(25 days)
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.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.