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The Andorate™ Auxiliary Water Connector (Model GAR027) is used in conjunction with irrigation tubing (not supplied), intended to provide irrigation fluids such as sterile water supplied to the Olympus 160 series endoscope during gastrointestinal endoscopic procedures when used in conjunction with an irrigation pump.

The Andorate™ Auxiliary Water Connector is intended for single-use and are supplied sterile. Single-use auxiliary water connector help prevential safety risks and eliminate the need for manual cleaning and reprocessing. The auxiliary water connector easily incorporate into infection prevention policies as a single use item. The Andorate™ Auxiliary Water Connector are manufactured for use in conjunction with irrigation tubing, and together with Olympus 160 series endoscopes. The auxiliary water connector is individually packed in sealed package, sold as a sterile device. In the submission, Andorate™ Auxiliary Water Connector is the only subject device. This submission does not include irrigation tubing or irrigation pump. The auxiliary water connector are designed to the auxiliary water port of the endoscopes. The auxiliary water connector consist of a backflow valve which prevent the backflow of water or biomaterials from the endoscope to the sterile water bottle.

The provided document (K182998) is a 510(k) summary for an auxiliary water connector for endoscopes. This type of device is a physical accessory and not a software algorithm or AI-driven system. Therefore, the questions related to AI/algorithm performance, such as sensitivity, specificity, MRMC studies, ground truth establishment for training/test sets, and sample sizes for training sets, are not applicable to this submission.

The acceptance criteria and proof of device performance (rather than algorithm performance) are based on non-clinical bench testing demonstrating functional equivalence and safety compared to a predicate device.

Here's a summary of the relevant information from the document:

1. Table of Acceptance Criteria and Reported Device Performance

For this medical device (Andorate™ Auxiliary Water Connector), the "acceptance criteria" are typically defined by functional performance requirements identified through risk analysis and comparison to a predicate device, and the "device performance" is demonstrated through bench testing.

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

The document states, "Smartdata performed bench testing to support substantial equivalence. The following testing was performed on Smartdata samples from initial production lots, including sterilization." It does not specify the exact sample size (number of units tested) for each specific test (e.g., how many connectors were tested for backflow).

• Sample Size: Not explicitly stated as a number of units, but "samples from initial production lots."
• Data Provenance: The tests were conducted by Smartdata Suzhou Co., Ltd. (China) and accredited laboratories (e.g., Sanitation Environment Technology Institute, Soochow University, for packaging tests). The data is prospective in the sense that it was generated specifically for this 510(k) submission on newly manufactured devices.

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

This concept is not applicable as this is a medical device (accessory) and not an AI/algorithm-driven diagnostic/screening tool. Ground truth for device performance is established through engineering and performance specifications and validated through bench testing, not expert interpretation of image data.

4. Adjudication Method for the Test Set

Not applicable. This is not an image-based diagnostic study requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC study was not done because this is a physical medical device (an auxiliary water connector) and not an AI/imaging algorithm. The study focuses on the device's physical and functional performance, not its impact on human reader accuracy.

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

Not applicable. This is a physical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by:

• Engineering Specifications: Design requirements for flow rates, dimensions, connection integrity, and backflow prevention.
• Predicate Device Performance: Benchmarking against the known performance of the legally marketed predicate device (ENDOGATOR FEQ, K092429).
• International Standards: Adherence to relevant standards for sterilization (ANSI/AAMI/ISO 10993-7), biocompatibility (ISO 10993-1), and packaging integrity.
• Risk Analysis: Addressing identified safety concerns, such as fluid leakage and backflow, which were noted in the FDA MAUDE database for similar devices.

8. The Sample Size for the Training Set

Not applicable. This is a physical device, not an AI model that requires a training set.

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

Not applicable, as no training set was used for an AI model.

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