(125 days)
The ConchaTherm® Neptune™ is a respiratory humidifier designed to heat and humidify respiratory gases delivered via endotracheal tubes, nasal cannula or face masks to adult, pediatric, infant and neonatal patients. This system may be used with either conventional (non-heated wire) breathing circuits or compatible (21-volt) Hudson Respiratory Care Incorporated (RCI) heated-wire circuits.
The ConchaTherm® Neptune™ can be used with ventilators, continuous flow systems, oxygen diluters and blenders, adjustable nebulizer adapters for aerosol therapy, or non-flammable anesthesia gases to help maintain patient body temperature.
The ConchaTherm® Neptune™ is designed to provide heat and moisture to the medical gases delivered to a patient via continuous flow, invasive ventilation or non-invasive ventilation. The ConchaTherm® Neptune™ heated humidifier is the main component of the Teleflex Medical ConchaTerm Humidification system, which allow gas to be delivered to a patient using various interfaces.
The ConchaTherm® Neptune™ heated humidification system consists of the ConchaTherm® Neptune™ heated humidifier, the CONCHA-COLUMN® humidifier cartridge, CONCHA sterile water reservoir, a Hudson RCI dual temperature probe, and either a non-heated wire breathing circuit or a Hudson RCI 21-volt heated-wire breathing circuit. The servo-controlled heated humidifier continuously monitors the proximal airway temperature and regulates the heat supplied to the column by the heating element, and if used, the heated-wire circuit.
This is a 510(k) summary for a medical device, the ConchaTherm® Neptune™ Heated Humidifier. It describes the device, its intended use, and the testing performed to demonstrate substantial equivalence to predicate devices. However, this document does not contain acceptance criteria or detailed study results in the format requested.
The document states that the device was evaluated for compliance with several international and national standards related to medical electrical equipment safety, electromagnetic compatibility, and humidifiers for medical use. These standards would contain performance requirements that the device must meet to be compliant. However, the specific acceptance criteria values and the reported device performance against those values are not provided in this summary.
Therefore, I cannot directly answer your request for a table of acceptance criteria and reported device performance from the provided text. The document also does not contain information about sample sizes for test sets, data provenance, expert qualifications for ground truth establishment, adjudication methods, MRMC studies, standalone algorithm performance, or training set details.
Based on the provided text, here's what I can extract and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
- Not provided in this document. The document states compliance with standards (IEC/EN 60601-1, CAN/CSA C22.2 No. 601.1-M90, IEC/EN 60601-1-2, ISO 8185), but not the specific performance metrics or their values.
2. Sample size used for the test set and the data provenance:
- Not provided in this document. The summary states "performance testing" was done, but gives no details on sample size or data origin.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not provided. This device is a hardware humidifier, not an AI/diagnostic software, so "ground truth" in the context of expert consensus on data is not relevant to this type of device submission. Performance is typically assessed against physical standards and engineering specifications.
4. Adjudication method for the test set:
- Not applicable/Not provided. See point 3.
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 is a hardware device, not an AI software.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a hardware device.
7. The type of ground truth used:
- Engineering specifications and compliance with voluntary performance standards. This is implied by the mention of ISO 8185 for humidification systems and IEC/EN standards for electrical safety and EMC. These standards define measurable physical and electrical performance parameters.
8. The sample size for the training set:
- Not applicable. This is a hardware device, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. See point 8.
In summary, while the document indicates that performance testing was conducted according to standards for a medical device, it does not provide the granular details of acceptance criteria or study results that would typically be associated with an AI/ML or diagnostic device submission.
§ 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).