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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 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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