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The Wexler Endoscope Accessories are indicated for use in endoscopic surgical procedures to provide minimally invasive handling during the instrument's intended function. Clamps and forceps are used to grasp tissue or other items in the surgical field, while scissors are used to cut tissue or other items and needle holders are employed during the suturing process.

The Wexler Endoscope Accessories is a group of instruments used during endoscopic procedures such as thoracoscopy and laparoscopy. The instruments include clamps, forceps, needle holders, and scissors. The devices are made of stainless steel, and are supplied non-sterile.

The provided text describes a 510(k) submission for Wexler Endoscope Accessories. It does not contain information about acceptance criteria, device performance testing, study design (sample size, data provenance, expert ground truthing, adjudication), or comparative effectiveness studies.

The submission focuses entirely on demonstrating substantial equivalence to a predicate device (Scanlan® thoracoscopic instruments, K945474) based on similar technological characteristics, intended use, and materials (stainless steel). The language used ("virtually identical," "no significant differences") suggests that formal performance studies with specific acceptance criteria were not required by the FDA for this particular submission, as the device is deemed sufficiently similar to an already cleared product.

Therefore, I cannot populate the requested tables and information. The document explicitly states:

• "There are no significant differences in either technology or performance specifications." This implies that performance testing beyond demonstrating substantial equivalence to the predicate was not performed or deemed necessary for this 510(k) clearance.

If this were a different type of submission (e.g., for a novel device or one with significant technological differences from predicates), such performance data would typically be included.

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