(202 days)
The ComfortLite 2 Nasal Mask is intended to provide an interface for Continuous Positive Airway Pressure (CPAP) or bi-level therapy. This mask is intended for single-patient reuse in the home and multi-patient, multi-use in the hospital/institutional environment. This mask is to be used on patients greater than 66 lbs / 30 kg.
The ComfortLite™ Nasal Mask is unchanged from the device design submitted and cleared in K053352. The Comfortlite Nasal Mask designed for patients ( > 66 Ibs / 30 kg ) as a nasal interface for application of non-invasive CPAP or bi-level therapy. It consists of a nasal interface with a built-in exhalation device, interface adjustment mechanisms, and 6" of standard 22 mm tubing connected to a crown swivel (elbow) for connection to the CPAP or Bi-level device. The mask is supported by a baseball-cap type headgear to allow a seal with the patient's nostrils via the nasal interface. Three types of nasal cushions are compatible with the base frame structure that comes in one frame size. These include a simple cushion, a direct seal cushion, and nasal pillows. All nasal interfaces are available in multiple sizes to meet the needs of the user.
The provided text describes a 510(k) summary for the ComfortLite™ Nasal Mask, focusing on its substantial equivalence to a predicate device and its intended use, particularly the inclusion of a multi-patient re-use claim. The performance data section refers to "Mask Efficacy Testing" to confirm the efficacy of cleaning methods.
However, the document does not contain specific details for many of the requested categories related to medical device AI/ML performance studies, as it describes a physical medical device (nasal mask) and not an AI or algorithm-driven diagnostic or therapeutic device. The "acceptance criteria" discussed are in the context of design verification tests, not a clinical performance study with statistical metrics for an AI system.
Here's the breakdown based on the provided text, and where information is missing (which is most categories, given the nature of the device):
1. Table of Acceptance Criteria and Reported Device Performance
The document mentions "Design verification tests were performed on the ComfortLite™ Nasal Mask... All tests were verified to meet the required acceptance criteria." and "The results of the testing confirm that exposure to the specified cleaning, and disinfection agents do not degrade the performance of the ComfortLite Nasal Mask as it was originally cleared in K053352."
However, it does not provide a specific table of acceptance criteria and reported device performance for a clinical or algorithmic study, as it is a physical device submission focused on material integrity and cleaning efficacy.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in detail for a clinical/algorithmic study. The general criterion is that cleaning and disinfection do not degrade performance. | Not specified with quantitative metrics. The document states "confirm that exposure to the specified cleaning, and disinfection agents do not degrade the performance of the ComfortLite Nasal Mask". |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. The testing described focuses on material/cleaning efficacy, not on a patient test set for an AI or diagnostic algorithm.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided. The ground truth relevant to this device would be the physical integrity and cleanliness post-processing, established by technical testing methods, not by human experts interpreting data.
4. Adjudication Method for the Test Set
This information is not provided.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC study was not done. This type of study is relevant for diagnostic performance of AI algorithms where human readers are involved. This submission is for a physical medical device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
No, a standalone algorithm performance study was not done. This device is a physical mask for CPAP/bi-level therapy.
7. The Type of Ground Truth Used
The ground truth implicitly used for the "Mask Efficacy Testing" and design verification would be technical measurements of material degradation, structural integrity, and cleanliness after exposure to cleaning/disinfection agents. This is not "expert consensus," "pathology," or "outcomes data" in the typical sense of a diagnostic device.
8. The Sample Size for the Training Set
This information is not provided and is not applicable to a physical device submission of this nature. "Training set" is a concept for machine learning models.
9. How the Ground Truth for the Training Set was Established
This information is not provided and is not applicable.
§ 868.5905 Noncontinuous ventilator (IPPB).
(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).