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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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