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The breathing set is an accessory to the F&P 950 Respiratory Humidifier. It is intended to provide heated and humidified CPAP to spontaneously breathing premature and full term neonates and infant patients (up to a weight of 10 kg) who require breathing support, due to conditions associated with prematurity (such as Respiratory Distress Syndrome) or other conditions where CPAP is required or desired. It is intended for use within a hospital clinical environment such as a NICU (Neonatal Intensive Care Unit) and PICU (Pediatric Intensive Care Unit), within the limits of its stated technical specifications.

The subject devices of this 510(k) are the F&P 950 Bubble CPAP Breathing Circuit Kits (950N60J and 950N62J). The F&P 950 Bubble CPAP Breathing Circuit Kits are single patient use and designed for use with the F&P 950 Respiratory Humidifier. The F&P 950 Bubble CPAP (continuous positive airway pressure) Breathing Circuit Kits provide breathing support to spontaneously breathing neonates and infants. The F&P 950 Bubble CPAP breathing circuit kits deliver heated and humidified respiratory gas through an inspiratory limb to the infant via a nasal interface. An expiratory limb connects to a Bubble CPAP generator to generate CPAP. The device is intended to be operated at input gas flows of 4 - 15 L/min with available CPAP levels of 3 - 10 cmH2O.

This document outlines the acceptance criteria and supporting studies for the F&P 950 Bubble CPAP Breathing Circuit Kits.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the F&P 950 Bubble CPAP Breathing Circuit Kits are primarily established through compliance with recognized medical device standards and comparison to a predicate device. The performance data section summarizes various tests conducted to demonstrate this compliance.

Since the document does not present specific quantitative acceptance criteria with corresponding performance metrics in a direct table format, I will reconstruct a table based on the information provided, inferring acceptance as "compliance" or "demonstrated safety/effectiveness" where specific numerical targets are not explicitly stated for the "acceptance criteria" column. The "reported device performance" will refer to the conclusion of the tests.

2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample sizes (number of devices or tests performed per device type) for the non-clinical tests (biocompatibility, electrical safety, human factors, bench/performance testing). It generally refers to "testing" or "studies" in the plural.

The data provenance is from non-clinical tests performed by the manufacturer, Fisher & Paykel Healthcare Limited, to evaluate the device against specified international standards and to demonstrate equivalence to a predicate device. This is prospective testing of the manufactured device components and systems. No country of origin for the data is explicitly mentioned beyond the manufacturer's location in New Zealand, but the tests are conducted against universally recognized international standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The studies listed are primarily non-clinical engineering and performance tests, not clinical studies requiring expert ground truth for diagnostic or clinical outcomes. For the Human Factors testing, "intended users" would have been involved, but their number and specific qualifications are not detailed.

4. Adjudication method for the test set
Not applicable. The tests described are objective, standard-based compliance evaluations or measurements, not clinical studies requiring expert adjudication of subjective outcomes.

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 mechanical breathing circuit kit, not an AI-powered diagnostic or assistive technology.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a mechanical breathing circuit kit; there is no algorithm involved.

7. The type of ground truth used
For the non-clinical tests, the "ground truth" is defined by the requirements and methodologies outlined in the referenced international standards (e.g., ISO, ASTM, ANSI, IEC). For example, a successful biocompatibility test means the materials met the specified criteria of the ISO 10993 series. A successful electrical safety test means the device operated within the limits defined by IEC 60601-1-2.

8. The sample size for the training set
Not applicable. This device is a mechanical medical device, not an AI/machine learning product that requires a training set.

9. How the ground truth for the training set was established
Not applicable. As above, this device does not utilize AI and therefore has no training set or associated ground truth.

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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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