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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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