Search Results

The Sialo Drain is a medical device for use by qualified surgeons in the treatment of salivary gland diseases for the purpose of drainage.

The Sialo Drain is an intraoral/extraoral drainage catheter, intended to allow continuous drainage of saliva and/or fluid irrigation of the salivary duct by temporary insertion into the salivary gland, whether orally or through the cheek.

The Sialo drain is a flexible, single lumen, sterile, single use, disposable cannula made of biocompatible radio-opaque polyurethane material.

The provided 510(k) summary for the Sialo Drain device does not contain the specific information required to complete the requested table and study description for acceptance criteria and device performance. This document is a premarket notification for a Class II medical device, and as such, it primarily focuses on demonstrating substantial equivalence to predicate devices based on design and intended use, rather than presenting detailed clinical study results with specific performance metrics and acceptance criteria.

The summary states: "The Sialo Drain device has been subjected to extensive safety, performance, and validation testing before release. Final testing of the SialoTech device included various performance tests designed to ensure that the device met all its functional specifications. Tests have been performed to ensure the device complies with industry and safety standards." However, it does not elaborate on what these specific "functional specifications" or "industry and safety standards" are, nor does it provide the results of these tests in a quantifiable manner that would allow for the filling out of a performance table against acceptance criteria.

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

Reasons for inability to complete the request:

• No explicit acceptance criteria: The document does not list any specific, quantifiable acceptance criteria.
• No reported device performance metrics: While it states "various performance tests" were conducted, it does not provide any numerical results (e.g., success rates, drainage volumes, infection rates, etc.) that could be considered reported device performance.
• No mention of clinical studies with human participants: The text describes "safety, performance, and validation testing," but these appear to be bench or lab-based tests to ensure functional specifications and compliance with standards, not clinical trials with human subjects.
• Missing details on sample size, data provenance, ground truth, expert qualifications, adjudication, MRMC, standalone studies, or training sets: Because the document does not detail clinical effectiveness studies, these elements are not present.

Ask a specific question about this device