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The SimpleSnip Suture Cutter is intended to cut sutures during all flexible endoscopic procedures.

The SimpleSnip Endoscopic Suture Cutter is sterile, single patient-use device intended to cut sutures during flexible endoscopic procedures. The cutting device goes through the working channel of the endoscope and is compatible with flexible endoscopes with a minimum channel diameter of 2.8mm. The device is available in two working lengths: 160cm working length for gastroscopes and 230 cm working length for colonoscopes. The device consists principally of a proximal handle assembly, a catheter with core wire, and a blade to cut the suture. Once the SimpleSnip device is inserted in the working channel of the endoscope, the blade is advanced from the catheter, the suture is captured within the blade such that when the blade is pulled back toward the catheter the suture is cut. The blade is rotatable to allow easy suture capturing and cutting.

I am sorry, but the provided text does not contain information about acceptance criteria and a study proving a device meets these criteria. The document is an FDA 510(k) clearance letter for the SimpleSnip Endoscopic Suture Cutter, detailing its substantial equivalence to a predicate device. It includes information about the device description, indications for use, comparison with a predicate device, and performance/biocompatibility/sterilization testing conducted.

Specifically, it states:

• "No clinical studies were deemed necessary to demonstrate the safety and effectiveness of the subject device." This means there isn't a clinical study with acceptance criteria and reported performance in the context of human data.
• The performance data mentioned is primarily bench testing and functional testing, as well as comparative testing against the predicate device for certain mechanical aspects (rotation, actuation, bending stiffness). These tests are designed to verify specifications and show equivalence, not necessarily to meet pre-defined clinical performance acceptance criteria against human outcomes.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for a test set or data provenance for a clinical study.
3. Number of experts or their qualifications for ground truth establishment.
4. Adjudication method.
5. MRMC comparative effectiveness study details.
6. Standalone algorithm performance.
7. Type of ground truth for a clinical study.
8. Sample size for a training set.
9. How ground truth for the training set was established.

This document focuses on demonstrating substantial equivalence through non-clinical data and comparison to a predicate device, which is common for 510(k) submissions where clinical studies are not deemed necessary.

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