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The PermaClip™ Cartridge with implantable titanium clips is intended for use during laparoscopic surgery to occlude a variety of vessels or other tubular structures.

The Microsurge Laparoscopic PermaClip™ Cartridge with implantable titanium clips is a disposable single patient use device fabricated from biocompatible stainless steels and biocompatible medical grade polymers. The PermaClip ™ cartridge contains up to 12 implantable titanium clips. The closed clip length is approximately 9 mm. The device is designed to be used in conjunction with a separately supplied reusable PermaClip™ Multi-Use Clip Applier to occlude blood vessels and other tubular structures during laparoscopic surgical procedures. The clip cartridge is attached to the clip applier handle via a lock/release mechanism, and inserted through a trocar to gain laparoscopic access. The clip cartridge jaws with the open clip in the jaws is placed around the vessel or other tubular structure. Actuation/compression of the clip applier handle/trigger drives a mechanism within the cartridge to close the cartridge jaws, thereby forming the clip securely around the vessel. Release/decompression of the clip applier handle/trigger allows the iaws of the cartridge to open and releases the clip from the cartridge jaws. The automatic feeding cartridge releases the next clip into the jaws for another application. The cartridge is sized to fit through a 10 mm cannula. The overall shaft length of the cartridge plus the clip applier handle is approximately 33 mm, consistent with other endoscopic instruments.

The provided 510(k) summary for the Microsurge Laparoscopic PermaClip™ Cartridge with Implantable Titanium Clips does not include any information about acceptance criteria or a study demonstrating device performance against such criteria.

The summary focuses on:

• Description of the device: How it works and its components.
• Intended Use: What the device is designed to do (occlude vessels/tubular structures during laparoscopic surgery).
• Technological Characteristics: Stating similarities to predicate devices in design, materials, and intended use.
• Conclusion: Reinforcing that it has the same intended use and basic technology as predicates, posing no new safety or effectiveness questions.

Therefore, I cannot provide the requested information in the table or answer the subsequent questions because the provided text does not contain any details about:

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

This type of 510(k) summary, particularly from 1996, often relies heavily on substantial equivalence to predicate devices rather than requiring extensive new performance data. Clinical trials or performance studies with acceptance criteria might not have been a primary requirement for this specific submission based on the presented information.

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