Search Results

The MIC-KEY Low Profile Gastrostomy Tube is designed as a replacement gastrostomy tube for use in a mature gastric stoma when a low profile device would benefit the patient.

Gastrostomy tubes are indicated for patients with inability to swallow, other neurological disorders, and other conditions for which tube feeding would benefit the patient in the judgment of the physician.

MIC-KEY® Low Profile Gastrostomy Tube

The provided document is a 510(k) premarket notification letter from the FDA for a medical device called the "MIC-KEY® Low Profile Gastrostomy Tube." This letter approves the device based on its substantial equivalence to a legally marketed predicate device.

It is important to understand that this document describes a regulatory approval process based on equivalence, not a study performing specific acceptance criteria for a novel AI/software device. This document does not contain information about:

• Acceptance criteria in the context of device performance metrics (like sensitivity, specificity, AUC).
• A study proving the device meets acceptance criteria in the way an AI/software device would.
• Sample sizes for test or training sets, data provenance, ground truth establishment, expert qualifications, or adjudication methods for performance evaluation.
• Multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.

Therefore, I cannot fill out the requested table and provide the detailed information about a "study that proves the device meets the acceptance criteria" because this document does not contain that type of information. It's a regulatory approval notice for a physical medical device.

Ask a specific question about this device