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The Fisher & Paykel Healthcare single-patient use masks are intended for use as an accessory to ventilators to enable non-invasive positive pressure ventilation (NPPV) therapy (CPAP or bi-level) to be delivered to spontaneously breathing adult patients (> 30 kg) with respiratory insufficiency or respiratory failure who have been prescribed NPPV. The masks are to be fitted and therapy maintained, by trained medical practitioners in a hospital/institutional environment with patient monitoring in place.

The F&P OptiNIV Vented Full Face Masks are oro-nasal full face masks that are intended for use as an accessory to deliver non-invasive positive pressure ventilation (NPPV) to a patient as part of a non-invasive ventilation system.

The OptiNIV Vented Full Face Masks are prescription-only, provided in a non-sterile state.

The F&P OptiNIV Vented Full Face Mask consists of a plastic shell with a seal to allow cushioning onto the patient's face, and straps to enable the mask to be secured over the head. The mask fits under the patient's nose and covers the nares of the nose and the mouth, with a soft seal to maintain pressure inside the mask whilst minimizing discomfort to the user.

The subject device is available in three sizes – A, B, and C to denote the seal sizes.

N/A

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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:

The remaining requested information is not applicable to this 510(k) submission as it pertains to an AI/software-driven diagnostic device, which the "F&P Optiflow Air/Oxygen Flow Source" is not. The document describes a physical medical device (breathing gas mixer) with its performance verified through non-clinical bench testing and compliance with relevant safety and performance standards for such equipment.

2. Sample size used for the test set and the data provenance: Not applicable. The document describes non-clinical performance testing against engineering specifications and relevant standards for a hardware device, not a test set of data for AI.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for diagnostic AI is not relevant for this hardware device.
4. Adjudication method: Not applicable.
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.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for this device's performance would be the specified output values (e.g., flow rate, oxygen concentration) measured by calibrated equipment during engineering and validation testing, as required by the listed standards.
8. The sample size for the training set: Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.

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OPT94X Model:
The F&P Optiflow+ is a nasal cannula patient interface for use with specified respiratory gas humidifiers to treat spontaneously breathing pediatric (3 years and older) to 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.

MYOPT9X Model:
The F&P Optiflow+ is a nasal cannula patient interface for use with specified respiratory gas humidifiers to treat spontaneously breathing pediatric (3 years and older) to adult patients who would benefit from receiving high flow warmed and 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+ Nasal Cannula range is a nasal cannula interface for use with a respiratory gas humidifier and flow generator to deliver Nasal High Flow (NHF) therapy.

The F&P Optiflow+ Nasal Cannula range 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.

The provided FDA 510(k) clearance letter and summary for the F&P Optiflow+ Nasal Cannula Range does not contain specific acceptance criteria or an analytical study proving the device meets those criteria.

This submission is for a labeling change only. The document explicitly states:

• "The modification in scope of this 510(k) submission is to change the labeling of the subject device only, specifically to the Indications for Use statement."
• "The subject device's technological characteristics, material composition, and intended use remain identical to those of the predicate device."
• "No new performance or biocompatibility testing was conducted on the subject device since the device design is identical to the predicate device."

Therefore, the information requested regarding acceptance criteria, reported performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth for training/test sets cannot be extracted from this document because such studies were not conducted for this specific 510(k) submission.

The clearance is based on the device being substantially equivalent to a previously cleared device (F&P Optiflow+ Nasal Cannula range, K162553), with the only change being an updated Indications for Use statement to be more defined and aligned with current labeling requirements. The original predicate device (K162553) would have had performance data supporting its clearance, but that data is not detailed in this particular document.

Summary based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance: Not provided in the document as no new performance testing was conducted. The document states the device's characteristics and performance are identical to the predicate device.
2. Sample Size for Test Set and Data Provenance: Not applicable, as no new performance testing was conducted.
3. Number of Experts and Qualifications: Not applicable, as no new clinical study requiring expert review was conducted.
4. Adjudication Method: Not applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable, as no new clinical study was conducted.
6. Standalone Performance (Algorithm only): Not applicable, as this is a medical device (nasal cannula), not an AI/algorithm-based device.
7. Type of Ground Truth Used: Not applicable, as no new performance testing was conducted.
8. Sample Size for Training Set: Not applicable.
9. How Ground Truth for Training Set Established: Not applicable.

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A-Model
The F&P Nova Nasal Mask is intended to be used by adults aged 22 years and older weighing ≥ 66 lb (30 ks) who have been prescribed non-invasive positive airway pressure therapy such as CPAP or Bi-Level by a physician. The Nova Nasal mask is intended for single-patient use in the home.

SLA-Model
The F&P Nova Nasal mask is intended to be used by adults aged 22 years and older weighing ≥ 66 lb (30 kg) who have been prescribed non-invasive positive airway pressure therapy such as CPAP or Bi-Level by a physician. The Nova Nasal mask is intended for single-patient use in the home and for multiple patient use in the hospital or other clinical setting where proper disinfection of the device can occur between patient uses.

The F&P Nova Nasal Mask is a non-invasive, Positive Airway Pressure (PAP) therapy nasal mask that features an over-the-nose cushion that seals the patient's nose, held in place by adjustable headgear straps. The mask is designed to aid in the delivery of PAP by providing an interface between the flow generator and tubing, and the patient. The F&P Nova Nasal Mask is a prescription-only device, provided in a non-sterile state.

The Nova Nasal Mask range is available in three cushion sizes – Small, Medium, and Large.

The mask has two models: A-Model and Sleeplab (SL) A-Model. Both models are identical except for their Indications for Use, Operating Environment, and Reusability. The A-Model is intended to be single-patient use in the home, while the SL A-Model is intended to be used on multiple patients in a hospital or other clinical setting where proper disinfection of the device can occur between patient uses.

I am sorry, but based on the provided FDA 510(k) Clearance Letter and the accompanying 510(k) Summary, there is no information provided regarding acceptance criteria for an AI/ML powered medical device, nor any study details that would prove such a device meets these criteria.

The document describes the clearance of a physical medical device, the F&P Nova Nasal Mask, which is a non-invasive positive airway pressure (PAP) therapy nasal mask. The performance data section lists standard engineering and biocompatibility tests typically performed on such devices (e.g., cleaning validation, leak, CO2 rebreathing, resistance to flow, vibration and noise, dead space analysis, human factors, mechanical integrity, shelf-life, and various ISO standards related to masks and biological evaluation).

Therefore, I cannot fulfill your request to describe acceptance criteria and a study for an AI-powered device using this document. The information you are asking for (e.g., sample sizes for test/training sets, data provenance, number/qualifications of experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth) are specifically relevant to the validation of AI/ML algorithms in medical devices, which this document does not cover.

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A-Model: The F&P Nova Micro Pillows Mask is intended to be used by adults weighing ≥ 66 lbs (30kgs) who have been prescribed non-invasive positive airway pressure therapy such as CPAP or bi-level by a physician. The F&P Nova Micro Pillows Mask is intended for single-patient use in the home.
SLA-Model: The F&P Nova Micro Pillows Mask is intended to be used by adults weighing ≥ 66 lbs (30kgs) who have been prescribed non-invasive positive airway pressure therapy such as CPAP or bi-level by a physician. The F&P Nova Micro Pillows Mask is intended for single-patient use in the home and for multiple-patient use in the hospital or other clinical settings where proper disinfection of the device can occur between patient uses.

The F&P Nova Micro Pillows Mask is a non-invasive, Positive Airway Pressure (PAP) therapy nasal pillows mask with a silicone seal that seals the nasal airway entrance of the Nova Micro Pillows Mask is designed to aid in the delivery of PAP by providing an interface between the flow generator and tubing, and the patient. The Nova Micro Pillows Mask features a pillows cushion with prongs that extrance of the patient's nasal nares, held in place by adjustable headgear straps. The Nova Micro Pillows Mask is a prescription-only device, provided in a non- sterile state. The F&P Nova Micro Pillows Maskrange is available in three cushion sizes – Small, Medium, and Large. The mask has two models: A-Model and Sleeplab (SL) A-Models are identical except for their Indications for Use, Operating Environment, and Reusability. The A-Model is intended to be single-patient use in the home, while the SL A-Model is intended to be used on multiple patients in a hospital or other clinical setting where proper disinfection of the device can occur between patient uses.

This document is a 510(k) Premarket Notification from the FDA regarding the F&P Nova Micro Pillows Mask. It primarily focuses on demonstrating substantial equivalence to a predicate device based on indications for use, technological characteristics, and non-clinical performance data.

However, the provided text does not contain the specific information requested about acceptance criteria and a study proving a device meets these criteria in the context of AI/ML performance. This document describes a medical device (a CPAP mask) that is not an AI/ML device according to the information provided. Therefore, there is no discussion of performance metrics like accuracy, specificity, sensitivity, or the methodology of an AI/ML study (e.g., sample size for AI training/test sets, expert adjudication methods, MRMC studies, or ground truth establishment).

The "Performance Data" section (Section VII) lists various non-clinical tests performed on the mask, such as Cleaning Validation, Leak, Dead Space Analysis, CO2 Rebreathing, Pressure-Flow Curve, Resistance to Flow, Vibration and Noise, Human Factors/Usability Engineering, Mechanical Integrity, and Shelf-Life. These are standard engineering and safety tests for a physical medical device, not performance evaluations for an AI/ML algorithm.

Therefore, I cannot provide the requested table or details about an AI/ML study from the given text. The information is simply not present because the device described is not an AI/ML device.

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This product is intended for use as an in-line pressure relief device, designed to limit the system pressure within the limits of its stated technical specifications.
This product is indicated for patients in a hospital for use by appropriately qualified healthcare professionals.

The F&P Optiflow Flow Diverter is intended for use as an in-line pressure relief device, designed to limit the system pressure when used with the compatible F&P Optiflow Oxygen Kits and nasal interfaces.
The F&P Flow Diverter is placed between the flow meter and the dryline during use. It is a multi-patient use prescription-only device, provided in a non-sterile state. It operates at flow rates between 5 to 70 L/min and is intended to be used by appropriately qualified healthcare professionals in hospitals.
When an anesthesia mask is applied over the Optiflow Switch interface, the respiratory gas no longer has a pathway to flow through the nasal interface to the patient. This will trigger respiratory gas flow to be diverted into the atmosphere.

The medical device in question is the "F&P Optiflow™ Flow Diverter", a nonrebreathing valve (Product Code: CBP).

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly provide a table of acceptance (performance) criteria with numerical targets. Instead, it states that "Performance testing of the Flow Diverter was completed and confirms the subject device does not raise new questions of safety and effectiveness." It implies that the device met the safety and performance standards outlined in the listed ISO and IEC standards.

However, based on the comparison table with the predicate device, we can infer some key performance characteristics. The document emphasizes equivalence to the predicate device, the "OJR215 Pressure Relief Manifold (K173770)".

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

The document does not explicitly state a sample size for a "test set" in the context of a clinical performance study. The testing described is non-clinical performance testing against standards. Therefore, concepts like sample size for clinical test data, country of origin, or retrospective/prospective data are not applicable here. The testing would have involved multiple units of the device under various conditions described by the cited standards.

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

Not applicable. This is not a clinical study involving expert interpretation or "ground truth" establishment in a diagnostic context. The performance is assessed against engineering and safety standards.

4. Adjudication Method for the Test Set:

Not applicable. There's no human interpretation or diagnostic assessment that would require an adjudication method.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is a mechanical pressure relief valve, 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 not an algorithm-based device.

7. The type of ground truth used:

The "ground truth" for this device would be its performance against the objective criteria defined in the referenced industry standards (e.g., ISO 80601-2-74:2017 for respiratory humidifying equipment, IEC 60601-1 for basic safety and essential performance, ISO 80601-2-90:2021 for respiratory high-flow therapy equipment). This includes measurements such as maximum pressure relief, flow rates, temperature tolerances, and mechanical integrity, as well as adherence to design principles and safety features.

8. The sample size for the training set:

Not applicable. This is a medical device, not a machine learning model requiring a training set.

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

Not applicable.

In summary:

The document describes a 510(k) submission for a non-AI, mechanical medical device. The "acceptance criteria" are primarily established by compliance with recognized international and national standards for medical devices and respiratory equipment (ISO, IEC, CGA), as well as demonstrating substantial equivalence to a predicate device. The "study" proving this is a series of non-clinical performance and safety tests conducted in accordance with these standards. The concepts of clinical test sets, ground truth by experts, and training sets for algorithms are not relevant to this type of device submission.

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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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This product is intended for delivery of respiratory gases to adult patients in a hospital.
This product is indicated for the delivery of nasal high flow (NHF) and low flow oxygen by appropriately qualified healthcare professionals.
This product can be used for pre-oxygenation, short-term supplemental oxygenation (up to 10 minutes) during intubation, and allows an anesthesia mask to be placed over the nasal interface to perform mask ventilation. by individuals who perform anesthesia care or airway management.
This product is not intended for apneic ventilation
This product is not indicated for use during CPR.

Fisher & Paykel Healthcare has designed the F&P Optiflow™ System with Optiflow Switch interface that allows for mask ventilation without the need to remove the nasal interface from the patient during therapy.
To support this function, an Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility and Flow Diverter is required. The subject device in this 510(k) is the Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility that is also referred to in this submission as the Optiflow Switch interface.
The product is intended for delivery of respiratory gases to adult patients in a hospital. The product is indicated for the delivery of nasal high flow (NHF) and low flow oxygen by appropriately qualified healthcare professionals.
This is a prescription-only device provided in a non-sterile state. It has a flow range of 5 to 70 L/min. The device will be offered in three sizes, small (S), medium (M), and large (L).
It is intended to be used in combination with a compatible respiratory humidifier. Optiflow Oxygen Kit and the Optiflow Flow Diverter (AA520J).

This document is a 510(k) Premarket Notification from Fisher & Paykel Healthcare Ltd for a medical device called the F&P Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility (AA041J). The purpose of this submission is to demonstrate that the new device is substantially equivalent to a legally marketed predicate device (Optiflow Nasal Oxygen Cannula with CO2 Sampling, K201723).

The document details the device's indications for use, its design and technological characteristics, and provides a summary of non-clinical tests performed to support its substantial equivalence. It does not contain information about acceptance criteria or a study that specifically "proves the device meets acceptance criteria" in terms of performance metrics like sensitivity, specificity, or reader improvement with AI assistance, as this is a medical device for respiratory gas delivery, not an AI/software device with diagnostic capabilities.

Therefore, many of the requested items (e.g., effect size of human readers with AI, standalone algorithm performance, number of experts for ground truth establishment) are not applicable to this type of device submission.

Here's an analysis based on the information available in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state "acceptance criteria" in the format of performance metrics against a target value for a diagnostic device. Instead, substantial equivalence is claimed based on non-clinical testing against relevant international and national standards, and a comparison of technological characteristics with the predicate device. The performance data is summarized as conforming to these standards.

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

• Sample Size: Not specified. The document refers to "performance testing" and "non-clinical tests" but does not detail the number of units tested.
• Data Provenance: Not specified. Given the nature of the tests (biological evaluation, safety, performance, usability), the data would likely be from manufacturer-conducted in-house or contracted laboratory testing rather than patient data from a specific country. This would be prospective testing of device samples.

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

This is not applicable as the device is not an AI/diagnostic software. Ground truth in this context would be defined by the technical specifications and standards it must meet, not by expert consensus on diagnostic images or clinical outcomes.

4. Adjudication method for the test set:

Not applicable. There's no diagnostic component requiring adjudication of human-interpreted results. Test results are against engineering specifications and standard requirements.

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 a respiratory gas delivery interface, 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 not an algorithm or software device.

7. The type of ground truth used:

The "ground truth" for this device would be defined by the technical specifications of the device itself and the requirements of the international and national standards (e.g., ISO 10993, ISO 80601-2-74, IEC 60601-1, ISO 5356-1, IEC 62366-1). For example, a flow range test would compare the device's actual flow output against its stated specification of 5-70 L/min.

8. The sample size for the training set:

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

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

Not applicable.

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This breathing set is an accessory to the F&P 950 Respiratory Humidifier to be used within the limits of its stated technical specifications.

It is intended for delivery of heated humidified high flow respiratory gases to adult patients in a hospital.

This product can be used on multiple patients when used with a hydrophobic filter between the product and the patient interface for a maximum of 24 hours after setup.

This product is for use by appropriately qualified healthcare professionals who perform anesthesia care and airway management.

The Fisher & Paykel Healthcare (F&P) Optiflow™ Oxygen Kit is a multiple-patient use breathing tube kit. This F&P Optiflow™ Oxygen Kit is presented as the AA451J.

The kit consists of a dry line, water bag, humidification chamber, inspiratory limb, tubing clips and datechange stickers.

The flow source delivers gas through a dryline to a humidification chamber that sits on a humidifier. As the gas passes through the chamber, it is heated and humidified. The gas then flows through the inspiratory limb, through a hydrophobic filter and then through a patient interface into the patients' upper airway via the nose.

The AA451J kit delivers humidified respiratory gases at flows from 5 to 70 L/min. When used with an FDAcleared hydrophobic filter, the AA451J kit can be used on multiple patients. The kit is reprocessed between each patient. The kit can be exposed to a maximum of 30 reprocessing cycles and used for a maximum of 24 hours after setup.

The scope of this 510(k) submission is limited to the AA451J, F&P Optiflow™ Oxygen Kit. The flow source, humidifier, hydrophobic filter and interface are not in the scope of this submission.

The provided text does not contain information about the acceptance criteria or a study proving that a software device meets acceptance criteria. The document is an FDA 510(k) clearance letter for a physical medical device, the "F&P Optiflow Oxygen Kit (AA451J)," which is a breathing set accessory for a respiratory humidifier.

The sections titled "PERFORMANCE DATA" (Section VII) and "CONCLUSION" (Section VIII) discuss performance testing, but this refers to non-clinical tests for the physical device's safety and effectiveness, such as biological evaluation, electrical safety, and respiratory humidifying equipment standards (e.g., ISO 10993-1, ISO 80601-2-74, IEC 60601-1). These tests are typically laboratory-based and relate to the device's physical properties, material compatibility, and functional performance (e.g., flow rates, humidification).

Therefore, I cannot provide the requested information regarding acceptance criteria for a software device based on the given input, as the document pertains to a hardware medical device.

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The myAirvo 3 is for the treatment of spontaneously breathing patients, infant to adult, who would benefit from receiving high flow warmed and humidified respiratory gases. This includes patients who have had upper airways bypassed. The flow may be from 2 - 60 L/min depending on the patient interface. The myAirvo 3 is for patients in homes and long-term care facilities.

The F&P myAirvo 3 device is a heated humidifier flow source. The subject device is 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 myAirvo 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 fan speed is directly related to the delivered flow and it is controlled by the software. The blower assembly output connects directly to a humidification chamber at the front of the device.

The second functional unit of the F&P myAirvo 3 device 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.

This document is a 510(k) Summary for the F&P myAirvo 3, a respiratory humidifier. It is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device. As such, it does not contain acceptance criteria or study data related to the performance of an AI/ML powered device. The provided text primarily focuses on comparative claims against a predicate device and adherence to various safety and performance standards relevant to a medical device's physical and functional specifications.

Therefore, I cannot extract information about acceptance criteria or a study proving an AI/ML device meets them from this document. The questions posed in the prompt (regarding AI/ML performance, sample sizes, expert ground truth, MRMC studies, standalone performance, etc.) are not applicable to the content provided, as it describes a traditional medical device (a respiratory humidifier) and not an AI/ML algorithm.

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