(382 days)
The Barrett's Cytology Device is intended to collect cytologic samples from the esophageal mucosa without the aid of endoscopy for the purpose of cytologic analysis to determine the presence of abnormalities like Barrett's Esophagus.
The Barrett's Cytology Device is a catheter that is advanced into the esophagus much like a gastric lavage catheter. The catheter with the aid of common intubation techniques is further advanced into the stomach. The placement into the stomach is confirmed by the use of a distal inflatable balloon which is used to identify the lower esophageal sphincter (LES). Identification of the LES is required because the target sample location is typically the distal esophagus. Once the LES is identified an external slide disc on the catheter is used to mark the length of the patient's esophagus from the dental arches. At this time the balloon will be deflated and the catheter withdrawn away from the LES into the esophagus using the slide disc and catheter markings for distance reference as to how far back the catheter is to be withdrawn. When the catheter is withdrawn to the desired location to sample a cytology brush contained within the catheter is deployed out the distal end of catheter and the cytologic brushing commences. Once the brushing of the esophagus is completed the brush is withdrawn back inside the catheter to contain the cell harvest within the catheter lumen. The entire catheter is withdrawn from the patient and the cytology brush is again deployed to prepare microscopic slides for analysis.
The provided document is a 510(k) summary for the "Barrett's Esophageal Cytology Device" and primarily focuses on its intended use and general regulatory information. It does not include detailed studies or data regarding specific acceptance criteria and device performance as requested.
Therefore, I cannot provide the complete answer based solely on the provided text. The document states that the "Summary of Safety and Effectiveness...reflects data available and presented at the time the submission was prepared," but the actual data and study details are not present in this excerpt.
However, I can extract the available information and highlight what is missing:
Acceptance Criteria and Device Performance Study
As per the provided 510(k) summary, specific acceptance criteria for device performance (e.g., sensitivity, specificity for detecting Barrett's Esophagus or dysplasia) and a detailed study proving the device meets these criteria are not included. The document describes the device's function and intended use but does not present a formal study with statistical data to validate its diagnostic accuracy.
Available Information and Missing Details:
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Table of Acceptance Criteria and Reported Device Performance: This information is not provided in the given text. The document describes the device's purpose to "collect cytologic samples...for the purpose of cytologic analysis to determine the presence of abnormalities like Barrett's Esophagus," but does not quantify performance metrics like sensitivity, specificity, or accuracy against specific criteria.
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Sample Size used for the test set and the data provenance: This information is not provided in the given text.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not provided in the given text.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: This information is not provided in the given text.
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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: This information is not provided. The device described is a cytology collection device, not an AI-assisted diagnostic tool for interpretation.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done: This information is not provided. Again, this device is for sample collection, not an AI algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc): This information is not provided in the given text. The device aims to collect samples for "cytologic analysis," implying the ground truth would be based on pathology/cytology reports, but the method for establishing it in a study is not detailed.
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The sample size for the training set: This information is not provided in the given text.
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How the ground truth for the training set was established: This information is not provided in the given text.
Summary of Device and Context from the Text:
- Device Name: Barrett's Esophageal Cytology Device
- Intended Use: To collect cytologic samples from the esophageal mucosa without the aid of endoscopy for the purpose of cytologic analysis to determine the presence of abnormalities like Barrett's Esophagus.
- Regulatory Clearance: K984168 (cleared on Dec 7, 1999)
- Classification: Class II, 21 CFR 876.1075 / Procode: 78 FCF
- Predicate Device: The submission implies comparison to legally marketed predicate devices, but specific details of the predicate device performance used for substantial equivalence are not provided in this excerpt.
- Methodology: Combines non-endoscopic intubation catheter methods and cytology brush technology. Involves advancing a catheter with an inflatable balloon to identify the LES, marking the esophagus length, withdrawing the catheter to the desired sampling location, deploying a cytology brush, and collecting cells.
Conclusion based on provided text:
The provided 510(k) summary describes the device and its intended use for collecting cytology samples. However, it does not contain the detailed study results, acceptance criteria, sample sizes, ground truth establishment methods, or expert qualifications that would typically be found in a study report proving the device meets specific performance criteria. The document refers to "data available and presented at the time the submission was prepared," but these specific data points are absent from the provided excerpt.
§ 876.1075 Gastroenterology-urology biopsy instrument.
(a)
Identification. A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification. (1) Class II (performance standards).(2) Class I for the biopsy forceps cover and the non-electric biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.