Search Results

The Sleepnet Mojo 2 and Veraseal 3 Full Face Non-Vented and AAV Non-Vented Masks are intended to provide a patient interface for application of noninvasive ventilation. The mask is to be used as an accessory to ventilators that have adequate alarms and safety systems for ventilator failure, and which are intended to administer positive pressure ventilation. The mask will be offered in a disposable version and a multi-use version. It is intended for use on adult patients (>30 kg), who are appropriate candidates for noninvasive ventilation.

Veraseal 3 - Disposable single use (hospital/institutional) Single patient, multi-use up to 7 days (hospital/institutional)

Mojo 2 -Single patient, multi-use (home or hospital/institutional)

The Sleepnet Mojo 2 and Veraseal 3 are full face mask used with non0invasive ventilation. They are available in multiple sizes and in a Non-Vented style with an elbow and Non-Vented with elbow and anti-asphyxia (AAV) valve.

The subject of this submission is:

• The Mojo 2 subject devices include a new contradiction and warning, which was not . included in the predicate device - K190533.
  Veraseal 3 is intended as a Disposable single use (hospital/institutional) and as a Single patient, multi-use up to 7 days (hospital/institutional)

Mojo 2 is intended as a Single patient, multi-use (home or hospital/institutional)

The provided text describes a 510(k) premarket notification for Sleepnet Corporation's Mojo 2 and Veraseal 3 Full Face Masks. This submission primarily focuses on changes to contraindications and warnings due to a previous recall, rather than new device performance data.

Therefore, the document explicitly states: "No new performance testing was conducted on the subject device, since the device designs are identical to the predicates." This means there is no study described that proves the device meets new acceptance criteria. The acceptance criteria and reported device performance are based on the predicate device (K190533) and its original clearance.

However, I can extract the information related to the device and the comparison to its predicate as requested in your format, noting the absence of new performance data.

Here's the information based on the provided text:

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

Since no new performance testing was conducted, there are no new specific acceptance criteria or reported performance data for the subject devices presented in this summary beyond the fact that their design is identical to the predicate. The "acceptance criteria" for this specific 510(k) submission revolve around demonstrating substantial equivalence, especially concerning the updated labeling.

The following table summarizes the key attributes and their comparison to the predicate device, implying that the acceptance for these attributes is "identical" to the predicate, which had presumably met its own performance acceptance criteria during its original clearance (K190533).

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

There is no new test set or data provenance information provided in this submission, as "No new performance testing was conducted." The basis of this submission is the identical design to a predicate device and updated labeling.

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)

Not applicable. No new test set and no ground truth establishment for a test set are described. The updated contraindications and warnings were established due to information from post-market surveillance related to a voluntary recall (Event 94169).

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

Not applicable. No new test set is 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

Not applicable. This device is a patient interface for ventilation, not an AI-assisted diagnostic or therapeutic device. No MRMC study was performed or is relevant.

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

Not applicable. This device is a mechanical patient interface, not an algorithm.

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

Not applicable for new data. The primary "ground truth" for the new contraindication/warning was post-market surveillance data leading to a voluntary recall (Event 94169), which indicated potential risks from magnets interacting with medical implants. This implicitly relies on real-world outcomes and expert clinical judgment regarding patient safety.

8. The sample size for the training set

Not applicable. This device is a mechanical patient interface, not an AI/ML device that requires a training set.

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

Not applicable. This device is a mechanical patient interface, not an AI/ML device.

Ask a specific question about this device