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The Tiara Medical Systems SNAPP-X 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-X is intended for single patient use and can be used in the home or in a hospital/institutional environment. The SNAPP-X is to be used on adult patients (>30Kg) for whom continuous positive airway pressure has been prescribed

The Tiara Medical Systems SNAPP™ -X Soft Nasal Accessory for Positive Pressure is a nasal cannula with inserts intended to be used with positive airway pressure devices such as CPAP (Continuous Positive Airway Pressure). 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 detergent such as Ivory® dishwasher liquid 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-X Headgear is available in multiple sizes to fit a broad range of facial structures, and attaches to the SNAPP-X via slots molded into the nasal insert body.

The provided document is a 510(k) summary for a medical device (Tiara SNAPP-X, a nasal mask). It describes the device, its intended use, and claims substantial equivalence to predicate devices. However, it does not contain any information regarding acceptance criteria or a study proving device performance against such criteria.

Here's why and what information is missing:

• Type of Device: The SNAPP-X is a physical medical device (nasal mask). Its performance is typically assessed through engineering design documentation, bench testing (e.g., flow resistance, dead space, leak integrity, material biocompatibility), and potentially limited clinical user studies for comfort or fit. It is not an AI/ML-driven diagnostic or prognostic device that would involve metrics like sensitivity, specificity, or AUC, or require ground truth established by experts.
• 510(k) Process: A 510(k) submission primarily demonstrates "substantial equivalence" to a legally marketed predicate device. This typically involves comparing technological characteristics and demonstrating that the new device is as safe and effective as the predicate. It usually does not require new clinical studies with patient outcomes or expert reads as would be the case for novel or high-risk devices, or AI/ML clinical decision support tools.
• Content of the Document: The document explicitly states: "Among the information and data presented in the 510(k) submission to support the substantial equivalency of the Tiara Medical Systems SNAPP™ X Soft Nasal Accessory for Positive Pressure to the specified predicate devices are: 1) device description, 2) indications for use, 3) bench test results, and 5) labeling. In particular, the bench testing demonstrated there was no difference in the performance, safety, or effectiveness between the Tiara Medical Systems SNAPP™-X Soft Nasal Accessory for Positive Pressure and the specified predicate devices." This confirms that performance was assessed via bench testing, not through clinical trials or expert read studies as outlined in your request.

Therefore, I cannot populate the requested table or answer the specific questions because the provided text does not contain the type of information related to acceptance criteria, expert adjudication, or clinical performance studies (especially MRMC or standalone performance for AI) that your prompt is looking for. The document focuses on demonstrating substantial equivalence primarily through device description, indications for use, and bench test results comparing it to existing predicate devices.

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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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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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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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The Tiara Medical Systems Advantage™ Nasal Mask is intended to be used with positive airway pressure devices such as CPAP (Continuous Positive Airway Pressure), operating at or above 3 cmH2O for the treatment of adult obstructive sleep apnea.

Not Found

I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study that proves the device meets the acceptance criteria.

The document is an FDA 510(k) clearance letter for the "Advantage™ Nasal Mask" and an "Indications for Use Enclosure." It confirms that the device is substantially equivalent to legally marketed predicate devices. However, it does not include:

• A table of acceptance criteria or reported device performance.
• Details about a specific study, including sample sizes, data provenance, expert numbers/qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth types.
• Information regarding training set size or how its ground truth was established.

The document primarily focuses on the regulatory clearance based on substantial equivalence, rather than detailing the technical studies and their results.

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The TIARA MEDICAL SYSTEMS INC. AirPilotMask ™ Nasal Mask is a non-sterile, clean, single patient reusable mask intended to be used with CPAP (continuous airway pressure) devices for the treatment of adult obstructive sleep apnea.

TIARA MEDICAL SYSTEMS INC. AirPilotMask™ Nasal Mask

The provided text pertains to an FDA 510(k) clearance letter for a medical device called "AirPilotMask, Model TMS-900." This document does not contain information about acceptance criteria, the study conducted to prove it meets acceptance criteria, sample sizes, expert qualifications, or ground truth establishment.

Therefore, I cannot fulfill your request for that information based solely on the provided text. The document is an administrative letter indicating that the FDA has reviewed the 510(k) submission and determined the device to be substantially equivalent to legally marketed predicate devices, allowing it to proceed to market. It does not detail the technical performance studies or criteria used to make that determination.

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