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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.

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Exceleron Medical bacterial filters are single use replacement filters intended for use in oxygen concentrator machines to help remove contaminants, including air borne bacteria and other particulate debris from an air stream. When used with oxygen concentrator machines, the replacement filters may be used in the home, nursing home, hospital, patient care facility.

A breathing circuit bacterial filter is a device that is intended to remove microbiological and particulate matter from the gases in the breathing circuit of a respiratory device. The filter is a replaceable accessory device used in oxygen concentrators, either as intake filters or final patient filters. The function of the oxygen concentrator machine is to draw room air into the machine's compressor and concentrate the oxygen content before delivering filtered, oxygen rich air to the patient. From the compressor, the filtered air proceeds to the sieve beds. The sieve beds in the oxygen concentrator machine condition the air, by removing nitrogen from the air stream, which results in a higher concentration of oxygen. The air then passes through the final patient filter before being supplied to the patient. The Exceleron Medical bacterial intake filter and the final patient filter are intended to remove air borne bacteria and other particulate debris from the air stream.

The provided document describes the acceptance criteria and the study results for the Exceleron Bacterial Filter. Here's a breakdown of the requested information:

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

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

The document does not explicitly state the sample size for the "test set" (i.e., the number of filters tested). It mentions "Design verification testing was performed for the Exceleron Bacterial Filter," implying a set of filters were manufactured and tested.

The data provenance is not specified regarding country of origin or whether it was retrospective or prospective. It is implied these were laboratory performance bench tests conducted by the manufacturer.

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 product is a bacterial filter, not a diagnostic device requiring expert interpretation of results. Therefore, there were no experts used to establish ground truth in the context of human interpretation of medical images or data. Ground truth for performance was established through standardized physical and biological testing.

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

Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving human interpretation of data. This is a performance bench test for a physical device, so no such adjudication method was used. The performance was measured directly through scientific methods.

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

No. This is a physical filter device, not an AI-assisted diagnostic tool.

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

Not applicable. This is a physical filter, not an algorithm.

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

The ground truth for the performance tests was established through:

• Quantitative measurement for Bacterial Filtration Efficiency (BFE) based on particle counts and filtration capabilities.
• Quantitative measurement for Air Flow Resistance.
• Standardized biological tests (cytotoxicity, sensitization, intracutaneous reactivity) according to ISO 10993-1 for biocompatibility.

8. The sample size for the training set

Not applicable. This is a physical device, not a machine learning model, so there is no training set.

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

Not applicable. There is no training set for a physical device.

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