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The ClearJet is an irrigation / biopsy adapter and irrigation tubing set used to cover the opening to the biopsy / suction / irrigation channel of standard endoscopes. It provides access for endoscopic device passage and exchange, helps maintain sufflation, minimizes leakage of biomaterial from the biopsy port throughout the endoscopic procedure, and provides access for irrigation. It is for use only by trained medical personnel located in hospitals, clinics, and doctors' offices.

The proposed ClearJet adapter is intended to perform irrigation through the working channel of an endoscope by providing a means to control the fluid irrigation with the cleared ClearPath control unit. The ClearJet's is design to improve procedure reliability by improving visualization during endoscopic procedures. The ClearJet utilizes an irrigation / biopsy valve adapter on doling attachment to an endoscope's working channel port for the purpose of performing a colon or stomach wash. The ClearJet is composed of two major units: - . A disposable Irrigator and - . A Control cabinet It is designed to fit the standard endoscope models of Pentax, Olympus, and Fuijinon.

The ClearJet is an endoscope accessory intended to improve visualization during endoscopic procedures by providing irrigation through the working channel of an endoscope. The 510(k) summary reports that the device's performance was evaluated through comparative flow and pressure testing.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a distinct "test set" in the context of clinical data for performance evaluation. The testing described is comparative flow and pressure testing, likely performed on the device itself rather than human or animal subjects. Thus, there's no mention of sample size for a test set derived from patient data, nor its provenance (country of origin, retrospective/prospective).

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. The ground truth for this device's performance was established through objective engineering measurements (flow and pressure testing) against predicate specifications, not expert interpretation of clinical data.

4. Adjudication Method

Not applicable. There was no clinical data requiring expert adjudication.

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

No. The document makes no mention of an MRMC study or any comparative effectiveness study with human readers, with or without AI assistance. The device is an accessory for irrigation, not an AI-powered diagnostic tool.

6. Standalone (Algorithm Only) Performance Study

Not applicable. The ClearJet is a physical medical device (an endoscope accessory), not a software algorithm. Therefore, "standalone" performance in the context of an algorithm does not apply.

7. Type of Ground Truth Used

The ground truth used was the specifications of the predicate devices for flow and pressure. The ClearJet's performance was compared against these objective engineering parameters.

8. Sample Size for the Training Set

Not applicable. The ClearJet is a physical medical device, not an AI or machine learning algorithm that requires a "training set."

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

Not applicable, as there is no training set for this device.

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