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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 FULL ADVANTAGE™ Full Face Mask is intended to be used with positive airway pressure devices such as CPAP (Continuous Positive Airway Pressure) for the treatment of adult obstructive sleep apnea.

The Tiara Medical Systems Full Advantage™ Full Face Mask is an externally placed mask covering the nose and mouth of the patient. It provides a seal such that positive pressure from a positive pressure source is directed to the patient's nose and mouth when either or both are open. It is held in place with an adjustable headgear. It may be cleaned with mild soap and water. The cleaning process requires limited disassembly.

The mask consists of a molded multiple sized polycarbonate shell with a soft, resilient silicone skincontacting cushion seal which conforms to the patient's facial features. A silicone forehead pad attaches to a polycarbonate frame and is adjustable to suit patient comfort.

The mask connects to a conventional air delivery hose between the mask and the positive airway pressure source via a standard 22 mm polycarbonate elbow/swivel/valve assembly. The elbow/swivel/valve assembly attaches to the front of the mask with a polyethylene split "c" clip. The built in vent ports are located on the elbow/swivel/valve assembly to provide a continuous air leak to prevent rebreathing of deadspace CO2, direct air away from the patient's face and chest, and eliminate the need for a separate exhalation device. The vent ports also allow the patient to exhale normally and do not interfere with the other performance requirements of the vent ports may be visually checked for obstruction prior to use. The elbow/swivel/valve assembly also includes a built in Anti-Asphyxia Valve which allows the patient to continue to breathe fresh air in the event of positive air pressure device failure or output deterioration, or delivery hose kinking/obstruction.

The provided text describes a 510(k) submission for a medical device, the Tiara Medical Systems Full Advantage™ Full Face Mask. However, it does not include information about acceptance criteria, a specific study proving the device meets those criteria, sample sizes, expert qualifications, or ground truth establishment—elements typically found in "performance data" or "clinical study" sections of a 510(k). The document primarily states that tests were performed to demonstrate substantial equivalence to predicate devices, but the details of these tests and their results are not provided.

Therefore, I cannot fulfill most of your request directly from the provided text.

Here's what can be extracted and what cannot:

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

• Cannot provide. The document states that "Tests performed on the Tiara Medical Systems Full Advantage™ Full Face Mask demonstrate substantial equivalence to the predicate devices listed above." However, it does not detail what those tests were, what acceptance criteria were set, or what specific performance metrics were achieved.

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

• Cannot provide. This information is not present in the provided text.

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)

• Cannot provide. This information is not relevant to a device submission of this type, as it's a physical mask, not an AI or diagnostic tool requiring expert ground truth for image interpretation.

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

• Cannot provide. This information is not relevant to a device submission of this type.

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

• Cannot provide. This type of study is specifically for AI/diagnostic devices and is not applicable to a nasal/full face mask.

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

• Cannot provide. Not applicable to a physical medical device like a mask.

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

• Cannot provide. Not applicable as this is a physical medical device. Performance data for such devices typically involves bench testing (e.g., pressure leaks, material compatibility, durability) and potentially limited human factor testing for comfort and fit, rather than "ground truth" as understood in diagnostic algorithms.

8. The sample size for the training set

• Cannot provide. Not applicable to a physical medical device.

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

• Cannot provide. Not applicable to a physical medical device.

Summary based on the provided text:

The submission for the Tiara Medical Systems Full Advantage™ Full Face Mask is a traditional 510(k) demonstrating substantial equivalence to previously marketed predicate devices (TMS Advantage II, Hans Rudolph 7600 Series, Respironics Spectrum 2). The basis for this claim is that "The technological characteristics... are equivalent to the predicate devices listed above" and "Tests performed on the Tiara Medical Systems Full Advantage™ Full Face Mask demonstrate substantial equivalence to the predicate devices listed above." However, the document does not elaborate on the specific acceptance criteria or the detailed results of these "tests." The device is a nasal/full face mask for use with CPAP devices for adult obstructive sleep apnea.

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