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510(k) Data Aggregation
(116 days)
The Sleepnet Mojo Full Face Vented Mask, Veraseal 2 Full Face Vented Mask, Innova Full Face Vented Mask and Ascend Full Face Vented Mask are intended to be used with positive airway pressure devices, such as CPAP or bilevel, operating at or above 3 cm H2O. The masks are to be used on adult patients (>30kg) for whom positive airway pressure therapy has been prescribed.
Mojo is intended for Single patient, multi-use in the home or hospital/institutional environment.
Veraseal 2 is intended for Short Term Single Patient use (maximum of 7 days) in the hospital institutional environment.
Innova is intended for Single patient, multi-use in the home or hospital/institutional environment.
Ascend is intended for Single patient, multi-use in the home or hospital/institutional environment.
The Sleepnet Mojo Vented Full Face Mask, Veraseal 2 Full Face Vented Mask, Innova Full Face Vented Mask and Ascend Full Face Vented Mask are used with positive pressure devices, such as CPAP and Bi-level.
The modifications to the cleared Mojo Full Face mask (K120463) are:
- Addition of contraindication and updated warning related to presence of magnets
- Change to the headgear material
- Addition of an XL size
The modifications to the cleared Veraseal Full Face mask (K120463) are:
- Modified design, now called the Veraseal 2 Full Face Vented Mask
- . Addition of an XL size
Other modifications include:
- Addition of the Innova Full Face Vented Mask version
- Addition of the Ascend Full Face Vented Mask version
This document does not describe an AI/ML device or a comparative effectiveness study. It is a 510(k) summary for several full face vented masks (Mojo, Veraseal 2, Innova, Ascend) and compares them to a predicate device (Mojo Full Face Mask and Veraseal Full Face Mask, K120463).
The summary focuses on demonstrating substantial equivalence to a previously cleared device through comparisons of indications for use, patient population, environment of use, and technological characteristics. This typically involves performance testing, biocompatibility, transportation, shelf-life, and reprocessing.
Therefore, many of the requested elements for an AI/ML device evaluation (e.g., sample size for test/training sets, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance) are not applicable to this document.
However, I can extract the acceptance criteria and reported device performance from the provided "Table of Comparison to Predicate" and "Non-Clinical Testing Summary" as they relate to these medical masks.
1. Table of Acceptance Criteria and the Reported Device Performance (as applicable to a physical medical device, not AI/ML):
| Acceptance Criteria (Typically based on ISO 17510 and predicate device performance) | Reported Device Performance (Subject Device: Mojo, Veraseal 2, Innova, Ascend Full Face Vented Mask) | Predicate Device Performance (K120463: Mojo, Veraseal Full Face Mask) | Explanation of Differences (and compliance) |
|---|---|---|---|
| Exhaust Flow Characteristics: (Comparison to predicate device) | Mojo: 3cmH2O: 17.88 lpm, 10cmH2O: 32.57 lpm, 20cmH2O: 48.90 lpm Veraseal 2: 3cmH2O: 22.08 lpm, 10cmH2O: 38.50 lpm, 20cmH2O: 54.30 lpm Innova: 3cmH2O: 22.08 lpm, 10cmH2O: 38.50 lpm, 20cmH2O: 54.30 lpm Ascend: 3cmH2O: 26.80 lpm, 10cmH2O: 41.50 lpm, 20cmH2O: 58.00 lpm | Mojo: 3cmH2O: 21.20 lpm, 10cmH2O: 37.20 lpm, 20cmH2O: 53.10 lpm Veraseal: 3cmH2O: 21.10 lpm, 10cmH2O: 36.40 lpm, 20cmH2O: 53.00 lpm | Similar. The exhaust flow characteristics of the subject devices are similar to the predicate. |
| Anti-Asphyxia Valve (AAV) Opening/Closing Pressure: (< 3 cm H2O as per ISO 17510) | Mojo: Opening - 1.10 cm H2O, Closing - 1.60 cm H2O Veraseal: Opening - 2.1 cm H2O, Closing - 2.28 cm H2O Innova: Opening - 2.1 cm H2O, Closing - 2.28 cm H2O Ascend: Opening - 1.92 cm H2O, Closing - 1.85 cm H2O | Mojo: Opening - 1.10 cm H2O, Closing - 1.60 cm H2O Veraseal: Opening - 1.29 cm H2O, Closing - 1.45 cm H2O | Similar. Pass/Fail criteria as per ISO 17510 is < 3 cm H2O. All subject devices meet the criteria. |
| Resistance to Flow (Pressure drop): (No specific acceptance criteria in ISO 17510, values are disclosed) | Mojo: 50 lpm: 0.40 cm H2O, 100 lpm: 0.65 cm H2O Veraseal 2: 50 lpm: 0.07 cm H2O, 100 lpm: 0.39 cm H2O Innova: 50 lpm: 0.07 cm H2O, 100 lpm: 0.39 cm H2O Ascend: 50 lpm: 0.11 cm H2O, 100 lpm: 0.59 cm H2O | Mojo: 50 lpm: 0.40 cm H2O, 100 lpm: 0.65 cm H2O Veraseal: 50 lpm: 0.49 cm H2O, 100 lpm: 0.89 cm H2O | Similar. There are no acceptance criteria in ISO 17510 for resistance to flow (pressure drop). The resistance values are disclosed in the IFUs. |
| CO2 Washout Profile (etCO2 % increase vs baseline) - ISO 17510:2015: (Compliance with ISO 17510) | Mojo: 3cmH2O: 5.1 (0%), 5cmH2O: 3.5 (-31%), 10cmH2O: 2.1 (-58%), SingleFault1: 7.4 (48%), SingleFault2: 7.5 (51%) Veraseal 2 / Innova: 3cmH2O: 5.9 (16%), 5cmH2O: 5.9 (16%), 10cmH2O: 5.7 (12%), SingleFault1: 6.4 (25%), SingleFault2: 7.4 (45%) Ascend: 3cmH2O: 5.0 (0%), 5cmH2O: 5.0 (0%), 10cmH2O: 4.8 (-4%), SingleFault1: 6.5 (30%), SingleFault2: 7.3 (46%) | Mojo and Veraseal: 3cmH2O: 6.1 (17%), 5cmH2O: 5.9 (14%), 10cmH2O: 5.8 (12%), SingleFault1: 6.3 (21%), SingleFault2: Not tested | Similar, complies with ISO 17510. The deadspace for all subject devices is within 5% of the predicate Mojo mask. The CO2 washout profile of all the subject devices has been verified to be adequate. |
| Sound Pressure and Sound Power Level: (Comparison to predicate device) | Mojo: Sound Pressure – 30.07 dBA, Sound Power – 33.09 dBA Veraseal 2 / Innova / Ascend: Sound Pressure – 29.98 dBA, Sound Power – 32.99 dBA | Mojo: Sound Pressure – 30.07 dBA, Sound Power – 33.09 dBA Veraseal: Sound Pressure – 29.98 dBA, Sound Power – 32.99 dBA | From K120463 (Identical values for corresponding models). |
| AAV Inspiratory/Expiratory Resistance in Single Fault Condition: (Comparison to predicate device) | Mojo®: Inspiratory - 0.8 cm H2O, Expiratory – 0.8 cm H2O Veraseal 2 / Innova / Ascend: Inspiratory - 0.6 cm H2O, Expiratory - 0.5 cm H2O | Mojo®: Inspiratory - 0.8 cm H2O, Expiratory - 0.8 cm H2O Veraseal: Inspiratory - 0.8 cm H2O, Expiratory - 0.8 cm H2O | From K120463 (Similar values, meeting functional requirements). |
| Internal Volume / Deadspace: (Within 5% of predicate Mojo mask, adequate CO2 washout) | Mojo: Small 160 ml, Medium 185 ml, Large 205 ml, XL 210 ml Veraseal 2: Small 155.3 ml, Medium 181.7 ml, Large 196.6 ml, XL 200.6 ml Innova: Small 155.3 ml, Medium 181.7 ml, Large 196.6 ml Ascend: Small 165 ml, Medium 212 ml, Large 221 ml | Mojo: Small 160 ml, Medium 185 ml, Large 205 ml Veraseal: Small 138 ml, Medium 165 ml, Large 181 ml | Similar. XL size has been added to the Mojo and Veraseal 2 masks. The deadspace for all subject devices is within 5% of the predicate Mojo mask. The CO2 washout profile of all the subject devices has been verified to be adequate. |
| Biocompatibility: (Materials identical to cleared predicate devices K120463 and K190254) | Materials in gas pathway and skin contact for all subject devices are identical to Sleepnet's own devices cleared under K120463 and K190254. | Materials identical to K120463. | The biocompatibility test results from the predicate device were leveraged for all subject devices. |
| Transportation and Shelf-life: (Leverage predicate device testing) | No changes in transportation or shelf-life, leveraging predicate device testing. | Predicate device testing results leveraged. | The performance post transportation and shelf-life test results from the predicate device were leveraged for the subject device. |
| Reprocessing: (Utilize same reprocessing instructions as predicate) | Utilizes the same reprocessing instructions as the predicate device. | Predicate device reprocessing instructions. | The reprocessing test results from the predicate device were leveraged for the subject device. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This document describes bench testing for physical device characteristics, not a dataset for an AI/ML model. Therefore, "sample size for the test set" and "data provenance" in the context of clinical data are not applicable. The testing was conducted on samples of the manufactured devices.
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 is not applicable as the study involves physical performance testing of medical masks against engineering standards (like ISO 17510), not expert-based ground truth for clinical interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for physical device performance testing.
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 is a 510(k) submission for physical medical masks, not an AI/ML device or MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a 510(k) submission for physical medical masks.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" here is the adherence to established international standards (like ISO 17510) and the demonstrated equivalence to a predicate device's performance characteristics through objective bench testing. This is typically measurement-based verification against engineering specifications.
8. The sample size for the training set
Not applicable. This document is not about an AI/ML device, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. This document is not about an AI/ML device.
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