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For the delivery of heated, humidified breathing gases to spontaneously breathing adult patients. This breathing set is suitable for use with Fisher & Paykel Healthcare MR850 Humidifiers in hospital and long-term care environments.

The F&P 850 AirSpiral Adult NIV and NHF Circuit Kit (850A61) is designed to provide a gas conduit between respiratory support equipment and a patient interface such as a mask, nasal prongs or tracheostomy interface for a spontaneously breathing Adult patient.

The Inspiratory Limb is an extruded bubble tube design 1.6 metres in length, and is intended to connect the gas path from humidification chamber to the patient interface. Additionally, temperature sensor clips and a gown clip are included to aid in cable management and to affix the circuit to a gown or sheet. The subject device is single use, prescription only and is provided in a non-sterile state.

The Disposable Exhalation Port is an optional accessory for NIV applications. It features a perforated ventilation hole and a 22mm/15mm coaxial taper connectir for connecting to patient interfaces and a 22mm tapered male connector for connecting to the patient end of the Inspiratory Limb. It also features a capped port for connecting to the Pressure Line.

I apologize, but the provided text does not contain information about an AI/ML-based medical device or any study related to its performance and acceptance criteria.

The document is an FDA 510(k) clearance letter for a medical device called the "F&P 850 AirSpiral Adult NIV and NHF Circuit Kit." This device is a heated breathing tube and associated components designed to deliver heated, humidified breathing gases to spontaneously breathing adult patients.

The 510(k) submission describes:

• The device's intended use and indications for use.
• A comparison of its technological characteristics with a predicate device (F&P AirSpiral Heated Breathing Tube K162553) and a secondary predicate (Philips Disposable Exhalation Port K982454).
• A summary of non-clinical tests performed to demonstrate substantial equivalence to the predicate devices. These tests relate to:
  • Compliance with various medical device standards (e.g., ISO, IEC).
  • Exhalation port equivalence (flow rates).
  • Pressure port equivalence (inspired volume).
  • Inhalation path equivalence (tidal volumes).
  • Human factors evaluation.

There is no mention of artificial intelligence, machine learning, deep learning, or any form of AI-based algorithm doing image analysis, risk prediction, or any other function that would require the kind of performance data usually associated with AI/ML device clearances (e.g., sensitivity, specificity, AUC).

Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, expert involvement, or MRMC studies, as the document clearly pertains to a non-AI medical device.

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This product delivers respiratory gases to adult patients. It is intended for use with an MR810 humidifier at flows from 5 to 70 L/min. 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 set-up.

This product is indicated for the delivery of Nasal High Flow (NHF) by appropriately qualified healthcare professionals under the direction of a physician anesthesiologist in a medical room. Qualitative carbon dioxide sampling can be used at nasal cannula flow rates from 5 to 50 L/min.

This product can be used for pre-oxygenation and short-term supplemental oxygenation (up to 10 minutes) during intubation in operating rooms under the direction of a physician anesthesiologist.

This product is not intended for apneic ventilation.

The Fisher & Paykel (F&P) Optiflow™ Oxygen Kit consists of a dry line, humidification chamber inspiratory tube, and tubing clips. The dryline transfers the respiratory gases from a flow source to the humidification chamber. The humidification chamber provides a reservoir filled to an indicated maximum level with sterile water. As the humiditier heats the water in the chamber, water vapor is formed, which heats and humidifies the respiratory gases delivered from the dryline. The respiratory gas is then transferred to the inspiratory tube. The inspiratory tube (also known as inspiratory limb) electrically heats the respiratory gas utilizing a heater wire to maintain the temperature of the gas. The inspiratory tube delivers the gas through an FDA-cleared filter and interface. The filter and the patient interface are not in the scope of this submission. The tubing clips are attached to the inspiratory tube. They are used to connect the tube to the hospital bed sheet or pillow.

The device delivers gas at flow rates between 5 and 70 L/min. The device is to be used by medical professionals on multiple patients over a 24-hour period.

Only the Optiflow™ Oxygen Kit is part of this 510(k) submission. The flow source, humidifier, filter and interface are not in the scope of this submission.

The document provided is a 510(k) Premarket Notification from the FDA for a medical device called the "Optiflow™ Oxygen Kit." This type of document focuses on demonstrating substantial equivalence to a predicate device rather than explicitly detailing acceptance criteria and performance data in the context of an AI/ML medical device.

Therefore, the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/ML device is not available in the provided text.

The document describes the device itself, its intended use, comparison to a predicate device (AirSpiral Heated Breathing tube), and the non-clinical testing performed to demonstrate its safety and effectiveness for a respiratory gas delivery system.

Here's what can be extracted from the document, though it doesn't align with the specific AI/ML questions:

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

The document does not present a table of acceptance criteria for an AI/ML model. Instead, it describes various performance tests for a respiratory device to ensure it meets safety and effectiveness requirements. These are primarily engineering and material performance criteria.

• Transportation testing: Performed following transport and storage simulation (ISTA 2A:2011).
• Mechanical strength testing: Performed following push, impact, drop, and mold stress relief conditioning (IEC 60601-1 15.3.2, 15.3.3, 15.3.4, and 15.3.5).
• Cleaning and low-level disinfection: Validated as per indications for use. |
  | Additional Performance Testing | - Permanent connections test
• Removable connections test
• Gas delivery test
• Resistance to flow test |
  | Standards Compliance | - ISO 80601-2-74:2017(E) (Respiratory humidifying equipment)
• IEC 60601-1-2 4th 2014 (Electromagnetic disturbances)
• IEC 62366-1:2015 (Usability engineering)
• ISO 5356-1:2004 (Anesthetic and Respiratory Equipment- Conical Connectors) |
  | Biocompatibility | - Evaluated according to ISO 10993-1:2018 and ISO 18562-1:2017. |

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 applicable as the device is a physical respiratory kit, not an AI/ML model that processes data. The tests are physical and laboratory-based.

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 applicable. Ground truth, in the context of an AI/ML model, refers to validated data labels. For a physical device, testing involves standard engineering and medical device compliance procedures by qualified personnel (e.g., engineers, lab technicians), not medical experts establishing a "ground truth" for interpretations.

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

This information is not applicable. Adjudication methods are relevant for human interpretation of data, often used in labeling datasets for AI/ML validation. This is not a component of testing a physical respiratory 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 information is not applicable. MRMC studies are designed to assess the diagnostic performance of human readers, typically with and without AI assistance, for image-based or similar data. The Optiflow™ Oxygen Kit is a direct medical device for gas delivery, not an AI-assisted diagnostic tool.

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

This information is not applicable. This question pertains to AI/ML algorithm performance.

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

This information is not applicable. See point 3.

8. The sample size for the training set

This information is not applicable. This device does not use a "training set" in the AI/ML sense.

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

This information is not applicable. This device does not have a "training set" or "ground truth" in the AI/ML sense.

In summary, the provided FDA 510(k) document concerns a traditional medical device (respiratory gas delivery kit) and its approval based on substantial equivalence and non-clinical performance testing. It does not contain any information relevant to the development, validation, or acceptance criteria for an AI/ML-based medical device.

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The Fisher & Paykel HC550 System is designed for use with artificial ventilation systems. Portable volume ventilation systems, pressure support ventilation and Continuous Positive Airway Airway Pressure (CPAP) systems may incorporate an HC550 to provide therapeutic levels of warm humidified air to adult patients with artificial airways or through mask ventilation.

The operating flow range is 5 to 120L/min depending on the patient interface.

The HC550 is designed for use in long term care facilities or the home under the prescription of a qualified medical professional.

The Fisher & Paykel Healthcare HC550 System is designed to condition gases for patients by raising the delivered water vapor content (humidity) and temperature of the gases.

The HC550 System consists of the following components:

• . HC550 Respiratory Humidifier
• . Accessories:
  • a) Breathing circuit (compatible adult breathing circuits as cleared in K983112, K020332, K034026, K103767, K122432)
  • b) Humidification Chamber (as cleared in K9341401 and K913368)
  • c) Heaterwire Adaptor (as cleared in K073706)
  • d) Temperature/Flow Probe (as cleared in K983112)
  • RT008 Air Entrainer (optional oxygen therapy accessory) (as cleared in K953711) e)

The device consists of an electrically powered heat controller, utilizing a microprocessor with embedded software, to control a heating element that transfers heat to the water in a humidification chamber.

A dryline tube (part of the breathing circuit) transports respiratory gases from a flow source (e.g. ventilator) to the humidification chamber where the gases are heated and humidified.

The inspiratory limb of the breathing circuit transports the heated and humidified gases from the humidification chamber to the patient. The inspiratory tube may be electrically heated by means of a heater-wire placed internally to the tube, which is controlled by the HC550 respiratory humidifier.

The expiratory limb of the breathing circuit transports expired gas from patient. In the case of a dual-heated breathing circuit, this limb may also be heated in the same manner as the inspiratory limb.

If a heated breathing circuit is used, the heaterwire adaptor provides electrical energy from the respiratory humidifier to the heaterwire in the breathing circuit.

Temperature probes in the gas path provide feedback on temperature and flow of the gas to regulate temperature and humidity to the patient.

HC550 System Acceptance Criteria and Study Details

This document describes the acceptance criteria and corresponding study results for the HC550 System, a respiratory gas humidifier. The information is extracted from the provided 510(k) Notification K132017.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the HC550 System are based on compliance with the ISO 8185:2007 standard for humidification systems. The device's performance is compared to these requirements.

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