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This document is a 510(k) clearance letter for the AVEA Disposable Expiratory Filter/Water Trap. It declares the device substantially equivalent to a predicate device and provides the regulatory information. Crucially, it does not describe a clinical study of the device against acceptance criteria for performance; instead, it relies on demonstrating identicality to a previously cleared predicate device.

Therefore, I cannot provide the requested information regarding:

A table of acceptance criteria and reported device performance.
Sample sizes, data provenance, and expert details for a test set.
Ground truth establishment and adjudication methods.
MRMC comparative effectiveness study results.
Standalone AI algorithm performance (as this is a physical medical device, not an AI software).
Training set sample size or ground truth establishment for a training set.

The document explicitly states:

"The subject and predicate devices are identical in all ways."
"The subject device and the predicate – AVEA disposable expiratory filter/water trap – K081837 is substantially equivalent based upon identicality."

This means that the study proving the device meets acceptance criteria for this specific 510(k) relies purely on the fact that it is a direct copy of a previously cleared device. The "acceptance criteria" here are essentially "be identical to the predicate device."

Here's what can be extracted from the document related to performance, based on the predicate device's listed performance:

1. Table of Acceptance Criteria (as per predicate device's listed performance) and Reported Device Performance (by virtue of identicality)

Performance Parameter	Acceptance Criteria (based on Predicate)	Reported Device Performance (Identical to Predicate)
Viral Filtration Efficiency (VFE) / Bacterial Filtration Efficiency (BFE)	99.999%	99.999%
DOP / POA Efficiency	99.97%	99.97%
Flow Resistance

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K Number

K223863

Device Name

BONHAWA Respiratory Humidifier

Manufacturer

Telesair, Inc.

Date Cleared

2023-10-13

(294 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K221338,K131895

Intended Use

The BONHAWA Respiratory Humidifier is intended to provide high flow warmed and humidified respiratory gases for administration to spontaneously breathing patients 20 kg and up, child to adults in hospitals. It adds heat and moisture to the flow of gases. The flow may be from 2 to 70 L/min depending on the patient interface.

The BONHAWA Respiratory Humidifier provides high flow gases with simultaneous oxygen delivery to spontaneously breathing patients without bypassed upper airways in hospitals.

Device Description

The BONHAWA Respiratory Humidifier is a heated humidifier with integrated blower, heater plate and heated breathing circuit that delivers warm and humidified respiratory gas to a patient via nasal cannula. A blower inside the device blends the externally provided oxygen with entrained filtered air and controls the gas flow rate delivered to the patient per the professional user established setting. An internal oxygen sensor monitors and reports the delivered oxygen concentration. The patient interface, heated breathing circuit chamber and chamber adapter are single use.

AI/ML Overview

The provided text is a 510(k) Premarket Notification for the BONHAWA Respiratory Humidifier. It focuses on demonstrating substantial equivalence to a predicate device (Airvo 2 Humidifier series) and a reference device (Airvo 3 High Flow Humidified Oxygen Delivery Device) based on technical characteristics and performance testing against recognized consensus standards.

However, the document does not contain information about acceptance criteria and a study that proves the device meets those criteria in the context of an AI/ML medical device. The device described is a physical medical device (a respiratory humidifier), not an AI/ML-driven diagnostic or therapeutic software. Therefore, the specific questions related to AI/ML device performance metrics (e.g., sample size for test sets, data provenance, expert ground truth, MRMC study, standalone performance, training set details) are not applicable and are not addressed in this filing.

The "Performance Testing" section (Page 11) states that substantial equivalence is based on:

Product validation and risk mitigation verification testing.
Meeting pertinent recognized consensus standards:
- ISO 80601-2-74:2017 (Respiratory humidifying equipment)
- IEC 60601-1:2005+AMD1:2012 (General requirements for basic safety and essential performance)
- IEC 60601-1-2:2014 +A1:2020 (Electromagnetic disturbances)
- IEC 60601-1-8 (Alarm systems)
- ISO 10993-1 (Biocompatibility)
- ISO 18562-1 (Biocompatibility of breathing gas pathways).

The table "Comparison of Technological Characteristics" (Pages 6, 7, 8, 9) effectively serves as the "acceptance criteria" through a direct comparison to the predicate and reference devices, demonstrating that the subject device's specifications are either identical or offer non-inferior performance without raising new safety or effectiveness concerns.

Given the nature of the device, the following points address the relevant aspects of your request based on the provided text:

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

The acceptance criteria are implicitly defined by the substantial equivalence comparison to the predicate and reference devices, and adherence to relevant consensus standards. The "reported device performance" is presented through direct specifications and the claim of meeting the standards.

Attribute	Acceptance Criteria (Predicate/Reference Standard)	Reported Device Performance (BONHAWA Respiratory Humidifier)	Notes/Differences
Classification Name	Humidifier, Respiratory Gas (Direct Patient Interface) (Predicate)	Humidifier, Respiratory Gas (Direct Patient Interface)	Similar to the predicate.
Regulation Number	21 CFR 868.5450 (Predicate)	21 CFR 868.5450	Similar.
Indications for Use	High flow warmed and humidified respiratory gases for spontaneously breathing patients. (Predicate similar, Reference broader to include infants and sub-acute facilities, and bypassed upper airways).	High flow warmed and humidified respiratory gases for administration to spontaneously breathing patients 20 kg and up, child to adults in hospitals. Without bypassed upper airways.	The subject device includes a more specific lower weight limit (20kg and up) and explicitly excludes use with bypassed upper airways, aligning more closely with the predicate's narrower scope for non-bypassed upper airways. The overall intended use of delivering high flow breathing gases with humidification remains similar.
Environment of Use	Hospitals (Predicate: Hospitals and long-term care facilities; Reference: Hospitals and sub-acute facilities)	Hospitals	Similar but not for long-term facility use as the predicate.
Patient Population	Pediatric to Adult (Predicate) / Infant to Adults (Reference)	Pediatric patients, 20kg and above, and Adult	Similar. More specific starting weight.
Breathing Type	Spontaneously breathing	Spontaneously breathing	Similar.
Flow Rate	Predicate: up to 60 L/min; Reference: up to 70 L/min	Pediatric: 2 - 25 L/min, Adults: 10 - 70 L/min	Subject device's adult flow rate (70 lpm) matches the reference device and is higher than the predicate (60 lpm), which is considered acceptable for achieving intended FiO2 by matching patient inspiratory demand.
Operating Principle	Constant flow of warmed, humidified gas delivery via blower and humidifier	Constant flow of warmed, humidified gas delivery via blower and humidifier	Similar.
Oxygen Input Source	Low-Pressure Oxygen (LPO) low-pressure connector (from rotameter)	Low-Pressure Oxygen (LPO) low-pressure connector (from rotameter)	Similar. The reference device also has a High-Pressure Oxygen (HPO) inlet.
Humidity Source	Heated humidification chamber	Heated humidification chamber	Similar.
Humidity Performance	At 37°C >= to 33mg/L, At 34°C >= to 12mg/L, At 31°C >= to 12mg/L	At 37°C >= to 33mg/L, At 34°C >= to 12mg/L, At 31°C >= to 12mg/L	Similar.
Temperature Range	31 - 37 °C	31 - 37 °C (Adult: 37°C, 34°C, 31°C; Pediatric: 34°C)	Similar.
Ambient Operating Temp	18 – 28 °C	18 – 28 °C	Similar.
Alarms	Visual and audible alarm system; Mute button	Visual and audible alarm system; Mute button	Similar.
Patient Interfaces	Nasal cannula, Unsealed tracheostomy connector, Unsealed mask adapter (Predicate/Reference)	Nasal cannula	Similar for the patient without bypassed airway (which is the stated indication). The subject device does not include tracheostomy or mask adapter interfaces.
Heated Breathing Tube	Single-lumen, spiral heater wires	Single-lumen, spiral heater wires	Similar.
Duration of Use	14 Days single patient use	14 Days single patient use	Similar.
Oxygen Concentration	Input Oxygen

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