(203 days)
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.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compliance with ISO 5367 (Breathing tubes intended for use with anaesthetic apparatus and ventilators) | The proposed devices were tested to ensure compliance to ISO 5367. |
| Compliance with ISO 5356-1 (Anesthetic and respiratory equipment -- Conical connectors -- Part 1: Cones and sockets) | The proposed devices were tested to ensure compliance to ISO 5356-1. |
| Compatibility with the Hudson RCI Neptune Heated Humidifier | Testing was performed to ensure compatibility with the Hudson RCI Neptune Heated Humidifier. |
| Useful life of 30 days | Testing was performed to ensure a useful life of 30 days. |
| Biocompatibility of patient contacting materials (Cytotoxicity, Sensitization, Irritation, Genotoxicity, Implantation) | Cytotoxicity, sensitization, irritation, genotoxicity, and implantation testing were performed to demonstrate biocompatibility of the patient contacting materials. |
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.
§ 868.5450 Respiratory gas humidifier.
(a)
Identification. A respiratory gas humidifier is a device that is intended to add moisture to, and sometimes to warm, the breathing gases for administration to a patient. Cascade, gas, heated, and prefilled humidifiers are included in this generic type of device.(b)
Classification. Class II (performance standards).