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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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InnoClip™ Disposable Clip Applier is indicated for patients undergoing laparoscopic surgical procedures involving occlusion of blood vessel, ducts and other tubular structures, and for radiographic marking.

The InnoClip™ Clip Applier is indicated for patients undergoing laparoscopic surgical procedures involving occlusion of blood vessel, ducts and other tubular structures, and for radiographic marking.

InnoClip™ Disposable Clip Applier consists of a molded handle and trigger, a 360° rotational knob, a cartridge housing shaft and a pair of jaws which is easy for surgeon to hold the operation field in the natural position. This device includes models DC5T1-BX and DC5T1-B6 that are designed to be inserted through 5 mm trocar sleeves.

InnoClip™ Disposable Clip Applier can be used on vessels or tubular structures. The multi-fire design of InnoClip™ Disposable Clip Applier enables the surgeon to apply a maximum number of 10 clips for DC5T1-BX or 16 clips for DC5T1-B6 during a laparoscopic procedure without withdrawing and reinserting the device. The pre-loaded clips in the shaft are advanced to the jaw to enclose and occlude the target vessel by gently pulling the trigger.

InnoClip™ Clip Applier has two parts, Reusable Handle and a Disposable Clip Cartridge. The Reusable Handle consists of a molded handle, trigger, openable cover and a 360° rotational knob. The Disposable Clip Cartridge consists of a cartridge housing shaft and a pair of jaws which provide secured of the clip to the targeted vessel. The Disposable Clip Cartridge and the Reusable Handle can be easily assembled together by inserting the Disposable Clip Cartridge through a slot located in the Reusable Handle. This device includes models RC5T1-BX and RC5T1-B6 that are designed to be inserted through 5 mm trocar sleeves.

InnoClip™ Clip Applier can be used on vessels or tubular structures. The multi-fire design of InnoClip™ Clip Applier enables the surgeon to apply a maximum number of 10 clips for RC5T1-BX or 16 clips for RC5T1-B6 during a laparoscopic procedure without withdrawing and reinserting the device. The reusable handle design also reduces the surgical cost and waste. The pre-loaded clips in the Disposable Clip Cartridge are advanced to the jaw to enclose and occlude the target vessel by gently pulling the trigger.

The provided text is a 510(k) Summary for the InnoClip™ Disposable Clip Applier and InnoClip™ Clip Applier devices. It describes the device, its intended use, and provides a summary of performance testing to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present acceptance criteria in a table format with specific quantitative thresholds. Instead, it describes performance testing and generally states that the devices "met all acceptance criteria" or "have similar device performance compared to the predicate."

Here's a summary derived from the text:

2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: The document does not specify the exact sample sizes (number of devices, number of clips tested, number of animals) used for any of the performance tests. It mentions performing "in-vitro tests" and "in-vivo ligation tests" but lacks quantitative details on sample size.
• Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. It is a submission by "Taiwan Surgical Corporation" but this does not confirm the location of the studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. The tests described (e.g., pull-out force, air leakage, in-vivo ligation) are largely objective performance tests of the device itself rather than assessments requiring human expert interpretation for ground truth.

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

This information is not applicable and not provided in the context of this device. The tests are focused on mechanical and functional performance, not diagnostic interpretations requiring adjudication.

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

This information is not applicable and not provided in the document. This device is a surgical clip applier, not an AI-powered diagnostic tool, so MRMC studies are not relevant.

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

This information is not applicable and not provided in the document. This is a mechanical surgical device and does not involve an algorithm.

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

The concept of "ground truth" as typically defined for AI or diagnostic devices (e.g., expert consensus, pathology, outcomes) is not directly applicable to the performance testing described for this mechanical surgical device. The "ground truth" for these tests would be the objective measurement results (e.g., actual pull-out force, actual air leakage rate, observable successful ligation in a animal model) as measured by laboratory equipment and veterinary observation, compared against pre-defined performance acceptance thresholds or predicate device performance.

8. The sample size for the training set

This information is not applicable and not provided in the document. This is a mechanical surgical device and does not use a training set as would an AI/machine learning model.

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

This information is not applicable and not provided in the document. This is a mechanical surgical device and does not use a training set.

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