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The single use ANDORATE® Suction Valve is used to control the suction function of an endoscope during GI endoscopic procedures.

The single use ANDORATE® Air/Water Valve is used to control the air / water function of an endoscope during GI endoscopic procedures.

The single use ANDORATE® Biopsy Valve is used to cover the opening to the biopsy/suction channel of gastro-intestinal endoscopes. The Biopsy Valve provides access for endoscopic device passage and exchange, helps maintain insufflation, minimizes leakage of biomaterial from the biopsy port through the endoscopic procedure and provides access for irrigation.

The single use ANDORATE® Auxiliary Water Connector is used in conjunction with irrigation tubing, intended to provide irrigation fluids such as sterile water supplied to the Gl endoscope during gastrointestinal endoscopic procedures when used in conjunction with an irrigation pump. The Auxiliary Water Connector is manufactured with a one-way valve to minimize the risk of crosscontamination of the irrigation system.

The subject devices are intended for single use. The components included are the ANDORATE® Suction Valve, ANDORATE® Air/Water Valve, ANDORATE® Biopsy Valve, and ANDORATE® Auxiliary Water Connector. The suction valve controls the suction function, the air/water valve controls air and water flow, the biopsy valve covers the biopsy port and allows access for devices, and the auxiliary water connector provides irrigation fluids and has a one-way valve. The devices are packed in a sealed pouch and are supplied sterile.

The provided text is a 510(k) summary for the ANDORATE® Valve Kit, which describes the device's technical characteristics and the non-clinical testing performed to establish substantial equivalence to predicate devices. However, this document does not contain information about acceptance criteria or a study proving the device meets specific acceptance criteria in the context of diagnostic accuracy, which is typically found in AI/ML device submissions.

The ANDORATE® Valve Kit consists of mechanical components (valves and connectors) used with endoscopes. The performance testing outlined is focused on engineering specifications and biocompatibility, not on diagnostic accuracy metrics like sensitivity, specificity, or AUC which would be relevant for devices that provide diagnostic or prognostic information based on AI/ML.

Therefore, for the requested information regarding acceptance criteria and a study proving the device meets acceptance criteria (especially points 1-7 which pertain to diagnostic performance), the document states that "bench testing was performed to support substantial equivalence on both the subject device and the predicate device." It then lists the types of tests conducted:

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

The document does not provide a formal table of acceptance criteria with corresponding performance values for a diagnostic AI/ML device. Instead, it states that "the performance data demonstrated that the subject devices met established specifications in the following non-clinical tests." The listed tests are functional and safety-related:

• ANDORATE® Suction Valve: Compatibility test, flow test, leakage, and pressing force test.
• ANDORATE® Air/Water Valve: Compatibility test, flow tests, leakage, and pressing force test.
• ANDORATE® Biopsy Valve: Vacuum leak and squeegee leak.
• ANDORATE® Auxiliary Water Connector: Endoscope compatibility, air leak, water leak.

The acceptance criteria for these tests are implied to be "established specifications" but are not explicitly detailed in the provided text (e.g., a specific leakage rate limit or flow rate range).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable and therefore not provided, as the device is a mechanical endoscope accessory and not an AI/ML diagnostic device that uses a "test set" of patient data in the typical sense. The "test set" here refers to the physical devices undergoing bench testing.

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)

This is not applicable as the device is a mechanical accessory, and its performance is evaluated against engineering specifications, not clinical interpretations requiring expert consensus for ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable, as there is no clinical data or diagnostic assessment requiring adjudication.

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 is not applicable, as the device is a mechanical accessory, not an AI-assisted diagnostic tool.

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

This is not applicable, as the device is a mechanical accessory, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the performance tests undertaken is based on engineering specifications and physical measurements (e.g., flow rates, leak resistance, force required for activation). There is no "pathology" or "outcomes data" ground truth as typically understood for diagnostic devices.

8. The sample size for the training set

This is not applicable, as the device is a mechanical accessory and does not involve an AI/ML algorithm requiring a training set.

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

This is not applicable, as the device is a mechanical accessory and does not involve an AI/ML algorithm or training set.

In summary, the provided document details the non-clinical (bench) performance testing of a mechanical endoscope accessory kit. It confirms that these tests demonstrated the device met "established specifications," which serves as the implicit acceptance criteria. However, it does not provide the detailed quantitative acceptance criteria or results in a table format, nor does it contain any information relevant to the evaluation of an AI/ML diagnostic tool.

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The single use ANDORATE® Air/Water Valve is used to control the air / water function of an endoscope during GI endoscopic procedures.

The single use ANDORATE® Suction Valve is used to control the suction function of an endoscope during GI endoscopic procedures.

The single use ANDORATE® Biopsy Valve is used to cover the opening to the biopsy/suction channel of Olympus® gastro-intestinal endoscopes. The Biopsy Valve provides access for endoscopic device passage and exchange, helps maintain insufflation, minimizes leakage of biomaterial from the biopsy port through the endoscopic procedure and provides access for irrigation.

The single use ANDORATE® Auxiliary Water Connector is used in conjunction with irrigation tubing, intended to provide irrigation via irrigation fluids such as sterile water supplied to the Olympus® GI endoscope during gastrointestinal endoscopic procedures when used in conjunction with an irrigation pump. The Auxiliary Water Connector is manufactured with a one-way valve to minimize the risk of cross-contamination of the irrigation system.

The subject devices are intended for single use. The components included in the submission are ANDORATE® Suction Valve, ANDORATE® Air/Water Valve, ANDORATE® Biopsy Valve, and AQUAPULSE® Auxiliary Water Connector.

The suction valve is designed to 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 endoscope 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 is intended 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 auxiliary water connector is manufactured for use in conjunction with irrigation tubing, and Olympus endoscope. It is designed to be attached 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 subject devices are packed in a sealed pouch and are supplied sterile. The subject devices in this submission have the same operation and method of action with the predicate devices.

The provided document is a 510(k) Premarket Notification for the ANDORATE® Valve Kit, which consists of various endoscopy accessories (Suction Valve, Air/Water Valve, Biopsy Valve, Auxiliary Water Connector). This notification focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study proving a new device meets specific acceptance criteria for a novel functionality, especially regarding AI/machine learning.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria, device performance, sample sizes for test/training sets, ground truth establishment, expert adjudication, or MRMC studies for an AI-powered device.

The study described is solely bench testing to demonstrate performance similarity to predicate devices, and biocompatibility testing.

Here's what can be extracted based on your prompt, addressing the lack of information where applicable:

1. Table of Acceptance Criteria and Reported Device Performance:

The document broadly states that "The bench testing was performed to support substantial equivalence on both the subject device and the predicate device. The performance data demonstrated that the subject devices met established specifications in the following non-clinical tests."

It lists the types of tests, implying the acceptance criteria were "met established specifications" or "performed comparably to predicate devices," but does not provide quantitative acceptance criteria or specific performance values for the ANDORATE® Valve Kit or its predicate devices.

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

• Sample Size: The document does not specify the number of units tested for any of the bench tests.
• Data Provenance: The tests were "bench testing," meaning laboratory-controlled environments. No patient data or clinical data is mentioned. The company (GA Health Company Limited) is based in Hong Kong, China. The testing location is not specified, but it would typically be a testing facility or the manufacturer's lab.

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

This is not applicable. The ground truth for this type of device (valves for endoscopes) is established by engineering specifications, functional requirements, and performance against predicate devices, not expert human interpretation of data like images or patient outcomes.

4. Adjudication method for the test set:

This is not applicable. There's no human interpretation or subjective assessment that would require an adjudication method.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

No, this was not done. This type of study is relevant for diagnostic or AI-assisted devices where human interpretation is a key component. The ANDORATE® Valve Kit is a mechanical accessory.

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

This is not applicable. This device is not an algorithm or software. It is a physical medical device accessory that assists a human operator (the endoscopist).

7. The type of ground truth used:

The "ground truth" for this device's performance is its adherence to engineering specifications, functional requirements, and comparative performance against legally marketed predicate devices in a laboratory setting through bench testing. There is no external "outcomes data" or "pathology" relevant to establishing the ground truth for simple valve functionality.

8. The sample size for the training set:

This is not applicable. There is no "training set" as this is not an AI/machine learning device.

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

This is not applicable. There is no "training set" for this type of device.

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