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The SOLID CLIP™ Single Use Clip Applier is intended for patients undergoing laparoscopic surgical procedures and can achieve dissection and ligation of blood vessels and other tubular structures for radiographic marking.

The SOLID CLIP™ Single Use Clip Applier is a sterile, single patient use device designed for an appropriately sized trocar sleeve or larger sized trocar sleeve with the use of a converter. It consists of a shaft with an outer diameter of 10 or 5 mm and length of 33 cm, a jaw for forming ligating clips, a pistol handle, an actuation trigger, a 360 degrees rotational knob, and a clip counter.

The shaft with outer diameter 10 mm was preloaded 10, 15, 20 ML (Medium-Large) or 10, 15 L (Large) titanium clips, outer diameter 5 mm shaft only preloaded 10, 15 ML (Medium-Large) titanium clips. Squeezing the trigger places a titanium clip in the jaws and closes the jaws to form the clip on the occlusion of the vessel or tubular structure.

The design of SOLID CLIP™ Single Use Clip Applier provides secured placement of the clip to the targeted vessel and enables the surgeon to apply the clips during a laparoscopic procedure without the need for withdrawing and reinserting the device each time a clip is put in place and closed.

The Medscope Biotech Co., Ltd. SOLID CLIP™ Single Use Clip Applier (K221495) demonstrated substantial equivalence to its predicate device through a series of non-clinical tests.

1. Table of Acceptance Criteria and Reported Device Performance:

The document provides a comparison of features and performance between the subject device (SOLID CLIP™ Single Use Clip Applier) and the predicate device (Endo Clip™ II Clip Applier, K143644). While specific acceptance criteria for each test result are not explicitly listed, the "Comparison" column indicates whether the subject device's performance is "Identical" or "Similar" and if it meets the criteria.

2. Sample size used for the test set and the data provenance:

The document does not explicitly state the sample sizes for the specific functional performance tests (e.g., number of clips tested for formation, gap, pull-out, slip force, airtight capability, or trigger force). The tests are described as "Non-Clinical Test" and "Performance Study (Functional Testing)", indicating in-vitro testing. The data provenance is not specified in terms of country of origin, but it is clear these are non-clinical (laboratory/bench) tests, not human or animal studies for these specific performance metrics.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. This device is not an AI/software device that requires expert review for ground truth establishment. The performance tests are based on objective physical measurements and comparisons to a predicate device's established performance.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable. Adjudication methods are typically relevant for studies involving human interpretation or subjective assessments, which is not the case for these non-clinical, objective functional tests.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This is a medical device (clip applier), not an AI-powered diagnostic or assistive tool for human readers.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable. This is a medical device, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For the non-clinical performance tests, the "ground truth" or reference points are largely based on:

• Predicate Device Performance: The performance characteristics of the legally marketed predicate device (Endo Clip™ II Clip Applier, K143644) serve as a benchmark for comparison.
• Established Engineering/Performance Standards: Implied adherence to good engineering practice and the ability to achieve the intended function safely and effectively.
• Reference Standards: For other tests like biocompatibility, sterilization, and MR compatibility, specific ISO and ASTM standards (e.g., ISO 10993, ISO 11135, ASTM F2052) serve as the "ground truth" for compliance.

8. The sample size for the training set:

Not applicable. This is a medical device, not a machine learning model requiring a training set.

9. How the ground truth for the training set was established:

Not applicable. As this is not an AI/ML device, there is no training set or associated ground truth establishment process.

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