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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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ReShape Calibration Tubes™ are 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™ is a flexible gastric tube designed to be used in gastric and bariatric surgical procedures and is available in three larger sizes. The trade name has been changed Gastrointestinal Boundary Identifier (GIBI HD ™) to ReShape Calibration Tubes ™ for these three (3) sizes.

The ReShape Calibration Tubes™ provide visible and tactile delineation of the gastroesophageal (GE) junction, and its location relative to the esophageal hiatus and antrum of the stomach. The device provides the ability to decompress the stomach, drain and remove gastric fluid and act as a sizing guide (Figure 1).

This document is a 510(k) premarket notification for a medical device called "ReShape Calibration Tubes™". The purpose of this submission is not to introduce a new device with novel performance criteria, but rather to establish substantial equivalence to a previously cleared predicate device due to a change in device name, minor edits to the Directions For Use (DFU), and the addition of a contraindication.

Therefore, the typical structure for describing acceptance criteria and a study proving a device meets them (as would be expected for a new device with performance claims) is not directly applicable here. This document primarily focuses on demonstrating that the changes made do not alter the established safety and effectiveness of the device as previously cleared.

Based on the provided text, here's how to address your request:

Key Takeaway: The device's performance was not re-evaluated in a new study for this 510(k) submission. Its performance has been established through the clearance of its predicate device (Gastrointestinal Boundary Identifier (GIBI HD ™) Calibration Tube, K221898). The current submission leverages the established performance of the predicate device to demonstrate substantial equivalence for the modified device.

1. A table of acceptance criteria and the reported device performance

Since this submission is based on substantial equivalence to a predicate device and no new performance data was generated for this specific submission, there isn't a direct "table of acceptance criteria and reported device performance" as you might find for a de novo submission or a device with new performance claims.

Instead, the acceptance criteria are implicitly that the ReShape Calibration Tubes™ are substantially equivalent to the predicate device (GIBI HD ™ Calibration Tube, K221898) across all relevant characteristics. The "performance" is considered to be the same as the predicate.

Here's how we can conceptualize it from the document:

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document explicitly states: "Bench testing was not conducted and remains same as the predicate device cleared under K221898." Therefore, there is no new test set, sample size, or data provenance information provided in this submission. The basis for substantial equivalence relies on the established performance of the predicate device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. As no new testing or clinical studies were conducted for this submission, no new ground truth was established by experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. As no new testing or clinical studies were conducted for this submission, no adjudication method was used.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a calibration tube used in surgical procedures, not an AI-assisted diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a physical medical device (calibration tube), not an algorithm or AI.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

For this submission, the "ground truth" is effectively the established safety and effectiveness of the predicate device (GIBI HD ™ Calibration Tube, K221898) based on prior regulatory clearance. The current submission's "ground truth" for its acceptance is that its modifications do not alter its substantial equivalence to that predicate device. The document does not detail how the predicate's original performance data was established (e.g., specific ground truth for its bench studies).

8. The sample size for the training set

Not applicable. This device is a physical medical device, not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established

Not applicable. This device is a physical medical device, not an AI/ML algorithm.

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