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The EsoCheck CCD 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 Lucid Diagnostics EsoCheck™ CCD 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 Once positioned, the balloon is inflated and withdrawn allowing its textured surface to swab the surface of the targeted segment of the esophagus, retrieving cells in the process.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cells on its surface into the capsule, where they are protected from dilution or contamination as the capsule is fully withdrawn from the patient.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.

The provided text describes the 510(k) premarket notification for the EsoCheck CCD Cell Collection Device. While it outlines the device's purpose, design, non-clinical tests conducted (verification and validation), and its substantial equivalence to predicate devices, it does not contain information regarding the acceptance criteria for device performance, nor details of a study that proves the device meets specific performance criteria related to diagnostic accuracy (e.g., sensitivity, specificity, or human reader improvement with AI assistance).

The document focuses on:

• Device Description: How the EsoCheck CCD Cell Collection Device works to collect esophageal cells.
• Intended Use: For collection and retrieval of surface cells of the esophagus from adults 22 years and older.
• Substantial Equivalence: Comparison to previously cleared predicate devices (Brandt Cytology Balloon, Cytosponge, Hobbs Medical Cytology Brush) based on intended use, population, anatomical location, design, principles of operation, and single-use disposition.
• Nonclinical Tests: Lists various verification (e.g., visual inspection, balloon inflation/deflation, tensile tests) and validation (biocompatibility, sterilization, shelf life, user validation) tests. These are primarily engineering and safety tests rather than performance tests for diagnostic accuracy.

Therefore, I cannot fulfill your request for the following information based solely on the provided text:

1. A table of acceptance criteria and the reported device performance: The document lists non-clinical tests but does not provide specific performance metrics (e.g., cell yield, diagnostic accuracy) or their acceptance criteria.
2. Sample size used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth and their qualifications: Not mentioned, as no diagnostic performance study is detailed.
4. Adjudication method for the test set: Not applicable based on the provided information.
5. MRMC comparative effectiveness study: Not conducted or mentioned. The device is a cell collection tool, not an AI-assisted diagnostic tool.
6. Stand-alone (algorithm only) performance: Not applicable, as it's a physical device, not an algorithm.
7. Type of ground truth used: Not mentioned.
8. Sample size for the training set: Not applicable, as there's no mention of an algorithm requiring a training set.
9. How ground truth for the training set was established: Not applicable.

The "user validation" listed under validation testing (page 5) might imply some form of study involving users, but the details (methodology, sample size, outcome metrics, acceptance criteria) are not provided in this regulatory letter and 510(k) summary. This submission is for a cell collection device based on substantial equivalence, not a novel diagnostic method requiring extensive clinical performance studies for de novo clearance or PMA.

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The Cytosponge Cell Collection Device is indicated for use in the collection and retrieval of surface cells in the esophagus for cytological and histological analyses.

The Cytosponge™ Cell Collection Device is a non-sterile, single-use device. The Cytosponge™ Cell Collection Device consists of a clear, size 00 vegetable-material-derived capsule which holds a 30mm compressed spherical sponge inside of the capsule. The capsule containing the sponge is attached to a silicone-coated braided polyester suture. The suture is attached and secured to a retainer card via an ABS plug. The capsule is swallowed and dissolves in the stomach thereby releasing the self-expanding sponge. The sponge is then retrieved from the stomach using the attached suture. During the retrieval process, the sponge collects cells from the outer layer of esophageal tissue.

This document is a 510(k) Summary for the Cytosponge Cell Collection Device, not a study describing acceptance criteria and device performance. Therefore, most of the requested information regarding acceptance criteria, study design, and performance metrics cannot be directly extracted from this document.

However, based on the provided text, I can infer the following:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table of acceptance criteria with specific numerical targets. It broadly states that functional testing was performed.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document, as it describes a device for cell collection, not an AI or diagnostic imaging device that requires expert ground truth for interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable/provided in the document. The document describes a physical medical device (cell collection device), not an algorithm requiring adjudicated interpretations for ground truth.

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

This information is not applicable/provided in the document. This is not an AI-assisted diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable/provided in the document. This is not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the Cytosponge Cell Collection Device, the "ground truth" would relate to its ability to collect cells for cytological and histological analysis. The document states the device collects cells for these analyses, implying that the ultimate "ground truth" for the collected cells would be established by cytological and histological pathology performed on the collected samples. However, the study described in this document focuses on the performance equivalence of the device itself (e.g., dissolution, tensile strength), rather than a clinical outcome study using pathology as ground truth.

8. The sample size for the training set

This information is not applicable/provided in the document. This is not an AI/machine learning device that uses a training set.

9. How the ground truth for the training set was established

This information is not applicable/provided in the document. This is not an AI/machine learning device.

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