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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 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-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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