Search Results

The Syntec, Inc. Disposable Endo Illuminators is used to illuminate with visible spectrum light the intraocuiar portion of the eye for improved visualization during vitreo-retinal surgery.

The Endo Illuminator is comprised of five basic components. The handpiece handle. The handpiece tube. The fiberoptic cable. The fiber optic cable sheath and the connector.

The provided text describes a medical device called the Syntec, Inc. Tru Light Endo Illuminator. However, the document is a 510(k) summary of safety and effectiveness, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and detailed performance metrics as you've requested.

Therefore, I cannot provide the information in the requested format because the input document does not contain the details of a study with acceptance criteria, specific performance metrics, sample sizes, expert qualifications, or ground truth methods.

The document states:

• "The Syntec, Inc. Tru Light Endoilluminator and the Grieshaber & Co. Disposable Standard Light Pipe are substantially equivalent since they both are used to for the same clinical purpose..."
• "Both devices are of a similar design and are made using the exact same materials."
• "The device is biocompatible with the body tissue and fluids that it comes in contact with as it is made of the same materials as the predicate device."
• "The light output intensity and spot size is the same as the predicate device. The only device differrences are cosmetic."

These statements indicate that the device's safety and effectiveness were demonstrated by showing it is essentially identical to a previously cleared device, not through an independent study with defined acceptance criteria and performance measurements.

Ask a specific question about this device