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The Sleepnet Mojo 2 Full Face Vented Mask, Veraseal 3 Full Face Vented Mask, and V3 Full Face Vented Mask are intended to be used with positive airway pressure devices, such as CPAP or bi-level, operating at or above 3 cm H2O.

The masks are to be used on adult patients (>30 kg.) for whom positive airway pressure therapy has been prescribed.

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

V3 -Single patient, multi-use (home)

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

The Sleepnet Veraseal 3, V3 and Mojo 2 Full Face Vented masks are identical to the predicate Veraseal 3, V3, and Mojo 2 Full Face Vented masks (K190254).

The subject of this submission is:

• Addition of a contraindication related to magnets on the Mojo 2 Full Face Vented mask .
• . Update to the warning related to magnets on the Mojo 2 Full Face Vented mask

The provided text describes a 510(k) premarket notification for a medical device, specifically full face vented masks (Mojo 2, Veraseal 3, V3 Full Face Vented Mask). This submission seeks to establish substantial equivalence to a predicate device (K190254). Crucially, the document explicitly states that no performance testing was conducted on the subject device because its design is identical to the predicate device. The only changes are the addition of a contraindication and an updated warning related to magnets, prompted by a prior recall.

Therefore, the information required to answer your query regarding acceptance criteria and the study proving the device meets those criteria (e.g., test set sample size, expert ground truth establishment, MRMC studies, standalone performance, ground truth type for training/test sets) is not present in the provided document. This document primarily focuses on demonstrating substantial equivalence based on identical design and leveraged predicate data, rather than new performance studies.

However, I can extract the specifications and comparison tables, which can be interpreted as the implicit "acceptance criteria" through their demonstration of identical characteristics to the predicate device. The "reported device performance" is then the stated performance of these identical characteristics.

Here's a breakdown of what can be inferred from the document, acknowledging the missing information about new performance studies:

A. Acceptance Criteria and Reported Device Performance (Inferred from Predicate Equivalence)

Since the subject device is identical to the predicate device (K190254) in design and performance, the "acceptance criteria" are effectively that the subject device's specifications match those of the predicate. The "reported device performance" is therefore the reported performance of the predicate device, which the subject device is stated to replicate.

B. Study Details (Not Applicable/Information Not Provided)

1. Sample size used for the test set and the data provenance: Not applicable. No new performance testing was conducted for this submission. The device design is identical to the predicate.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No new performance testing was conducted.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No new performance testing was conducted.
4. 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 face mask, not an AI-powered diagnostic tool.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a face mask, not an algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. No new performance testing was conducted.
7. The sample size for the training set: Not applicable. No new performance testing was conducted, and this is a physical device, not a machine learning model requiring a training set.
8. How the ground truth for the training set was established: Not applicable.

Summary of the Study Proving Acceptance Criteria:

The "study" proving the device meets the acceptance criteria is the demonstration of substantial equivalence to a previously cleared predicate device (K190254). The manufacturer asserts that the subject devices (Mojo 2, Veraseal 3, V3 Full Face Vented Mask) are identical in design, indications for use, technology, principle of operation, environment of use, patient population, and performance characteristics to the predicate.

The only modifications are to the labeling, specifically the addition of a new contraindication and an updated warning statement for the Mojo 2 mask related to magnets. These changes were a proactive measure following a voluntary recall and information from post-market surveillance.

Therefore, the evidence for meeting acceptance criteria relies entirely on the prior clearance of the predicate device (K190254) and the assertion that the new device is functionally identical, with only labeling changes to address safety information not present in the original predicate's labeling. No new performance data, clinical trials, or expert consensus studies were performed or presented for this specific 510(k) submission.

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The Sleepnet Mojo 2 Full Face Vented Mask, Veraseal 3 Full Face Vented Mask, and V3 Full Face Vented Mask are intended to be used with positive airway pressure devices, such as CPAP or bi-level, operating at or above 3 cm H₂O.

The masks are to be used on adult patients (>30 kg.) for whom positive airway pressure therapy has been prescribed.

Veraseal 3: Disposable single use (hospital/institutional), Single patient, multi-use up to 7 days (hospital/institutional)
V3: Single patient, multi-use (home)
Mojo 2: Single patient, multi-use (home or hospital/institutional)

The Sleepnet Mojo 2, Veraseal 3 and V3 Full Face mask are provided with an exhalation elbow and anti-asphyxia (AAV) valve.

The subject of this submission is:

• Slight redesign of the shape of the masks but no appreciable differences as the identical exhalation elbow and anti-asphyxia valve (AAV)
• Add an additional size, ex-large, mask to the product line
• Support useful life of the V3 and Mojo 2 up to 6 months as a single patient, multi-use mask

Veraseal 3 is intended as a Disposable single use (hospital/institutional) and as a Single patient, multi-use up to 7 days (hospital/institutional)
V3 is intended as a Single patient, multi-use (home)
Mojo 2 is intended as a Single patient, multi-use (home or hospital/institutional

The provided document, a 510(k) summary for certain full face vented masks, focuses on demonstrating substantial equivalence to predicate devices rather than detailing a study that proves the device meets specific acceptance criteria through novel performance data. The core of this submission is about showing that the new masks are as safe and effective as pre-existing, legally marketed devices.

Therefore, many of the requested details, such as sample sizes for test sets, number of experts for ground truth, MRMC studies, standalone algorithm performance, and training set information (which are typical for AI/ML device submissions or devices requiring extensive clinical performance testing), are not applicable to this 510(k) for a respiratory mask.

However, based on the principle of demonstrating substantial equivalence, we can infer the "acceptance criteria" and "device performance" relate to meeting the standards of the predicate device and relevant international standards.

Here's an interpretation of the available information in the context of the prompt:

Acceptance Criteria and Reported Device Performance

The document states that the performance of the new masks was "compared" to predicate devices and that the new masks "Meets ISO 17510 testing". This indicates that the acceptance criteria are adherence to established performance benchmarks (likely from ISO 17510) and performance comparable to the predicate device.

1. Table of Acceptance Criteria and the Reported Device Performance

Study Details (as inferable from a 510(k) for a medical device)

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

• Sample Size: Not explicitly stated as a number of patients or cases but rather as a series of bench tests on device samples. For physical device testing (like pressure drop, CO2 washout, mechanical drop), typically multiple units of the device are tested to ensure consistency and reliability. The specific number of units tested for each benchmark is not provided in this summary.
• Data Provenance: The data are generated from bench testing (laboratory-based performance evaluations) rather than clinical studies with patient data. The country of origin of the data is not specified but would be where the manufacturer (Sleepnet Corporation, Hampton, NH, USA) conducts its testing or where a contracted testing facility is located. The tests are prospective in the sense that they are conducted specifically for this submission to demonstrate performance.

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

• Not Applicable. For mechanical/performance bench testing of a device like a mask, "ground truth" is established through physical measurements and adherence to engineering specifications and international standards (like ISO 17510), rather than expert consensus on medical images or clinical outcomes. The "experts" would be the engineers and technicians performing and verifying the tests, ensuring compliance with established protocols and standards.

4. Adjudication method for the test set

• Not Applicable. Adjudication methods (like 2+1, 3+1) are typically used for establishing ground truth in clinical data (e.g., radiology reads) where subjective interpretation might vary. For bench testing, test results are typically objective measurements compared against predefined pass/fail criteria or reference values.

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 physical medical device (mask), not an AI/ML diagnostic or assistive device that involves "human readers" or "AI assistance."

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

• Not Applicable. Same as above, not an AI/ML algorithm.

7. The type of ground truth used

• The "ground truth" for the bench tests is defined by engineering specifications, international standards (specifically ISO 17510), and the performance characteristics of the legally marketed predicate devices. For example, the acceptable range for CO2 washout is defined by ISO standards, and the performance of the predicate device serves as a comparative benchmark.

8. The sample size for the training set

• Not Applicable. This is not an AI/ML device that requires a "training set" for model development.

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

• Not Applicable. (See point 8).

In summary, this 510(k) relies heavily on demonstrating that the new mask designs maintain the same essential safety and performance characteristics as the previously cleared predicate device, and that they meet relevant international standards through various bench tests. The "study" here is a series of engineering and performance evaluations designed to prove this equivalence, rather than a clinical trial or AI model validation study.

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