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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.

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

The document lists "Bench Testing" reports (e.g., DHF_1343, DHF_1290, DHF_1296, etc.) which indicate non-clinical lab-based testing. However, the specific sample sizes used for these tests are not provided within this document. The provenance of this data is from the manufacturer, Crospon Ltd. in Ireland, as indicated by the company's address. The testing is non-clinical, so "retrospective or prospective" does not directly apply in the same way it would for clinical data, though it represents new testing performed for this submission.

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 document details bench testing (non-clinical), not clinical trials involving human subjects or expert assessment of medical images for ground truth. Therefore, information about the number of experts or their qualifications for establishing ground truth is not applicable and not provided in this submission.

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

As this document describes bench testing, there is no adjudication method for a test set involving human interpretation of results. The "ground truth" for the bench tests would have been established by the test protocols and measurement instruments.

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

There is no mention of an MRMC comparative effectiveness study, human readers, or AI assistance in this document. This submission is for a medical device (catheter) and focuses on its physical and functional equivalence to predicate devices through non-clinical testing.

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

This document describes a physical medical device (catheter) with a measurement function described as "electrically using the same impedance planimetry measuring technique as that deployed in the predicate EndoFLIP® system." While there is a "measurement" aspect, it's not an AI algorithm in the typical sense that would have a standalone performance evaluated for "algorithm only" against human-in-the-loop. The performance listed (range, resolution, accuracy) refers to the device's ability to measure diameter, which is a standalone function of the device and its associated controller.

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

For the non-clinical bench testing, the "ground truth" would be established by controlled experimental conditions, metrology standards, and validated measurement equipment. For example, in "Balloon Compliance Tests," the ground truth for displacement or pressure would come from calibrated sensors and known physical properties. There is no expert consensus, pathology, or outcomes data relevant to these non-clinical tests.

8. The sample size for the training set

This document describes a medical device, not an AI algorithm that requires a "training set." Therefore, this information is not applicable and not provided.

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

As there is no training set for an AI algorithm, this information is not applicable and not provided.

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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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The EndoFLIP® EF-620 catheter is indicated for use as an adjunct to a bougie for measuring the size of a gastric sleeve created during bariatric surgery. It is suitable for diameter measurements for 22 to 60 French sleeves.

The EF-620 catheter is to be used only with the EndoFlip System.

The EndoFLIP® comprises a measuring system and a single use catheter to assist in measuring the gastric sleeve. 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 into the stomach by an anesthesiologist with placement being confirmed by the surgeon under direct laparoscopic visualization. One the balloon has been correctly located, it is then inflated with the diluted saline solution to user programmed volume. The display estimates the gastric sleeve diameter at sixteen points along the balloon. The system also allows snapshots to be taken and compared to real-time images.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

Study Details

The provided document describes a 510(k) submission, which focuses on demonstrating substantial equivalence to a predicate device rather than a comprehensive clinical or standalone performance study in the way one might evaluate a new AI algorithm.

1. Sample sized used for the test set and the data provenance:

• The document states, "We performed the appropriate bench testing to demonstrate that the new catheter in combination with the EndoFLIP® controller performs within the specifications of the predicate catheter with the EndoFLIP® controller."
• The exact sample size for the "bench testing" is not directly specified in the document.
• Data provenance is not specified. The testing appears to be internal bench testing, likely conducted in a lab environment.

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

• Not applicable. This device measures physical dimensions using a specific electromechanical system. The "ground truth" for its accuracy would likely be established using calibrated physical measurement tools (e.g., precise calipers, micrometers, or reference gauges) in a laboratory setting, not expert human readers. There is no mention of human experts being involved in establishing ground truth for the diameter measurements.

3. Adjudication method for the test set:

• Not applicable. As the "ground truth" is established by physical measurement tools, there is no need for expert adjudication.

4. 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 such study was conducted or reported. The EndoFLIP® system is a measurement device that provides data; it does not involve AI assistance for human readers in interpreting images or making diagnoses.

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

• While the device itself is a "standalone" system in terms of performing its measurement function, the "performance" section refers to the system's ability to accurately measure diameter, which is its core function. There isn't an "algorithm only" component that would perform a task typically done by a human, making this question less applicable in the context of this specific device's function. The stated accuracy reflects its standalone measurement capability.

6. The type of ground truth used:

• The ground truth for the diameter measurements would be based on calibrated physical measurements (e.g., using precision measurement tools) of known diameters against which the device's readings are compared.

7. The sample size for the training set:

• Not applicable. The EndoFLIP® system, as described, is an electromechanical measurement device. It does not utilize machine learning or AI that would require a "training set" in the conventional sense. Its function is based on established physical principles and calibrated components.

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

• Not applicable. As no training set for a machine learning model is involved, this question is not relevant.

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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.

The EndoFLIP® comprises a measuring system and a single use catheter to assist in measuring the stoma. 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 alongside an endoscope and introduced across the gastric band under direct visualization. Where available, fluoroscopy may be used to guide the catheter since the measurement electrodes are clearly visible in the image field. Once the balloon has been correctly located, it is then inflated with the diluted saline solution to a user programmed volume. The display shows the changes in the estimated stoma diameter as the gastric band is filled. The system also allows snapshots to be taken and compared to the real-time images.

Here's a breakdown of the acceptance criteria and study information for the EndoFLIP® System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided 510(k) summary does not contain information on the sample size used for a test set, nor does it specify data provenance (country of origin, retrospective/prospective). The performance acceptance criteria are presented as specifications of the device itself, likely derived from internal validation rather than a clinical test set.

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

The document does not mention any experts used to establish ground truth for a test set or their qualifications. The performance specifications appear to be technical measurements of the device's accuracy in measuring physical parameters (diameter, pressure, volume) rather than interpreting clinical images or patient outcomes.

4. Adjudication Method for the Test Set

Since no clinical test set or expert ground truthing is described, an adjudication method for a test set is not applicable and not mentioned.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not mentioned or performed according to this 510(k) summary. The device focuses on measuring physical parameters rather than assisting human readers in diagnostic tasks.

6. Standalone (Algorithm Only) Performance Study

The provided text details the performance of the "EndoFLIP® system" as a whole, including its components (measuring system and catheter). The performance specifications for estimated balloon diameter, pressure, and volume are presented as the device's standalone capabilities. Therefore, a standalone performance was done for the reported specifications. However, this is for the device as a whole, rather than a distinct "algorithm only" component usually associated with AI devices.

7. Type of Ground Truth Used

The "ground truth" for the reported performance metrics (diameter, pressure, volume) would be physical measurements calibrated against known standards. For example, the accuracy of diameter measurement would be validated against objects of known diameters, and pressure/volume against calibrated sensors. The document does not explicitly state the methodology for establishing this ground truth, but it is implied by the nature of the measurements.

8. Sample Size for the Training Set

The 510(k) summary does not mention a "training set" or its sample size. The EndoFLIP® System is a physical measurement device, not a machine learning or AI-driven system that typically requires a training set for algorithm development.

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

As no training set is mentioned or applicable, the method for establishing its ground truth is not applicable and not provided.

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