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The ERBEFLO CleverCap® Hybrid CO2 Tubing/Cap Sets and CO2 Connector Tube provide sterile water and CO2 or air (if CO2 is not used) to an endoscope for endoscopic procedures.

In general; the Hybrid CO2 Tubing/Cap Sets and CO2 Connector Tubes will be manufactured with medical grade materials or agents used in the medical device industry such as plastics, nickel plated brass, nitrile rubber, acrylic, nylon, ink. solvent, adhesive, etc. The devices provide as a conduit for water for endoscopic irrigation and lens cleaning as well as air or CO2 for insufflation.

There are three (3) types of ERBEFLO CleverCap Hybrid CO>Tubing/Cap Sets for which each respectively interfaces with a specified brand of scope (i.e., Pentax, Olympus, and Fujinon) along with one (1) CO2 Connector Tube to attach to a CO2 source. The Sets consist of multiple tubing segments and a cap. The cap of a Set attaches with an air tight seal to a water source (i.e., a sterile water bottle). Then from the water bottle cap, irrigation tubing of a Set interfaces with a designated pump and via ERBEFLO 2 connector accessories to the specified endoscope for endoscopic lavage. The next segment, the air/water tubing (also coming from the same water bottle cap), connects to an air/water port of a specified scope for air insufflation as well as lens cleaning [Note: The air/water tubing is a tube within a tube in which the endoscope's processor or CO2 Source (if used) is used to pressurize the bottle for functionality (air and water to the endoscope). Also, for the Pentax Set there is an additional air inlet tube that directs air for endoscope functional use. Or if CO2 is used, pressurization (air and water function) occurs via a CO2 Source through a CO2 Connector Tube and a Pentax CO2 Adaptor (Pentax part #OF-G11).]. The third and final seqment for both the Olympus and Fujinon Sets is for connecting to the CO2 Connector Tube for CO2 insufflation. For each Set, both the irrigation as well as the air/water tubing segments have a backflow valve and a clamp to close the tubing while not in use. Additionally, each Set is designed for use with designated irrigation pumps and has an air/water connector(s) for its specified The Hybrid CO2Tubing/Cap Sets are provided sterile and are endoscope. disposable.

The CO₂ Connector Tube has a standard female luer connector for accessing a CO₂ Source. The other end of the Tube has a hydrophobic air/gas filter which filters particulates from the CO2 Source and keeps fluid from flowing into the CQ2 Source. The filtered end of the CO2 Connector Tube attaches to the CO2 segments of the Sets or in the case of the Pentax Set, the Pentax CO2 Adaptor that adjoins the Set to the Endoscope. The CO2 Connector Tube is provided non-sterile and is disposable.

The provided text describes a medical device, the ERBEFLO CleverCap® Hybrid CO2 Tubing/Cap Sets and CO2 Connector Tube, and its review process for 510(k) clearance. However, it does not contain information related to software algorithms, AI, or diagnostic performance metrics typically associated with AI/ML device studies.

Therefore, I cannot provide a table of acceptance criteria and reported device performance related to AI/ML or answer most of the specific questions you've asked, as it appears this is a submission for a physical medical device (tubing and caps) and not a software-driven diagnostic tool.

The document focuses on demonstrating substantial equivalence to predicate devices through various non-AI related evaluations and tests, such as:

• Biological Evaluation: To ensure biocompatibility of materials.
• Performance Feasibility Testing: Comparing flow performance to predicate devices.
• Flow Rate Testing: Measuring irrigation and lens cleaning flow rates.
• Pressure Testing: Ensuring the device can withstand maximum internal pressures.
• Durability Testing: Confirming suitability for 24-hour use.
• 2X Sterilization Functional Testing: Verifying performance after double sterilization.
• Packaging Evaluation: Assessing adequacy and integrity of packaging.
• Sterilization Evaluation: Demonstrating product sterility.

These tests are designed to show that the new device is as safe and effective as existing legally marketed devices, rather than to prove diagnostic accuracy from an AI algorithm.

Summary of what can be extracted from the provided text regarding "acceptance criteria" and "study":

1. A table of acceptance criteria and the reported device performance:

   • Acceptance Criteria (Implied): The device must perform comparably to or better than predicate devices in terms of flow performance, flow rates (irrigation and lens cleaning), withstand maximum internal pressures, be durable for 24-hour use, retain functionality after 2X sterilization, and be biocompatible. Packaging must be adequate, and sterility must be demonstrated according to recognized standards.
   • Reported Device Performance:
     • Biological Evaluation: "demonstrated that there were no biocompatibility issues."
     • Performance Feasibility Testing: "showed that the flow performance... was as good or better than the predicate devices."
     • Flow Rate Testing: "were found to be comparable to or better than the predicate devices and/or commercially available products."
     • Pressure Testing: "demonstrated that the proposed devices would withstand maximum internal pressures."
     • Durability Testing: "proved durable for 24 hour use."
     • 2X Sterilization Functional Testing: "met established performance specifications."
     • Packaging Evaluation: "demonstrated the adequacy and integrity."
     • Sterilization Evaluation: "demonstrate product sterility."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not described in the provided text. The document refers to "evaluations and tests" but does not detail sample sizes for these tests, nor does it mention data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable or described. The "ground truth" here is based on engineering specifications and performance benchmarks, not expert diagnostic interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable or described.

5. 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, as this is not an AI/ML device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI/ML device.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): The "ground truth" or reference standard for this device's performance evaluation would be defined engineering specifications, established scientific methods (e.g., for flow rates, pressure resistance, sterility), and comparison to the performance of the predicate device.

8. The sample size for the training set: Not applicable, as this is not an AI/ML device. There is no concept of a "training set" for this product.

9. How the ground truth for the training set was established: Not applicable, as this is not an AI/ML device.

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