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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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Protego Air Water Connector: The single use Protego Air Water Connector is intended to connect an air/CO2 source, a sterile water source and an endoscope to supply air/CO2 and water during gastrointestinal endoscopic procedures.

Protego Air Water Bottle Tubing: Protego Air Water Bottle Tubing is to connect an air/CO2 source, a sterile water source (water bottle), and an endoscope to supply air/CO2 and water during gastrointestinal endoscopic procedures. It is a 24-hour multi-patient use device.

Protego Hybrid Tubing: Protego Hybrid Tubing is intended to connect an air/CO2 source, a sterile water source and an endoscope to supply air/CO2, water and irrigation during endoscopic procedures in conjunction with an irrigation pump. It is a 24-hour multi-patient use device.

The Protego Air Water Connector is intended for single use then discarded. The Protego Air Water Bottle Tubing and Protego Hybrid Tubing are intended for 24-hour use then discarded. All Protego Air Water Connector, Protego Air Water Bottle Tubing and Protego Hybrid Tubing are provided sterile. The Air Water Connector is used in conjunction with air water bottle tubing or hybrid tubing, intended to supply air/CO2 and water during gastro-intestinal endoscopic procedure. It is connected to the air/water port of the endoscope to provide connection from the air/water bottle tubing to the endoscope. The Air Water Bottle Tubing is connected to the air/water port of the endoscope and the sterile water bottle to supply air/ CO2 or sterile water during the GI endoscopic procedure. The Hybrid Tubing is composed of air/water bottle tubing and irrigation tubing, which is intended to connect an air/CO2 source, a sterile water source (water bottle), and an endoscope to supply air/CO2 and water during gastro-intestinal endoscopic procedure.

The provided text describes a 510(k) summary for medical devices (Protego Air Water Connector, Protego Air Water Bottle Tubing, and Protego Hybrid Tubing) and does not contain information about an AI-based diagnostic device. Therefore, it does not include details on acceptance criteria, a study proving AI device performance, sample sizes for test/training sets, expert consensus, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for such devices.

The document details the substantial equivalence of the subject devices to predicate devices based on:

• Intended Use: The devices are intended to connect air/CO2 and sterile water sources to an endoscope for gastrointestinal endoscopic procedures, with some variations in single-use vs. 24-hour multi-patient use.
• Technological Characteristics: Comparisons are made regarding product code, regulatory classification, regulation number, regulation description, environment of use, single-use/reusable nature, materials, manufacturing method, packaging, sterilization, and shelf life.
• Performance Testing: Bench testing was performed to support substantial equivalence.

Here's a breakdown of the information that is present in the document, which pertains to the physical medical devices, not an AI diagnostic system:

1. Acceptance Criteria and Reported Device Performance (as listed in the document for the physical devices):

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

• The document mentions "bench testing was performed to support substantial equivalence on both the subject device and the predicate device" (Page 7, Section 9).
• It does not specify the precise sample sizes used for each of these bench tests, nor does it detail data provenance (country of origin, retrospective/prospective) as these are physical device tests, not clinical data sets in the diagnostic sense.

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

• Not applicable. This is not an AI diagnostic device where expert ground truth is established for image interpretation or similar. The "performance" here refers to physical and functional characteristics of the tubing/connectors.

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

• Not applicable, for the same reason as point 3.

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. This is a physical medical device, not an AI-assisted diagnostic tool.

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

• Not applicable. This is not an AI algorithm. Its performance is measured directly through bench testing of its physical and functional properties.

7. The type of ground truth used:

• The "ground truth" for these devices is objective, measurable engineering and material specifications (e.g., flow rates, pulling forces, leakage, sterility, biocompatibility standards). It is not based on expert consensus, pathology, or outcomes data in the way a diagnostic AI device would be.

8. The sample size for the training set:

• Not applicable. There is no AI training set for these devices.

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

• Not applicable, as there is no training set for an AI model.

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

The single use ANDORATE® Biopsy Valve is used to cover the biopsy/suction channel of endoscope. The biopsy valve provides access for endoscopic device passage and exchange and minimizes leakage of biomaterial from the biopsy port through the endoscopic procedure.

The subject devices are intended for single-use and are supplied sterile. The suction valve is designed to be attached to the suction port of the bronchoscope and the biopsy valve is designed to be attached to the biopsy port of the bronchoscope. The activation of the suction valve allows the user to aspirate excess fluids or other debris obscuring the bronchoscopic image while biopsy 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 suction valve and biopsy valve kit is compatible with Olympus® 160/180/190/260/290 Series Bronchoscopes.

The provided text is a 510(k) Summary for medical device clearance, specifically concerning the ANDORATE® Suction Valve and ANDORATE® Biopsy Valve. It outlines the safety and effectiveness information for these devices and compares them to a predicate device.

However, the document does not contain the detailed information necessary to fully answer the request regarding acceptance criteria and the study proving the device meets those criteria, particularly in the context of an AI/algorithm-driven device.

The request asks for details like:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth, training set size, and how training ground truth was established.

The provided document describes physical medical devices (valves for bronchoscopes), not an AI/algorithm. Therefore, concepts like "AI assistance," "human readers," "effect size of human readers improve with AI," "standalone algorithm performance," and "training/test sets for an algorithm" are not applicable to the information given.

The document does mention "Performance Test" in Section 9, stating:
"The bench testing was performed to support substantial equivalence on both the subject device and the predicate device. The following bench testing was performed - endoscope compatibility test, suction flow, vacuum leak, water leak test, pressing force test and fatigue test for suction valve and endoscope compatibility, vacuum leak and squeegee leak test for biopsy valve. The performance data demonstrated that the subject devices met established specifications."

While this section indicates that performance tests were done and met specifications, it does not provide the acceptance criteria or the specific performance results in a quantitative manner. It also does not involve human readers, AI, or traditional "ground truth" as it would apply to a diagnostic algorithm.

Conclusion based on the provided text:

The provided document is for physical medical devices (valves), not an AI/algorithm. Therefore, most of the requested information (related to AI performance, human reader studies, training/test sets for AI, ground truth establishment for AI) is not present and not applicable to this submission.

The document states that bench testing was performed and the devices met established specifications. However, the specific quantitative acceptance criteria and the reported performance values are not detailed in this summary.

To answer your request based only on the provided text:

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

   • Acceptance Criteria: Not explicitly detailed in quantitative terms within the summary, but implied that each test (endoscope compatibility, suction flow, vacuum leak, water leak, pressing force, fatigue, squeegee leak) had "established specifications."
   • Reported Device Performance: The document summarily states: "The performance data demonstrated that the subject devices met established specifications." No specific quantitative results are provided.

2. Sample sized used for the test set and the data provenance: Not applicable to this type of device testing as described. The testing is bench testing on physical units.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically defined for AI/diagnostic algorithms is not relevant here.

4. Adjudication method for the test set: Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done: No, not applicable. This is not an AI-assisted diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No, not applicable. This is not an algorithm.

7. The type of ground truth used: Not applicable. The "ground truth" for these physical devices would be their ability to perform their mechanical functions according to engineering specifications.

8. The sample size for the training set: Not applicable (not an AI/ML algorithm).

9. How the ground truth for the training set was established: Not applicable (not an AI/ML algorithm).

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The 24 hour use AquaPulse® Irrigation Tubing (tubing and accessories to accommodate various GI endoscopes and irrigation pumps) is intended to provide irrigation via a sterile water bottle during gastrontestinal endoscopic procedures when used in conjunction with an irrigation pump.

The AquaPulse® Irrigation Tubing is intended for 24-hour use and then discarded. The irrigation tubing is manufactured for use in conjunction with sterile water bottle, and together with irrigation pumps. The irrigation tubing is individually packed in sealed package, sold as a sterile device. The irrigation tubing is designed to the auxiliary water connector or biopsy irrigation accessory and to be inserted into pump head of the irrigation pump to provide irrigation through the auxiliary water channel to the distal end of endoscope.

This document describes a 510(k) premarket notification for the AquaPulse® Irrigation Tubing. This is not a medical device that uses AI or machine learning.

Therefore, most of the requested information regarding acceptance criteria and study proving device performance related to AI/ML (e.g., sample size for training/test sets, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth for AI) is not applicable to this submission.

Here's a breakdown of the applicable information based on the provided text, and an explanation of why other aspects are not present:

Analysis of the Provided Document for Device Acceptance Criteria and Study

The provided document is a 510(k) premarket notification for a medical device called "AquaPulse® Irrigation Tubing." This type of submission is for demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving novel efficacy or performance through extensive clinical trials as would be required for a completely new device or a device with new technology (like AI/ML).

The core of this submission revolves around bench testing and biocompatibility testing to show that the modified device is as safe and effective as its predicate. It does not involve artificial intelligence or machine learning components.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is not an AI/ML device, the "acceptance criteria" are related to manufacturing specifications, material properties, sterilization, and basic functional performance, rather than diagnostic accuracy or predictive power. The document summarizes these in comparison to a predicate device to establish substantial equivalence.

Reported Device Performance:

• Flow Performance: "The bench testing was performed to support substantial equivalence such as verification tests on flow performances of modified devices. The performance data demonstrated that the subject devices met established specifications and it demonstrated substantial equivalence to the previously cleared predicate devices." (Section 9)
• Sterilization: "The EO sterilization cycle has a Sterility Assurance Level (SAL) of 10⁻⁶. EO residuals on the components are below the maximum levels defined in ANSI/AAMI/ISO 10993-7 Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide sterilization residuals." (Section 10)
• Shelf Life: "The modified devices have a three (3) year shelf life, based on the design and existing sterile barrier data from the existing packaging integrity test and performance test were conducted after accelerated aging test. The test result can imply that the modified device can provide and maintain a sterile barrier and its intended performance for at least the claimed shelf life." (Section 11)
• Biocompatibility: "The test result shows that the modified devices are biocompatible" in accordance with ISO 10993-1 for surface devices with mucosal membrane contact for limited duration (not more than 24 hours). (Section 12)

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

• Sample Size for Test Set: Not specified in terms of number of units tested. For bench tests, it typically refers to a number of manufactured units subjected to specific physical and chemical tests (e.g., flow rate, material composition, sterilization validation samples, accelerated aging samples, biocompatibility samples). The document states "The test result shows that the modified devices are biocompatible" and "The performance data demonstrated that the subject devices met established specifications," implying samples were tested, but not the specific quantity.
• Data Provenance: Not explicitly stated as "country of origin of the data." These are likely lab/bench test results generated by the manufacturer (GA Health Company Limited, Hong Kong, CHINA) or a contracted testing facility.
• Retrospective or Prospective: Not applicable. These are laboratory/bench test results of physical properties and performance, not patient data.

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

• Not applicable. This device does not generate diagnostic interpretations or clinical assessments that would require human expert ground truth establishment. The "ground truth" for this device's performance is established by meeting engineering specifications through bench testing and validated laboratory methods (e.g., flow rate measurements, sterility testing, chemical analysis for residuals, biocompatibility assays).

4. Adjudication Method for the Test Set

• Not applicable. As no expert interpretation or human assessment of results requiring consensus was involved, no adjudication method was used.

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

• No. An MRMC study is designed to evaluate the impact of a diagnostic AI system on human reader performance. This device is an irrigation tubing, not a diagnostic imaging or AI system.

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

• Not applicable. This device is hardware and does not contain an algorithm.

7. The Type of Ground Truth Used

• Functional/Performance Specifications & Regulatory Standards: The "ground truth" here is adherence to engineering design specifications, validated sterilization parameters (SAL 10⁻⁶, EO residuals), biocompatibility standards (ISO 10993-1), and demonstrated performance equivalence (flow rate, shelf life) to the predicate device. This is based on objective measurements rather than clinical outcomes or expert review of images/data.

8. The Sample Size for the Training Set

• Not applicable. This is not an AI/ML device that requires a training set.

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

• Not applicable. As there is no training set for an AI/ML model.

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The single use andorate® Suction Valve is used to control the suction of an endoscope during GL 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 subject devices are intended for single-use and are supplied sterile. 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.

This is a 510(k) premarket notification for andorate Suction Valve and andorate Air/Water Valve. The document states that performance tests were conducted to support substantial equivalence to a predicate device. However, the document does not provide specific acceptance criteria or detailed results of these tests in a quantitative manner that would allow for a table of acceptance criteria and reported performance. It only lists the types of tests performed.

Therefore, many of the requested details cannot be extracted from the provided text.

Here is the information that can be extracted:

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

The provided document lists the types of performance tests conducted but does not specify the numerical acceptance criteria or the quantitative results of these tests.

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

The document does not specify the sample size for the test set or the data provenance. It only states that "bench testing was performed."

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 information is not applicable as the study involved bench testing (performance tests) of a medical device (suction and air/water valves), not data analysis requiring expert interpretation or ground truth establishment.

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

This information is not applicable for bench testing of a medical device.

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 information is not applicable as the study involved bench testing of a physical medical device, not an AI-assisted diagnostic tool.

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

This information is not applicable for bench testing of a physical medical device.

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

For bench testing, the "ground truth" would be the engineering specifications and performance standards that the device is designed to meet. The document states that the performance data "demonstrated that the subject devices met established specifications."

8. The sample size for the training set

This information is not applicable as the study involved bench testing of a physical medical device, not an AI model that requires a training set.

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

This information is not applicable as there was no training set for an AI model. For the device itself, the "ground truth" or acceptable performance standards for the bench tests would have been established based on engineering specifications and relevant regulatory guidelines.

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The Universal Endoscope Tip Guard is intended to protect tip of the endoscope during transport and storage. It is not intended for use during sterilization.

The Andorate® Universal Endoscope Tip Guard is intended for single use. The universal endoscope tip guard is used to cover distal end of an endoscope prior to transportation and storage. The universal endoscope tip quard is individually packed in sealed package, and it is available both non-sterile and sterile.

The provided document describes the Andorate Universal Endoscope Tip Guard (K202838), which is intended to protect the tip of an endoscope during transport and storage. It is explicitly stated that it is not intended for use during sterilization.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

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The 24 hour use AquaPulse® Irrigation Tubing (tubing and accessories to accommodate various GI endoscopes and irrigation pumps) is intended to provide irrigation via a sterile water bottle during gastrointestinal endoscopic procedures when used in conjunction with an irrigation pump.

The AquaPulse® Irrigation Tubing is intended for 24-hour use and then discarded. The irrigation tubing is manufactured for use in conjunction with sterile water bottle, and together with irrigation pumps. The irrigation tubing is individually packed in sealed package, sold as a sterile device. The irrigation tubing is designed to the auxiliary water connector or biopsy irrigation accessory and to be inserted into pump head of the irrigation pump to provide irrigation through the auxiliary water channel to the distal end of endoscope.

This document is a 510(k) premarket notification for the AquaPulse® Irrigation Tubing, submitted by GA Health Company Limited to the FDA. The purpose of this notification is to demonstrate that the AquaPulse® Irrigation Tubing is substantially equivalent to a legally marketed predicate device.

Here's an analysis based on your request, focusing on typical acceptance criteria and study information for medical devices, specifically highlighting what is not present in this 510(k) summary since it's for a relatively simple device where clinical studies are often not required for substantial equivalence.

1. Table of acceptance criteria and reported device performance:

The document summarizes performance testing, but does not provide a detailed table of acceptance criteria and specific performance values with pass/fail results. Instead, it offers a general statement about meeting specifications.

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

• Test Set Sample Size: Not explicitly stated for any of the performance tests (flow, sterility, shelf life, biocompatibility).
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). This type of detail is often not included in a 510(k) summary for bench testing.

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

• Not applicable (N/A). This document describes testing for a physical medical device (irrigation tubing) where performance is measured objectively (e.g., flow rate, sterility, chemical residue). It does not involve expert-established ground truth like in an AI/imaging device study.

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

• N/A. Adjudication methods are typically relevant for studies involving human interpretation or subjective assessments, not for objective bench testing of device performance.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size:

• No. An MRMC study is not relevant for this type of device. The study described is a series of bench tests comparing the subject device to a predicate device.

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

• No. This is not an AI/algorithm-based device. The "standalone" performance refers to the device's inherent functional characteristics (flow, sterility, etc.) as evaluated in the bench tests.

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

• Objective measurements and established scientific standards. For example:
  • Flow Performance: Likely compared to established predicate performance or engineering specifications.
  • Sterility: Measured against a Sterility Assurance Level (SAL) of 10^-6.
  • EO Residuals: Measured against limits defined by ANSI/AAMI/ISO 10993-7.
  • Biocompatibility: Evaluated according to ISO 10993-1 guidelines through biological tests.

8. The sample size for the training set:

• N/A. This device does not use machine learning or AI, and therefore does not have a "training set" in that context.

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

• N/A. As there is no training set for an AI/ML model, this question is not applicable.

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The Andorate® Disposable Suction Valve is used to control the suction of an endoscope (Fujifilm 700 series) during a GI Endoscopic procedure.

The Andorate® Disposable Air/Water valve is used to control the air/water function of an endoscope (Fujifilm 700 series) during a GI Endoscopic procedure.

The subject devices are intended for single-use and are supplied sterile. Disposable suction and air/water help prevential safety risks and eliminate the need for manual cleaning and reprocessing. The subject devices are easily incorporated into infection prevention policies as a single use item. 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 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 suction and air/water are housed together with biopsy valve and auxiliary water connector in a single tray and packaged in sealed packed. The subject devices are supplied as sterile The subject devices in this submission have the same operation and method of action with the predicate device.

The provided document is a 510(k) Premarket Notification for medical devices, specifically for disposable suction and air/water valves used with endoscopes. It outlines the regulatory submission to the FDA, demonstrating substantial equivalence to a predicate device.

Based on the provided document, here's a description of the acceptance criteria and the study that proves the device meets them:

Crucially, this submission is for physical medical devices (disposable valves), not an AI/software device. Therefore, many of the questions related to AI acceptance criteria (e.g., ground truth, expert adjudication, MRMC studies, training set) are not applicable to this document.

The primary acceptance criteria for these physical devices are based on bench testing demonstrating functional performance, safety, and compatibility, along with biocompatibility testing and sterilization validation. The study performed is a series of non-clinical, bench-top tests.

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

Note on "Reported Device Performance": The document states that "The bench testing was performed to support substantial equivalence" and "The test result can imply that the subject devices can provide and maintain a sterile barrier and its intended performance before the expiration date," and "The test result shows that the subject devices are biocompatible." While specific quantitative results are not detailed in this summary, the submission asserts that all tests were conducted and the devices met the necessary criteria for their intended use and substantial equivalence claim.

Regarding the AI-specific questions, they are largely N/A for this K200495 submission which is for physical medical devices.

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

• Sample Size for Test Set: Not explicitly stated as a number of "cases" or "patients." These are physical devices. The "test set" would be a quantity of manufactured valves used for bench testing. The document states "The bench testing was performed to support substantial equivalence. The following testing were performed on subject devices from initial production lots, including sterilization." It does not specify the exact number of units per test.
• Data Provenance: Not applicable in the context of an AI dataset. The data provenance here refers to the results of physical and chemical tests conducted on the manufactured valves. The manufacturer is GA Health Company Limited. The shelf-life tests were conducted by "Sanitation Environment Technology Institute, Soochow University," which implies the testing was done in China (where Soochow University is located). The document does not specify whether the data is retrospective or prospective, as it's not a clinical study in that sense; rather, it's product testing.

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

• N/A. This is a physical device submission, not an AI/diagnostic software. Ground truth for these devices is established through engineering specifications, material science, and established medical device testing standards (e.g., for flow rates, leak integrity, biocompatibility).

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

• N/A. Not applicable for a physical device bench test. Test results are typically objective measurements against predefined specifications.

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:

• N/A. No MRMC study was conducted or is applicable for this physical medical device. The device is a disposable valve, not an AI diagnostic tool that assists human readers.

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

• N/A. No algorithm is involved. This is a physical device.

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

• N/A (in the AI sense). The "ground truth" for this device's performance is defined by established engineering and medical device standards for mechanical integrity, fluid dynamics (suction/air/water flow), material properties (biocompatibility), and sterilization efficacy. For example, a "Vacuum Leak Test" would have a specific maximum allowable leak rate as its ground truth.

8. The sample size for the training set:

• N/A. There is no "training set" as this is a physical medical device, not an AI model.

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

• N/A. Not applicable. There is no AI training set.

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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® Disposable Biopsy Irrigator is intended to enable simultaneous irrigation and instrumentation in the endoscope's biopsy channel.

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 biopsy irrigator is intended to cover the endoscope biopsy port for sealing and endoscopic device passage/ exchange, at the same time use in conjunction with irrigation tubing. consists of a backflow valve which prevent the backflow of water or biomaterials from the endoscope to the irrigation tubing.

The biopsy irrigator and biopsy valve are packed individually in a sealed packed. The subject devices are supplied as sterile The subject devices in this submission have the same operation and method of action with the predicate devices.

The provided text is a 510(k) Premarket Notification for the Andorate Biopsy Valve and Andorate Biopsy Irrigator, seeking substantial equivalence to existing predicate devices. It describes the devices, their intended use, technological characteristics, and performance data. However, this document does not describe a study involving a medical device that uses AI or machine learning algorithms, nor does it contain information about expert ground truth establishment, reader studies, or training/test sets for such algorithms.

The document details the acceptance criteria and study proving the devices meet these criteria for mechanical and material performance of traditional medical devices. Therefore, I will extract information relevant to those types of devices based on the provided text.

Here's the information parsed from the document for the Andorate Biopsy Valve and Andorate Biopsy Irrigator:

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

The document outlines performance tests conducted for each device. The reported performance is that the tests were conducted and the results imply that the subject devices provide and maintain a sterile barrier and their intended performance before the expiration date, and that they support safety and efficacy, and substantial equivalence to predicate devices. Specific quantitative acceptance criteria values are not provided in this summary, but rather the types of tests performed.

Andorate® Disposable Biopsy Valve:

Andorate® Disposable Biopsy Irrigator:

General Performance Criteria (Both Devices):

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