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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):

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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 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.

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The iQ 2 Nasal Vented Mask and Phantom 2 Nasal Vented Mask are intended to be used with positive airway pressure devices, such as CPAP or bi-level, operating at 3 cmH2O to 30 cmH2O. The masks are to be used on adult patients (>30 kg) for whom positive airway pressure therapy has been prescribed. The masks are intended for single-patient multi-use in the home, hospital or institutional environment.

The Sleepnet iQ 2 and Phantom 2 Nasal Vented masks are nearly identical to the Predicate Sleepnet iQ 2 and Phantom 2 Nasal Mask (K211274). The subject of this submission is: Addition of a contraindication related to magnets on the iQ 2 Nasal Vented Mask and Phantom 2 Nasal Vented Mask; Update to the warning related to magnets on the iQ 2 Nasal Vented Mask and Phantom 2 Nasal Vented Mask. Device provides a seal over the nose to allow for delivery of pressurized air from a positive airway pressure device. Device has an exhalation port for flushing out exhaled CO2. The device is passive until connected to the positive pressure device.

This document is a 510(k) Premarket Notification from the FDA regarding the iQ 2 Nasal Vented Mask and Phantom 2 Nasal Vented Mask. The primary purpose of this submission is to address regulatory changes related to the addition of a contraindication regarding magnets and an update to the warning related to magnets for these devices.

The document states that the Sleepnet iQ 2 and Phantom 2 Nasal Vented masks are "nearly identical" to their predicate devices (Sleepnet iQ 2 and Phantom 2 Nasal Mask, K211274). Therefore, the study described here is fundamentally a comparative study to a predicate device rather than a de novo study proving the device meets new acceptance criteria independently. The acceptance criteria for the subject devices are the performance characteristics of the predicate device.

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

The acceptance criteria are implicitly defined by the performance of the predicate device (K211274). The reported device performance for the subject device (K241469) is stated to be "identical" to the predicate for all technical parameters, as no new performance testing was conducted.

Regarding the study that proves the device meets the acceptance criteria:

The provided document describes a 510(k) Premarket Notification which focuses on demonstrating substantial equivalence to a previously cleared predicate device (K211274). The core argument for meeting acceptance criteria is that the subject devices are "nearly identical" to the predicate, with the only changes being updates to contraindications and warnings regarding magnets.

Therefore, the "study" to prove the device meets acceptance criteria is primarily a comparison of characteristics and leveraging of previous test results.

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

• Test Set Sample Size: No new test set sample size is mentioned for the subject device (K241469) because "No new performance testing was conducted on the subject device, since the device designs are identical to the predicates." The acceptance criteria are based on the performance of the predicate device, for which the original testing details are not provided in this document.
• Data Provenance: Not explicitly stated for the original predicate testing, but the context implies data would have been generated as part of the K211274 submission.
• Retrospective or Prospective: Not specified, but generally, 510(k) submissions for devices leverage existing data or conduct prospective bench testing. In this case, existing data from the predicate was leveraged.

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 question is not applicable to this submission. The device is a medical mask, and the evaluation relies on direct device performance metrics (e.g., exhaust flow, dead space, resistance to flow, sound levels), not on expert interpretation of medical images or data requiring ground truth establishment by clinical experts. The "ground truth" for these engineering metrics would be established by validated test methods and equipment.
• The significant change in this submission relates to the contraindication and warning for magnets, which would have been driven by post-market surveillance or new scientific understanding concerning magnet interactions with medical implants (as indicated by "New as per recall event #94169"), likely involving medical experts but not in the context of establishing ground truth for a test set.

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

• This is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation of subjective data (e.g., image reading) where disagreement among experts needs resolution. This submission focuses on objective engineering performance characteristics of a physical device.

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

• This is not applicable. MRMC studies are specific to evaluating AI/CAD systems that assist human readers in tasks like image interpretation. This submission is for a physical medical device (nasal mask) and does not involve AI assistance or human readers in that context.

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

• This is not applicable. This submission is for a physical medical device and does not involve an algorithm or AI.

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

• As explained in point 3, this is not applicable in the traditional sense of medical ground truth. The "ground truth" for the device's technical specifications (exhaust flow, dead space, resistance, sound) would be established through scientific measurement and adherence to relevant industry standards (bench testing), which were performed on the predicate device and deemed sufficient for the subject device due to identical designs.

8. The sample size for the training set

• This is not applicable. This submission is for a physical medical device and does not involve AI or machine learning that would require a training set.

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

• This is not applicable for the same reasons as point 8.

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The iQ 2 and Phantom 2 Nasal Mask is intended to be used with positive airway pressure devices, such as CPAP or bilevel, operating at or above 3 cm H2O to 30 cm H2O. The mask is to be used on adult patients (>30kg) for whom positive airway pressure therapy has been prescribed. The mask is intended for single-patient multi-use in the home, hospital or institutional environment.

The Sleepnet iQ 2 and Phantom 2 Nasal masks are patient interfaces for use with positive pressure equipment, i.e., CPAP and bi-level. They incorporate an exhaust port in the shell. The 2 styles are similar: Same patient population and Indications for Use, Same headgear, Same headgear connector components, Same tubing assembly, Same materials and manufacturing processes. They differ only in: Mask shell shape, Gel cushion shape.

This is a 510(k) summary for the iQ 2 and Phantom 2 Nasal Mask, which is a medical device and not an AI/ML product. Therefore, it does not contain the information requested in your prompt regarding acceptance criteria and studies for an AI/ML device.

The document discusses the substantial equivalence of the iQ 2 and Phantom 2 Nasal Mask to a predicate device (iQ Nasal Mask) based on non-clinical testing for biocompatibility and performance bench testing against standards like ISO 17510-2 and ISO 5356-1.

Here's a breakdown of what the document does provide, and why it doesn't fit your AI/ML criteria:

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

   • The document provides a "Table of Comparison to Predicate" (page 5) which lists various attributes like product classification, indications for use, patient population, technical characteristics, and performance characteristics (Exhaust flow, Dead space, Resistance to flow, Sound pressure and Sound power level).
   • However, these are comparison points to a predicate device, not pre-defined acceptance criteria for an AI/ML model's performance metrics (like accuracy, sensitivity, specificity, AUC). For performance characteristics like "Exhaust flow" there's a comparison to the predicate, and for "Resistance to flow" and "Sound pressure/power level" it states there are "no acceptance criteria" in the relevant ISO standard but notes similarities or differences to the predicate.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. This document describes physical device testing, not data-driven model testing.

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. "Ground truth" in the context of AI/ML diagnostic performance is not relevant here.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

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 not an AI-assisted device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for the physical device performance would be the results of the bench tests against established standards.

8. The sample size for the training set: Not applicable. This is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document details the regulatory clearance of a physical medical device (nasal mask) based on substantial equivalence to a predicate device and adherence to relevant performance standards through bench testing, not a study of an AI/ML device.

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The Innova™ Nasal Non-Vented Mask is intended to be used as an accessory to CPAP/bi-level positive pressure systems containing exhalation valves. This product is indicated for use with CPAP/BI-LEVEL systems that have adequate alarins for positive pressure delivery failure. The mask is ingle patient, multi-use in the home, hospital or institutional environment on adult patients (>30kg/66 lbs.).

The Sleepnet Innova™ Non-Vented Nasal mask is a patient interface for use with positive pressure equipment.
There are 2 labeled versions:

• Single patient, multi-use (home or hospital/institutional) up to 6 months .
• Single patient, multi-use up to 7 days (hospital/institutional) .

The Sleepnet Innova™ Nasal Non-Vented Mask is evaluated for substantial equivalence to the predicate device, K102317 - Sleepnet iQ Ventilation Nasal Mask. The evaluation relies on non-clinical bench testing to demonstrate similar performance characteristics.

1. Acceptance Criteria and Reported Device Performance:

2. Sample Size and Data Provenance:

The provided document does not specify a distinct sample size for a test set. The data presented are reported performance characteristics of the Innova Nasal Non-Vented Mask, which are compared against known performance characteristics of the predicate device. The information is derived from non-clinical bench testing. The country of origin of the data is not specified, but the submission is to the US FDA, implying compliance with US regulatory standards. The data is prospective, generated from tests on the subject device.

3. Number of Experts and Qualifications:

Not applicable. The study involves non-clinical bench testing and performance measurements, not expert evaluation of medical cases or images.

4. Adjudication Method:

Not applicable. The study involves non-clinical bench testing and performance measurements, not expert evaluation of medical cases or images.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, a MRMC comparative effectiveness study was not done. This submission pertains to a medical device (nasal mask) and its performance characteristics through bench testing, not an AI or imaging diagnostic tool that would typically involve human readers.

6. Standalone Performance Study:

Yes, a standalone performance study in the form of non-clinical bench testing was done for the device. This includes measurements for:

• Pressure drop
• Unintentional leak
• Internal Volume / Dead space
• Mechanical drop test
• Cleaning validation
• Shelf-life via Accelerated aging per ASTM F1980:16
• Biocompatibility testing in accordance with ISO 10993-1:2018 and ISO 18562-1:2017 (for mask materials) and ISO 10993-5:2009 and ISO 10993-10:2010 (for headgear material).
• Testing following ISO 17510:2015

7. Type of Ground Truth Used:

The "ground truth" for the non-clinical bench testing is established through standardized testing methodologies and physical measurements, and comparison against the performance of a predicate device. For example, dead space is a direct measurement, resistance to flow is measured using specific flow rates, and unintentional leak is measured at different pressures. The predicate device's performance data serves as the comparative "truth" for demonstrating substantial equivalence.

8. Sample Size for the Training Set:

Not applicable. This is not a machine learning or AI algorithm, and therefore there is no "training set." The performance data is based on physical testing of the device.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no training set.

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The Sleepnet Moio 2 and Veraseal 3 Non-Vented and AAV Non-Vented Full Face 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 multiuse 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:

• . Slight redesign of the shape of the masks but no appreciable differences as the elbow is identical to the predicate
• Add an anti-asphyxia valve (AAV) option .
• Add an additional size, ex-large, mask to the product line ●

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 FDA 510(k) summary (K190533) describes the acceptance criteria and supporting studies for the Sleepnet Mojo 2 and Veraseal 3 Full Face Non-Vented Masks.

1. Table of Acceptance Criteria and Reported Device Performance

The submission focuses on establishing substantial equivalence to a predicate device (K063806 - Sleepnet Mojo Full Face mask) and reference devices (K101129 – Respironics - AF531 SE Full Face Mask, K121692 - MiniMe 2 nasal) through non-clinical bench testing. The acceptance criteria are implicitly based on being "similar" to the predicate or reference device, or meeting specific ISO standards.

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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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The Hard Shell Vented Nasal Mask is intended to provide an interface for application of positive airway pressure therapy, such as CPAP or bi-level.

The mask is intended for:

• Single use, disposable .
• . Single patient, multi-use in the home setting
• . Multi-patient, multi- use in the hospital or institutional settings
• Single patient, short-term use (up to 7 days) in the hospital or institutional settings ●

The masks are to be used on adult patients (>66 lbs. />30 kg) for whom CPAP or bi-level therapy has been prescribed.

The SleepNet Innova Nasal Vented Mask is similar to other CPAP mask. The Innova Nasal Vented mask is nearly identical to our iQ Nasal mask, K102317, except for the following changes:

• Slightly different indications for use, but the predicate is Respironics ComfortGel Blue . Nasal mask, K092835.
• . A range of durations of use for marketing purposes only
  • o single use, disposable
  • single patient, multi-use up to 7 days o
  • single patient, multi-use in home setting o
  • o multi-patent, multi-use in institutional settings
• . material for shell, hard vs. soft
• a new exhaust elbow design .

Here's an analysis of the provided 510(k) summary for the SleepNet Innova Nasal Vented Mask, addressing your specific questions:

Device Name: Innova Nasal Vented Mask (also referred to as Hard Shell Vented Nasal Mask)
510(k) Number: K121321
Predicate Device: Respironics ComfortGel Blue Nasal Mask (K092835)

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Innova Nasal Vented Mask are based on demonstrating equivalence or being "well within" the established limits of the predicate device (Respironics ComfortGel Blue Nasal Mask, K092835) or relevant ISO standards.

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