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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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