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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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The Microsurge Thoracoscopic Scissors are a line of reusable general surgical scissors intended to be used to cut, dissect and manipulate tissues during general open and thoracoscopic procedures.

The Microsurge Thoracoscopic Scissors are a modular line of reusable surgical scissors consisting of various size scissors shafts and tips. These integral shafts and tips are essentially identical to the scissors shafts of the Microsurge Detachatip Surgical Instruments and are intended to be used in conjunction with the handles that have been cleared for marketing as part of the Microsurge Detachatip Surgical Instruments. The scissors tips and shafts are sized to fit through 5 mm cannula or directly through intercostal incisions. The shafts range in length from 24 to 43 cm, consistent with other endoscopic instruments such as the Detachatip line manufactured by Microsurge. The shafts are provided either straight or with a prefabricated reverse "S" shaped curve. "The curve provides for increased range of motion when rotating the instrument, thus improving access to internal structures during endoscopic procedures. The shafts are also equipped with a cleaning port to enhance cleaning via direct delivery of cleaning solutions to the lumen of the instruments. The scissors tips are provided in a variety of styles: curved (Metzenbaum), straight, and hook. Each style is suited for specific surgical requirements and tissue types.

I am sorry, but based on the provided text, I cannot extract the information required to populate the table and answer your questions regarding acceptance criteria and device performance study details.

The provided text describes a 510(k) summary for the "Microsurge Thoracoscopic Scissors." It focuses on the device's description, intended use, technological characteristics, and comparison to predicate devices, asserting that it is "at least as safe and effective."

However, it does not include:

• Specific acceptance criteria for performance metrics (e.g., cutting force, sharpness, durability cycles).
• Reported device performance data against such criteria.
• Details of a study proving the device meets acceptance criteria, such as:
  • Sample size for the test set or training set.
  • Data provenance.
  • Number or qualifications of experts.
  • Adjudication methods.
  • Results of a multi-reader multi-case study.
  • Results of a standalone algorithm-only study.
  • Type of ground truth used.

The text mentions "a rigorous, company-devised test simulating the device's anticipated field use to evaluate its durability," and "conformance with well-established biocompatibility standards." However, it does not provide details of these tests or their results.

Therefore, I cannot generate the requested table or answer the subsequent questions.

Ask a specific question about this device

Ask a specific question about this device