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The Andorate Auxiliary Water Connector (Model GAR048) is used in conjunction with irrigation tubing (not supplied), intended to provide irrigation fluids such as sterile water supplied to the Pentax 90 series endoscope during gastrointestinal endoscopic procedures when used in conjunction with an irrigation pump.

The disposable Andorate Valves Set (Model GAR037) consists of one suction valve, one air/water valve and one biopsy valve.

• The Andorate Disposable Suction Valve is used to control the suction of an endoscope (for Pentax 90 series Endoscope) during a GI Endoscopic procedure.

• The Andorate Disposable Air/Water valve is used to control the air/water function of an endoscope (for Pentax 90 series Endoscope) during a GI Endoscopic procedure.

• The Andorate Disposable biopsy valve is used to cover the endoscope biopsy port during an endoscopy procedure. In addition, the valve provides access for endoscopic device passage and exchange, helps maintain insufflation and minimizes leakage of biomaterial from the biopsy port throughout the endoscopic procedure.

The Andorate® Valves Set and Andorate® Auxiliary Water Connector are intended for single-use and are supplied sterile. Single-use valves sets and auxiliary water connector help preventing potential safety risks and eliminate the need for manual cleaning and reprocessing. The valves set and auxiliary water connector are easily incorporated into infection prevention policies as a single use item.

The Andorate® Auxiliary Water Connector is manufactured for use in conjunction with irrigation tubing, and together with Pentax 90 series endoscope. The auxiliary water connector is individually packed in sealed package, sold as a sterile device. The auxiliary water connector is designed to the auxiliary water port of the endoscopes. The auxiliary water connector consists of a backflow valve which prevent the backflow of water or biomaterials from the endoscope to the sterile water bottle.

The Andorate® Valves Set is manufactured for use with Pentax 90 series endoscope. The suction, air/water, and biopsy valves are housed in a single tray and packaged in sealed packed. The valves set is sold as a sterile device.

• The Suction Valve component of the Andorate® Valves Set is designed to o be attached to the suction port of the endoscope and the air/water valve is designed to be attached to the air/ water port of the endoscope. The activation of the suction valve allows the user to aspirate excess fluids or other debris obscuring the endoscopic image, while the activation of the air/ water valve allows the user to control air and water flow to assist in cleansing the lens during procedures.
• The Biopsy Valve component of the Andorate® Valves Set is intended to O cover the endoscope biopsy port during an endoscopy procedure. In addition, the valve provides access for endoscopic device passage and exchange, helps maintain insufflation and minimizes leakage of biomaterial from the biopsy port throughout the endoscopic procedure.

The subject devices in this submission have the same operation and method of action as the predicate devices. In the submission, Andorate® Valves Set and Andorate® Auxiliary Water Connector are the only subject device. This submission does not include irrigation tubing or irrigation pump.

The provided document describes the K191231 submission for the Andorate® Valves Set (GAR037) and Andorate® Auxiliary Water Connector (GAR048). This is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and performance data for a novel device. Therefore, much of the requested information regarding detailed acceptance criteria, specific device performance metrics against those criteria, and information about expert consensus, training sets, and MRMC studies is not available in this document as it's typically required for software-as-a-medical-device (SaMD) or AI-driven diagnostic devices.

However, based on the information provided, here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't provide a table of quantitative acceptance criteria with corresponding performance metrics for the proposed devices in the way an AI/SaMD 510(k) summary would. Instead, it lists the types of non-clinical performance tests conducted to demonstrate substantial equivalence to predicate devices, focusing on functional and safety aspects. The reported performance is generally stated as having met the requirements, implying equivalence to the predicates.

2. Sample Size for the Test Set and Data Provenance

• Sample Size of Test Set: The document does not specify exact sample sizes for each non-clinical performance test. It states that "Smartdata performed bench testing to support substantial equivalence. The following testing were performed on Smartdata samples from initial production lots, including sterilization." This implies a representative sample was tested, but no specific number is given.
• Data Provenance: The tests were performed on "Smartdata samples from initial production lots," which would originate from Smartdata Suzhou Co., Ltd. in China. The data is retrospective in the sense that it was collected from manufactured devices for the purpose of the 510(k) submission.

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

• This information is not applicable and not provided. The devices are physical medical instruments (valves and connectors), not diagnostic or AI-driven devices that would require expert consensus for ground truth. Performance was evaluated through objective bench testing.

4. Adjudication Method for the Test Set

• This is not applicable as the tests performed are objective bench tests, not subjective interpretations requiring adjudication.

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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically conducted for diagnostic devices (especially those involving image interpretation by human readers) to assess the impact of AI assistance on reader performance. The devices in this submission are accessories for endoscopes, not diagnostic tools.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• No, a standalone (algorithm only) study was not done. This is relevant for AI algorithms. The devices are mechanical accessories, not algorithms.

7. Type of Ground Truth Used

• The "ground truth" for the performance tests was defined by established engineering and medical device standards, functional requirements, and comparison to the predicate devices. For example, for a "Vacuum Leak Test," the ground truth is simply the absence of leakage beyond a specified threshold, determined by the test method. For biocompatibility, it's compliance with ISO 10993 standards.

8. Sample Size for the Training Set

• Not applicable. These are physical hardware devices; there is no "training set" in the context of an AI/ML algorithm. Their design and manufacturing processes are developed through traditional engineering methods and validated through bench testing.

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

• Not applicable as there is no training set for these devices.

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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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