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The Puresom Nasal (CPAP) Mask system is for use with continuous positive airway pressure devices (CPAP), operating at or above 3cmH2O for the treatment of obstructive sleep apnea. The mask is intended for single patient use and can be used in the home or in a hospital/ institutional environment. The mask is to be used on adult patients (>30Kg) for whom continuous positive pressure airway has been prescribed.

The Puresom Nasal (CPAP) Mask is intended to be used with positive airway pressure devices such as CPAP. It provides a seal such that positive pressure from positive pressure source is directed into the patient's nose. It is held in place with an adjustable headgear. It may be cleaned with a mild detergent, such as Ivory® dishwashing liquid or unscented baby shampoo in water. The design consists of latex-free silicone cushion designed to fit over the patients' nose. The cushion is designed in such a way that it minimizes leaks and is comfortable for the patient. The cushion shall be connected to a polycarbonate frame that supports the cushion and provides a connection for a 90º elbow. The elbow shall be capable of rotating freely through 360º. The silicone cushion is designed in such a way that it can be easily removed by the patient, from the polycarbonate frame for cleaning or replacement purposes. The elbow connects to a conventional air delivery hose between the mask and the positive airway pressure source via a 22mm polycarbonate fitting on the elbow. The 22 mm connector is designed in such a way that it can rotate freely through 360º. The built in vent openings are molded into the front side of the elbow and a snap-on shroud is assembled to the elbow to direct the air away from the patient's face and chest. The vent openings may be visually inspected for obstruction prior to use.

Here's a breakdown of the acceptance criteria and study information for the Puresom Nasal Mask based on the provided text:

Acceptance Criteria and Device Performance

Study Information

1. Sample size used for the test set and the data provenance:

   • The document does not explicitly state the sample sizes for the test sets used in each non-clinical test (e.g., how many masks were dropped for the drop test, or how many units were subjected to the shipping test). It generally refers to "All material," "The cavities of each model," "All sample plots," and "All units."
   • The provenance of the data (country of origin, retrospective or prospective) is not specified. However, given it's a 510(k) submission to the FDA, the testing would be conducted in controlled environments by the manufacturer or authorized testing facilities. It's not a clinical study involving patient data.

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

   • This question is not applicable to the non-clinical engineering and performance tests described. Ground truth established by human experts (e.g., radiologists) is typically relevant for AI/imaging device studies. The tests here relate to physical and functional properties of the mask.

3. Adjudication method for the test set:

   • Not applicable. The tests involve objective measurements against predefined requirements (e.g., volume, CO2 percentage, flow rates, dBA levels, physical damage).

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:

   • No. This is a non-clinical 510(k) submission for a physical medical device (nasal mask) and does not involve AI or imaging analysis with human readers.

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

   • No. This is a physical medical device; there is no algorithm or AI component involved.

6. The type of ground truth used:

   • The "ground truth" for these tests are the established industry standards, regulatory requirements, and engineering specifications (e.g., ISO standards, specific volume limits, CO2 percentages, sound levels, physical damage criteria). The device's performance is compared directly against these objective criteria.

7. The sample size for the training set:

   • Not applicable. This is not an AI/machine learning device. There is no concept of a "training set" in this context.

8. How the ground truth for the training set was established:

   • Not applicable, as there is no training set for this device.

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The Tiara Medical Systems SNAPP is intended to be used with continuous positive airway pressure devices (CPAP), operating at or above 3 cmH20 for the treatment of obstructive sleep apnea. The SNAPP is intended for single patient use and can be used in the home or in a hospital/institutional environment. The SNAPP is to be used on adult patients (>30Kg) for whom continuous positive airway pressure has been prescribed.

The Tiara Medical Systems SNAPP Soft Nasal Accessory for Positive Pressure is a nasal cannula with inserts intended to be used with positive anway pressure devices such as CPAP (Continuous Possure). It provides a seal such that positive pressure from a positive pressure source is directed into the patient's nose. It is held in place with an adjustable headgear. It may be cleaned with mild soap and water. The cleaning process does not require disassembly.

The device consists of latex-free silicone air delivery tubes connecting a polycarbonate Wye adapter / swivel with a latex-free silicone soft, resilient nasal inserts which form a seal with the nostrils.

The device connects to a conventional air delivery hose between itself and the positive airway pressure source via a standard 22 mm polycarbonate fitting on the combination Wye adapter / swivel. The built in vent slots are molded into the underside of the nasal insert body to direct air away from the patient's face and chest, and eliminate the need for a separate exhalation device. The vent slots may be visually checked for obstruction prior to use. The SNAPP Headgear is available in three sizes to fit a broad range of facial structures, and attaches to the SNAPP via slots molded into the nasal insert body.

The provided text is a 510(k) summary for the Tiara Medical Systems SNAPP Soft Nasal Accessory for Positive Pressure, a nasal cannula for use with CPAP devices. It details the device's description, intended use, and claims of substantial equivalence to predicate devices. However, it does not contain the specific information requested regarding acceptance criteria or a detailed study proving the device meets said criteria.

The document states that "bench testing demonstrated there was no difference in the performance, safety, or effectiveness between the Tiara Medical Systems SNAPP Soft Nasal Accessory for Positive Pressure and the specified predicate devices." This is a general statement of equivalence, not a report of a specific study against predefined acceptance criteria.

Therefore, I cannot provide the requested table or detailed answers to questions 1-9 as the necessary information is not present in the provided text. The document focuses on establishing substantial equivalence based on overall comparison to predicate devices rather than reporting on a study with explicit acceptance criteria for the new device.

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