Search Results

The Giltech Plus Connecting Tube Sets will consist of: (a) Insufflation Tubing Sets (b) Suction / Irrigation Sets (c) Urinary Extension Tubing (d) Tubing Sets necessary to connect two devices, however never to be used to transmit a gas or a liquid for intravenous or intramuscular transmission.

Not Found

I am sorry, but based on the provided document, there is no information about acceptance criteria, device performance, or a study conducted to prove the device meets any criteria.

The document is an FDA 510(k) clearance letter for the "Giltech Plus Connecting Tube Set." This letter primarily:

• Confirms that the device is "substantially equivalent" to predicate devices marketed before May 28, 1976.
• Outlines general regulatory obligations for the manufacturer.
• Lists the "Indications For Use" for the device, which describes its intended functions and types of tubing sets included.

The document does not contain details about:

1. Acceptance criteria or reported device performance.
2. Sample size or data provenance for a test set.
3. Number or qualifications of experts for ground truth.
4. Adjudication method.
5. Multi-reader multi-case (MRMC) comparative effectiveness study.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size or ground truth establishment for a training set.

Ask a specific question about this device