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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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Intended Use HAMILTON-H900

The HAMILTON-H900 humidifier is intended to add moisture and to warm breathing gases during invasive and non-invasive mechanical ventilation. The intended area of use is the intensive care ward or the recovery room.

The HAMILTON-H900 humidifier is a medical device intended for use by qualified, trained personnel under the direction of a physician and within the limits of its stated technical specifications.

Intended Use HAMILTON-BC8010

The HAMILTON-BC8010 breathing set is intended to be used together with compatible Hamilton Medical respiratory gas humidifiers during invasive and noninvasive mechanical ventilation of pediatric and neonatal patients.

Intended Use HAMILTON-BC4010

The HAMILTON-BC4010 breathing set is intended to be used together with compatible Hamilton Medical respiratory gas humidifiers during invasive and noninvasive mechanical ventilation of pediatric and neonatal patients.

HAMILTON-H900

The HAMILTON-H900 respiratory gas humidifier is designed to add heat and moisture to respiratory gases, which are then administered to patients who need invasive or noninvasive ventilation. The breathing gas is passed through a humidifier chamber, where the gas is heated and humidified using an external heat source.

The HAMILTON-H900 humidifier uses breathing circuits that are recognized automatically when connected to the humidifier. The humidifier uses two heating systems as heat sources:

• -A heating plate that has contact with the metal plate of a special humidifier chamber inserted into the base of the humidifier prior to application, thus heating the water contained inside the chamber.
• -The controlled heating within the breathing circuits.

The respiratory gas exiting the humidifier chamber is continuously monitored using temperature sensors that are integrated into the humidifier base. Additionally, a temperature probe inside the breathing tube is used to measure the temperature of the gas delivered to the patient airway.

The design of the breathing tubes offers heating performance over the entire length by providing constant heating of the entire tube wall, from the chamber exit to the patient connection. A float mechanism, together with detection of the water level inside the humidifier chamber and the autofill mechanism, keeps a constant water level.

HAMILTON-BC8010

The HAMILTON-BC8010 is a single-use, dual-limb breathing circuit comprising heated inspiratory and heated expiratory tubes. The humidifier chamber uses a float mechanism to keep a constant water level inside the auto-feed chamber.

HAMILTON-BC4010

The HAMILTON-BC4010 is a single-imb breathing circuit comprising a heated inspiratory tube. The humidifier chamber uses a float mechanism to keep a constant water level inside the auto-feed chamber.

HAMILTON-HC322/HC310

The HAMILTON-HC322/HC310 are single-use humidifier chambers with a float mechanism to keep a constant water level inside the auto-feed chamber. The HAMILTON-HC322 humidifier chamber is part of the HAMILTON-BC8022/BC4022 breathing sets and the HAMILTON-HC310 humidifier chamber is part of the HAMILTON-BC8010/BC4010 breathing sets, as cleared in K152029.

This is a 510(k) summary for a medical device (respiratory gas humidifier and breathing circuits), not an AI/ML medical device. Therefore, the information requested about acceptance criteria, study details, and ground truth establishment, which are typical for AI/ML device submissions, are not primarily available or applicable in the provided text.

The document discusses substantial equivalence to predicate devices based on technological characteristics and performance, focusing on non-clinical data. It does not describe an AI/ML algorithm that predicts or diagnoses based on medical images or other data, nor does it detail a study that evaluates the performance of such an algorithm against a ground truth established by experts.

However, I can provide the acceptance criteria and performance as described for this specific device, based on the provided text, recognizing that it's not in the context of an AI/ML model.

Here's an analysis of the provided text, focusing on the closest equivalents to your requested information, understanding the context is a medical device, not an AI/ML diagnostic:

The provided text is a 510(k) summary for the Hamilton-H900 Humidifier and Hamilton-BC series breathing circuits. This document outlines the rationale for the device's substantial equivalence to previously cleared predicate devices. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to engineering and performance specifications and non-clinical testing, rather than the type of clinical performance study typically conducted for AI/ML diagnostic or predictive devices.

Therefore, many of the requested points (e.g., number of experts for ground truth, adjudication methods, MRMC study, standalone performance for an algorithm) are not applicable to this type of device submission.

Here is the information extractable from the document, focusing on performance characteristics and non-clinical testing rather than AI/ML specific criteria:

Acceptance Criteria and Reported Device Performance (Non-AI/ML Context)

The acceptance criteria are implied by the "Characteristic used for comparison" and the "HAMILTON-H900 (Subject device)" column in Table 1 for the humidifier and Table 2 for the breathing circuits. The "reported device performance" is the statement that the subject device meets these established characteristics, which are largely identical to the predicate device.

1. Table of Acceptance Criteria and the Reported Device Performance

For HAMILTON-H900 (Humidifier):

For HAMILTON-BC8010 / BC4010 (Breathing Circuits):

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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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