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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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The GIBI HD™ is 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 Gastrointestinal Boundary Identifier, or GIBI HD™, is a flexible gastric tube designed to be used in gastric and bariatric surgical procedures. The catheter provides visible and tactile delineation of the antrum of the stomach along with the ability to decompress the stomach, drain and remove gastric fluid and size a gastric pouch.

The dual lumen GIBI HD utilizes one lumen for drainage, suction and irrigation and the second lumen to inflate/deflate the balloon. The catheter is attached to a 32-inch suction tubing and a 6inch tubing with a stopcock for filling the balloon.

The provided document is a 510(k) premarket notification for the Gastrointestinal Boundary Identifier (GIBI HD™). It describes the device, its indications for use, and a comparison to a predicate device, including performance data from bench tests.

Acceptance Criteria and Device Performance Study for the Gastrointestinal Boundary Identifier (GIBI HD™)

The document primarily focuses on bench testing to demonstrate substantial equivalence, rather than clinical studies involving human patients or complex AI algorithms. Therefore, many of the typical questions regarding AI-driven medical devices (like MRMC studies, ground truth establishment for complex imaging, training set details, or expert adjudication) are not applicable to this submission.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document states "Samples" for the performance tests, but does not specify the exact sample size (N) used for each test. The tests are bench tests, meaning they were performed in a lab setting, not on patient data. Therefore, the concept of "country of origin of the data" or "retrospective/prospective" study design in the context of clinical data does not apply here. The data provenance is from in-house bench testing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. The ground truth for this device is based on engineering specifications and measurable physical properties (e.g., fluid retention volume, force required for separation, length, diameter, and presence of markings) as evaluated during bench testing. This does not involve expert interpretation of medical images or clinical outcomes.

4. Adjudication Method for the Test Set

Not applicable. As the tests are physical measurements and functional evaluations, there is no need for expert adjudication in the classic sense. The "ground truth" is determined by the Pass/Fail criteria directly from the physical testing.

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 mechanical surgical instrument, not an AI-driven diagnostic or interpretative tool. No MRMC study was conducted or is relevant for this type of device.

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

Not applicable. This is not an algorithm or software device.

7. The Type of Ground Truth Used

The ground truth used for these performance tests is defined by the engineering specifications and physical requirements for the device's components and functionality. This is a technical ground truth based on measurable physical properties rather than clinical outcomes, pathology, or expert consensus on medical images.

8. The Sample Size for the Training Set

Not applicable. This is a manufactured physical good, not an AI model requiring a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As this device does not involve a training set for an AI model, this question is not relevant.

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The LAP-BAND® System Calibration Tube is indicated for use in gastric surgical procedures to decompress the stomach, drain and remove gastric fluid and size the gastric pouch.

The Lap-Band® System Calibration Tube is a flexible gastric tube designed to be used in gastric and bariatric surgical procedures. The catheter provides visible and tactile delineation of the antrum of the stomach along with the ability to decompress the stomach, drain and remove gastric fluid and size a gastric pouch.

The dual lumen Calibration Tube utilizes one lumen for drainage, suction and irrigation and the second lumen to inflate/deflate the balloon. The catheter is attached to a 32-inch suction tubing and a 6-inch tubing with a stopcock for filling the balloon.

The provided text is a 510(k) summary for the ReShape Lifesciences Lap-Band System Calibration Tube. It describes the device, its indications for use, and the basis for substantial equivalence to a predicate device. The information required to answer your request, specifically regarding detailed acceptance criteria and the study that proves the device meets them, is primarily found in the "Performance Data" section.

Here's a breakdown of the requested information based on the provided document:

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

Biocompatibility Testing:

2. Sample sizes used for the test set and the data provenance:

• Sample Size: The document does not explicitly state the sample sizes (number of units tested) for each specific bench test. It only provides the "Pass" result, indicating that the tested units met the criteria.
• Data Provenance: The studies were described as "bench" and "animal studies." There is no information regarding the country of origin of the data, nor whether the studies were retrospective or prospective experiments on the device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• This document describes bench testing and biocompatibility testing for a medical device (calibration tube), not a diagnostic AI system or a study requiring human expert assessment for ground truth. Therefore, there were no "experts" in the sense of clinicians establishing ground truth for a diagnostic test set. The acceptance criteria are based on engineering and material science standards (e.g., force, volume, material properties).

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

• Not applicable. As noted above, this is not a study assessing human or AI diagnostic performance requiring adjudication of interpretations. The tests described are objective, quantitative measurements or qualitative observations (e.g., presence/absence of allergic response) against predefined criteria.

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 document pertains to the clearance of a physical medical device (a calibration tube) and its performance in bench and animal studies to demonstrate substantial equivalence, not a diagnostic AI system. Therefore, no MRMC study with human readers assisting AI was conducted or reported.

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

• Not applicable. This device is not an algorithm or AI system.

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

• The "ground truth" for the performance data in this context is defined by the pre-defined acceptance criteria based on established engineering principles, material science, and ISO standards for biocompatibility. For example, for the Burst Test, the ground truth is simply whether the balloon remained intact at the specified pressure. For biocompatibility, it's the observed biological reactions (or lack thereof) compared to ISO standards.

8. The sample size for the training set:

• Not applicable. This device is not an AI system that requires a "training set."

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

• Not applicable. As this is not an AI system, there is no "ground truth for a training set."

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