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The Neonatal ConchaSmart Breathing Circuits are intended for neonatal and infant patients in professional healthcare environments as a conduit for respiratory gas between a patient and a ventilator or Infant Flow Generator (for single limb configuration) and include heated wire(s) for use with the Hudson RCI Neptune Heated Humidifier. The heated wires are intended to aid in maintaining the set patient temperature and minimize condensation in the ventilator tubing.

The Neonatal ConchaSmart Breathing Circuits are intended for neonatal and infant patients in professional healthcare environments as a conduit for respiratory gas between a patient and a ventilator or Infant Flow Generator (for single limb configuration) and includes heated wire(s) for use with the Hudson RCI Neptune Heated Humidifier. The heated wires are intended to aid in maintaining the set patient temperature and minimize condensation in the ventilator tubing.

These devices are made of corrugated tubing (10mm in diameter), which houses the heated wires and are kitted with various adaptors and connectors to aid the respiratory care clinician in system configuration. In general these heated wire circuits are connected to both a ventilator and a Hudson RCI Neptune Heated Humidifier. The single limb configuration is compatible with the CareFusion Infant Flow system.

All Neonatal ConchaSmart Breathing Circuits have a useful life of 21 days. Neonatal ConchaSmart Breathing Circuits are sold non-sterile.

The provided text describes a 510(k) premarket notification for a medical device, the "Neonatal ConchaSmart Breathing Circuits." The submission aims to demonstrate substantial equivalence to legally marketed predicate devices. The document details the device's indications for use, technological characteristics, and performance data from non-clinical testing.

However, the information provided focuses on the physical and functional performance of the breathing circuits themselves, rather than an AI/ML-driven device's performance measured against acceptance criteria in a clinical or image-based diagnostic setting. Specifically, it does not contain the following information typically found in an AI/ML device submission for establishing acceptance criteria and proving performance:

• A table of acceptance criteria for AI/ML performance metrics (e.g., sensitivity, specificity, AUC) and reported device performance against these.
• Sample sizes for test sets in an AI/ML context (e.g., number of images, patient cases).
• Data provenance (country of origin, retrospective/prospective) for an AI/ML test set.
• Number of experts and their qualifications for establishing ground truth for an AI/ML test set.
• Adjudication methods for AI/ML ground truth.
• Multi-reader multi-case (MRMC) comparative effectiveness study details (effect size of human reader improvement with AI assistance).
• Standalone performance (algorithm only without human-in-the-loop) for an AI/ML device.
• Type of ground truth used (e.g., expert consensus, pathology, outcomes data) for an AI/ML device.
• Sample size for AI/ML training set.
• How ground truth for the AI/ML training set was established.

The document discusses engineering acceptance criteria related to standards for breathing circuits (e.g., resistance to flow, compliance, leakage, useful life, electrical safety, biocompatibility) and confirms that the device passed these tests. It indicates the device functions as intended with a specific humidifier.

Therefore, I cannot extract the requested information as the document describes a traditional medical device (breathing circuits) and not an AI/ML medical device where such acceptance criteria and study designs (related to AI model performance, human-in-the-loop studies, ground truth establishment for AI) would be relevant.

The acceptance criteria and study described in the document are limited to the physical and functional aspects of a non-AI/ML medical device.

The closest information provided related to "acceptance criteria" and "study proving it meets criteria" is:

Acceptance Criteria (Extrapolated from "Test Objective" and ISO Standards):

Study Proving Device Meets Acceptance Criteria:

The study involved a series of non-clinical, laboratory-based tests.

1. Sample Size Used for Test Set and Data Provenance: The document does not specify a "sample size" in terms of number of patient cases or images, as it is not an AI/ML study. It refers to testing "the proposed devices," implying physical units of the Neonatal ConchaSmart Breathing Circuits. The tests were performed in a lab setting, not using human data/patients, so "provenance" in the sense of country of origin or retrospective/prospective is not applicable.
2. Number of Experts and Qualifications for Ground Truth: Not applicable for this type of device where laboratory measurements against international standards establish "truth."
3. Adjudication Method: Not applicable. Lab testing against defined physical and electrical parameters.
4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. This is for AI/ML devices involving human readers.
5. Standalone Performance: Not applicable in the context of an AI/ML algorithm. The device performance itself is evaluated (e.g., its resistance to flow, electrical safety, etc.).
6. Type of Ground Truth Used: The "ground truth" here is adherence to specified parameters and performance limits defined by international standards (e.g., ISO 5367, IEC 60601-1, ISO 8185, ISO 5356-1, ISO 10993) and the manufacturer's design verification testing for compatibility and durability.
7. Sample Size for Training Set & How Ground Truth for Training Set was Established: Not applicable, as this is not an AI/ML device relying on a "training set" of data.

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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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