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The ERBEFLO® 2 Disposable Tubing System is intended to provide sterile water source through an irrigation pump and an endoscope (or to an endoscope) for endoscopic procedures.

The ERBEFLO® 2 Disposable Tubing System products are manufactured with medical grade materials or agents used in the medical device industry such as plastics, brass, adhesive, etc. The devices consist of tubing sets, port connectors, channel adapter, and back flow valve to deliver sterile water source through designated pumps and to/or through a scope channel of various endoscopes for irrigation in endoscopy procedures. Clinicians connect the associated products to a water source (i.e., a sterile water bottle) and then to a designated pump and endoscope. The ERBEFLO® 2 Disposable Tubing System are provided sterile and are disposable.

The ERBEFLO® 2 Disposable Tubing System, as described in K190469, is intended to provide a sterile water source through an irrigation pump and an endoscope for endoscopic procedures. The information provided outlines several evaluation and testing types that address different aspects of the device's performance, safety, and efficacy. However, it does not present a formal table of acceptance criteria with corresponding reported performance for each criterion. It rather lists the types of tests performed and general conclusions about meeting performance specifications or demonstrating adequacy.

Here's an attempt to structure the information based on the provided text, while acknowledging that a direct "acceptance criteria" table is not explicitly given:

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 the sample size used for any of the described tests (e.g., number of tubing systems, connectors, or test cycles). It also does not specify the data provenance (e.g., country of origin, retrospective or prospective).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. The tests described are primarily engineering and performance evaluations, not diagnostic accuracy studies involving expert interpretation of data.

4. Adjudication Method for the Test Set

This information is not provided in the document. Given the nature of the tests (functional, mechanical, sterility), an adjudication method in the context of expert consensus is not applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The submission focuses on the safety and efficacy of the device itself through various engineering and sterilization tests, not on its impact on human readers' performance with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable as the ERBEFLO® 2 Disposable Tubing System is a physical medical device (tubing system), not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the tests described is based on:

• Established performance specifications (for visual inspection, flow, pressure, tensile strength, durability, connections).
• Recognized standards (for biocompatibility, sterilization, packaging, ethylene oxide residuals).
• Demonstrated functional properties (sufficient back flow protection, 24-hour multi-patient use, usability according to instructions).

8. The Sample Size for the Training Set

This information is not applicable as the product is a medical device, not an AI or machine learning model that requires a training set.

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

This information is not applicable as there is no training set for this device.

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The ERBEFLO™ 2 Disposable Tubing System is intended to provide sterile water from a water source through an irrigation pump and an endoscope (or to an endoscope) for endoscopic procedures.

The ERBEFLO™ 2 Disposable Tubing System consists of tubing sets, port connectors, channel adapter, and backflow valve to deliver sterile water from a water source through designated pumps and to/or through a scope channel of various endoscopes. Clinicians connect the associated Product(s)/Component(s) to a water source (i.e., a sterile water bottle) and then to a designated pump and endoscope. The ERBEFLO™ 2 Disposable Tubing System is provided sterile and is disposable.

The provided text describes a 510(k) submission for the ERBEFLO™ 2 Disposable Tubing System. While it mentions that performance testing was conducted, it does not provide specific acceptance criteria or detailed results of those tests. Instead, it broadly states that "performance testing involving flow rates, back flow pressure, internal pressure, and durability testing was performed" and that the device had "comparable dimensional, flow, back flow pressure, internal pressure, and durability characteristics" to the predicate device.

Therefore, I cannot fully complete the requested table and answer all questions due to the lack of detailed information in the provided document.

Here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: Not specified. The document only states that "performance testing" was performed.
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). This was an internal test performed by the manufacturer, ERBE USA, Inc.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• This question is not applicable. The device is a disposable tubing system, and its performance (flow rates, pressure, durability) would typically be evaluated through objective engineering and laboratory tests, not by human expert assessment of images or clinical outcomes that require a "ground truth" to be established by experts.

4. Adjudication method for the test set

• This question is not applicable, as it relates to expert review for subjective assessments, which is not relevant for this type of device's performance testing.

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

• This question is not applicable. The ERBEFLO™ 2 Disposable Tubing System is a medical device for fluid delivery, not an AI-powered diagnostic or assistive technology.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• This question is not applicable. The device is a physical medical device, not an algorithm.

7. The type of ground truth used

• This question is not entirely applicable in the same way as for AI/diagnostic devices. For engineering performance tests like flow rates, pressure, and durability, the "ground truth" is typically the measured physical properties against predefined engineering specifications and regulatory standards. The document implies comparison to the predicate device's characteristics as a benchmark.

8. The sample size for the training set

• This question is not applicable. There is no mention of a "training set" as this is a physical medical device, not a machine learning model.

9. How the ground truth for the training set was established

• This question is not applicable for the same reason as above.

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