Search Results

The AirLife DuoTherm™ Heated Humidifier is intended to add moisture to, and warm, the breathing gases for administration to a patient. Gases available for medical use do not contain sufficient moisture and may damage or irritate the respiratory tract, or desiccate secretions of patients whose supraglottic airways have been bypassed. This product is non-sterile, reusable, and intended to be used in professional healthcare environments under the supervision of a licensed healthcare practitioner.

The AirLife DuoTherm™ Humidification Chamber is intended to hold water required to humidify breathing gases delivered to patients ranging from neonates to adults using a heated humidifier. The product is a single use device, nonsterile, and used in professional healthcare environments under the supervision of a licensed healthcare practitioner.

The AirLife DuoTherm™ Neonate Heated-Wire Circuits are intended to deliver and warm breathing gases before they enter the patient's airway. The Neonate Heated-Wire Circuits are used with a pediatric population, specifically the neonate (birth to 28 days) and infant (29 days to 2 years) pediatric subgroups with an ideal body weight of 0.5 to 8kg that requires mechanical ventilation, positive pressure breathing or general medical gases, respectively. The Neonate Heated-Wire Circuits are used for flow rates greater than 1 LPM. The product is single patient use, non-sterile, and used in professional healthcare environments under the supervision of a licensed healthcare practitioner.

The AirLife DuoTherm™ Pediatric Heated-Wire Circuits are intended to deliver and warm breathing gases before they enter the patient's airway. The Pediatric Heated-Wire Circuits are used with the pediation, specifically infant (29 days to 2 years) and children (2 years) with an ideal body weight of 6 to 42kg that requires mechanical ventilation, positive pressure breathing or general medical gases, respectively. The Pediatric Heated-Wire Circuits are used for flow rates greater than 2 LPM. The product is single use, non-sterile, and used in professional healthcare environments under the supervision of a licensed healthcare practitioner.

The AirLife DuoTherm™ Adult Heated-Wire Circuits are intended to deliver and warm breathing gases before they enter the patient's airway. The Adult Heated-Wire Circuits are used with the adult population and pediation, specifically those with an ideal body weight of 30kg or above, that requires mechanical ventilation, positive pressure breathing or general medical gases, respectively. The Adult Heated-Wire Circuits are used for flow rates greater than 3 LPM. The product is single-use, non-sterile, and used in professional healthcare environments under the supervision of a licensed healthcare practitioner.

The AirLife DuoTherm™ Adult Heated-Wire NIV Circuit is intended to deliver and warm breathing gases before they enter the patient's airway. The Adult Heated-Wire NV Circuit is used with the spontaneously breathing adult population (>21 years), specifically those with an ideal body weight of 30kg or above, that benefit from high flow therapy. The Adult Heated-Wire NIV Circuits are used for flow rates greater than 5 LPM. The product is single-use, non-sterile, and used in professional healthcare environments under the supervision of a licensed healthcare practitioner.

The AirLife DuoTherm™ Humidification System is used to deliver heated, humidified breathing gases to a patient's airway when he/she is mechanically ventilated, receiving continuous noninvasive (NIV) positive airway pressure or high-flow oxygen therapy. The system is intended for use in a standard hospital or professional health care environment.

The AirLife DuoTherm™ Humidification System consists of:

• A heated humidifier, which includes reusable temperature probes, heated wire adapters, and a power cord,
• A humidification chamber, and
• . Heated wire circuits, which include neonate, pediatric, and adult single and dual limb circuits, as well as an adult heated wire NIV circuit.

Based on the provided text, the document is a 510(k) Premarket Notification for the AirLife DuoTherm™ Humidification System. This type of submission aims to demonstrate that a new medical device is substantially equivalent to a legally marketed predicate device, rather than proving its safety and efficacy from scratch through extensive clinical trials. Therefore, the information provided focuses on non-clinical performance testing and comparison to predicate devices, rather than a traditional clinical study with human data.

There is no clinical study data provided in this document that would define acceptance criteria for AI model performance (e.g., accuracy, sensitivity, specificity) against a ground truth established by experts using a test set, nor does it describe an MRMC study.

The document explicitly states:
"There was no clinical testing required to support the AirLife DuoTherm™ Humidification System, as the intended use and indications for use are equivalent to the primary predicate and reference devices. These types of devices, including the primary predicate device, have been on the market with a proven safety and efficacy record for the use of the device. The non-clinical testing detailed in this submission supports the substantial equivalence of the AirLife DuoTherm™ Humidification System, and its safety and effectiveness."

Therefore, I cannot provide the requested information regarding acceptance criteria, training/test sets, expert adjudication, or MRMC studies as these were not part of the demonstrated substantial equivalence for this particular device.

However, I can summarize the non-clinical performance testing and the basis for the substantial equivalence claim as described in the document.

Summary of Acceptance Criteria and Device Performance (Non-Clinical):

The acceptance criteria for the AirLife DuoTherm™ Humidification System were met by demonstrating compliance with various national and international consensus standards for medical electrical equipment, respiratory humidifying equipment, biocompatibility, and software. The device performance is deemed acceptable because it met the requirements of these standards and was shown to be substantially equivalent to existing predicate devices with a proven safety and efficacy record.

Table of Acceptance Criteria and Reported Device Performance (as inferred from the document):

Regarding the specific questions about an AI/Algorithm performance study:

1. A table of acceptance criteria and the reported device performance: As explained above, for the AirLife DuoTherm™ Humidification System, this refers to compliance with performance and safety standards for medical devices and demonstration of substantial equivalence to predicate devices, not AI performance metrics.
2. Sample sized used for the test set and the data provenance: Not applicable. No test set for an AI algorithm performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth established by experts for an AI algorithm.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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. No MRMC study was conducted or required.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/algorithm-driven device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable. No training set for an AI/algorithm.
9. How the ground truth for the training set was established: Not applicable.

In conclusion, this FDA 510(k) submission pertains to a physical medical device (a humidification system) and its components, demonstrating substantial equivalence to existing devices through non-clinical testing and comparison of fundamental characteristics. It does not involve AI or an algorithm whose diagnostic or prognostic performance would be evaluated through the types of studies described in the prompt.

Ask a specific question about this device