(142 days)
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.
§ 868.5905 Noncontinuous ventilator (IPPB).
(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).