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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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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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The EsoFLIP® Balloon Dilation Catheter is indicated for use in a clinical setting for dilating the gastro-esophageal junction of a patient with Achalasia.

The EsoFLIP® balloon dilation catheter is a modification of the predicate Crospon EndoFLIP® catheters. The EsoFLIP® is a small catheter with an inflatable balloon which is inserted into the gastro-esophageal junction of a patient with Achalasia. It is connected to the EndoFLIP® controller system (K I20997) and the catherer 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 EsoFLIP® catheter is inserted by the clinician. The proposed balloon dilation catheter, EsoFLIP®, can also make diameter measurements electrically using the same impedance planimetry measuring technique as that deployed in the predicate EndoFLIP® system. K 120997.

This document is a 510(k) Premarket Notification for the EsoFLIP® Balloon Dilation Catheter. It outlines the device's description, indications for use, comparison to predicate devices, and a summary of non-clinical testing.

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

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

The document does not explicitly state "acceptance criteria" for each performance metric with specific thresholds. Instead, it states that "The results demonstrate that the EsoFLIP® has met the performance specifications." and that the device is "substantially equivalent" to predicate devices. The performance data provided is primarily a comparison to the predicate device's specifications.

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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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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.

The EndoFLIP® system and catheter are identical to the predicate K092850, except the addition of the new software which permits a programmed series of inflations of the balloon in steps of volume. This feature is equivalent to a modality offered by the predicate Barostat (K991288).

The device is not intended to perform a diagnostic test.

The provided text is a 510(k) summary for the EndoFLIP® Barostat Mode device. It describes the device, its indications for use, and a comparison to predicate devices, but it does not contain information about specific acceptance criteria or a study proving the device meets those criteria, nor any performance data resulting from such a study.

The document states:

• "No comparative bench testing was required as the change is a software change only."
• "The proposed software modification does not change the performance specification of the EndoFLIP®, which remains identical to the predicate K092850."

Therefore, I cannot fulfill your request for the following information based on the provided text:

1. A table of acceptance criteria and the reported device performance
2. Sample sized used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
4. Adjudication method for the test set
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, and the effect size
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
8. The sample size for the training set
9. How the ground truth for the training set was established

The document focuses on demonstrating substantial equivalence to predicate devices based on indications for use, environment of use, patient population, technology/design, and materials, asserting that the software change does not alter performance specifications.

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The EndoFLIP® EF-800 is an external channel for an endoscope (9.0 to 12.2 mm in diameter) used to aid in the insertion, advancement, and removal of endoscopic devices during endoscopic procedures. The EndoFLIP® ECD is single patient use, disposable. Environments of use - Hospitals, Sub-acute care institutions, Surgery Centers, doctor's offices where endoscopic procedures may be performed.

The EndoFLIP® ECD EF-800 External Channel Device (ECD) is an endoscopic accessory designed to provide an additional channel external to the endoscope for inserting, advancing, and removing endoscopic devices thereby preserving the working channel of the endoscope for other instruments.

Here's an analysis of the provided text regarding the acceptance criteria and study for the EndoFLIP® ECD EF-800, structured as requested.

The provided document is a 510(k) Summary, which is typically a premarket notification to the FDA to demonstrate that a device is substantially equivalent to a legally marketed predicate device. In many cases, for devices of this type (an accessory to an endoscope), the "acceptance criteria" are demonstrating equivalence in technical characteristics and performance to predicate devices, rather than establishing new clinical thresholds. The "study" often refers to non-clinical testing.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of the K110531 submission, the "acceptance criteria" are implied by the comparison to predicate devices, focusing on demonstrating similar functional, material, and safety characteristics. The performance reported is primarily through compatibility and age testing to ensure the device performs as expected for its intended use.

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

For the "Performance Testing" mentioned (Age testing and Compatibility testing), the document does not specify:

• The exact sample size used for these tests.
• The origin of data (e.g., country of origin).
• Whether the data was retrospective or prospective.

These tests are typically bench or lab-based rather than clinical studies with human participants.

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

This type of information (number and qualifications of experts for ground truth) is typically relevant for studies involving subjective assessment (e.g., image interpretation). For a device like an endoscopic accessory undergoing performance testing (age testing, compatibility testing), the "ground truth" would be established by objective measurements and standardized test protocols, not by expert consensus on, for example, image interpretation. Therefore, this information is not applicable in the context of the provided regulatory submission.

4. Adjudication Method for the Test Set

As the performance testing described is objective (age testing, compatibility with endoscopes), there is no mention of an adjudication method (like 2+1 or 3+1). Such methods are typically used when subjective expert assessments need to be reconciled, which is not the case here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. MRMC studies are typically clinical trials designed to compare the diagnostic performance of different methods (e.g., AI vs. human readers, or human readers with vs. without AI assistance) across multiple readers and cases. This submission focuses on demonstrating substantial equivalence of a physical medical device accessory through comparison of technical specifications and non-clinical performance tests.

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

No, this is not applicable. The EndoFLIP® ECD EF-800 is a physical medical device accessory (an external channel for an endoscope), not a diagnostic algorithm or an AI-powered system. Therefore, the concept of "standalone algorithm performance" (without human-in-the-loop) does not apply.

7. The Type of Ground Truth Used

For the performance tests mentioned:

• Age testing: The "ground truth" would be the stability and integrity of the device materials and function over a specified period, verified by empirical observation/measurement (e.g., material degradation, functional checks after accelerated aging) against predefined engineering specifications.
• Compatibility testing: The "ground truth" would be the successful and unimpeded sliding of the device over various endoscope diameters, verified by direct observation/measurement (e.g., successful navigation, absence of damage to either device) against specified dimensional and functional tolerances.

This is based on engineering specifications and objective physical measurements, not expert consensus, pathology, or outcomes data in a clinical sense.

8. The Sample Size for the Training Set

Not applicable. This device is a physical medical accessory, not an AI or machine learning model 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 in the context of machine learning.

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The EndoFLIP® EF-900 Gastric Tube is intended for use in bariatric surgical procedures to provide a sized support bougie, and to permit stomach decompression, gastric fluid drainage and removal. It is also intended for use to aid deployment of EndoFLIP® EF-620, EF-325, and BF-325 catheters.

The EndoFLIP® Gastric Tube is a simple single lumen tube which acts as a support bougie for a 43 Fr lumen and may be used to aid in the EndoFLIP® catheter, K092850 and K 102214, deployment. It may also be used for drainage, suction or irrigation as it is open at both ends and features a number of side-holes at the distal end. A connector is supplied to push-on the proximal end to aid attachment to a suction system. The tube is 75 cm long and markings are provided at 20 cm and 70 cm from the distal end. The EndoFLIP® Gastric Tube is supplied non-sterile and is single patient use, disposable. An alcohol swab is provided to wipe down the tube exterior prior to use.

The Crospon Ltd. EndoFLIP® Gastric Tube EF-900 is a single-lumen tube intended for use in bariatric surgical procedures as a support bougie, for stomach decompression, gastric fluid drainage and removal, and to aid deployment of other EndoFLIP® catheters.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided document does not specify a separate test set or sample size for the performance testing mentioned (age testing, kink test, biocompatibility). The testing appears to be conducted on the device itself as part of product validation.

Data provenance (e.g., country of origin, retrospective/prospective) is not applicable or provided for these types of engineering/material tests.

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

This information is not applicable to the type of performance testing described. The acceptance criteria relate to physical and material properties, not clinical diagnostic accuracy or similar evaluations that would require expert-established ground truth.

4. Adjudication Method for the Test Set

This information is not applicable as there is no mention of a human expert review process for the performance criteria. The testing involves objective measurements against established engineering and biocompatibility standards.

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

No MRMC comparative effectiveness study was mentioned. The device is a surgical tool, not an imaging or diagnostic device that would typically undergo such a study.

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

No standalone or algorithm-only performance study was conducted. The device is a physical instrument, not an AI or software-based system.

7. Type of Ground Truth Used

The "ground truth" for the performance criteria appears to be established by engineering specifications, international standards (e.g., ISO 10993-1), and internal performance specifications. For example, the biocompatibility ground truth is conformity to ISO 10993-1. For age and kink testing, the ground truth is likely predefined thresholds for durability and functionality under specified conditions.

8. Sample Size for the Training Set

This information is not applicable. The device is a medical instrument and does not involve AI or machine learning that would require a "training set."

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

This information is not applicable for the same reason as above.

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