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The Comfort Flo Humidification System provides a continuous flow of heated and humidified gas to spontaneously breathing patients. It is indicated for single use by neonate/infant, pediatic, and adult patients in professional healthcare environments.

The Comfort Flo Humidification System is intended to deliver heated and humidified respiratory gases to spontaneously breathing patients. The Comfort Flo Humidification System is designed to be used in conjunction with the Neptune Heated Humidifier with ConchaSmart Technology for neonate/infant, pediatric, and adult populations. The Comfort Flo Humidification System includes a Heated Wire Breathing Circuit, a ConchaSmart Column, and various Class I exempt accessories.

The document describes the acceptance criteria and performance of the Comfort Flo Humidification System, primarily focusing on its substantial equivalence to a predicate device (K131912).

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Test Set Sample Size: Not explicitly stated in the provided document. The document mentions "The proposed Corrugated Comfort Flo Heated Wire Breathing Circuit" and "the proposed device," implying that testing was conducted on samples of the new design.
• Data Provenance: The document does not specify the country of origin of the data. The testing appears to be "bench testing" or "laboratory testing" based on the nature of the tests (ISO standards, physical and functional performance). It is prospective in the sense that the testing was performed on the new device (or samples thereof) to demonstrate its performance.

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

• This information is not applicable as the described testing involves objective physical and functional performance criteria against established ISO standards, rather than subjective expert assessment or "ground truth" derived from human interpretation.

4. Adjudication method for the test set:

• This information is not applicable. The testing involves objective measurements and adherence to specified performance parameters defined by ISO standards. Therefore, an adjudication method for human interpretation is not relevant.

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:

• A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically associated with AI/CAD systems that assist human interpretation of medical images, which is not the nature of the Comfort Flo Humidification System.

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

• A standalone algorithm-only performance study was not done. This device is a medical apparatus (humidification system), not an algorithm or AI.

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

• The "ground truth" for the performance evaluation of the Comfort Flo Humidification System is based on International Organization for Standardization (ISO) standards and specific engineering/performance requirements. This includes:
  • ISO 8185:2007 - Respiratory tract humidifiers for medical use
  • ISO 5356-1:2004 - Anaesthetic and respiratory equipment -- Conical connectors
  • ISO 5367:2000 - Breathing tubes
  • ISO 10993 series - Biological evaluation of medical devices (for biocompatibility)
  • Specific functional parameters like visual inspection, length, connection strength, temperature/flow, rainout control, enthalpy, resistance to flow, leakage, humidity output, warm-up time, and temperature tracking.

8. The sample size for the training set:

• This information is not applicable. The Comfort Flo Humidification System is a physical medical device, not an AI/machine learning model that requires a training set. The term "training set" is typically used in the context of developing AI algorithms.

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

• This information is not applicable for the same reason as #8. No training set or associated ground truth was relevant for this device.

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The COMFORT FLO™ Humidification System is intended to provide a continuous flow of heated and humidified gases to spontaneously breathing patients.

Indications For Use:
To provide a continuous flow of heated and humidified gas to spontaneously breathing patients.

The COMFORT FLO™ Humidification System is a gas delivery system.This system is designed to deliver heated and humidified respiratory gases to spontaneously breathing adult, pediatric, infant, and/or neonatal patients. This delivery system will be used in conjunction with the ConchaTherm Heated Humidifier product line. The COMFORT FLO™ Humidification System consists of a heated circuit, a Concha® Column, and a nasal cannula patient interface. All components of the COMFORT FLO™ Humidification System are non-sterile with the exception of the gamma-sterilized Concha® Column.

The provided text describes the COMFORT FLO™ Humidification System and its 510(k) submission, including a summary of testing conducted to demonstrate its performance. Here's a breakdown of the requested information based on the text:

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

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

• Sample Size for Test Set: The document does not specify the exact number of units or test runs used for the evaluation. It mentions "The COMFORT FLO™ Humidification System was evaluated and tested under simulated and extended use hospital conditions."
• Data Provenance (Country of Origin): Not explicitly stated, but the applicant (Teleflex Medical) is located in Bannockburn, IL, USA, and the FDA's address is Rockville, MD, USA. This suggests the testing was likely conducted in the USA or supervised by US entities.
• Retrospective or Prospective: The testing described is prospective, as it was conducted specifically to demonstrate the device's performance for this 510(k) submission.

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 section is not applicable as the study did not involve human interpretation or subjective assessment of data requiring expert consensus or ground truth in the way medical imaging or diagnostic algorithms would. The study focused on the functional performance of a medical device against objective physical parameters (humidity, temperature, flow rate, duration).

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

This section is not applicable for the same reasons as point 3. The testing involved objective measurements of physical parameters, not subjective assessments 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 section is not applicable. An MRMC study is relevant for evaluating diagnostic or interpretive AI systems with human readers. This submission is for a medical device (humidification system) with no AI component or human interpretative task.

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

This section is not applicable as there is no algorithm or AI component mentioned in the device description or testing summary. The device's performance was evaluated as a standalone physical system.

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

The "ground truth" in this context refers to the specified physical parameters/performance requirements for the device: 100% Relative Humidity, 37°C, 1 to 40 LPM flow rate, and maintenance of functional integrity for 14 days. Compliance was assessed against these objective, measurable conditions.

8. The sample size for the training set

This section is not applicable. The device is a physical medical system, not an AI or machine learning algorithm that requires a training set.

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

This section is not applicable as there is no training set mentioned or implied for this type of device.

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