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The Endoflip System is indicated for use in a clinical setting to measure and dimensions in the esophagus, pylorus, and anal sphincters in adults and to measure pressure and dimensions in patients from 5 years of age. 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 Endoflip System comprises a measuring system and a single use catheter to provide programmed balloon distensions.

The provided text describes a 510(k) premarket notification for the Endoflip System, focusing on adding a specific age range (pediatrics) to its indications for use. The document does not contain information about the acceptance criteria or a study designed to prove the device meets specific performance criteria linked to those acceptance criteria.

The submission asserts that "There is no change between the Predicate device (K160725) and Endoflip System" and "There is no change in the technological characteristics of Endoflip System from the cleared predicate device (K160725)." Therefore, the performance data presented primarily focuses on the safety and clinical utility in the pediatric population, rather than proving specific performance metrics of the device itself.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

• Cannot be provided. The document does not specify quantitative acceptance criteria for device performance (e.g., accuracy, precision, sensitivity, specificity) for the Endoflip System itself. The "Clinical Evaluation" section mentions using the Endoflip in pediatric patients to assess myotomy adequacy and esophageal distensibility, but it does not present specific performance metrics from a study against predefined acceptance criteria.

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

• Partially available, but not for a formal test set with defined performance metrics. The "Clinical Evaluation" mentions a "literature review" of existing studies using Endoflip in pediatric populations. It states, "Specifically, Endoflip was used in pediatric achalasia patients during myotomy surgeries..." and "Other application described in the literature review involves the use of Endoflip in children with Eosinophilic esophagitis (EoE)..."
• Sample size: Not explicitly stated as a single number. It is implied that multiple studies were reviewed, involving an unspecified number of pediatric patients for achalasia and EoE.
• Data provenance: Not specified (e.g., country of origin, retrospective/prospective for the individual studies reviewed). The studies were part of a "literature review."

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)

• Cannot be provided. The document does not describe a formal process of establishing ground truth by a panel of experts for a specific performance study. The "Clinical Evaluation" refers to the device being used in clinical settings where surgeons and clinicians would interpret the device output in the context of patient care and surgical outcomes (e.g., "real time assessment of the adequacy of the myotomy"), but this is not a structured ground truth establishment for a performance study.

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

• Cannot be provided. No formal adjudication method is mentioned as there isn't a described performance study with a test set requiring such a process.

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. The Endoflip System is a gastrointestinal motility monitoring system, not an AI or imaging interpretation device that would typically involve "human readers" or "AI assistance" in the sense of a diagnostic interpretation product. The document makes no mention of AI.

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

• Not applicable / Cannot be provided. The Endoflip System measures physiological parameters (pressure and dimensions) which are then interpreted by clinicians. It is not an "algorithm only" device in a standalone performance context like an AI-based diagnostic tool.

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

• Implied clinical outcomes, but not formally defined for a performance study. For the pediatric use described, ground truth might relate to surgical success (adequacy of myotomy), patient symptoms, or other clinical assessments (e.g., diagnosis of EoE or achalasia, and response to treatment). However, this is inferred from the clinical applications mentioned, not from a specific "ground truth" definition within a performance study section.

8. The sample size for the training set

• Not applicable / Cannot be provided. The Endoflip System is a measurement device and not an AI/machine learning algorithm that would have a "training set" in the conventional sense.

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

• Not applicable / Cannot be provided. As it's not an AI/ML device with a training set, this question is not relevant.

In summary, the provided document is a 510(k) summary for a change to the indications for use of an existing device (Endoflip System) to include a pediatric age range. It relies on the substantial equivalence to a predicate device (K160725) and a "clinical evaluation" via literature review to support the safety and potential benefit of the device in the pediatric population, rather than presenting a de novo performance study against new acceptance criteria.

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The EsoFLIP® ES-310 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-310 balloon catheter is to be used only with the EndoFLIP® system.

The EsoFLIP® ES-310 catheter is a balloon dilation catheter. It is used by surgeons or gastroenterologists to dilate esophageal strictures due to esophageal surgery, primary gastroesophageal reflux, and radiation therapy. This indication for use is identical to the predicate EsoFLIP® ES-series (ES-320) predicate, K142000.

The EsoFLIP® catheter connects to the EndoFLIP® imaging system in the same fashion as the predicate EsoFLIP® catheter, to display an image of the cross-sectional-areas (CSAs) of the dilation balloon, and to allow the balloon to be inflated using the EndoFLIP® syringe driver.

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

The provided document is a 510(k) summary for the EsoFLIP® ES-310 balloon catheter and focuses on demonstrating substantial equivalence to a predicate device. It does not describe a clinical study with acceptance criteria and a detailed analysis of device performance against those criteria in the way a clinical trial report would.

Instead, the document details non-clinical comparative performance and specifications, primarily through bench testing, to show that the new device operates similarly to the predicate device and meets its stated specifications.

Here's an analysis based on the provided text, addressing your questions where possible:

Acceptance Criteria and Study for EsoFLIP® ES-310 Balloon Catheter

The EsoFLIP® ES-310 balloon catheter underwent non-clinical bench testing to demonstrate its performance and substantial equivalence to its predicate device, the EsoFLIP® ES-series (ES-320) (K142000). The "acceptance criteria" are implied by the device's specifications and the need to demonstrate equivalent performance to the predicate.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally implied to be that the device performs to its stated specifications and is safe and effective for its intended use, similar to the predicate device. The document doesn't explicitly list "acceptance criteria" but rather "specifications" for the device, which are implicitly the targets for acceptance.

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

• Sample Size: The document does not specify the sample size for individual bench tests (e.g., how many balloons were tested for burst pressure or fatigue). It states "The Performance Testing included..." and lists the tests.
• Data Provenance: The data is from non-clinical bench testing. The country of origin for the testing is not explicitly stated, but the company is Crospon Ltd. from Galway, Ireland. The tests were performed to support substantial equivalence to a legally marketed predicate device in the US.

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

• This is a non-clinical bench testing report. Therefore, there were no human experts establishing ground truth in the context of clinical interpretation, as would be the case for an AI diagnostic device. The "ground truth" for bench testing is established by engineering specifications, validated measurement equipment, and standardized testing protocols.

4. Adjudication Method for the Test Set

• Not applicable as this is a non-clinical bench testing report and does not involve human interpretation or clinical adjudication.

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. This document is for a physical medical device (a balloon catheter for dilation), not an AI software device. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or applicable.

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

• Not applicable. This device is a physical catheter designed for use in conjunction with the EndoFLIP® system and by a clinician. It is not an algorithm evaluated for standalone performance.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• For the bench testing, the "ground truth" refers to the established engineering specifications, physical measurements from calibrated instruments, and standardized test methods (e.g., a burst pressure test aims to find the actual burst pressure, which is the "truth" for that specific sample under the test conditions).

8. The Sample Size for the Training Set

• Not applicable. This document describes a physical medical device. There is no concept of a "training set" in the context of software algorithms or machine learning models for this device. The design and manufacturing processes are validated, not "trained."

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

• Not applicable for the reasons stated in point 8.

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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 modification to the EndoFLIP® System is the addition of display functionality. This functionality is software and is referred to as the FLIP Topography module which is a supplemental accessory.

The addition of the supplemental accessory FLIP Topography module does not modify the predicate EndoFLIP® System or change the intended use of the device. This modification does not alter the fundamental scientific technology; the EndoFLIP® System algorithm or change the hardware and accessories associated with the EndoFLIP® System.

FLIP Topography displays the traditional EndoFLIP® data plus FLIP Topography adds historical data graphs (live data for the last 40 seconds) for use by the clinician.

This document is a 510(k) Summary for the FLIP Topography module, an accessory to the EndoFLIP® system. It outlines various aspects of the device but explicitly states that no clinical investigation was needed because the modification (adding display functionality) does not change the fundamental scientific technology or hardware/software performance. Therefore, detailed information about acceptance criteria and a study proving those criteria are met is not present in the provided text.

Based on the provided text, here's what can be extracted and what information is missing:

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

The document states: "Verification activities for the modification were performed and the results demonstrated that the predetermined acceptance criteria were met." However, it does not list what those predetermined acceptance criteria were or the specific reported performance against those criteria.

The verification activities included:

• Data acquisition
• Display characteristics (labels, accuracy, etc.)
• Data management
• Communication

The "Performance" row in the comparison table simply states: "No performance testing for a display device only." This implies that the performance expectations were primarily around accurate data display and handling, rather than new physiological measurements.

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

This information is not provided as no clinical investigation or specific "test set" for performance evaluation of the FLIP Topography module was conducted or described in this document. The document explicitly states, "As there are no changes in hardware or software that will impact performance, there is no need to validate the changes through a clinical investigation."

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)

This information is not provided as no clinical investigation or expert-driven ground truth establishment was conducted for the FLIP Topography module, as per the submission's rationale.

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

This information is not provided as no clinical investigation or expert adjudication process was conducted for the FLIP Topography module.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. The FLIP Topography module is a software display functionality that presents existing data from the EndoFLIP® system, not an AI or diagnostic algorithm that would typically be evaluated in an MRMC study.

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

A standalone performance study of an algorithm was not done in the context of this submission for the FLIP Topography module. The module is described as display functionality, not a standalone diagnostic algorithm.

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

This information is not provided as no new ground truth establishment was required for this accessory, which primarily displays data. The core EndoFLIP® system, to which this is an accessory, would have had its own ground truth established during its original clearance process (K160725 and K092850), but this document does not detail it.

8. The sample size for the training set

This information is not provided. The FLIP Topography module is a display functionality and not an AI/machine learning model that typically requires a training set.

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

This information is not provided. As above, no training set or its ground truth establishment is discussed for this display module.

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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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