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The AIR/WATER VALVE MAJ-1444 and SUCTION VALVE MAJ-1443 have been designed for use with an Olympus ultrasound endoscope for the gastrointestinal (GI) tract, as follows.

Air/Water Valve (MAJ-1444)

• To feed air to remove any fluids or debris adhering to the objective lens.
• To feed water for lens washing.
• To fill the balloon with sterile water.

Suction Valve (MAJ-1443)

• To remove any fluids, debris, or air from the patient.
• To remove the water from the balloon.

The Suction Valve MAJ-1443 and Air/Water Valve MAJ-1444 have been designed for use with an Olympus ultrasound endoscope for the gastrointestinal (GI) tract. The subject devices are reusable. The subject devices are compatible with Olympus endoscopes GF-UCT180 and GF-UE160-AL5.

The Suction Valve MAJ-1443 is attached to the suction cylinder of a compatible endoscope to remove any fluids, debris, or air from the patient and to remove water from the balloon. Suction Valve MAJ-1443 has no patient-contacting components and is a reusable device.

The Air/Water Valve MAJ-1444 is attached to the air/water cylinder of a compatible endoscope to feed air to remove any fluid or debris adhering to the objective lens, to feed water for lens washing, and to fill the balloon with sterile water. MAJ-1444 has indirect patient-contacting components and is a reusable device.

The subject device has the same technological characteristics and similar design as the applicable predicate device.

The provided text is an FDA 510(k) clearance letter for two medical device accessories: the Suction Valve (MAJ-1443) and the Air/Water Valve (MAJ-1444). These devices are classified as endoscopic accessories.

Based on the information provided, the study conducted to prove the device meets acceptance criteria focused on bench testing to demonstrate the functionality of reusable accessories, rather than a clinical study involving human patients, AI integration, or multi-reader multi-case (MRMC) studies.

Here's an analysis of the provided text in relation to your request:

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

The document states: "The following performance bench tests were conducted. All test samples passed pre-defined acceptance criteria." However, it does not provide the specific numerical acceptance criteria or the quantitative reported performance for each test. It only lists the types of tests performed.

Therefore, while the document confirms that acceptance criteria were predefined and met, the specific details of these criteria and the quantitative performance results are not included in this FDA clearance letter. This information would typically be found in the full 510(k) submission.

Regarding the other points of your request, much of the requested information (especially concerning AI, human readers, ground truth establishment for AI models, and large-scale clinical studies) is not applicable to this particular device and its clearance.

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

• Sample Size for Test Set: The document simply states "Test samples were final, finished devices." It does not specify the number of samples tested for each performance bench test.
• Data Provenance: The tests were "bench testing" performed by Olympus. The data provenance is laboratory/bench data generated internally for regulatory submission. It is not patient data, and therefore, concepts like "country of origin of the data" or "retrospective/prospective" study design in a clinical sense do not apply.

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

• Not Applicable. For a device like an endoscope valve, the "ground truth" for its performance is typically established through engineering specifications, material science, and functional testing as defined by recognized standards and internal quality control. This does not involve expert readers establishing ground truth on medical images or clinical outcomes.

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

• Not Applicable. Adjudication methods are relevant for studies where human interpretation of data (e.g., medical images) is involved and consensus is needed. For bench testing of mechanical or functional properties, the "adjudication" is based on objective measurements against engineering 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:

• No. This was not an AI-enabled device. The document describes a traditional medical device accessory (valves for endoscopes). MRMC studies are specific to evaluating diagnostic performance, often of AI algorithms assisting human readers.

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

• No. This device is not an algorithm. It's a physical accessory; therefore, standalone algorithm performance is not applicable.

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

• For these devices, the "ground truth" is defined by engineering specifications and functional requirements (e.g., specific flow rates, suction pressures, resistance to leakage, durability under repeated use, compatibility with specified endoscopes). Successful performance means meeting these pre-defined technical criteria. There is no biological "ground truth" like pathology for these mechanical accessories.

8. The sample size for the training set:

• Not Applicable. This is not an AI/machine learning device; hence, there is no "training set."

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

• Not Applicable. Since there is no training set, no ground truth was established for it.

In summary: The provided FDA 510(k) clearance letter pertains to reusable endoscope valves. The clearance was based on bench testing demonstrating the functional performance and durability of the devices. It is a traditional medical device clearance and does not involve AI, clinical efficacy studies with human participants, or complex ground truth establishment methods typical for AI or diagnostic imaging devices. The specific quantitative acceptance criteria and detailed performance results from these bench tests are not present in this summary document but would be part of the full 510(k) submission.

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The Disposable Endoscopy Valve Set is a collection of several sterile units. It is intended to be fitted to multiple endoscope working channels/ports to control the flow of fluids, gases and other materials.

• Disposable Air/Water Valve: This unit is intended to be fitted to an endoscope air/water channel to control the inflow of medical gases and water, whilst preventing back-flow.

• Disposable Suction Valve: This unit is intended to be fitted to an endoscope suction channel to control the operations of suction, whilst preventing inflow of air.

• Disposable Biopsy Valve: This unit is intended to be fitted to an endoscope biopsy port to prevent leakage of gases and body fluids during an endoscopic procedure.

• Disposable Water Jet Adapter: This unit is designed to prevent backflow and intended to provide irrigation via sterile water supply during GI endoscopic procedures when used in conjunction with an irrigation pump.

The Disposable Endoscopy Valve Set is a collection of several sterile units. It is intended to be fitted to different endoscopes' working channels/ports to control the flow of fluids, gases and other materials. The sterile units may consist of Disposable Air/Water Valve, Disposable Suction Valve, Disposable Biopsy Valve and Disposable Water Jet Adapter. Disposable Endoscopy Adapter Set may be configured as single valve or multiple valves in any combination up to a maximum of 4 valves.

This FDA 510(k) clearance letter pertains to a Disposable Endoscopy Valve Set, which is a Class II device. The document explicitly states that no clinical study was conducted for this submission (K250732) and that no clinical test data is included. Instead, the clearance is based on the device being "substantially equivalent" to a predicate device (Disposable Endoscopy Adapter Set, K220210) through non-clinical performance data, primarily bench testing.

Therefore, many of the requested criteria related to clinical studies, human readers, ground truth, and training sets are not applicable to this specific clearance. I will extract the information that is present in the document regarding the acceptance criteria and the study (bench testing) that supports it.

Here's a breakdown of the requested information based on the provided document:

Acceptance Criteria and Device Performance for Disposable Endoscopy Valve Set (K250732)

1. Table of acceptance criteria and the reported device performance:

The document details extensive performance characteristics for each component of the Disposable Endoscopy Valve Set. Since the submission relies on substantial equivalence through bench testing, the reported device performance is indicated as "Substantially equivalent supported by bench testing" for each characteristic compared to the predicate device.

Disposable Air/Water Valve:

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The Luer-Split MAJ-2092 has been designed to be attached to the instrument channel port of Olympus endoscopes to allow both irrigation and the use of EndoTherapy accessories.

The Luer-Split MAJ-2092 ("Luer-Split") has been designed to be attached to the instrument channel port of endoscopes to allow both irrigation and the use of endoscopy accessories. The Luer-Split is a reusable device after appropriate cleaning and disinfection/ reprocessing as stated in the instruction manual accompanied with device. The Luer-Split is provided as a single model (MAJ-2092) and packed as a single unit. The Luer-Split is mounted on the instrument channel port of endoscope and the sealing accessory (i.e., single use biopsy valve) is attached on the proximal end of the Luer-Split. The side arm/T-Pipe of the Luer-Split, also referred to as the irrigation port, is connected to the irrigation tube and irrigation equipment. EndoTherapy devices are inserted via attached sealing accessory to perform procedures.

It appears you've provided the text of an FDA 510(k) clearance letter for the "Luer-Split MAJ-2092." However, the content of this document does not describe acceptance criteria for a device's performance nor does it detail a study proving the device meets those criteria in the context of an AI/software as a medical device (SaMD) product.

This 510(k) is for an endoscope accessory (a physical device), not a software or AI product. The "Non-Clinical and/or Clinical Tests Summary & Conclusions" section mentions "Performance Testing - Bench" (Flow Rate, Composite Durability), "Human Factors Validation," and "Reprocessing Validation," along with "Biocompatibility Evaluation." It explicitly states "Clinical testing is not applicable."

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance related to AI/software performance.
• Sample size and data provenance for a test set in an AI/software study.
• Number of experts and their qualifications for ground truth establishment for AI/software.
• Adjudication method for an AI/software test set.
• MRMC comparative effectiveness study for human readers with/without AI assistance.
• Standalone AI algorithm performance.
• Type of ground truth for AI/software.
• Sample size and ground truth establishment for an AI/software training set.

The provided document simply isn't about an AI/SaMD product. It's a clearance letter for a mechanical accessory for endoscopes.

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The Defendo Fujifilm 700 Single Use Cleaning Adapter is intended to be used only to pre-clean the endoscope's air/water channel post-procedure, and not to be used during a patient procedure.

This device is intended to be used only to pre-clean the endoscope's air/water channel post-procedure, and not to be used during a patient procedure.

The Defendo Fujifilm 700 Single Use Cleaning Adapter is a single use, non-sterile disposable valve that fits onto the air/water cylinder of Fujifilm endoscopes (that do not contain a balloon channel). It allows air and water to be flushed through the endoscope's air/water channels after an endoscopic procedure is completed to remove debris. The adapter is not intended to be used with patients and a warning tag comes with the device providing this information. The materials of the valve are nonpatient contacting. The Defendo Fujifilm 700 Single Use Cleaning Adapter assembly consists of a cap, a spring, a spring cup, an overmolded boot, the cleaning valve stem, the valve stem backflow umbrella valve, and valve stem sealing gaskets and a warning label.

This document is a 510(k) premarket notification from the FDA for a medical device. It is not a study demonstrating the performance of an AI/ML powered device. Most of the requested information regarding AI/ML study design and results is therefore not applicable.

The device is the "Defendo Fujifilm 700 Single Use Cleaning Adapter," which is a non-sterile, single-use disposable valve intended to pre-clean endoscope air/water channels post-procedure. The submission is a "Special 510(k)" to obtain clearance for a non-sterile version of a previously cleared sterile device (K232329).

Here's the relevant information based on the provided text, with explanations why certain points are not applicable:

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

The document provides a summary table of non-clinical performance testing. The "Acceptance Criteria" column consistently states "Meet acceptance criteria" without detailing the specific numeric or qualitative thresholds for each test. However, the "Results" column consistently states "Pass," indicating that the device met these (undisclosed) criteria for all tests.

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

• Sample Size: The document does not specify the sample size for any of the non-clinical tests conducted.
• Data Provenance: The document does not specify the country of origin of the data or whether the tests were retrospective or prospective. Given that these are benchtop "non-clinical" performance tests for a physical device, the concepts of retrospective/prospective clinical data or patient data provenance do not apply.

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. The device is a mechanical cleaning adapter, not an AI/ML-powered diagnostic tool. "Ground truth" in the context of expert consensus or clinical diagnosis is not relevant to its performance testing. The "truth" here is objective physical measurements and functional performance as per engineering specifications.

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

Not applicable. As noted above, this is not a study requiring expert adjudication of clinical findings.

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 not an AI/ML device, nor is it a clinical study involving human readers.

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

Not applicable. This is not an AI/ML algorithm.

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

The "ground truth" for this device's performance testing consists of engineering specifications, material properties, and functional requirements (e.g., specific flow rates, force thresholds, leak prevention). It is established through physical measurements and bench testing against predefined criteria, not against clinical expert consensus, pathology, or outcomes data.

8. The sample size for the training set

Not applicable. This device does not involve a training set for an AI/ML model.

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

Not applicable. This device does not involve a training set for an AI/ML model.

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The Single Use Cleaning Adapter is intended to be used only to pre-clean an endoscope's air/water channel post-procedure, and not to be used during a patient procedure.

This device is intended as part of the pre-cleaning process, to help clear the air/water channel of Olympus GI endoscopes post procedure.

The Defendo Single Use Cleaning Adapter for Olympus Endoscopes is a single use, sterile disposable valve that fits onto the air/water cylinder of Olympus endoscopes (that do not contain a balloon channel). It allows air and water to be flushed through the endoscope's air/water channels after an endoscopic procedure is completed to remove debris. The adapter is not intended to be used with patients and a warning tag comes with the device providing this information. The materials of the valve are nonpatient contacting. The adapter is used post-procedure to pre-clean the endoscope before it goes through high-level disinfection and/or sterilization. The adapter is attached to the air/water channel of an endoscope. When the adapter is attached to the endoscope, air can flow down the channel of the endoscope. If water is desired to flow down the channel, the device is depressed. When released, air will once again flow down the endoscope channel. The Defendo Single Use Cleaning Adapter for Olympus Endoscopes assembly consists of a cap, a spring, a spring cup, an overmolded boot, the cleaning valve stem, the valve stem backflow umbrella valve, and valve stem sealing gaskets and a warning label.

The provided document is a 510(k) premarket notification from STERIS Corporation to the FDA for a medical device called "Defendo Single Use Cleaning Adapter for Olympus Endoscopes." However, this document does not contain information about an AI/ML-driven device or studies related to AI/ML performance.

The listed tests (Button cycling/leak test, Fluid Flow Path, Air Flow Rate, CO2 Flow Rate, Water Flow Rate, Backpressure Hold Test, Valve to Port Attachment Force, Valve to Port Removal Force, Valve Depression Force, Cap breakage strength, Sterile Barrier: Visual Inspection, Sterile Barrier: Dye Penetration) are all related to the mechanical and physical performance of a cleaning adapter, not to the performance of an AI algorithm.

Therefore, I cannot extract the information requested about acceptance criteria and studies proving the device meets criteria in the context of an AI/ML device. The document describes a physical medical device (a cleaning adapter) and its non-clinical performance testing.

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The DEFENDO EUS Air/Water Valve is intended to be used to control the air/water function of an endoscope during an GI Endoscopic procedure.

The DEFENDO EUS Suction Valve is intended to be used to control the suction function of an endoscope during a GI Endoscopic procedure.

The DEFENDO EUS Air/Water Valve and the DEFENDO EUS Suction Valve are accessories to an echoendoscope.

The EUS Air/Water valve allows the end user to control air or CO2 insufflation down the endoscope's accessory channel, control water used to wash the lens of the endoscope and insufflate a balloon at the distal end of the echoendoscope

The DEFENDO EUS Suction valve allows the user to control suction through the echoendoscope's accessory channel and suction to the balloon at the distal end of the echoendoscope.

Both devices are single-use devices, supplied sterile.

The provided document is a 510(k) summary for a medical device called "DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS". This document primarily focuses on demonstrating substantial equivalence to a predicate device, specifically for an extended shelf life. It is not a study proving the device meets acceptance criteria in the context of an Artificial Intelligence (AI) or machine learning (ML) enabled medical device, where terms like "ground truth," "expert consensus," "MRMC study," and "training set" are core to the evaluation.

Therefore, I cannot fulfill all parts of your request based on the provided text. The document describes a biological/mechanical device and its non-clinical performance testing for an extended shelf life, not the performance of an AI/ML algorithm.

However, I can extract the information related to the acceptance criteria and study results that are present for this specific type of device.

Here's what can be extracted and what cannot:

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

This information is present for the non-clinical performance testing of the mechanical device.

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 states that "Identical testing was conducted on both the predicate (cleared) 1 year version of the device and proposed 3 year shelf life version of the device." It then clarifies, "The three year shelf life summary is below." However, the specific sample size (N) for each test is not provided. The testing is physical/mechanical in nature, not data-driven in the sense of patient data. Therefore, "country of origin of the data" or "retrospective/prospective" are not applicable.

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 document describes non-clinical performance testing of a physical medical device, not an AI/ML algorithm requiring expert ground truth for image interpretation or diagnosis.

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

This is 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

This is not applicable as the document is not about an AI-assisted device.

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

This is not applicable as the document is not about an AI algorithm.

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

This is not applicable in the context of AI/ML. For this mechanical device, the "ground truth" for each test is a direct measurement against a predefined physical, mechanical, or functional standard (e.g., does it leak? does the spring compress within range?).

8. The sample size for the training set

This is not applicable as the document does not describe an AI/ML device with a training set.

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

This is not applicable as the document does not describe an AI/ML device with a training set or ground truth in that context.

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The Disposable Endoscope Valve Sets is a collection of several sterile units. It is intended to be fitted to multiple endoscope working channels/ports to control the flow of fluids, gases and other materials. It includes an Air/Water Valve, a Suction Valve, a Biopsy Valve and an Auxiliary Water Connector.

• Air/Water Valve: This unit is intended to be fitted to an endoscope air/water channel to control the inflow of medical gases and water, whilst preventing back-flow.

• Suction Valve: This unit is intended to be fitted to an endoscope suction channel to control the operations of suction. whilst preventing inflow of air.

• Biopsy Valve: This unit is intended to be fitted to an endoscope biopsy port to prevent leakage of gases and body fluids during an endoscopic procedure.

• Auxiliary Water Connector: This unit is intended to provide irrigation via sterile water supply during GI endoscopic procedures when used in conjunction with an irrigation pump.

The Disposable Endoscope Valves Set is a collection of several sterile units, it is intended for single-use and supplied sterile. The subject device is intended to be fitted to multiple endoscope working channels/ports to control the flow of fluids, gases and other materials. It includes an Air/Water Valve, a Suction Valve, a Biopsy Valve and an Auxiliary Water Connector.

• The Suction Valve component of the Disposable Endoscope Valves Set is designed to be attached to the suction port of the endoscope, allowing the user to aspirate excess fluids or other debris obscuring the endoscopic image.

• The Air/Water Valve component of the Disposable Endoscope Valves Set is designed to be attached to the air/ water port of the endoscope, 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 Disposable Endoscope Valves Set 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 component of the Disposable Endoscope Valves Set is designed to be attached to the auxiliary water port of the endoscopes. The auxiliary water connector consists of a backflow valve that prevents the backflow of water or biomaterials from the endoscope to the sterile water bottle.

The provided text is a 510(k) summary for the Disposable Endoscope Valves Set (AF series). It focuses on demonstrating substantial equivalence to a predicate device based on non-clinical performance testing. It does not describe a study involving human-in-the-loop performance, expert readers, or AI assistance for image interpretation. Therefore, many of the requested elements are not applicable to the information contained in this document.

Here's an analysis based only on the provided text:

Preamble:
The document describes a medical device (Disposable Endoscope Valves Set) that physically controls fluids and gases during endoscopic procedures. It is not a device that performs AI-assisted image analysis or requires human interpretation of images for its function. Consequently, specific criteria related to AI performance, human reader studies (MRMC), or a comprehensive test set with ground truth established by experts for diagnostic accuracy are not found in this regulatory submission. The studies described are engineering and performance validation tests for the physical device.

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

The document lists performance tests conducted, but does not provide a formal table of acceptance criteria with corresponding performance data. Instead, it states that "Non-clinical testing...was conducted to verify that the subject device met all design specifications, demonstrated safety and essential performance...". The individual tests are listed, implying that the acceptance criterion for each was successful completion.

Summary of Performance Tests Implemented (Implied Acceptance: "Met All Specifications"):

Other Non-Clinical Testing:

• Biocompatibility: In accordance with ISO 10993 series (MTT Cytotoxicity, Skin Sensitization, Skin Irritation, Acute Systemic Toxicity, Pyrogen Test).
• Sterilization Validation: In accordance with ISO 11135, ISO 11737-2, ISO 10993-7, USP .
• Shelf Life and Sterile Barrier System: In accordance with ASTM F1980, ISO11607-1, ISO11607-2, ASTM F 1929, ASTM D 3078, DIN 58593-6, ASTM F88/F88M, ASTM D4169.

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

The document does not specify exact sample sizes for each "bench-A" performance test. It mentions that "performance tests were implemented on both the subject device and the predicate device," implying a comparative, laboratory-based testing approach.

• Sample Size: Not explicitly stated for each test, but implied to be sufficient for engineering validation.
• Data Provenance: Laboratory testing, likely conducted by the manufacturer (Alton (Shanghai) Medical Instruments Co. Ltd.) in China, as part of their regulatory submission for the U.S. FDA. The tests are non-clinical, likely prospective validation tests performed on newly manufactured devices.

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

Not applicable. This device is a physical instrument, not an AI or diagnostic imaging device that requires expert-established ground truth from medical images. The "ground truth" for its performance is engineering specifications and physical measurements, not clinical diagnoses.

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

Not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in human reader studies or for training/validating AI models with subjective interpretations (e.g., radiology image interpretation). This document describes the engineering performance validation of a physical 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

No. An MRMC study is not applicable as this is a physical medical instrument (endoscope valves), not a diagnostic algorithm or AI-assisted interpretation tool. The document explicitly states "N/A, no clinical studies are available for the subject device."

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

Not applicable. The device is a physical set of valves, not an algorithm.

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

Not applicable. The "ground truth" for this device's performance relates to its physical and functional specifications (e.g., flow rates, leakage prevention, depression force, material compatibility, sterility, shelf life). These are established through engineering standards and testing, not clinical outcomes or expert consensus on medical images.

8. The sample size for the training set

Not applicable. This device does not involve a "training set" in the context of machine learning or AI.

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

Not applicable. As there is no training set for an AI/ML algorithm, no ground truth was established in this context.

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The DEFENDO™ FUJIFILM™ 500/600 Single Use Air/Water Valve is intended to control the air/water function on an endoscope during a GI endoscopic procedure.

The DEFENDO™ FUJIFILM™ 500/600 Single Use Suction Valve is intended to control the suction function on an endoscope during a GI endoscopic procedure.

The DEFENDO™ FUJIFILM™ 500/600 Single Use Biopsy Valve is intended for covering the endoscope biopsy port during an endoscopy procedure. The single use Biopsy Valve provides access for endoscopic device passage and exchange, help maintain sufflation, and minimize leakage of biomaterial from the biopsy port throughout the endoscopic procedure.

The ENDOGATOR™ FUJIFILM™ 500/600 Single Use Connector is intended to be used in conjunction with Endogator Irrigation Tubing to provide irrigation via sterile water during GI endoscopic procedures when used with an irrigation pump (or cautery unit).

The Defendo Fujifilm 500/600 Single Use Valves Set, the subject of this 510(k), are a family of ready-to-use, sterile, single use valves designed to be used on the Fujifilm 500/600 series GI endoscopes as accessories. The specific valves include the Defendo Fujifilm 500/600 Single Use Air/Water Valve, the Defendo Fujifilm 500/600 Single Use Suction Valve, the Defendo Fujifilm 500/600 Single Use Biopsy Valve, and the Endoqator Fujifilm 500/600 Single Use Connector.

The Air/Water valve allows the end-user to control and maintain air or CO2 insufflation down the endoscope's accessory channel and control the water used to wash the lens of the endoscope during an endoscopic procedure.

The Suction valve allows the user to control suction through the endoscope's accessory channel and serves as a fluid-removal conduit to aspirate fluids from the patient. This allows the clinician to remove fluids/soil from the GI tract during an endoscopic procedure.

The Biopsy valve allows instruments/devices to be passed through it while maintaining insufflation, allowing suction, and guiding instruments through the biopsy channel during endoscopic procedures.

The Connector allows attachment between the irrigation tube set via its luer connection and the compatible endoscope at its dedicated auxiliary water connection. This is sometimes also referred to as the auxiliary water iet valve.

These valves are supplied in various kits. The kits are combinations of two or more of the different valves listed above.

The provided FDA 510(k) summary (K232067) describes the acceptance criteria and the study that proves the device meets those criteria for the Defendo Fujifilm 500/600 Single Use Air/Water Valve, Defendo Fujifilm 500/600 Single Use Suction Valve, Defendo Fujifilm 500/600 Single Use Biopsy Valve, and Endogator Fujifilm 500/600 Single Use Connector.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't provide explicit numerical acceptance criteria for each test. Instead, it states that "non-clinical performance testing was performed on the subject device to support the substantial equivalence determination" and concludes that the device "has shown to be substantially equivalent to the predicate and having met the acceptance criteria based on its indications for use." This implies that the performance of the new devices was within acceptable ranges compared to the predicate devices or met internal engineering specifications for each test.

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

The document does not specify the exact sample sizes used for each non-clinical performance test. It only mentions that "non-clinical performance testing was performed."

The data provenance is from non-clinical performance testing. There is no indication of human data, so country of origin and retrospective/prospective classification are not applicable in this context. These are laboratory/engineering tests performed by the manufacturer.

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

This information is not applicable. The performance tests are engineering and materials science tests, not clinical evaluations requiring expert interpretation for ground truth. The "ground truth" for these tests would be objective measurements against established technical specifications or predicate device performance.

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

This information is not applicable as the studies were non-clinical performance tests, not clinical evaluations requiring adjudication of subjective assessments. The results would be objective measurements.

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

No, an MRMC comparative effectiveness study was not done. This device is a single-use valve/connector for endoscopes, not an AI-powered diagnostic or assistive tool for human readers.

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

This information is not applicable. 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 these non-clinical performance tests would be objective measurements against established technical specifications or the performance of the legally marketed predicate devices. For example, a flow rate test would have a specified minimum/maximum flow, or a leak test would have a maximum allowable leak rate. Biocompatibility utilized ISO 10993 standards.

8. The sample size for the training set

This information is not applicable. This is a medical device accessory undergoing non-clinical performance testing, not a machine learning model requiring 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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ENDORAIL is an accessory to an endoscope and is intended to ensure positioning of a standard endoscope (i.e. an endoscope with an instrument channel that is at least 3.7mm diameter and is used for standard endoscopic visualization) during endoscopy of the large intestine.

ENDORAIL is a colonoscopy add-on device developed to be used without any modification to colonoscopes and peripheral devices currently utilized. It is an accessory for colonoscopy aimed at facilitating progression of the endoscope in the large intestine. The device works as a magnetic anchor that allows the operator to guide the colonoscope and to straighten colon curves and loops. ENDORAIL includes a Balloon Guide that can be introduced, when needed, through the endoscope instrument channel during the colonoscopy, if this procedure becomes challenging. The system does not require to be premounted and does not interfere with the normal colon examination process. The Balloon Guide is advanced beyond the colonoscope tip where the balloon is filled with a ferromagnetic fluid and magnetically anchored to a magnetic Handpiece placed on the patient's abdomen. Once anchored, the colonoscope can be easily straightened and guided along the device, allowing a fast and safe inspection of the entire colon. Once the challenging segment of the colon is resolved, or the colonoscopy procedure is completed, the Balloon Guide can be retrieved.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Reported Device Performance

Study Details

2. Sample Size and Data Provenance

• Test Set Sample Size: 38 patients were enrolled and included in the statistical analysis.
• Data Provenance: Prospective, multi-center clinical trial conducted in Italy, Germany, and Belgium.

3. Number of Experts and Qualifications for Ground Truth (Test Set)

The document does not explicitly state the number of experts used to establish the ground truth for the test set cases or their specific qualifications beyond being "specialized medical staff" and "Principal Investigators" at the trial centers. However, the study involved:

• Principal Investigator: Prof. Alessandro Repici (IRCCS Humanitas Research Hospital, Milan, Italy)
• Principal Investigator: Prof. Helmut Neumann (GastroZentrum Lippe, Germany, affiliated with Universität Mainz)
• Principal Investigator: Prof. Raf Bisschops (University Hospitals Leuwen, Belgium)

These individuals are implied to be highly qualified gastroenterologists or endoscopists.

4. Adjudication Method for the Test Set

The document does not describe a formal adjudication method for the test set cases, such as "2+1" or "3+1." The evaluation of outcomes (completion rate, adverse events) was directly reported as observed during the clinical study.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study was a single-arm interventional study.

6. Standalone Algorithm Performance

This section is not applicable as ENDORAIL is a physical accessory to an endoscope, not a software algorithm or AI-driven device intended for standalone performance.

7. Type of Ground Truth Used

The ground truth for the acceptance criteria (colonoscopy completion and adverse events) was based on clinical observation and outcomes data from the prospective clinical trial. Colonoscopy completion was defined as caecal intubation being achieved. Adverse events were observed and classified by medical staff.

8. Sample Size for the Training Set

This section is not applicable. As ENDORAIL is a physical medical device accessory and not a machine learning algorithm, there is no "training set" in the context of AI/ML. The device's design and functionality were developed and validated through non-clinical testing and then evaluated in a clinical trial.

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

This section is not applicable as there is no training set for a physical device.

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The Defendo Pentax Single Use Air/Water Valve is intended to control the air/water function on an endoscope during a GI endoscopic procedure.

The Defendo Pentax Single Use Suction Valve is intended to control the suction function on an endoscope during a GI endoscopic procedure.

The Defendo Pentax Single Use Biopsy Valve is intended for covering the endoscope biopsy port during an endoscopy procedure. The single use Biopsy Valve provides access for endoscopic device passage and exchange, help maintain sufflation, and minimize leakage of biomaterial from the biopsy port throughout the endoscopic procedure.

The Endogator Pentax Single Use Connector is intended to be used in conjunction with Endogator Irrigation Tubing to provide irrigation via sterile water during GI endoscopic procedures with an irrigation pump (or cautery unit).

The Defendo Pentax Single Use Valves Set, the subject of this 510(k), are a family of ready-to-use, sterile, single-use valves designed to be used on the Pentax endoscopes as accessories. The specific valves include the Defendo Pentax Single Use Air/Water Valve, the Defendo Pentax Single Use Suction Valve, the Defendo Pentax Single Use Biopsy Valve, and the Endogator Pentax Single Use Connector.

The Air/Water valve allows the end-user to control and maintain air or CO2 insufflation down the endoscope's accessory channel and control the water used to wash the lens of the endoscope during an endoscopic procedure.

The Suction valve allows the user to control suction through the endoscope's accessory channel and serves as a fluid-removal conduit to aspirate fluids from the patient. This allows the clinician to remove fluids/soil from the GI tract during an endoscopic procedure.

The Biopsy valve allows instruments/devices to be passed through it while maintaining insufflation, allowing suction, and guiding instruments through the biopsy channel during endoscopic procedures.

The Connector allows attachment between the irrigation tubset via its luer connection and the compatible endoscope at its dedicated auxiliary water connection. This is sometimes also referred to as the auxiliary water jet valve.
These valves are supplied in various kits. The kits are combinations of two or more of the different valves listed above.

The provided text describes a 510(k) premarket notification for a set of single-use endoscopy valves. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting a full clinical study with acceptance criteria for device performance. Therefore, the document does not contain the detailed information typically found in a study proving a device meets specific performance acceptance criteria, such as clinical effectiveness or diagnostic accuracy.

The document discusses non-clinical performance testing to support substantial equivalence, but these tests are not presented as meeting specific clinical acceptance criteria or performed as a comparative effectiveness study with human readers or standalone algorithm performance.

Here's an attempt to answer your questions based on the available information, noting where information is not present:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) summary does not use the term "acceptance criteria" for clinical performance. Instead, it describes non-clinical performance testing conducted to demonstrate the safety and effectiveness of the device as substantially equivalent to predicate devices. The "reported device performance" are the results of these non-clinical tests.

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

The document does not specify the sample size for individual non-clinical tests (e.g., how many valves were tested for flow rate or mechanical properties). It refers to "testing" as being performed on "the subject device."

The data provenance is from non-clinical performance testing conducted by the manufacturer, Medivators (A Subsidiary of STERIS Corporation), located in Conroe, TX 77303, USA. These are laboratory-based tests, not clinical data from patients.

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

This information is not applicable to this 510(k) submission. The "ground truth" concept is typically relevant for studies involving diagnostic accuracy or clinical outcomes where human expert assessment is needed. This submission relies on engineering and laboratory testing for functional performance and safety.

4. Adjudication Method for the Test Set

This information is not applicable to this 510(k) submission. Adjudication methods (like 2+1 or 3+1) are used in clinical trials to establish a definitive diagnosis or outcome, often from multiple expert opinions. The testing mentioned here is non-clinical and lab-based.

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. An MRMC study is relevant for evaluating the performance of diagnostic imaging devices, often involving AI. The devices described here are single-use endoscopic valves, which are mechanical accessories, not diagnostic imaging devices or AI tools.

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

This information is not applicable. Standalone algorithm performance is relevant for AI-based devices. The devices described here are mechanical endoscopic accessories.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The document speaks of "non-clinical performance testing" and "biocompatibility assessment" to demonstrate substantial equivalence to predicate devices. The "ground truth," in this context, would be the established functional performance characteristics and safety profiles of the predicate devices, along with relevant engineering standards and regulatory requirements. It is based on engineering benchmarks, physical measurements, and internationally recognized standards (e.g., ISO 10993 for biocompatibility, ISO 11607/ASTM 4169 for packaging).

8. The Sample Size for the Training Set

This information is not applicable. A "training set" refers to data used to train machine learning algorithms. The devices described are mechanical accessories and do not involve AI or machine learning.

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

This information is not applicable for the reasons stated in point 8.

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