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The EndoFLIP® System is indicated for use in a clinical setting to measure pressure and dimensions in the esophagus. pylorus, and anal sphincters. It is intended to be used as an adjunct to other diagnostic methods as part of a comprehensive evaluation of patients with symptoms consistent with gastrointestinal motility disorders.

The EF-325 series of catheters can make pressure and dimensional measurements in the esophagus, pylorus, and anal sphincters; whereas the BF-325 series and EF-825 catheters can make dimensional measurements in the esophagus. pylorus, and anal sphincters. The EF-620 catheter can make dimensional measurements in the esophagus.

Other indications for use include:

· To estimate the size of a stoma produced by a gastric band (all EndoFLIP catheters)

· For use as an adjunct to a bougie for measuring the size of a gastric sleeve created during bariatric surgery, where it is suitable for diameter measurements for 22 to 60Fr sleeves (EF-620 catheter)

The EndoFLIP® system and its accessory catheters are identical to the reference Crospon EndoFLIP® K120997. The proposed modifications to the EndoFLIP® system is to expand the anatomical locations to encompass the measurement of pressures and dimensions in the esophagus, pylorus, and anal sphincters.

The provided document is a 510(k) Pre-Market Notification for the EndoFLIP® System. It describes the device's indications for use and compares it to predicate and reference devices to demonstrate substantial equivalence. However, it does not contain specific acceptance criteria or a detailed study report with the requested performance metrics, sample sizes, ground truth establishment, or expert information typically found in a clinical study section.

Instead, it relies on a comparison to previously cleared devices and cites independent clinical studies as evidence supporting the expanded indications for use.

Therefore, most of the requested information cannot be extracted directly from this document.

Here's what can be gathered, with caveats:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document. The document states "no design changes to the system or catheters and therefore no change in performance" and "No comparative bench testing was required as there are no design changes to the system or catheter." This implies that the performance of the current device is considered equivalent to its previously cleared versions.

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

This information is not provided for a specific test set directly tied to this 510(k) submission. The document cites 11 independent clinical studies that have "been performed for the cited anatomical locations." The sample sizes and data provenance (country of origin, retrospective/prospective) would need to be extracted from the individual cited publications, which are not included in this document.

3. Number of Experts and Qualifications

This information is not provided in the document. This would be specific to how the ground truth was established within the cited independent clinical studies.

4. Adjudication Method

This information is not provided in the document. This would be specific to how the ground truth was established within the cited independent clinical studies.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A MRMC comparative effectiveness study is not mentioned in the document. The device is a "Gastrointestinal motility monitoring system" for measuring pressure and dimensions, not an imaging device typically evaluated with human readers and AI assistance in an MRMC study.

6. Standalone (Algorithm Only) Performance Study

As this is a measurement device for physical parameters (pressure and dimensions) and not an AI-based diagnostic algorithm, a standalone algorithm-only performance study as typically understood for AI devices is not applicable and therefore not mentioned.

7. Type of Ground Truth Used

The type of ground truth used would be based on the nature of measurements in the cited independent clinical studies. Given the device measures "pressure and dimensions," the ground truth would likely involve direct physical measurements obtained through established medical procedures or validated alternative measurement techniques, as conducted by medical professionals in a clinical setting. However, the document does not explicitly state the type of ground truth for the cited studies.

8. Sample Size for the Training Set

This information is not provided. The document describes a medical device for measurement, not an AI/ML-based device that would typically have a "training set."

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

This information is not provided. As above, it's not applicable for this type of medical device's submission.

Summary of what can be extracted from the document:

• Device Name: EndoFLIP® System
• Regulation Number: 21 CFR § 876.1725
• Regulation Name: Gastrointestinal Motility Monitoring System
• Regulatory Class: II
• Product Code: FFX
• Predicate Device: K991288 - G&J Electronics, Distender Series II Barostat
• Reference Devices: K120997 – EndoFLIP® system – Crospon Ltd., K092850 - EndoFLIP® system - Crospon Ltd.
• Indications for Use (Expanded in this submission): To measure pressure and dimensions in the esophagus, pylorus, and anal sphincters as an adjunct to other diagnostic methods for patients with symptoms consistent with gastrointestinal motility disorders. Also, to estimate stoma size with gastric bands and measure gastric sleeve size during bariatric surgery.
• Technology/Design/Features/Materials/Performance Specifications: Identical to previous EndoFLIP® systems (K092850), implying no changes from previously cleared performance.
• Clinical Evidence: The submission supports its expanded indications by citing 11 independent clinical studies that have evaluated the device for the new anatomical locations (anal sphincter, pylorus, upper esophageal sphincter). The details of these studies (sample size, ground truth, etc.) are not in this document but are found in the cited scientific literature.

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The EsoFLIP® ES balloon catheter is indicated for use to dilate esophageal strictures due to esophageal surgery, primary gastro-esophageal reflux and radiation therapy.

Note: The EsoFLIP® ES catheter is to be used only with the EndoFLIP® system.

The EndoFLIP® system is an endoscopically placed device that utilizes a catheter for various indications. Crospon submitted and received 510(k) clearances for the EndoFLIP® System with a number of different catheters with different indications for use. This submission is seeking to expand the indication for use for the proposed EsoFLIP® ES catheter to dilate esophageal strictures due to esophageal surgery, primary gastro-esophageal reflux and radiation therapy.

In all cases the catheters are to only be used with the EndoFLIP® system.

Here's an analysis of the provided text regarding the EsoFLIP® ES Balloon Dilation Catheter, focusing on acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence to predicate devices, rather than establishing new, specific acceptance criteria for performance metrics like sensitivity, specificity, or image quality, which are more common for diagnostic AI/imaging devices. Instead, the acceptance criteria revolve around engineering specifications and material compatibility.

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

This submission describes non-clinical bench testing rather than human clinical trials or studies with patient data. Therefore, the concept of a "test set" in the context of collected patient data (e.g., images for an AI algorithm) is not applicable here.

• Sample Size: Not specified in terms of patient data. For bench tests, the number of catheter units tested would be the "sample size," but this is not explicitly stated.
• Data Provenance: Not applicable as it's mechanical/material bench testing, not derived from a patient population or geographical region.
• Retrospective/Prospective: Not applicable.

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

This information is not provided and is not applicable to the type of testing described. Ground truth for these engineering tests would be established by validated measurement equipment and adherence to engineering specifications and international standards (e.g., ISO 10993-1).

4. Adjudication Method for the Test Set:

This information is not provided and is not applicable. Adjudication methods are typically used for expert review of human data, particularly in clinical studies or AI algorithm validation to resolve discrepancies in diagnoses or interpretations.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or described. This type of study is relevant for evaluating diagnostic aids where human readers' performance with and without the device is compared. The EsoFLIP® ES is a therapeutic device (dilation catheter) with measurement capabilities, not a diagnostic imaging aid.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance):

Yes, in a sense, a standalone study (bench testing) was performed. The "Non-clinical Testing Summary - Bench Testing" section lists various tests (e.g., Accuracy Test, Balloon Burst Test, Fatigue Test) that evaluate the device's inherent mechanical performance and capabilities (e.g., measurement range and accuracy) without direct human intervention in the performance measurement itself, beyond setup and data collection. The device itself performs the "measurement" function to provide an estimated diameter (Dest).

7. Type of Ground Truth Used:

The ground truth for the bench testing would be established by:

• Engineering Specifications: Pre-defined design limits and performance expectations for the device components.
• Reference Standards: Calibrated measurement equipment and established testing methodologies (e.g., for accuracy, burst pressure, fatigue).
• International Standards: Compliance with standards like ISO 10993-1 for biocompatibility.

8. Sample Size for the Training Set:

This information is not applicable. The EsoFLIP® ES is a physical medical device, not an AI or machine learning algorithm that requires a "training set" of data.

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

This information is not applicable as there is no training set for this device.

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