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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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The Conchasmart and ISO-GARD Breathing Circuits are intended for adult patients in professional healtheare facilities as a conduit for respiratory gas between a patient 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 breathing circuit.

ConchaSmart and ISO-GARD breathing circuits provide a conduit for respiratory gases between the patient and the ventilator/Hudson RCI Neptune Heated Humidifier. The heated wires inside the breathing circuits are used to minimize condensation in the circuit and to aid in maintaining the designated humidity and temperature of the respiratory gas. ConchaSmart and ISO-GARD breathing circuits are intended for use with adult patient populations in professional healthcare environments. These devices are made of corrugated tubing (22 mm in diameter) which house the heated wires and are kitted with various adaptors and connectors to aid the respiratory care clinician in system configuration.

Here's an analysis of the provided text in relation to acceptance criteria and study details, presented as requested:

Device Name: ConchaSmart and ISO-GARD Breathing Circuits
Regulation Name: Respiratory Gas Humidifier
Product Code: BTT

1. Table of Acceptance Criteria and Reported Device Performance

The document describes performance testing rather than explicitly stating quantitative "acceptance criteria" and "reported device performance" in a direct numerical comparison format that is typical for diagnostic tools. Instead, it focuses on compliance with standards and compatibility.

2. Sample size used for the test set and the data provenance

The document does not provide specific sample sizes for the testing described. It broadly states that "testing was performed."

The data provenance is not explicitly mentioned (e.g., country of origin, retrospective/prospective). However, given the context of a 510(k) summary, the testing would have been conducted by the manufacturer (Teleflex Medical, Incorporated, USA) to support their submission.

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 testing described (compliance with ISO standards, compatibility, useful life, biocompatibility) typically relies on laboratory measurements and established protocols rather than expert clinical interpretation for "ground truth" in the way it might be for a diagnostic AI device.

4. Adjudication method for the test set

This information is not applicable and not provided in the document. The testing involved objective measurements and compliance checks against established standards, not human expert adjudication of subjective results.

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 information is not applicable and not provided in the document. The device is a breathing circuit, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies involving human readers or AI assistance are not relevant to this device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable and not provided in the document. The device is a physical breathing circuit, not an algorithm.

7. The type of ground truth used

The "ground truth" for the performance evaluation in this context refers to established international standards (ISO 5367, ISO 5356-1), manufacturer specifications (compatibility with Hudson RCI Neptune Heated Humidifier, 30-day useful life), and biocompatibility testing protocols for patient-contacting materials. It is not based on expert consensus, pathology, or outcomes data in the way it would be for a diagnostic device.

8. The sample size for the training set

This information is not applicable and not provided in the document. The device is a physical medical device, not a machine learning model, so there is no "training set."

9. How the ground truth for the training set was established

This information is not applicable and not provided in the document, as there is no "training set" for this type of device.

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