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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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The US Endoscopy Endoscopic Suture Cutter Device is intended to be used in conjunction with an endoscope to grasp and cut suture in the GI tract.

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The provided document is a 510(k) clearance letter from the FDA for a medical device called "The US Endoscopy Endoscopic Suture Cutter Device." This type of document primarily confirms that the device is substantially equivalent to legally marketed predicate devices and is thus cleared for market.

Crucially, 510(k) notifications do not typically include detailed studies or acceptance criteria for device performance in the way that a PMA (Pre-Market Approval) or clinical trial report would. The 510(k) process focuses on demonstrating substantial equivalence, often through bench testing, materials characterization, and comparisons to predicate devices, rather than extensive clinical efficacy studies with specific performance metrics and acceptance criteria.

Therefore, based solely on the provided text, it is not possible to provide the requested information about acceptance criteria and the study proving the device meets them. The document does not contain:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for test sets or data provenance.
3. Information on experts used to establish ground truth or their qualifications.
4. Adjudication methods.
5. MRMC comparative effectiveness study details or effect sizes.
6. Standalone algorithm performance (as this is a physical medical device, not an AI algorithm).
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

The document states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." This indicates that the clearance was based on substantial equivalence, not on meeting specific, pre-defined performance acceptance criteria from a comprehensive study detailed in this document.

To find the kind of information requested, one would typically need to refer to the full 510(k) submission itself (which is often voluminous and not publicly released in its entirety), or any associated clinical trial publications if they were part of the submission (though for 510(k)s, clinical data is often not required or is limited).

In summary, the provided text does not contain the information needed to answer the prompt.

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