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The Tiara Medical Systems Advantage II Nasal Mask 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 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 airway pressure has been prescribed.

The Tiara Medical Systems Advantage II™ Nasal Mask is an externally placed mask covering the nose such that positive pressure from a positive pressure source is directed of 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 requires limited disassembly.

The mask consists of a molded polycarbonate shell with a soft, resilient silicone skin-contacting rille mask conforms to the patient's facial features. A silicone forehead cushion is available for added comfort.

The mask connects to a conventional air delivery hose between the mask and the positive airway pressure source the mask with a polyethylene split "c" ring. The built in vent slots (2) are located attacres to the from of the make with a perfect'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.

Canadation access is available in a variety of sizes to fit a broad range of facial structures, and attaches to the mask via slots contained within the shell.

The provided submission document K031935 for the Tiara Medical Systems Advantage II™ Nasal Mask is a 510(k) premarket notification. This type of submission primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing extensive details about specific acceptance criteria and detailed study results.

The document does not contain the requested information regarding specific acceptance criteria, detailed study results, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

Here's a breakdown of what can be inferred and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated in terms of quantitative measures like pressure accuracy, leak rates, or specific comfort metrics. The document broadly states "Design verification tests were performed on the TMS Advantage II Nasal Mask as a result of risk analysis and product opportunities and were verified to meet acceptance criteria." This implies that internal acceptance criteria were met, but these criteria are not detailed.
• Reported Device Performance: Not quantitatively reported. The document states that the modifications "have no impact on the safety and efficacy of the device" compared to the predicate, and that it is "substantially equivalent."

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: Not mentioned.
• Data Provenance: Not mentioned. It's safe to assume this was an internal validation based on the nature of the submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

• Experts and Qualifications: Not mentioned. Given that this is a nasal mask, "ground truth" might refer to performance metrics against engineering specifications, not clinical diagnoses by experts.

4. Adjudication Method:

• Adjudication Method: Not mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

• MRMC Study: No, this is highly unlikely for a nasal mask. MRMC studies are typically used for diagnostic imaging devices where human readers interpret results, and AI might assist in that interpretation. This document is for a physical medical device (nasal mask).

6. If a Standalone (Algorithm Only) Performance Study Was Done:

• Standalone Study: No, this is not applicable. The device is a physical nasal mask, not an algorithm.

7. The Type of Ground Truth Used:

• Ground Truth: Not explicitly stated. For a physical device like a nasal mask, "ground truth" would likely refer to engineering specifications, performance standards (e.g., airflow resistance, pressure integrity, material biocompatibility), and user comfort/fit assessments against pre-defined criteria. The document mentions "Design verification tests" and "risk analysis and product opportunities," implying a focus on meeting safety and performance standards for the device itself.

8. The Sample Size for the Training Set:

• Training Set Sample Size: Not mentioned. This concept is typically relevant for machine learning algorithms, which are not involved here.

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

• Ground Truth for Training Set: Not applicable, as there's no machine learning algorithm involved requiring a "training set."

Summary of Key Information Provided:

• Device Trade Name: Advantage II Nasal Mask
• Intended Use: With continuous positive airway pressure devices (CPAP) operating at or above 3 cmH2O for the treatment of obstructive sleep apnea in adult patients (>30kg). Intended for single-patient use at home or in hospital/institutional environments.
• Predicate Devices: TMS Advantage Series (K012207) and Sullivan AutoSet Nasal CPAP System (K980721).
• Basis for Substantial Equivalence: Same intended use, operating principle, technology, materials in contact with skin, and manufacturing process as the predicate devices.
• Verification: "Design verification tests were performed... and were verified to meet acceptance criteria." "Modifications ... have no impact on the safety and efficacy of the device."

In conclusion, the provided 510(k) submission, as expected for this type of device and regulatory pathway, focuses on demonstrating substantial equivalence through design verification against internal criteria and comparison to predicate devices, rather than detailed clinical study data with specific acceptance criteria as might be seen for novel diagnostic or therapeutic devices.

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