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The device is a single patient use, disposable device that can be used in a setting when a suction tube is used on a patient-for oral suctioning-whether for anesthesia. nursing home, ambulatory, ICU, respiratory, or ER situations. It will provide a clean, conveniently located receptacle wherein to store the suction tube and its attached suction hose while needed/used on one patient. It also will secure the suction hose in a manner which will eliminate the constant hissing. It will hold other contaminated disposables at the end of patient use, or a case, to allow for safe, efficient clean-up. It would be used whenever blood and body secretions (as saliva) contained on the suction tube is a concern.

The device is a single patient use, disposable device that can be used in a setting when a suction tube is used on a patient-for oral suctioning-whether for anesthesia. nursing home, ambulatory, ICU, respiratory, or ER situations. It will provide a clean, conveniently located receptacle wherein to store the suction tube and its attached suction hose while needed/used on one patient. It also will secure the suction hose in a manner which will eliminate the constant hissing. It will hold other contaminated disposables at the end of patient use, or a case, to allow for safe, efficient clean-up. It would be used whenever blood and body secretions (as saliva) contained on the suction tube is a concern.

I am sorry, but based on the provided document, I cannot describe the acceptance criteria or a study that proves the device meets specific acceptance criteria. The document is a 510(k) clearance letter from the FDA for the "Germ Trapper Suction Tube Holder" (later referred to as "Secretion Trapper TM Suction Tube Holder").

This letter states that the device is substantially equivalent to legally marketed predicate devices, allowing it to proceed to market. However, it does not contain any information about specific acceptance criteria, performance metrics, or details of a study (such as sample sizes, ground truth establishment, or expert qualifications) that would typically be performed to demonstrate device performance and meet those criteria.

The document primarily focuses on:

• Confirming the 510(k) clearance.
• Stating the regulatory class (Class II).
• Listing the product code (JOL).
• Providing the indications for use for the device.
• Referencing general controls provisions of the Act (like annual registration, GMP, labeling).

Therefore, I cannot provide the requested information from the given text.

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