the ground truth for the training set was established: Not applicable.

Summary of what is provided:

The document describes the HVT 2.0, a High Flow Humidified Oxygen Delivery Device, and its comparison to a predicate device (Precision Flow HVNI). The main point is to demonstrate "substantial equivalence" of the HVT 2.0 to the predicate device, not to prove algorithm performance against specific criteria.

The "studies" mentioned are non-clinical performance and bench testing, including:

• Biocompatibility testing (leveraged from prior testing, compliant with ISO 10993-1)
• Electrical safety and electromagnetic compatibility (compliant with IEC 60601-1 and IEC 60601-1-2)
• Alarms testing (compliant with IEC 60601-1-8)
• RFID testing (compliant with AIM 7351731)
• Software verification, validation, and hazard analysis (compliant with FDA guidance for software and ISO 14971:2019)
• Bench/Performance Testing, including:
  • Precision Flow and HVT 2.0 Comparison Testing (to demonstrate same HVNI technological characteristics and performance)
  • Oxygen accuracy/Blender Performance
  • Temperature accuracy/Thermal Stability
  • Flow rate accuracy
  • Humidification output (ISO 80601-2-74)
  • Patient contacting surface temperature/Thermal Safety
  • Volume of liquid exiting the humidification chamber outlet
  • Continuous use (Use Lifespan)
  • Operating environment
  • Nurse call compatibility
  • Usability/Human Factors
  • Cleaning Validation (for hardware)

The conclusion is that "Any differences in technological characteristics of the devices do not raise different questions of safety and effectiveness based on the performance testing, further supported by the prior clearance of the Reference Device HVT 2.0, cleared under K203357. The devices are substantially equivalent."

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Precision Flow® HVNI is intended for use to add warm moisture to breathing gases from an external source for administration to a neonate/infant, pediatric and adult patients in the hospital and subacute institutions settings. It adds heat and moisture to a blended medical air/ oxygen mixture and assures the integrity of the precise air/oxygen mixture via an integral oxygen analyzer. The flow rates may be from 1 to 40 liters per minute via nasal cannula.

Precision Flow® HVNI provides high velocity nasal insufflation (HVNI) with simultaneous oxygen delivery to augment breathing of spontaneously breathing patients suffering from respiratory distress and/or hypoxemia in the hospital setting. Precision Flow® HVNI is not intended to provide total ventilatory requirements of the patient and not for use during field transport.

The Precision Flow® HVNI system delivers high flow rates of heated and humidified blended breathing gas through high flow nasal cannulas. The Precision Flow® HVNI system can connect to air and oxygen source. The Precision Flow® HVNI may be operated with limited performance at gas inlet pressures as low as 4 psi (28 kPa). For the full specified range of gas flows and oxygen percentages, both gas inlet pressures must be at minimum 40 psi (276 kPa).The main unit contains an integrated blender that delivers the targeted gas mixture to the disposable patient circuit (DPC). The Disposable Patient Circuit contains:

• Water path: tubing from sterile water supply to vapor transfer cartridge
• . Vapor transfer (humidification) cartridge: 2 types; low flow (1-8 lpm) and high flow (5-40 lpm)
• Delivery Tube: triple lumen tubing
• . Nasal Cannula

The device automatically senses cartridge type. The available set temperature range is 33 °C to 39 °C. The device also contains a backup battery to provide power only for 15 minutes.

Here's a breakdown of the acceptance criteria and the study information for the Precision Flow® HVNI, based on the provided text:

Acceptance Criteria and Device Performance

The acceptance criteria for the Precision Flow® HVNI are primarily non-clinical, focusing on safety, performance standards, software validation, and labeling requirements. The clinical studies establish safety and effectiveness by demonstrating non-inferiority or comparable outcomes to existing treatments.

*   **Data Provenance for all neonate studies:** Published literature, likely international based on author names and journal types, but not explicitly stated for each study.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
* Similar to the adult study, ground truth involved clinical outcomes assessed by treating medical professionals (neonatologists, nurses, etc.) within the context of their respective clinical trials or retrospective data collection. Specific expert qualifications beyond clinical roles are not detailed within the provided text.

3. Adjudication method for the test set:

   • Not explicitly stated as a formal adjudication panel. Outcomes were generally defined by protocol-driven clinical events (e.g., extubation failure, need for intubation, physiological parameters).

4. 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. These are clinical studies comparing therapies, not AI assistance for human readers.

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

   • No.

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

   • Outcomes Data: Primary ground truths included extubation failure rates, rates of intubation/mechanical ventilation, occurrences of pneumothorax, nosocomial infection, ROP surgery, bronchopulmonary dysplasia (BPD), air leaks, IVH, NEC, sepsis, duration of respiratory support, need for surfactant, time to full feeds, length of stay, mortality, and nasal trauma scores.

7. The sample size for the training set:

   • Not applicable.

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

   • Not applicable.

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