Search Results

The ClearPath Tubing is intended to provide irrigation fluids, such as water, during gastrointestinal endoscopic procedures when used in conjunction with the ClearPath irrigation system components (ClearPath Lower GI, ClearPath Upper GI, and ClearPath Irrigator).

The ClearPath Tubing is intended to provide irrigation fluids, such as water, during gastrointestinal endoscopic procedures when used in conjunction with the ClearPath irrigation system components (ClearPath Upper GI, ClearPath Lower GI, and ClearPath Irrigator). The ClearPath Tubing is single use, disposable.

The ClearPath irrigation system is designed to improve procedure reliability by improving visualization during endoscopic procedures by performing a colon or stomach wash.

The ClearPath Tubing is used to connect the irrigation fluid source (i.e. water bottle), via the peristaltic pump, to the cleaning device of the ClearPath product family (ClearPath Lower GI, K091305 and K113050, ClearPath Upper GI, K093779 and K113166, and ClearPath Irrigator, K 101094). Note that only the ClearPath accessories are to be used with the ClearPath Tubine.

Here's a breakdown of the acceptance criteria and study information for the ClearPath Tubing, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text focuses on establishing substantial equivalence to predicate devices for the ClearPath Tubing, which is an irrigation tube for gastrointestinal endoscopic procedures. As such, the "acceptance criteria" are more related to functional performance and safety demonstration rather than specific quantitative metrics often seen with diagnostic devices.

2. Sample Size for the Test Set and Data Provenance

The document does not specify a "test set" in the context of a clinical study with a defined sample size of patients or cases. The performance testing appears to be primarily engineering or bench testing focused on the physical integrity and function of the tubing itself. This type of testing typically involves a number of manufactured units but not a patient-centric test set.

• Sample Size: Not specified in terms of patient/case count. The testing focused on manufactured tubing units.
• Data Provenance: Not applicable in the context of patient data. The tests are likely internal laboratory tests.

3. Number of Experts and Qualifications

This information is not applicable. The device is an irrigation tube, and its performance testing as described focuses on physical properties (leakage, degradation) rather than diagnostic performance requiring expert interpretation.

4. Adjudication Method

This information is not applicable. There's no mention of a human-in-the-loop diagnostic study or a need for expert adjudication.

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

No MRMC comparative effectiveness study was mentioned or conducted. This type of study is more common for diagnostic devices where AI assistance could impact human interpretation.

6. Standalone (Algorithm Only) Performance

Not applicable. The ClearPath Tubing is a physical medical device (irrigation tube), not an algorithm or AI system.

7. Type of Ground Truth Used

The "ground truth" for this device's performance acceptance is based on the satisfactory results of engineering tests (leak detection, material integrity, visible degradation) rather than clinical outcomes, pathology, or expert consensus on a diagnosis. The primary "ground truth" for regulatory approval is demonstrating substantial equivalence to predicate devices through functional and design similarities.

8. Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI/ML-based system that requires a training set.

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

Not applicable. As noted, there is no training set for this type of device.

Ask a specific question about this device