Search Results

The InnoMed Technologies IT Nasal Mask is intended to be used as a patient interface for currently-marketed CPAP and Bi-Level positive-pressure ventilation devices capable of generating pressures up to 20cm H₂O. It is indicated for use in non-critical care applications such as treatment of adult obstructive sleep apnea and ventilatory support during respiratory insufficiency.

The InnoMed Technologies IT Nasal Mask is available by prescription, and is intended for single patient use only for adult patients (>30kg) in home or hospital settings.

The IT Nasal mask consists of a polycarbonate faceplate shaped to fit around the patient's nose, and a silicon cushion covering the edge of the faceplate where the mask makes contact with the patient's face. At the front of the mask's faceplate is a 90-degree elbow attached so as to allow it to rotate 360 degrees relative to the faceplate.

The other end of the elbow is configured as a standard female 22mm fitting for the attachment of a separate exhalation port/swivel that is supplied with each IT Nasal Mask. This exhalation port is configured so as to sufficiently exhaust exhaled air from the patient at a proper flow rate. The other end of the exhalation port/swivel allows connection to a CPAP or bi-level positive pressure ventilator's flexible breathing circuit tubing.

The IT Nasal mask is available in seven different sizes in order to accommodate a broad range of facial feature variations.

The IT Nasal Mask is secured to the patient by a single-piece nylon cloth headset. The headset has four straps which allow the mask to be adjusted for proper fit and patient comfort, and provide for quick removal of the mask.

The InnoMed IT Nasal Mask is intended to be used as a patient interface for CPAP and Bi-Level positive-pressure ventilation devices. The study conducted for this device was to demonstrate substantial equivalence to legally marketed predicate devices, not a comparative effectiveness study with human readers or a standalone algorithm performance study.

Here's the information regarding the acceptance criteria and study as requested, based on the provided text:

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

The provided document describes the general performance characteristics that were tested for equivalence to predicate devices, but does not list specific numerical acceptance criteria with corresponding device performance metrics in a tabular format. Instead, it states that "Testing demonstrated that the important clinical performance characteristics were equivalent to those of the predicate devices."

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

The document does not specify the sample size used for the test set, nor does it explicitly state the data provenance (e.g., country of origin, retrospective or prospective). The testing appears to be primarily laboratory-based to establish equivalence in performance characteristics.

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 described is for device performance characteristics (flow rate, resistance, volume, biocompatibility) rather than a study requiring expert-established ground truth related to clinical outcomes or interpretations.

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

This section is not applicable for the type of device performance testing described.

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 MRMC comparative effectiveness study was done, as this is a physical medical device (nasal mask) and not an AI-powered diagnostic tool. The study aimed to demonstrate equivalence to predicate devices, not an improvement in human reader performance with AI assistance.

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

This section is not applicable as the device is a physical nasal mask, not an algorithm.

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

The "ground truth" for the performance characteristics mentioned (exhalation port flow rate, exhalation port resistance, and mask volume) would be objective physical measurements, typically obtained through standardized laboratory testing methods, not expert consensus, pathology, or outcomes data. For biocompatibility, the ground truth would be adherence to industry standards, again through laboratory testing.

8. The sample size for the training set

This section is not applicable. The device is a physical medical device and does not involve AI or machine learning models that require a training set.

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

This section is not applicable. The device does not involve AI or machine learning models, and therefore no training set or its associated ground truth establishment is mentioned.

Ask a specific question about this device