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The U-CLIP™ Device is intended for endoscopic and non-endoscopic general soft tissue and prosthetic material approximation/attachment and/or ligation and the creation of anastomosis in blood vessels, grafts and other tubular structures.

The U-CLIP™ device is a self-closing clip for anastomosis and tissue and prosthetic material approximation or attachment applications. The U-CLIP" consists of a self-closing Nitinol clip connected to surgical needles via flexible members. These U-CLIPs'" include a Nitinol wire coil surrounding the Nitinol wire core. This design allows precise placement of clips prior to closure, and facilitates an interrupted "suture" technique by eliminating knot tying. The device is manufactured from a standard implantable grade of Nitinol.

Here's a breakdown of the acceptance criteria and study information for the U-CLIP™ Devices, Models B140, B160 & B180, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document (510(k) summary) does not explicitly list quantitative acceptance criteria in a table format alongside specific performance metrics. Instead, it states a general conformity to specifications and equivalence to a predicate device.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the exact sample size used for the test set in terms of number of devices or clinical cases. The testing mentioned appears to be primarily in vitro and in vivo (though the clinical context is referring to previous submissions, not this one specifically).

• Sample Size (Test Set): Not explicitly stated. The document refers to "Verification and validation testing" which included "clip strength and tissue drag forces."
• Data Provenance: Not explicitly stated regarding country of origin. The study appears to be entirely pre-market verification and validation testing, implying controlled laboratory conditions rather than retrospective or prospective clinical data from human subjects in this specific submission. However, the summary does mention reliance on "in vitro, in vivo, and clinical performance information provided in previous pre-market notifications," suggesting that real-world or animal data might have supported prior iterations of the device.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

The document does not describe the use of experts to establish "ground truth" for the test set, as the testing focuses on engineering performance (clip strength, tissue drag) directly measured against specifications. There's no indication of human interpretation or diagnostic accuracy being evaluated for this device.

4. Adjudication Method for the Test Set

Not applicable. The testing described is against engineering specifications, not human interpretation requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. An MRMC study is not mentioned or implied, as this is a medical device for approximation/ligation, not an imaging or diagnostic device that relies on human readers.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This is a physical, implantable medical device, not a software algorithm.

7. Type of Ground Truth Used

The "ground truth" for the verification and validation testing appears to be documented product and performance specifications for clip strength and tissue drag forces. These are engineering specifications that the device must meet.

8. Sample Size for the Training Set

Not applicable. This is a medical device, not an AI/machine learning model that requires a training set.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no training set for this type of device.

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