(17 days)
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 Once positioned, the balloon is inflated and withdrawn allowing its textured surface to swab the surface of the targeted segment of the esophagus, retrieving cells in the process.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cells on its surface into the capsule, where they are protected from dilution or contamination as the capsule is fully withdrawn from the patient.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:
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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."
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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.
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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.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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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.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
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The sample size for the training set: Not applicable. No training set for an algorithm is mentioned.
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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.
§ 874.4710 Esophagoscope (flexible or rigid) and accessories.
(a)
Identification. An esophagoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the esophagoscope and is intended to examine or treat esophageal malfunction symptoms, esophageal or mediastinal disease, or to remove foreign bodies from the esophagus. When inserted, the device extends from the area of the hypopharynx to the stomach. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the flexible foreign body claw, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps and flexible biopsy curette, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.