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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 and adolescents, 12 years of age and older.

The EsoCheck Cell Collection Device is a non-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 Once positioned, the balloon is inflated and withdrawn allowing its textured surface to swab the surface of the targeted segment of the esophagus, retrieving cells in the process.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cells on its surface into the capsule, where they are protected from dilution or contamination as the capsule is fully withdrawn from the patient.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 subject device is technologically identical to the previously-cleared predicate device (K222366). The only modification to the subject device is of its sterility, which has been modified to non-sterile (i.e., provided non-sterile and not requiring end-user sterilization before use).

The provided document does not contain information regarding acceptance criteria or studies proving device performance in the sense of clinical performance or diagnostic accuracy. Instead, it is an FDA 510(k) clearance letter and summary for a medical device, the EsoCheck Cell Collection Device.

This document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving a diagnostic algorithm's performance against clinical acceptance criteria. The key point is that the only modification to the device is its sterility status (from sterile to non-sterile). Therefore, the "performance data" section in this document refers to engineering and safety performance related to this change (e.g., bioburden testing), not clinical accuracy or effectiveness in diagnosing a condition.

Therefore, I cannot fulfill the request as it pertains to the clinical performance of a diagnostic device, the establishment of ground truth, or an MRMC study.

Here's a breakdown of why and what information is present:

• No Acceptance Criteria for Diagnostic Performance: The document does not define metrics like sensitivity, specificity, or accuracy for the EsoCheck device's ability to diagnose a condition. Its function is to collect cells, not to perform a diagnosis itself.
• No Study Proving Diagnostic Performance: There is no mention of a study evaluating the device's diagnostic accuracy or comparing its performance against a ground truth for a disease.
• The "Performance Data" Section: This section specifically states, "All prior testing of the predicate device remains applicable to the subject device because sterilization status could not affect device performance (thus no new performance testing is required), and the prior sterilization method (EtO) constituted worst case test conditions for other types of testing (i.e., biocompatibility and packaging/shelf life)." The only new testing mentioned is "bioburden testing" to support the change to non-sterile status. This is a safety and manufacturing performance test, not a clinical diagnostic performance test.

To directly address your requested points based on the provided text, the answer for most will be "Not Applicable" or "No information provided," as the document's purpose is different from what your prompt assumes:

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

   • Acceptance Criteria: Not applicable for diagnostic performance. The implicit acceptance criterion for this 510(k) was that changing the sterility status to non-sterile did not negatively impact safety or essential functioning, which was demonstrated by bioburden testing.
   • Reported Device Performance:
     • Bioburden Testing: Showed "an absence of specific objectionable organisms and acceptable bioburden levels."
     • Cell Adherence: "Functionally, the ability of cells to adhere to the EsoCheck balloon surface is unimpacted by device sterility."

2. Sample sized used for the test set and the data provenance: Not applicable. No clinical test set data is provided. The bioburden testing would have involved samples from the manufactured device, not patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical ground truth establishment is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

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: Not applicable. This device is a cell collection tool, not an AI-powered diagnostic algorithm.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.

8. The sample size for the training set: Not applicable. No training set for an algorithm is mentioned.

9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a regulatory submission for a physical medical device (cell collection device), not a document detailing the validation of a diagnostic algorithm or AI system.

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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 and adolescents, 12 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 esophaqus. 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 EsoCheck Cell Collection Device, but it does not contain specific acceptance criteria or performance metrics in a table format, nor does it detail a study that defines such criteria and measures the device's performance against them.

The "Performance Data" section in the document refers to a GLP animal study that supported the expansion of the device's indications for use to include adolescents. However, this study focused on safety (successful esophageal deployment and no significant injuries) rather than specific performance metrics like sensitivity, specificity, or cell collection efficiency which would typically be associated with acceptance criteria for such a device.

Here's an analysis based on the information provided, and what is missing:

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

• Missing. The document does not provide a table with acceptance criteria or quantitative performance metrics for cell collection, diagnostic accuracy, or similar. The "performance data" discussed is related to safety for expanded use in adolescents.

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

• The only study mentioned is a GLP animal study in a porcine model.
• Sample size: Not specified.
• Data provenance: Prospective (animal study).

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)

• Not applicable. The animal study was for safety (lack of injury), not for establishing diagnostic ground truth requiring expert interpretation of collected samples.

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

• Not applicable. The animal study focused on physical outcomes (esophageal deployment, injury assessment), not diagnostic interpretation requiring adjudication methods.

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 device is a cell collection device, not an AI-assisted diagnostic tool.

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

• No. This device does not have an AI algorithm.

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

• For the animal study related to the expanded indication, the "ground truth" was the absence of significant injuries and successful deployment observed during evaluations after the procedure. This would be based on direct veterinary assessment or pathological examination of the animal tissues.

8. The sample size for the training set

• Not applicable. The device is a physical cell collection device; there is no mention of a training set for an algorithm.

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

• Not applicable. (No training set for an algorithm).

Summary of what is available regarding performance for the expanded indication:

The document states: "The animal study found that the EsoCheck Cell Collection Devices demonstrated successful esophageal deployment, and evaluations after the EsoCheck procedure found no significant injuries in the test population." This is the reported performance for the specifically mentioned study designed to support the expanded indication for adolescents. It focuses on the safety and mechanical functionality in an adolescent-representative model.

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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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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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