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The gathering and recovery of cells and cellular material from the mucosa in the esophagus for cytological and histological analyses.

The EsophaCap® Swallowable Cellular Retrieval Device is a non-sterile, non-endoscopic, singleuse Esophageal cell sampling device. The EsophaCap® is composed of an open-cell polyether polyurethane foam sphere attached to a polyester tether cap. The open-cell foam sphere ranging in diameter sizes from 20 mm to 35mm is compressed and encapsulated within a vegetable (hypromellose (HPMC)) capsule. When swallowed the EsophaCap® capsule dissolves releasing the foam sphere. The foam sphere expands to form a cytology and cellular retrieval device that allows a circumferential "bottle brush" collection using the expanded "open cell" foam sphere. The radiopaque polyester tether/stylus is used to slowly withdraw the foam sphere through the esophagus and then to subsequently retrieve the foam sphere with the cellular sample.

The provided text describes the EsophaCap® Swallowable Cellular Retrieval Device, its intended use, and its equivalence to predicate devices, but it does not contain information about acceptance criteria and a study proving the device meets those criteria from an AI/ML perspective. The document focuses on regulatory clearance (510(k)) based on substantial equivalence to existing devices.

The "Testing Performance Data" section mentions "bench testing, biocompatibility testing and user input" and lists specific bench tests like "dissolution testing, and tether /stylus tensile testing, and tether/stylus length test." These are engineering and material performance tests, not clinical studies demonstrating performance against diagnostic or other clinical acceptance criteria that would typically be associated with an AI/ML device.

Therefore, I cannot provide the requested information, specifically:

1. A table of acceptance criteria and the reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts used to establish ground truth and their qualifications.
4. Adjudication method for the test set.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done.
6. If a standalone (algorithm only) performance was done.
7. The type of ground truth used.
8. The sample size for the training set.
9. How the ground truth for the training set was established.

This device, as described, is a physical medical device (cellular retrieval device), not an AI/ML diagnostic or predictive tool, and thus the typical metrics and study designs for AI/ML devices are not applicable or reported in this document.

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