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ReShape Calibration Tubes™ are indicated for use in gastric and bariatric surgical procedures to decompress the stomach, drain and remove gastric fluid, irrigate, and act as a sizing guide.

The Gastric Balloon Suction Catheter is indicated for use in gastric surgical procedures to decompress the stomach, drain and remove gastric fluid, irrigate, and act as a sizing guide.

The ReShape Calibration Tubes™ (Model B-2032, B-2040, and B-2017) and the Gastric Balloon Suction Catheter (Model B-2020) are manufactured by our company, ReShape Lifesciences. These catheters are flexible gastric tubes designed to be used in gastric and bariatic surgical procedures. The catheters provide visible and tactie delineation of the gastroesophageal (GE) junction and its location relative to the esophageal hiatus and antrum of the stomach. These devices provide the ability to decompress the stomach, drain and remove gastric fluid, irrigate, and act as a sizing guide.

This document is a 510(k) Premarket Notification from the FDA regarding ReShape Lifesciences' Calibration Tubes and Gastric Balloon Suction Catheter. It is a clearance letter, not a study report. Therefore, it does not contain the detailed information necessary to describe the acceptance criteria and the study proving the device meets those criteria as requested in the prompt.

The document states:

• "There are no changes to the principle of operation or technological characteristics of the devices."
• "The minor differences between the predicate devices include the material change to the black length marking ink/paste printed on the outer shaft of the catheters. Other minor labeling updates include product name change, the addition of a general contraindication, and labeled shelf life, which have no impact on the substantial equivalence."
• "The final finished subject devices with the proposed design modification have been tested in accordance with applicable ISO 10993 standards and in compliance with 21 CFR Part 58, and concluded non-cytotoxic, non-sensitizing, and non-irritant."
• "The labeled shelf life of 7 years is supported by leveraging the shelf life data of Model B-2017 previously cleared under K220455 with appropriate rationale."
• "No bench testing, packaging study, usability study, or sterility are deemed applicable or necessary for these with proposed modifications."

This indicates that the modifications were minor and largely related to material changes and labeling, not a fundamental change requiring a new, extensive performance study as one might expect for a novel AI/software device. The 510(k) process often relies on demonstrating substantial equivalence to a predicate device rather than conducting new, large-scale clinical trials.

Therefore, I cannot populate the requested table or answer the specific questions about sample sizes, expert involvement, MRMC studies, or training sets because the provided text does not contain this information. The document is a regulatory approval, not a detailed scientific study report.

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