Search Results

The THERMALITE® CPAP Heated Tubing is a heated wire breathing tube intended to provide warmed and/or humidified breathing gases before they enter a patient's airway. It is indicated for single-patient reuse in the home and in clinical settings, such as hospitals, institutions, sleep laboratories, and sub-acute care facilities. It may be used with noninvasive ventilation for adult patients.
It is compatible with the Philips Respironics DreamStation 2 heated humidifiers.

The Exceleron Medical, LLC (Exceleron) THERMALITE® CPAP Heated Tubing (THERMALITE) is a heated tube that connects between a continuous positive airway pressure (CPAP) machine and the patient's interface, typically a CPAP mask. The THERMALITE is compatible with the Philips Respironics DreamStation 1 and DreamStation 2 heated humidifiers.
The THERMALITE has a unique design that helps prevent condensate from forming within the heated air stream during CPAP therapy by controlling the airflow temperature, creating an environment to maintain water in its vapor form. This condition of condensation is commonly known as "rainout," and is usually the result of temperature and humidity differentials between the device versus the surrounding air.
The THERMALITE is available in a three (3) or two (2) wire configuration.

The provided text is a 510(k) Premarket Notification for a medical device called "THERMALITE CPAP Heated Tubing." It details the device's characteristics, indications for use, comparison to a predicate device, and a summary of performance testing. However, it does not contain specific acceptance criteria values or detailed study results in the format typically requested for AI/ML device performance.

Therefore, many of the requested items cannot be fully answered with the provided text. I will answer what is available and indicate where information is missing.

1. A table of acceptance criteria and the reported device performance

The document lists various tests performed based on international standards and guidance documents. It states that "Test results indicated that the Exceleron THERMALITE complies with the applicable Standards and guidance documents" and "Test results indicated that the Exceleron THERMALITE complies with internal requirements, applicable Standards, and the guidance documents." However, it does not provide specific numerical acceptance criteria (e.g., "temperature must be within X +/- Y °C") or the exact reported performance values (e.g., "observed temperature was Z °C").

Acceptance Criteria and Reported Device Performance (as far as available in the text):

The purpose of the device is to provide "warmed and/or humidified breathing gases" and "prevent condensate from forming within the heated air stream during CPAP therapy by controlling the airflow temperature, creating an environment to maintain water in its vapor form." The predicate device description mentions "air passing through the tubing is warmed to or above the dew point (of the air existing the humidifier) reducing or eliminating water condensation and/or pooling of water in the breathing circuit 41 °C. The raising of the gas temperature does not exceed." This implies a performance target but no specific results for the subject device are given beyond general compliance. |

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The document refers to "test results" and "verification and validation activities" but does not detail the sample sizes for these tests or the data provenance. These are bench tests on the device itself, not clinical studies with patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This question is not applicable as the device is a heated tubing for CPAP machines, not an AI/ML diagnostic or therapeutic device requiring expert interpretation of results or establishment of ground truth from clinical data. The "ground truth" for this type of device is established through engineering and performance specifications and testing against those specifications and relevant international standards.

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

This question is not applicable for the same reasons as #3. There is no clinical imaging or diagnostic data requiring adjudication.

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 question is not applicable. This is a physical medical device (heated tubing), not a software/AI device that would involve human readers or AI assistance.

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

This question is not applicable. This is a physical medical device.

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

The "ground truth" for this device is based on engineering specifications, compliance with international standards (e.g., ISO, IEC), and internal requirements for safety and performance (e.g., biocompatibility limits, electrical safety thresholds, EMC limits, and performance parameters for heating and humidification as defined in the standards). It is not derived from clinical expert consensus, pathology, or outcomes data in the way an AI/ML diagnostic device's ground truth would be.

8. The sample size for the training set

This question is not applicable. This is a physical medical device, not an AI/ML device that requires a training set.

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

This question is not applicable. See #8.

Ask a specific question about this device