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• The EndoFLIP® system is an endoscopically placed device indicated for use in patients fitted with a gastric band. The device is intended to estimate the size of the stoma produced by the gastric band in a clinical setting.
• EndoFLIP® EF-620 catheter is indicated for use in measuring the size of a gastric sleeve created during bariatric surgery. It is suitable for diameter measurements for 22 to 60 French sleeves.
• The EndoFLIP® system is indicated for use in a clinical setting as a pressure and dimension measurement device and as an adjunct to other methods in the comprehensive evaluation of patients with symptoms consistent with esophageal sensory hypersensitivity.
  Note: EndoFLIP is a measurement system. It is not intended to perform a diagnostic test. The EF-325L has a locating LED used in conjunction with the shaft markings to locate the balloon midpoint.

The EndoFLIP® comprises a measuring system and a single use or reusable catheter to assist in measuring the lumen diameter at 16 points (EF family) or 8 points (BF family). The EndoFLIP® comprises a measuring system and catheter to assist in measuring lumens. In practice, the EndoFLIP® balloon catheter is attached to a syringe, pre-filled with a diluted saline solution, which is inserted into the syringe pump on the front of the EndoFLIP® system. The deflated balloon is inserted under direct laparoscopic visualization. Once the balloon has been correctly located, it is then inflated with the diluted saline solution to a user programmed volume.

The acceptance criteria and study information for the EndoFLIP® System with catheters (EF-325, EF325N, EF-325L, BF-325 BF-325N, EF-620) are detailed below.
This submission is for modifications to an existing device, primarily extending shelf life and adding an LED to one catheter model (EF-325L). The testing performed is focused on demonstrating that these changes do not alter the substantial equivalence to the predicate devices. The document explicitly states that the indications for use, technology, construction, environment of use, patient population, and materials in contact with the patient are "Identical, unchanged" or "similar" to the predicates.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size:
  • For the shelf-life test, the document states "The additional accelerated aging testing demonstrated that they performed to their specifications." However, a specific sample size for this testing is not provided.
  • For other aspects of substantial equivalence (indications, technology, materials, etc.), the justification relies on the device being "identical, unchanged" or "similar" to predicate devices, meaning no new clinical or non-clinical test sets are explicitly detailed with sample sizes beyond the shelf-life study.
• Data Provenance: The document does not specify the country of origin for any conducted tests. The tests performed were primarily non-clinical (shelf-life, biocompatibility in earlier submissions). The data would be considered retrospective in the sense that it refers to the performance of existing predicate devices and comparative analysis rather than new prospective clinical trials for the modifications.

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

• The document does not describe any test sets requiring expert ground truth establishment for the modifications. The evaluation is focused on demonstrating substantial equivalence to predicate devices, which implies that the performance characteristics of the predicate devices serve as the "ground truth" for comparison.

4. Adjudication Method for the Test Set

• No adjudication method is described, as there is no mention of a test set requiring expert review or consensus for the modifications.

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

• No MRMC comparative effectiveness study was done. This device is a measurement system and does not involve AI assistance or human readers for interpretation, therefore, this type of study is not applicable.

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

• No standalone algorithm performance study was done. The device and its modifications are mechanical/electronic measurement tools, not an algorithm or AI system. Its performance (e.g., diameter and pressure measurement accuracy) is inherent to the device's design and verified through engineering testing, not standalone algorithm performance.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

• The ground truth for the device's original performance (diameter, resolution, accuracy) would be based on physical and engineering measurements against known standards, established during the initial clearances for the predicate devices. For the current submission, the "ground truth" for the new device is its identity or similarity to these already cleared predicate devices for all specified characteristics.

8. The Sample Size for the Training Set

• Not applicable. This device is not an AI/ML device that requires a training set.

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

• Not applicable. As stated above, this device does not utilize a training set.

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