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The EsoCheck Cell Collection Device is indicated for use in the collection and retrieval of surface cells of the esophagus in the general population of adults, 22 years of age and older.

The EsoCheck Cell Collection Device is a sterile single-use disposable non-endoscopic balloon capsule catheter designed to collect and retrieve surface cells of the esophagus. The balloon capsule is attached to a catheter and swallowed with the balloon deflated and inverted. Once positioned, the balloon is inflated and withdrawn allowing its textured surface to swab the surface of the targeted segment of the esophagus, retrieving cells in the process. The balloon is then deflated, retracting it along with the retrieved cells on its surface into the capsule, where they are protected from dilution or contamination as the capsule is fully withdrawn from the patient. The balloon is cut from the capsule and placed in the desired specimen container. The specimen is then sent for diagnostic processing and analysis.

This version of the device is a modification to the predicate EsoCheck CCD Cell Collection Device that was cleared under K183262. The minor changes made to the device include minor changes to the secondary packaging design change (addition of a tether) to increase tensile stiffness of the catheter during removal. In addition, the previous version of the device utilized 2 syringes, a 20cc syringe and a 5cc syringe, to complete the procedure. The modified device will utilize a single 20cc syringe to streamline the process and the syringe will have markings printed on its surface indicating different volumes.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the EsoCheck Cell Collection Device.

Important Note: The provided document is a 510(k) summary for a device (EsoCheck Cell Collection Device), not an AI algorithm. Therefore, many of the typical AI/ML-related questions (e.g., ground truth for training/test sets, expert adjudication, MRMC studies, standalone algorithm performance) are not applicable to this submission. The "study" mentioned here refers to device validation tests, not a clinical performance study involving AI.

Acceptance Criteria and Device Performance (Based on Device Modifications)

The document primarily discusses the validation of modifications to an already cleared device, not the initial clearance of a novel device. The "acceptance criteria" are implied by the nature of the tests performed to ensure the modified device remains safe and effective and is substantially equivalent to its predicate.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document only states that these tests were performed and implies successful completion, leading to the conclusion of substantial equivalence. It does not provide specific metrics or thresholds (e.g., "sterility assurance level X achieved," "packaging passed drop test Y," "95% of users found the device easy to use").

2. Sample Size and Data Provenance

Since this is a device modification validation and not a clinical study on patient data for an algorithm, the concepts of "sample size for the test set" and "data provenance" (country, retrospective/prospective) as they relate to AI/ML clinical performance are not directly applicable or reported in this document. The "tests" refer to laboratory and engineering validations.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. Ground truth for AI/ML performance is irrelevant here as it's a device. The "experts" would be the engineers and quality control personnel conducting the validation tests, but their number and qualifications are not specified nor relevant in the context of AI ground truth.

4. Adjudication Method for the Test Set

Not applicable. There is no "test set" in the sense of clinical data requiring expert adjudication, as this is a device validation.

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

Not applicable. This is not an AI-assisted diagnostic tool; it is a cell collection device. Therefore, no MRMC study, human reader improvement, or effect size is relevant.

6. Standalone Algorithm Performance

Not applicable. There is no algorithm here whose standalone performance would be measured.

7. Type of Ground Truth Used

The "ground truth" for these device validation tests would be:

• Sterilization: Regulatory standards (AAMI TIR 28:2016) and passing criteria for sterility.
• Packaging: Engineering specifications and industry standards for package integrity.
• Shelf-Life: Material degradation limits and functional requirements over time.
• Usability: User feedback and task completion rates against predefined usability goals.
• Bench Performance: Engineering specifications and functional requirements of the device (e.g., aspiration volume, balloon inflation/deflation, tether tensile strength).

The document does not detail the specific metrics for these.

8. Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI model requiring a training set of data.

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

Not applicable. See point 8.

Summary of the Device and its Modifications:

The EsoCheck Cell Collection Device is a sterile, single-use, disposable, non-endoscopic balloon capsule catheter designed to collect surface cells from the esophagus. The procedure involves swallowing the deflated capsule, inflating the balloon once positioned, and then withdrawing it to swab the esophageal surface. Cells are then retracted into the capsule and protected during withdrawal.

The modified device, K210137, has minor changes compared to its predicate (K183262):

• Minor changes to the secondary packaging design (addition of a tether to increase tensile stiffness during removal).
• Changed from using two syringes (20cc and 5cc) to a single 20cc syringe with printed volume markings to streamline the process.

The "Performance Data" section lists the types of tests performed to validate these minor modifications: Sterilization Validation, Packaging Validation, Shelf-Life Testing, Usability Confirmation Testing, and Bench Performance Testing. The conclusion is that these tests demonstrate the modified device is as safe and effective as the predicate and is substantially equivalent.

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