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The inspired™ VHB20 Heated Humidifier is intended to be used to warm and add humidity to gases delivered to patients requiring mechanical ventilation or positive pressure breathing assistance or general medical gases.

The inspired TM VHB20 Heated Humidifier is indicated for use by trained personnel only within a hospital/institutional environment. It is compatible with the Fisher and Paykel MR290 Humidification Chamber (Single Use), RT380 Dual Heated Breathing Circuit and RT265 Dual Heated Infant Breathing Circuit.

The subject device, inspired™ VHB20 Heated Humidifier, is indicated to add humidity and heat to the breathing gasses delivered to patients requiring mechanical ventilation or positive pressure breathing assistance.

It consists of an electrically powered heat controlled with a microprocessor to provide software control of the heating element that transfers heat to the water in a chamber.

Breathing tubes enable the humidified gas to be transported to the patient which may also be electrically heated (if connected), by means of a heater-wire placed internally to the tubes, to minimize the loss of humidity. A passive electrical adaptor provides electrical energy from the humidifier to the heater-wire in the breathing circuit. Over-current protection is provided by the SMPS inside the inspired™ VHB20 Heated Humidifier, which incorporates an over-current protection that will be triggered (cut-out) if output power of the SMPS reaches 110% of the rating (100W). The SMPS will recover automatically after fault condition is removed, while the humidifier will restart. This safety feature protects the humidifier from short-circuits in the DC part of the circuit, and prevents voltage and current transients on the heater-wire.

The inspired™ VHB20 Heated Humidifier provides heated and humidified gas with flow rates of 5 to 60 lpm (invasive) and 5 to 120 lpm (non-invasive).

The inspired™ VHB20 Heated Humidifier is a mains powered device that complies with ES60601-1, IEC 60601-1-2, ISO 80601-2-74 and AIM 7351731.

The provided text describes a 510(k) premarket notification for a medical device, the "inspired™ VHB20 Heated Humidifier." This document focuses on demonstrating substantial equivalence to a predicate device, the Fisher & Paykel MR850 Respiratory Humidifier. The information provided is primarily for regulatory clearance based on equivalence, not a clinical study proving specific performance metrics against acceptance criteria in the way one might see for a novel AI/ML device.

Therefore, many of the requested items related to Acceptance Criteria and Study Design (e.g., sample size for test sets, ground truth establishment by experts, MRMC studies, standalone performance with effect sizes) are not applicable to this type of regulatory submission for a respiratory gas humidifier. The "acceptance criteria" here are based on demonstrating that the new device is as safe and effective as a legally marketed predicate device, primarily through bench testing comparing its performance specifications.

However, I can extract the relevant "acceptance criteria" (which are performance specifications) and the "reported device performance" from the provided Table 1, and comment on other requested points based on the available information.

Acceptance Criteria and Reported Device Performance

The "acceptance criteria" for this type of device are generally its performance specifications that demonstrate it operates within safe and effective parameters, comparable to a predicate device. The "reported device performance" is the measured performance of the proposed device.

Here's a table comparing the subject device's reported performance against the predicate's, which implicitly serves as the "acceptance criteria" for substantial equivalence:

Study Details (Based on provided text)

1. Sample size used for the test set and the data provenance:

   • Sample Size: Not specified in terms of patient or clinical samples, as this is a bench test for a physical device. Electrical safety, EMC, and software verification/validation are typically performed on a limited number of manufactured units.
   • Data Provenance: The origin of the data is from "Bench testing" and "Non-Clinical Testing Summary" performed by the manufacturer, Vincent Healthcare Products Limited. It is a retrospective submission based on completed testing. There is no mention of country of origin for the testing data specifically, but the manufacturer is based in Hong Kong and the submission is to the US FDA.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not Applicable. This is a physical device with measurable performance specifications (temperature, humidity, flow, electrical safety). "Ground truth" is established by direct measurement using calibrated equipment and standard test methods (e.g., ISO, IEC standards mentioned) and comparison to the predicate's known specifications. This does not involve human expert interpretation of clinical data to establish a "ground truth."

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not Applicable. Adjudication methods like 2+1 or 3+1 are used for human review processes (e.g., clinicians interpret images and a tie-breaker resolves discrepancies). For bench testing of a device's physical performance, the results are quantitative and directly measured against specifications.

4. 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:

   • No. An MRMC study is relevant for AI/ML-driven diagnostic devices where human reader performance is being evaluated with or without AI assistance. This document is for a heated humidifier, which is not an AI/ML diagnostic device.

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

   • Yes (conceptually). The device's performance specifications (temperature control, humidity output, etc.) were verified independently through bench testing (Non-Clinical Testing Summary: Bench testing). This is analogous to a standalone performance evaluation for a physical device, though the term "algorithm only" doesn't directly apply as it's not a purely software-based diagnostic algorithm. The software verification and validation are for the embedded system controlling the humidifier.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   • The "ground truth" for this device's performance is established by direct physical measurement against predefined engineering specifications and international standards (e.g., IEC 60601-1, ISO 80601-2-74) and comparison to the well-established performance of a predicate device. This is primarily a technical/engineering ground truth, not a clinical one derived from patient outcomes or expert consensus on medical images/diagnoses.

7. The sample size for the training set:

   • Not Applicable. This is a hardware medical device with embedded software, not a machine learning model that requires a training set.

8. How the ground truth for the training set was established:

   • Not Applicable. As there is no machine learning model or training set, this question is not relevant.

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