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This device is intended for the delivery of high flow respiratory gases (within the limits of its stated technical specifications) to patients in a hospital by appropriately qualified healthcare professionals.

This product is not intended to be used on patients with bypassed upper airways.

This product is not intended to be life-sustaining or life-supporting.

This product is not intended for apneic ventilation.

The F&P Optiflow Air/Oxygen Flow Source is a respiratory high flow therapy device designed to generate a flow of air and/or oxygen. The device allows selectable flow rates up to 70L/min with selectable oxygen concentrations ranging from 21% to 100%.

The subject device is a multi-patient use prescription only device, provided in a non-sterile state. It operates at flow ranges between 0 to 70 L/min and is intended to be used by appropriately qualified healthcare professionals in hospitals.

The provided FDA 510(k) clearance letter and summary for the "F&P Optiflow Air/Oxygen Flow Source" is for a hardware device, a breathing gas mixer, not a software or AI-driven diagnostic device. Therefore, the majority of the requested information regarding acceptance criteria, study design, expert involvement, and ground truth for AI/software performance is not applicable based on the provided document.

The document primarily focuses on demonstrating substantial equivalence to predicate devices through comparisons of technological characteristics and compliance with general medical device standards. There is no information regarding AI-specific performance metrics, clinical studies involving human readers, or detailed ground truth establishment for diagnostic capabilities.

Below is a table summarizing the general performance data found, where applicable, according to the structure requested, along with an explanation for the absence of AI-specific information.

Acceptance Criteria and Device Performance for F&P Optiflow Air/Oxygen Flow Source

This device is a hardware breathing gas mixer, not an AI or software-driven diagnostic tool. As such, the typical acceptance criteria and study designs associated with AI performance (e.g., sensitivity, specificity, human reader improvement, adjudication, ground truth for AI training/testing) are not present in this 510(k) summary. The "performance data" section primarily refers to compliance with safety, electrical, and performance standards for medical electrical equipment and gas mixers.

1. Table of Acceptance Criteria and Reported Device Performance:

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The Vivo 45 LS ventilator (with or without the SpO2 and CO2 sensors) is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. Specifically, the ventilator is applicable for pediatric through adult patients weighing more than 5 kg (11 lbs.), however, the mouthpiece ventilation modes are for adult patients only.

The Vivo 45 LS with the SpO2 sensor is intended to measure functional oxygen saturation of arterial hemoglobin (%SpO2) and pulse rate.

The Vivo 45 LS with the CO2 sensor is intended to measure CO2 in the inspiratory and expiratory gas.

The device is intended to be used in home, institution, hospitals and portable applications such as wheelchairs and gurneys. It may be used for both invasive and non-invasive ventilation. The Vivo 45 LS is not intended to be used as an emergency transport or critical care ventilator.

The Viyo 45 LS Ventilator is a portable, microprocessor controlled turbine based pressure support, pressure control or volume controlled ventilator intended for the care of individuals who require mechanical ventilation.

Flow and pressure are read using flow and pressure sensors. Essential parameters such as pressure, flow and volume are presented on the ventilator screen, both in the form as graphs and numbers.

Operator actions are performed via the front panel where the buttons and an LCD screen are located (and two dedicated buttons on the top of the ventilator control starting/stopping treatment and pausing the alarm audio). There are dedicated LEDs and buttons for managing alarm conditions and an Information button which provides integrated user support.

The Vivo 45 LS can be operated by external AC or DC power supply and contains an integrated battery as well as an optional click in battery.

The Vivo 45 LS can be used with two types of patient circuits: single limb patient circuits including an active exhalation valve and single limb patient circuits including a passive leakage port.

The Vivo 45 LS can be operated in the following combinations of ventilation and breath modes:

• PSV-Pressure Support Ventilation
• PSV(TgV)-Pressure Support Ventilation with Target Volume ●
• PCV-Pressure Controlled Ventilation
• PCV(TgV)-Pressure Controlled Ventilation with Target Volume ●
• PCV(A)-Assisted Pressure Controlled Ventilation
• PCV(A+TgV)-Assisted Pressure Controlled Ventilation with Target Volume ●
• PCV-SIMV-Pressure Controlled Ventilation with Synchronized Intermittent Mandatory Ventilation
• PCV-MPV-Pressure Controlled Ventilation with MouthPiece Ventilation ●
• . VCV-Volume Controlled Ventilation
• VCV(A)-Assisted Volume Controlled Ventilation
• VCV-SIMV-Volume Controlled Ventilation with Synchronized Intermittent Mandatory ● Ventilation
• VCV-MPV- Volume Controlled Ventilation with MouthPiece Ventilation ●
• CPAP-Continuous Positive Airway Pressure, with optional features for HFNT-High Flow ● Nasal Therapy

High flow nasal therapy (HFNT) may be prescribed for spontaneously breathing patients undergoing non-invasive ventilatory therapy using a small, medium or large nasal cannula interface. The user may prescribe a flow rate setting in the range of 4 to 60 liters per minute. It is recommended to use an external humidifier, the Fisher & Paykel MR 850, during HFNT, due to possibly higher humidification output requirements of the patient. The Vivo 45 LS automatically disables the internal humidifier when the HFNT feature is being used.

Conditioning of the breathing air's temperature and humidity level may be prescribed for noninvasively ventilated patients using the integrated humidifier and heated wire patient circuit of the Vivo 45 LS at the clinician's discretion to enhance patient comfort and compliance. The humidification function is enabled by the Vivo 45 LS only when the device is powered by AC Mains and is automatically disabled including power to the heating plate when the device is powered by battery. The humidifier heating level can be selected by the user by setting the heating level (1-5) on the device user interface.

The Vivo 45 LS provides the user with available settings that determine the power delivered to the heater wire. This setting is in terms of a patient-end temperature in the range of 16 to 30° C. The heated wire patient circuit contains a temperature sensor located at the patient connection port, and the firmware of the Vivo 45 LS continuously monitors the temperature and automatically adjusts the power delivered to the heater wire to maintain the temperature at the user set point.

The provided text is a 510(k) summary for the Breas Medical AB Vivo 45 LS ventilator. It details the device's characteristics, comparisons to predicate devices, and performance data to demonstrate substantial equivalence to legally marketed devices.

However, the document does not contain the kind of information requested in your prompt regarding acceptance criteria and a study proving a device meets a specific acceptance criteria table. Instead, it discusses:

• Substantial Equivalence: The primary goal of this submission is to demonstrate that the modified Vivo 45 LS is substantially equivalent to a previously cleared predicate device (K193586) and reference devices. This is done by showing similar intended use, technological characteristics, and performance data.
• Performance Testing: It lists various performance tests conducted according to relevant standards (e.g., electrical safety, EMC, usability, alarm systems, biocompatibility, accuracy of controls and monitored values, cybersecurity, software verification/validation, human factors). The text states that "all tests passed" or "met all specifications," implying that the device did meet internal acceptance criteria for these tests, but these specific criteria are not explicitly detailed in a table for most categories.
• Human Factors Study: A summative human factors study was performed to assess user safety and effectiveness, including specific findings related to critical tasks and risk mitigation.

Therefore, I cannot generate the requested table of acceptance criteria and reported device performance from the provided text, nor can I provide specific details on sample sizes, ground truth establishment, or MRMC studies in the manner you've outlined, as that level of detail is not present for quantitative performance metrics tied to specific acceptance thresholds.

Based on the provided text, here's what can be extracted regarding the types of studies and the nature of the performance assessment:

The document focuses on demonstrating substantial equivalence for a modified medical device. This is a regulatory pathway where the new device is shown to be as safe and effective as a legally marketed predicate device. The "proof" is largely comparative and based on meeting recognized standards and internal specifications, rather than a standalone clinical trial proving a specific performance target against a pre-defined acceptance criterion.

Here's a breakdown of the information that is available or implicitly stated, addressing your points where possible, and noting what is missing:

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

   • Not explicitly provided in the document for the overall device.
   • The document presents tables comparing the subject device's features and performance specifications (e.g., accuracy of controls, accuracy of monitored values, alarm settings) to the predicate device. It then broadly states that "testing confirmed that the Vivo 45 LS meets its accuracy specifications," implying acceptance criteria were met but not detailing them in a distinct "acceptance criteria vs. reported performance" table.
   • For example, under "Accuracy of Controls," it lists "Inspiratory Pressure: max of ±0.5cmH2O, ±5%" for both subject and predicate device, and notes "Same." This implies this was an acceptance criterion, and performance matched it. However, actual reported device performance (e.g., "The device demonstrated an inspiratory pressure accuracy of ±0.3cmH2O, ±4%") is not provided.

2. Sample sized used for the test set and the data provenance:

   • Human Factors Testing: The only specific sample size mentioned is for the summative human factors study:
     • Sample Size: 15 Respiratory Therapists (RTs), 15 Registered Nurses (RNs), and 15 Lay Caregivers (LCGs). Total = 45 participants.
     • Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). It's a "summative human factors testing" which is typically prospective.

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

   • Not applicable directly in the context of setting "ground truth" for diagnostic accuracy, as this is a ventilator, not a diagnostic imaging device.
   • For Human Factors: The experts involved would be the human factors professionals designing and performing the study, and potentially clinicians involved in scenario review. Their number and specific qualifications are not detailed.

4. Adjudication method for the test set:

   • Not applicable directly for diagnostic accuracy.
   • For Human Factors: Errors and difficulties observed during the human factors study were subject to "root cause analysis." The method of adjudication for identifying these errors or classifying them (e.g., by multiple observers) is not specified.

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 addressed. This type of study (MRMC for AI assistance) is relevant for AI-powered diagnostic aids, not for the core function of a mechanical ventilator.
   • The "human factors testing" evaluated user interaction and safety with the device, not the device's diagnostic performance in assisting human "readers."

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

   • Not detailed for the AI (if any). The device is a ventilator, a mechanical and software-controlled device. Its "standalone performance" refers to its ability to meet specifications for delivering ventilation, controlling parameters, and managing alarms.
   • The document states: "Performance testing included testing to the standards and procedures listed below:" and then lists many standards, followed by "The Vivo 45 LS with humidifier and heated wire patient circuit met all specifications, and the comparative waveforms testing demonstrated equivalence to the cleared Vivo 45 LS device." and "Testing of the Vivo 45 LS was performed to confirm accuracy of controls and monitored values. The testing confirmed that the Vivo 45 LS meets its accuracy specifications." This implies rigorous standalone testing.

7. The type of ground truth used:

   • For ventilator performance (pressure, flow, volume, etc.): "Ground truth" would be established by reference measurement devices/standards in a laboratory setting. The specific reference standards used are implied to be those within the listed IEC and ISO standards that the device was tested against.
   • For Biocompatibility: "Ground truth" is established by laboratory analyses against specified chemical and biological endpoints (e.g., absence of VOCs above threshold, non-cytotoxic results, non-sensitizing results), based on ISO standards.
   • For Human Factors: "Ground truth" for safe and effective use is established by the pre-defined critical tasks that users must perform successfully without errors that lead to harm. "Root cause analysis" was performed on observed errors.

8. The sample size for the training set:

   • Not applicable. This document describes the testing and regulatory submission for a physical medical device (ventilator) with integrated software, not an AI/ML algorithm that undergoes "training."

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

   • Not applicable for the same reason as above.

In summary, while the document confirms rigorous testing against various standards and specifications, it does not present the specific acceptance criteria and detailed reported performance in a structured comparative table as requested for an AI/ML driven diagnostic device. The focus is on demonstrating compliance with regulatory standards and substantial equivalence to a predicate device, rather than proving a statistical performance metric against clinical ground truth for a novel AI indication.

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OPT96X Model: The F&P Optiflow+ Duet is a nasal cannula patient interface for use with specified respiratory gas humidifiers to treat spontaneously breathing pediatric (10 years and up) and adult patients who would benefit from receiving high flow warmed and humidified respiratory gases to the upper airway. This device is designed to be used in a hospital, sub-acute facility, or long-term care facility by appropriately qualified healthcare professionals, or in the home by lay users operating the device as prescribed by a healthcare professional.

MYDUETXXX Model: The F&P Optiflow+ Duet is a nasal cannula patient interface for use with specified respiratory gas humidifiers to treat spontaneously breathing pediatric (10 years and up) and adult patients who would benefit from receiving high flow warmed and humidified respiratory gases to the upper airway. This device is designed to be used in a long-term care facility by appropriately qualified healthcare professionals, or in the home by lay users operating the device as prescribed by a healthcare professional.

The F&P Optiflow+ Duet Nasal Cannula is a nasal cannula interface for use with a respiratory gas humidifier and flow generator to deliver Nasal High Flow (NHF) therapy to spontaneously breathing patients. The F&P Optiflow+ Duet Nasal Cannula is a prescription-only device, provided in a non-sterile state and intended to be used in a hospital, sub-acute facility, or long-term (managed) care facility by appropriately qualified healthcare professionals, or in the home by lay users operating the device as prescribed by a healthcare professional. The device is single patient use only for up to 14 days in the hospital and up to 30 days in the home/long-term care facilities.

This document is a 510(k) Premarket Notification from the FDA regarding a medical device, the F&P Optiflow+ Duet Nasal Cannula. It focuses on demonstrating the device's substantial equivalence to a legally marketed predicate device, rather than proving that an AI/ML powered device meets specific acceptance criteria.

Therefore, the requested information regarding acceptance criteria, study details for AI/ML performance, sample sizes for test/training sets, expert consensus for ground truth, and MRMC studies for AI assistance cannot be extracted from this document, as it pertains to a different type of device and regulatory submission.

The document provides information on the non-clinical performance tests conducted for the F&P Optiflow+ Duet Nasal Cannula to demonstrate its substantial equivalence to its predicate device (F&P Optiflow+ Nasal Cannula OPT94X, K162553).

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

This document does not present acceptance criteria in a quantitative table format that shows a direct "acceptance criteria vs. reported performance" for the device's primary function in terms of a specific output (like an AI model's accuracy, sensitivity, or specificity). Instead, the "performance" is demonstrated through compliance with various international standards and general performance specifications like flow ranges.

However, we can infer some "performance" aspects from the comparison table on pages 6-7, although they are mostly qualitative or specify operating ranges.

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Servo-air Lite Ventilator System is an assist ventilation in spontaneously breathing patients who require mechanical ventilation due to respiratory failure or chronic respiratory insufficiency. It offers noninvasive ventilation, invasive ventilation, and respiratory monitoring.

Servo-air Lite Ventilator System is intended for adult and pediatric patients weighing 15 kg and above.

Servo-air Lite Ventilator System is to be used only by healthcare professionals.

Servo-air Lite Ventilator System is to be used only in professional health care facilities and for transport within these facilities. It is not intended for transport between health care facilities.

The Servo-air Lite Ventilator System consists of a Patient Unit where gases are mixed and administered, and a User Interface where the settings are made and ventilation is monitored.

The Servo-air Lite Ventilator System is based on the cleared reference device Servo-air Ventilator System (K192604), with additions based on reference device Servo-u Ventilator System (K201874).

The ventilator delivers controlled or supported breaths to the patient, with constant pressure, using a set oxygen concentration. The ventilator can also deliver High Flow therapy with a constant flow.

Servo-air Lite contains a dedicated controller circuit for the Aerogen Solo nebulizer (included as standard).

Accessories for CO2 monitoring are available as options.

The Servo-air Lite Ventilator System will produce visual and audible alarms if any parameter varies beyond pre-set or default limits and log alarm recordings.

The system contains provisions for battery modules to supply the system in the case of mains power failure or during intra-hospital transport.

The provided text describes a 510(k) submission for the Servo-air Lite Ventilator System, which is a medical device and not an AI/ML-based device. Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set information is not applicable in the context of an AI/ML device.

The document discusses non-clinical testing and performance for the ventilator system, focusing on:

• Software: Code review, static code analysis, unit tests, and integration tests.
• Performance: System testing, regression testing, free user testing, and waveform testing.
• Biocompatibility: Volatile Organic Compounds, Particulate Testing, Leachable testing.
• Human Factors Validation Testing.
• Compliance with various product standards (e.g., ANSI/AAMI ES 60601-1, IEC 60601-1-2) and biocompatibility standards (AAMI/ANSI/ISO 10993-1).

The conclusion states that the device is substantially equivalent to the predicate device (Respironics V60 K102985) based on equivalent indications for use and that no new questions of safety and effectiveness are raised. They have conducted risk analysis and performed necessary verification and validation activities to demonstrate that the design output meets the design input requirements and appropriate product standards.

However, the document does not provide specific acceptance criteria in a table or detailed results of these tests that would typically be presented for an AI/ML device's performance metrics like sensitivity, specificity, or AUC.

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The F&P 950 Respiratory Humidifier is intended to provide heat and humidity to respiratory gases delivered to patients. It is for use in a hospital or long-term care facility by a health professional.

F&P 950 Breathing Circuit Kits: 950A80J, 950A81J, 950A82J, 950A61J, 950A61J, 950A40J, AA451SU
The breathing set is an accessory to the F&P 950 Respiratory Humidifier. It is intended for delivery of heated humidified respiratory gases to adult, adolescent and child patients, within the limits of its stated technical specifications.

F&P 950 Breathing Circuit Kits: 950P81J, 950P40J
The breathing set is an accessory to the F&P 950 Respiratory Humidifier. It is intended for delivery of heated humidified respiratory gases to neonatal, infant, child and adolescent patients of its stated technical specifications.

F&P 950 Breathing Circuit Kits: 950N80J, 950N81J, 950N61J, 950N40J
The breathing set is an accessory to the F&P 950 Respiratory Humidifier. It is intended for delivery of heated humidified respiratory gases to neonatal, infant and child patients, within the limits of its stated technical specifications.

The F&P 950 Respiratory Humidifier is designed to warm and humidify air after it leaves a commercially available flow source and to maintain the air in a warmed and humidified condition to the point of delivery into the patient via heated tubing.

The F&P 950 Respiratory Humidifier is made up of a heaterbase, sensor cartridge and expiratory heater wire adapter with breathing circuit kits to support the use with adult, pediatric and neonatal patients. Breathing circuit kits enable the use of the F&P 950 Respiratory Humidifier with clinical procedures such as invasive ventilation and nasal high flow.

The device is a programmable electrical medical device that uses sensors throughout the system to humidify the gas. Gas travels through the chamber where it is humidity is requlated through monitoring the gas temperature exiting the chamber to achieve the target humidity level. The gas is then transported to the patient through a heated delivery tube. The gas temperature exiting the heated delivery tube is monitored to minimize the formation of condensate.

The document is a 510(k) Summary for the F&P 950 Respiratory Humidifier and its accessory breathing circuit kits. It outlines the device's indications for use and compares its technological characteristics to a primary predicate device (F&P MR850 Respiratory Humidifier) and several secondary predicate devices for the various breathing circuit kits. The summary also details the non-clinical tests performed to demonstrate substantial equivalence.

Here's the requested information based on the provided text, focusing on acceptance criteria and supporting studies:

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

   Acceptance Criteria	Reported Device Performance
   Delivered humidity level (Bypassed airway)	>33mg/L for flow 12mg/L for flow

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F&P Optiflow Junior 2: The Fisher & Paykel Healthcare Optiflow Junior 2 nasal cannula is a single use nasal cannula intended for use with a nasal high flow therapy (NHF) system to deliver heated and humidified nasal high flow therapy to spontaneously breathing patients. This product is designed for use in hospital environments and must be prescribed by a physician. The intended pediatric subpopulations targeted for use of the F&P Optiflow Junior 2 Nasal Cannula range includes: Neonates, birth up to 1 month of age, Infants, 1 month up to 2 years of age, Children, 2 years up to 12 years of age.

F&P Optiflow Junior 2+: The Fisher & Paykel Healthcare Optiflow Junior 2+ nasal cannula is a single use nasal cannula intended for use with a nasal high flow therapy (NHF) system to deliver heated and high flow therapy to spontanously breathing patients. This product is designed for use in hospital environments and must be prescribed by a physician. The intended pediatric subpopulation targeted for use on the F&P Optiflow Junior 2+ Nasal Cannula includes: Infants. 1 month up to 2 years of age, Children, 2 years up to 12 years of age.

F&P Optiflow Junior 2 HM Cannula: The Fisher & Paykel Healthcare Optiflow Junior 2 nasal cannula is a single use nasal cannula intended for use with a nasal high flow therapy (NHF) system to deliver heated and high flow therapy to spontaneously breathing patients. This product is designed for use in long term care environments and must be prescribed by a physician. The intended pediatric subpopulations targeted for use of the F&P Optiflow Junior 2 Nasal Cannula range includes: Infants, 1 month up to 2 years of age, Children, 2 years up to 12 years of age.

F&P Optiflow Junior 2+ HM Cannula: The Fisher & Paykel Healthcare Optiflow™ Junior 2+ nasal cannula is a single use nasal cannula intended for use with a nasal high flow (NHF) therapy system to deliver heated and high flow therapy to spontanously breathing patients. This product is designed for use in long term care environments and must be prescribed by a physician. The intended pediatric subpopulation targeted for use on the F&P Optiflow Junior 2+ Nasal Cannula includes: Infants, 1 month up to 2 years of age, Children, 2 years up to 12 years of age.

The F&P Optiflow Junior 2 / 2+ Nasal Cannula Interface Range are single-use patient interfaces that are intended to deliver heated and humidified Nasal High Flow therapy to spontaneously breathing neonates, infants and children. It is intended to be prescription-only and provided in a non-sterile state.

The F&P Optiflow Junior 2 Product Codes are OJR410 (XS), OJR414 (M), OJR416 (L) OJR416HM (L), OJR418 (XL), and OJR418HM (XL).

The F&P Optiflow Junior 2+ Product Codes are OJR520 (XXL) and OJR520HM (XXL).

Optional Kits:
Ventilator Transition Kits: The F&P Optiflow Junior 2 and 2+ Ventilator Transition Kits allow the use of the F&P Optiflow Junior 2 and F&P Optiflow Junior 2+ cannula with approved Fisher & Paykel Healthcare breathing circuits when connected to a ventilator to deliver heated and humidified nasal high flow (NHF) therapy. This kit contains the F&P Optiflow Junior 2 and 2+ cannula (subject device) and a 12F/15M Adaptor.

Blender Transition Kits: The F&P Optiflow Junior 2 and 2+ Blender Transition Kits allow the use of F&P Optifilow Junior 2 and 2+ cannula with approved Fisher & Paykel Healthcare breathing circuits when connected to a blender heated and humidified nasal high flow (NHF) therapy to spontaneously breathing patients who require breathing support. This kit contains F&P Optiflow Junior 2 and 2+ cannula (subject device), a 12F/15M Adaptor and a Pressure Relief Manifold (cleared in K173770).

Here's a breakdown of the acceptance criteria and the study information based on the provided document.

It's important to note that this document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed clinical trial results for novel devices. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study, standalone algorithm performance, or specific effect sizes for human improvement with AI assistance are not applicable here as this is a medical device (nasal cannula) and not an AI/ML powered device.

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

The document doesn't explicitly define "acceptance criteria" against numerical targets in the way an AI/ML device would. Instead, substantial equivalence is demonstrated through a comparison of the subject device's (F&P Optiflow Junior 2 / 2+ Nasal Cannula Interface Range) characteristics and performance against a predicate device (F&P Optiflow Junior Nasal Cannula, K162553). The "acceptance" is that the device has similar technological characteristics, intended use, and performs safely and effectively as demonstrated through non-clinical testing.

Here's a table summarizing the comparison, with "Reported Device Performance" reflecting how the subject device aligns with or deviates from the predicate, implying acceptability.

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

This document describes non-clinical performance testing rather than a clinical study with a "test set" of patients. Therefore, specific sample sizes for patient data or data provenance (country of origin, retrospective/prospective) are not provided as it's not relevant to this type of submission. The "test set" would refer to the physical devices and materials tested in the various engineering and biocompatibility evaluations. These tests are conducted by the manufacturer, Fisher & Paykel Healthcare Ltd. (New Zealand).

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 is not applicable to a 510(k) submission for a non-AI medical device like a nasal cannula. "Ground truth" in this context would come from recognized standards, engineering specifications, and established biocompatibility principles, not from expert review of patient data.

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

This is not applicable. Adjudication methods are typically used in clinical studies for interpretation of complex diagnostic results to establish a consensus ground truth, which is not relevant for the engineering and biocompatibility tests conducted for this device.

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 is not applicable. The device is a nasal cannula, not an AI-powered diagnostic or assistive tool. No human "readers" or AI assistance are involved in its primary function, and therefore, an MRMC study or effect size related to AI improvement is irrelevant.

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

This is not applicable as the device is not an algorithm or AI system.

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

For the non-clinical tests conducted, the "ground truth" is established by:

• International and National Standards: e.g., ISO and ASTM standards for dimensions, materials, biocompatibility, packaging, and shelf life.
• Engineering Specifications: Internal design specifications and performance requirements for the cannula's physical properties, leak rates, flow rates, and connection integrity.
• Risk Management Processes: Identified hazards and associated mitigations based on expected device performance.

8. The sample size for the training set

This is not applicable. There is no "training set" in the context of a non-AI medical device submission.

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

This is not applicable as there is no "training set."

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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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Indications for use - AIRVO nebulizer adapter:

When used with a nebulizer:

The nebulizer adapter is a medical device accessory for single-patient use to facilitate aerosolization of Albuterol sulfate for inhalation to adult patients receiving high-flow humidified breathing gases via tracheostomy patient interface. Intended for use by healthcare professionals in hospitals or long-term care facilities.

When used without a nebulizer:

For use in hospitals and long-term care facilities, for the delivery of humidified respiratory gases to patients via nasal, tracheostomy and mask interfaces.

The Airvo Nebulizer Adapter (hereafter named "nebulizer adapter") is a single use accessory device designed to facilitate aerosolization of a physician-prescribed solution for inhalation to patients receiving high flow humidified breathing gases. The nebulizer adapter is a prescription-only accessory device, provided in a non-sterile state.

The nebulizer adapter is kitted with the AirSpiral tube and MR290 humidification chamber cleared in K162553, to be used in conjunction with Airvo series humidifiers (K131895) along with patient interfaces cleared in K162553.

The device is labelled for use with Salbutamol/ Albuterol only.

Here's a breakdown of the acceptance criteria and study information for the Airvo Nebulizer Adapter, based on the provided FDA 510(k) summary:

This device is a nebulizer adapter, not an AI-powered diagnostic device, so many of the requested categories (like MRMC study, expert qualifications for ground truth, AI improvement effect size, standalone algorithm performance, or training set details) are not applicable. The "ground truth" for this type of medical device largely pertains to its physical and functional performance against established medical device standards and the predicate device, rather than a diagnostic label.

Acceptance Criteria and Reported Device Performance

Device Name: Airvo Nebulizer Adapter
Predicate Device: Aeroneb Solo Nebulizer System / Aeroneb Solo Adapter (K133360)

Study Details

Given this is a 510(k) for a medical device accessory and not an AI/CADe/CADx device, the study information requested regarding human readers, AI assistance, ground truth experts, and training sets is not directly applicable in the context of this submission. The "studies" were primarily non-clinical, benchtop performance, and engineering tests to demonstrate substantial equivalence to the predicate device and compliance with relevant standards.

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

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
The document does not specify exact sample sizes for each non-clinical test (e.g., number of nebulizer adapters tested for respirable dose, number of cycles for shelf life, etc.). The provenance would be the manufacturing site laboratory in New Zealand, and the data is prospective, generated specifically for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not Applicable. For this type of device, "ground truth" is established by adherence to recognized national and international consensus standards (e.g., ASTM, ISO), engineering specifications, and comparative testing against a legally marketed predicate. The "experts" are the engineers and medical device professionals who design and execute these tests and evaluate the results against the defined criteria. Their qualifications would involve expertise in medical device engineering, respiratory therapy, and regulatory affairs.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not Applicable. Adjudication methods like 2+1 or 3+1 refer to agreement among multiple human readers for diagnostic truth-finding in image-based AI studies. This is a non-clinical device performance study. Test results are typically reviewed and approved by internal quality and regulatory personnel.

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 a physical medical device, not an AI-powered diagnostic tool.

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. The "standalone" performance would be its mechanical and functional characteristics as tested on a benchtop.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for this device is based on:

• Adherence to recognized national and international consensus standards: (e.g., ISO 80601-2-74 for respiratory humidifying equipment, ISO 10993 for biocompatibility, ISO 18562 for breathing gas pathways).
• Performance specifications and engineering requirements: The device's ability to reliably deliver the specified respirable dose and MMAD, maintain pressure, prevent condensate buildup, and ensure component integrity.
• Direct comparative testing against a legally marketed predicate device: Demonstrating that the subject device's performance is equivalent to or better than the predicate's performance in critical aspects (e.g., respirable dose, MMAD).

8. The sample size for the training set:
Not Applicable. This device is not an AI model, so there is no "training set."

9. How the ground truth for the training set was established:
Not Applicable.

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The SERVO-U ventilator system is:

• intended for respiratory support, monitoring and treatment of neonatal, pediatric and adult patients
• to be used only by healthcare providers
• to be used only in professional healthcare facilities and for transport within these facilities

For NAVA and Edi monitoring, it is in addition intended:

• to provide monitoring of the patient's breathing drive
• to improve synchrony between the ventilator system and patient when the electrical signal from the brain to the diaphragm is active
• for use on all patients with no contraindication for insertion/exchange of a nasogastric tube

The SERVO-n ventilator system is:

• intended for respiratory support, monitoring and treatment of neonatal and pediatric patients
• to be used only by healthcare providers
• to be used only in professional healthcare facilities and for transport within these facilities

For NAVA and Edi monitoring, it is in addition intended:

• to provide monitoring of the patient's breathing drive
• to improve synchrony between the ventilator system and patient when the electrical signal from the brain to the diaphragm is active
• for use on all patients with no contraindication for insertion/exchange of a nasogastric tube

The SERVO-U/n 2.1 is available in two models, SERVO-U and SERVO-n. The SERVO-U/n 2.1 consists of a Patient Unit where gases are mixed and administered, and a User Interface where the settings are made and ventilation is monitored. The SERVO-U/n 2.1 is based on the cleared predicate device SERVO-U/n 1.1 (K151814), with some improvements. The ventilation modes in the SERVO-U/n 2.1 are similar as in the predicate device, even though the standard configurations of available modes and optional modes differ between the devices, i.e. SERVO-U, SERVO-n and the cleared predicate device SERVO-U/n 1.1. The ventilator delivers controlled or supported breaths to the patient, with constant flow, constant pressure or pressure proportional to the Edi signal (the electrical activity of the diaphragm) of the patient, using a set oxygen concentration. SERVO-U/n contains a dedicated controller circuit for the Aerogen Pro and Solo nebulizers (included as standard). Accessories for CO2 monitoring and flow and pressure measurements at the Y piece (Y sensor) are integrated as options. The SERVO-U/n Ventilator System will produce visual and audible alarms if any parameter varies beyond pre-set or default limits and produce alarm recordings. The system contains provisions for battery modules to supply the system in the case of mains power failure or during intra-hospital transport.

The provided text is a 510(k) summary for the SERVO-U/n Ventilator System 2.1. It details the device's intended use and compares it to a predicate device, CERVO-U/n 1.1. However, it does not describe an AI/algorithm-driven device performance study with acceptance criteria, sample sizes, expert ground truth, or MRMC studies.

Instead, the document states: "No clinical investigation has been performed since it has been concluded based on literature data, state of the art knowledge and applicable product standards that SERVO-U/n 2.1 has no new clinical aspects or risks which are not already discussed and evaluated in the 510(k) submission for the cleared predicate device SERVO-U/n 1.1 (K151814)."

Therefore, I cannot provide the requested information about acceptance criteria and a study proving device performance in the context of an AI/algorithm-driven device, as no such study is presented or referenced in the provided text.

The document primarily focuses on demonstrating substantial equivalence to a predicate device through:

• Comparison of Intended Use: States it's identical.
• Comparison of Technology Characteristics: Details improvements and changes from the predicate without introducing AI components.
• Non-clinical Testing and Performance: Lists design verification activities (code review, unit tests, system tests, regression testing, etc.), compliance with product standards (e.g., ANSI/AAMI, IEC, ISO), and biocompatibility evaluation.

The key takeaway is that the clearance for the SERVO-U/n Ventilator System 2.1 is based on its substantial equivalence to a previous version and adherence to recognized standards, not on an AI performance study.

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The 900PT561 heated breathing tube is for delivery of humidified respiratory gases. For use with AIRVO™ and AIRVO™ 2 Series humidifiers in hospitals and long-term care facilities. For use at flows from 2 to 60 L/min depending on the patient interface.

The 900PT560 and 900PT560E heated breathing tube is for delivery of humidified respiratory gases. For use with myAIRVO™ and myAIRVO™ 2 Series humidifiers in homes and long-term care facilities. For use at flows from 2 to 60 L/min depending on the patient interface.

Compatible patient interfaces: nasal cannula, tracheostomy direct connection, mask adapter.

The AirSpiral heated breathing tube is an accessory to the AIRVO 2 Series Humidifiers and comes in various packaging configurations with or without a humidification chamber, for hospital, long term care, or home use. The tube wall is made from air filled plastic spirally wound in a concentric manner to form the lumen. The trapped air in the plastic utilizes the thermal insulation properties of air. The heater wire is also wound into the wall of the tube to provide direct heating of the tube wall instead of being placed in the gas path. These features help reduce condensation inside the tube.

The AirSpiral heated breathing tube represents an alternative to the existing predicated heated breathing tube accessory in the predicate AIRVO 2 Series Humidifier K131895. It is provided in the same packaging configurations, can be used on AIRVO and AIRVO 2 Series humidifiers over the complete flow range, and uses similar patient interfaces, as the predicate breathing tube and patient interfaces. The patient interfaces consist of Nasal Cannula, Tracheostomy Direct Connection, and Mask Interface Adapter. Of the nasal cannula, spare part Wigglepads for Junior nasal cannula are available to replace those fitted on the cannula if needed. They provide adhesion to hold the cannula in place on the patient. Humidification chambers consist of an autofeed chamber with feedset, and a manual fill chamber, to contain water for humidification.

The document describes the acceptance criteria and the studies conducted to demonstrate the substantial equivalence of the AirSpiral Heated Breathing Tube to its predicate device.

Here's an analysis of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify exact sample sizes for each non-clinical test (e.g., how many tubes were tested for condensation, useful life, etc.). It generally states that "The AirSpiral Heated Breathing Tubes passed the acceptance criteria for all tests."

• Test Set Sample Size: Not explicitly stated for most tests, but testing was performed on "The AirSpiral Heated Breathing Tubes" which implies a representative sample.
• Data Provenance: The studies were non-clinical performance and biocompatibility tests conducted by the manufacturer, Fisher & Paykel Healthcare, based in Auckland, New Zealand. The data is thus internal, prospective test data generated specifically for this submission.

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

This section is not applicable as the studies were non-clinical performance and biocompatibility tests, not studies requiring expert review of medical images or data from human subjects to establish ground truth. The "ground truth" here is objective physical and chemical measurements against defined engineering and regulatory standards.

4. Adjudication Method for the Test Set

This is not applicable for non-clinical performance and biocompatibility testing. Ground truth was established through validated measurement methods and adherence to scientific and regulatory standards (e.g., ISO 8185, ISO 10993).

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 is not applicable. The device is a heated breathing tube, not an AI-powered diagnostic or assistive tool for human readers. No MRMC studies were conducted or relevant.

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

This is not applicable. The device is a medical accessory (heated breathing tube), not an algorithm. Therefore, no standalone algorithm performance was assessed.

7. The Type of Ground Truth Used

The ground truth for the tests was based on:

• Pre-defined engineering specifications and performance targets (e.g., for pressure loss, tensile strength, condensation reduction).
• Compliance with recognized international standards (e.g., ISO 8185:2007 for system performance, IEC 60601-1 for electrical safety, ISO 10993 series for biocompatibility).
• Regulatory requirements laid out in FDA guidance documents.

8. The Sample Size for the Training Set

This is not applicable. The device is a physical medical component, not a machine learning or AI model. Therefore, no "training set" in the context of AI development was used.

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

This is not applicable, as there was no training set used for an AI model.

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