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The Endoscopic Clean Connecting Tubes includes five subsets as below, they are intended to o provide sterile water and/ or CO2 and/ or air to an endoscope during gastrointestinal endoscopic procedure. These devices are intended to be used by healthcare professional only. This device is intended to be used for not more than 24 hours. It is a 24-hour multi-patient use device. It is supplied in sterile.

The Endoscopic CO2 Source Tubing is intended to be used with a CO2 insufflator along with Clean Cap or Hybrid Irrigation Tubing to supply CO2 to a GI endoscope during GI endoscopic procedures.

The proposed device includes two (2) categories:

• Endoscopic Clean Connecting Tubes
• Endoscopic CO2 Source Tubing

The proposed device, Endoscopic Clean Connecting Tubes, is to connect an air/ CO2 source, a sterile water source (water bottle), and an endoscope to supply air/ CO2 and water during gastrointestinal endoscopic procedures. This device is intended to be used for not more than 24 hours. It is a 24-hour multi-patient use device. It is supplied in sterile.

The Endoscopic Clean Connecting Tubes includes five (5) subsets:

• Irrigation Tube;
• Clean Cap
• Clean Cap with CO2 Source Tube
• Hybrid Irrigation Tubing
• Hybrid Irrigation Tubing With CO2 source tube

The Endoscopic CO2 Source Tubing is designed to be attached to the air/water bottle tubing and the outlet of the CO2 insufflator to provide irrigation and CO2 insufflation through the air/water channel to the distal end of endoscope. It is composed of one female luer connector, one male luer connector, one rigid tube and air/gas filter. The air/gas filter can filter particulates from the CO2 source and keeps fluid from flowing into the CO2 Source.

The Endoscopic Clean Connecting Tubes and CO2 Source Tubing are provided sterile. The both device is sterilized by EO and the shelf life is three (3) years.

The provided text describes a 510(k) premarket notification for "Endoscopic Clean Connecting Tubes" and "Endoscopic CO2 Source Tubing." This documentation focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the performance of an AI/ML device against specific acceptance criteria.

Therefore, I cannot provide the information requested in the prompt because the provided text pertains to a Class II medical device (endoscopic accessories) and not an AI/ML device. The submission does not describe an AI/ML algorithm requiring a test set, expert ground truth labeling, MRMC studies, or standalone performance metrics for an AI system. The non-clinical testing mentioned refers to standard medical device performance tests like water flow rate, leakage, compatibility, and biocompatibility, not AI performance metrics.

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The Clean Connecting Tube (tubing and accessories to accommodate various GI endoscopes and irrigation pumps) is intended to provide irrigation via sterile water and to supply air(via an air pump) or CO2(Via a CO2 pump) along with sterile water during GI endoscopic procedures when used in conjunction pump or electrosurgical unit.

The Clean Connecting Tube is intended for 24 hour multiple-patient use and then discarded. The Clean Connecting Tube design minimizes infection control risks that are associated with manual cleaning and sterilization.The maximum number of patient is up to 15 in 24 hours , and maximum duration of us shall not exceed 15h. The check valve attached to the irrigation tubing shall be replaced after every patient use. The Clean Connecting Tube is manufactured for use in conjunction with sterile water bottle, and together with irrigation pump. The Clean Connecting Tube is designed to be attached to the auxiliary water connector or biopsy irrigation accessory and to be inserted into pump head of the irrigation pump to provide irrigation pump to provide irrigation through the auxiliary water channel to the distal end of endoscope.

I am sorry, but the provided text does not contain the information required to answer your request regarding the acceptance criteria and study proving a device meets these criteria. The document is a 510(k) premarket notification letter from the FDA regarding a "Clean Connecting Tube" device and its substantial equivalence to a predicate device.

It primarily discusses:

• The FDA's review and determination of substantial equivalence.
• Regulatory classifications and requirements for the device.
• A comparison of the proposed device ("Clean Connecting Tube") with a predicate device ("Universal Irrigation Solution Hybird™").
• Non-clinical performance data (bench tests, compliance with ISO standards), stating "The results of all testing were passing."
• A clear statement that "No Clinical Study is included in this submission."

Therefore, I cannot provide details on:

1. A table of acceptance criteria and reported device performance (beyond "passing" for bench tests).
2. Sample sizes for a test set or data provenance.
3. Number/qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study or effect size.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This document indicates that substantial equivalence was primarily established through a comparison of technological characteristics and non-clinical bench testing, rather than human-in-the-loop or standalone AI performance studies typically associated with the type of acceptance criteria you are asking about.

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