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Fuse Colonoscopy System: The Fuse Colonoscope with FuseBox Processor is intended for diagnostic visualization of the digestive tract. The system also provides access for therapeutic interventions using standard endoscopy tools. The system consists of EndoChoice camera heads, endoscopes, video system, light source and other ancillary equipment. Fuse Colonoscopes, in conjunction with the FuseBox® processor, are indicated for use within the lower digestive tract (including the anus, rectum, sigmoid colon, colon and ileocecal valve) for adult patients. The system includes Lumos, a digital post processing inage enhancement technology. Lumos is intended to be used as an optional adjunct following white light endoscopy and is not intended to replace histopathological sampling as a means of diagnosis.

Fuse 1G Gastroscopy System: The Fuse 1G Gastroscope with FuseBox Processor is intended for diagnostic visualization of the digestive tract. The system also provides access for therventions using standard endoscopy tools. The system consists of EndoChoice camera heads, endoscopes, video system, light source and other ancillary equipment. The Fuse 1G Gastroscope, in conjunction with the FuseBox processor, is indicated for use within the upper digestive tract (including the esophagus, stomach and duodenum). The system includes Lumos, a digital post processing image enhancement technology. Lumos is intended to be used as an optional adjunct following white light endoscopy and is not intended to replace histopathological sampling as a means of diagnosis.

The Fuse Endoscopy System is a GI platform indicated for diagnostic visualization and therapeutic intervention of the digestive tract. The system labeled for healthcare facilities/hospitals enables physicians to view a high-resolution wide field of view. The FuseBox is responsible for image processing, transferring video signals from the endoscope, pneumatic control, and outputting high definition (HD 1080p) video signal. The current FuseBox version, unlike the version used with the two predicate devices, includes image post processing algorithm as an adjunct tool to white light visualization.

The feature provides real-time enhancement and will be used as an adjunctive tool. to supplement the white light endoscopic examination. The new feature may enhance appearance of surface vessels, visualization of the mucosal surface texture and visibility of borders of areas of interest when present.

The provided text describes the Fuse® Endoscopy System with FuseBox® Processor, which includes a digital post-processing image enhancement technology called Lumos. The information primarily focuses on establishing substantial equivalence to predicate devices for regulatory approval, rather than detailed acceptance criteria and a specific study proving it meets those criteria.

However, I can extract the available information and structure it as requested, making note of where specific details are not provided in the document.

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

The document does not explicitly state numerical acceptance criteria for the Lumos feature. Instead, it refers to overall device safety and effectiveness. The performance characteristics mentioned are comparisons to predicate devices for the white light aspects of the system. For Lumos, it states its function as an "enhancement feature."

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 mentions "Clinical Survey on videos with the Lumos compared to white light" was performed. However, it does not provide any details regarding:

• The sample size of videos or cases used in this clinical survey.
• The provenance of the data (e.g., country of origin).
• Whether the data was retrospective or prospective.

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)

The document does not specify the number of experts or their qualifications used to establish ground truth for the "Clinical Survey on videos." It only states that a clinical survey was conducted.

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

The document does not provide any information about the adjudication method used for the "Clinical Survey on videos."

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

The document mentions a "Clinical Survey on videos with the Lumos compared to white light." While this implies a comparison, it does not explicitly state that it was a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. Furthermore, it does not provide any effect size or quantitative measure of how much human readers improve with AI (Lumos) vs. without AI assistance. It only broadly states that the feature "may enhance appearance of surface vessels, visualization of the mucosal surface texture and visibility of borders of areas of interest."

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

The document describes Lumos as an "optional adjunct" and an "adjunctive tool to supplement the white light endoscopic examination." This strongly suggests that it is not intended for standalone performance but rather for human-in-the-loop use. No standalone algorithm performance study is described.

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

The document does not explicitly state the type of ground truth used for the "Clinical Survey on videos." Given the context of "diagnostic visualization" and "adjunct following white light endoscopy," it's plausible that expert interpretation/consensus of standard white light imagery or potentially pathological findings serve as an implicit ground truth, but this is not mentioned. It specifically states that Lumos "is not intended to replace histopathological sampling as a means of diagnosis."

8. The sample size for the training set

The document does not provide any information regarding the sample size for a training set. The descriptions focus on the device's function and comparison to predicate devices, not on the development or training of the Lumos algorithm.

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

Since no training set details (including sample size) are provided, the document does not describe how ground truth for a training set was established.

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The water bottle cap irrigation system (tubing and accessories to accommodate various endoscopes and irrigation pumps) is intended to provide irrigation via sterile water supply during GI endoscopic procedures when used in conjunction with an irrigation pump.

The EndoChoice Water Bottle Cap Irrigation System is a sterile, consumable, 24-hour multi-patient use device designed to fit commercially available sterile water bottles and irrigation pumps for providing sterile water during endoscopic procedures.

The EndoChoice water bottle cap system is comprised of a polycarbonate standard water bottle cap, medical grade PVC tubing that extends from the endoscope connector into the water bottle, and a medical grade stainless steel cylinder that serves as both the water intake portion of the disposable water bottle cap and a weight to hold the tubing down while in the water bottle.

The bottle tubing is added into the sterile water bottle and the irrigation system is fastened via the tubing system cap.

Flexible pump tubing connected to the top of the water bottle cap runs to the tubing connector reducer. This flexible tubing is the part of the device that is placed into the irrigation pump. A tubing connector reducer joins the flexible tubing and rigid tubing. The rigid tubing runs to the tubing Luer connector. The tubing Luer connector has the first one-way check valve which prevents potential backflow of fluid from the endoscope into the tubing set. The separately packaged, single-use endoscope connectors (used to connect the tubing set to the auxiliary water channel) also contain one-way valves used to prevent potential backflow.

As with the predicate, the separately packaged, single-use connectors are used to connect to different endoscope models, and all include the second one-way valve to prevent contamination due to potential backflow.

Between patients, the endoscope connectors must be changed to ensure that there is no risk of cross contamination. EndoChoice water bottle irrigation tubing fits standard threaded lid disposable sterile water bottles of approximately 33 mm diameter.

The water bottle cap system is supplied sterile and can be used up to 24 hours.

The provided document is a 510(k) summary for the EndoChoice Water Bottle Cap Irrigation System. It discusses the device's equivalence to a predicate device based on non-clinical testing. However, the document does not contain information about acceptance criteria, device performance metrics, sample sizes for test sets (as this is not an AI/algorithm-based device and thus doesn't have a "test set" in that context), ground truth, or MRMC studies.

Therefore, I cannot fulfill the request for a table of acceptance criteria and reported device performance, or details about the other points, as the necessary information is not present in the provided text.

The document only states that:

• Non-clinical testing (benchtop funcional performance testing, post-aging; and biocompatibility testing per ISO 10993-1) was performed.
• "All test results passed, demonstrating that the device is safe and effective in comparison with the predicate device."

This indicates that internal acceptance criteria for these tests were met, but the specific criteria and detailed results are not provided.

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The Single-Use Biopsy Valve provides access for endoscopic device passage and exchange, helps maintain sufflation, and minimizes leakage of biomaterial from biopsy port throughout the endoscopic procedure, and provides access for irrigation.

The Seal "Single-Use Biopsy valve is provided non-sterile, and is composed of a cylindrical base and a connected cap. The Single-Use Biopsy Valve provides sealable access via the working channel port of an endoscope for surgical instruments. The valve consists of an attached cap and valve body with a circular opening. The cap is pre-perforated, and ensures instrument access and removal is tight and leak-free.

The valve is designed with a hollow body with a distal end that releasably attaches to the inlet port of the working channel. The valve body provides a flexible diaphragm seal that separates the body into a proximal chamber and distal chamber. The distal chamber secures onto the endoscope, while the proximal chamber secures the cap. Instruments are inserted through the cap and chambers, through the diaphragm seal, and into the endoscope. The diaphragm seal is configured such that a seal is formed due to deformation of the elastomer around an instrument when it is inserted through the opening, preventing fluids from passing through the biopsy valve.

The cap serves two primary functions. One function of the cap is to provide an additional seal around surgical instruments to prevent leakage. The second function is to allow modification of pressure during insufflation by opening the cap, allowing gasses to flow from the endoscope, and out of the biopsy valve.

The provided text is a 510(k) summary for a medical device (Seal Biopsy Valve) and does not contain information about acceptance criteria for a study or the study details you are asking for. It focuses on demonstrating substantial equivalence to a predicate device.

Therefore, I cannot provide the requested information. The document details administrative information, the intended use of the device, its description, and a comparison to a predicate device to confirm substantial equivalence, rather than a performance study with acceptance criteria.

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The SmartStart™ air/water valve is intended be used to control the air/water function on an endoscope during a GI endoscopic procedure.

The SmartStart™ suction valve is intended to be used to control the suction function on an endoscope during a GI endoscopic procedure.

The device is intended for single-use, and is supplied sterile, single-use air/water and suction valves help prevent potential safety risks and eliminate the need for manual cleaning and reprocessing. These valves easily incorporate into infection prevention policies as a single patient use item. The air/water valve is designed to be attached to the air/water port of the endoscope and the suction valve to the suction 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 provided document is a 510(k) premarket notification for the SmartStart™ Air/Water and Suction Valves. It aims to demonstrate substantial equivalence to predicate devices, rather than establishing de novo performance criteria. Therefore, this document does not contain the information requested in the prompt regarding acceptance criteria and the comprehensive study details for a device meeting those criteria.

Specifically, the document focuses on demonstrating that the SmartStart™ valves perform similarly to already approved devices. It does not provide:

• A table of distinct acceptance criteria (e.g., sensitivity, specificity, accuracy targets) for the device's clinical performance.
• Details of a study proving the device meets specific performance acceptance criteria beyond basic physical and functional tests (like air/water flow and leakage).
• Information on sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth types for clinical efficacy.
• Details regarding training sets for an AI/algorithm-based device, as this is a medical device and not an AI-driven software.

The performance testing section (8.3) mentions "acceptance criteria for air flow, water flow and leakage," but it does not specify what those criteria are or provide detailed results from a study that quantifies the device's performance against these criteria. It simply states that the device "will perform in accordance with the acceptance criteria."

This type of submission relies on comparative analysis with existing predicate devices, focusing on technical characteristics, indications for use, and a limited set of non-clinical performance and safety tests (sterilization, shelf-life, biocompatibility, and basic functional tests).

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The EndoChoice water bottle cap system is intended to be used with an air source or carbon dioxide (CO2) with the purpose of supplying sterile water to the endoscope during endoscopic procedures. It is compatible with commercially available sterile water bottles.

The EndoChoice water bottle cap system is a sterile disposable device designed to fit commercially available sterile water bottles for providing sterile water during endoscopic procedures. The water bottle cap system is designed with a clip that is placed on the tubing to stop water flow from the water bottle when the endoscope is not in use.

The device attaches via a connector to the air/water port of an endoscope. The water bottle cap itself is attached to a standard sterile water bottle. Air supplied from the processor unit then pressurizes the water bottle, providing water flow when then air/water valve of the endoscope is depressed. Some models provide a feature that provides an option to use a CO2 air source. Instructions state that the device is to be used by trained endoscopy professionals.

This FDA 510(k) premarket notification describes a medical device, the "EndoChoice Water Bottle Cap System," and makes a case for its substantial equivalence to a legally marketed predicate device. However, it does not contain the kind of detailed information about acceptance criteria and a study that proves the device meets them, as requested in your prompt.

Here's why and what information is available:

This document is a 510(k) submission, which is a premarket notification demonstrating that the device is at least as safe and effective as a legally marketed predicate device. It typically relies on comparing the new device to an existing one (the predicate) and showing that any differences do not raise new questions of safety or effectiveness. This is different from a PMA (Premarket Approval) which requires clinical trials to demonstrate safety and effectiveness for novel devices.

Therefore, the document does not provide:

• A table of acceptance criteria and reported device performance in terms of specific metrics like sensitivity, specificity, accuracy, etc.
• Sample sizes used for a test set, data provenance, ground truth establishment for an AI/diagnostic device.
• The number of experts or their qualifications for ground truth.
• Adjudication methods.
• A multi-reader multi-case (MRMC) comparative effectiveness study.
• Standalone algorithm performance.
• Ground truth type for a diagnostic device.
• Training set sample size or how its ground truth was established.

What the document does provide, and how it relates to proving safety and effectiveness for this type of device (an accessory for endoscopes):

1. Acceptance Criteria and Device Performance (Implicit):

For this device, the "acceptance criteria" are implicitly tied to demonstrating that the modified device performs comparably to the predicate device and meets safety standards, particularly concerning its function in supplying sterile water and biocompatibility.

2. Sample Size for Test Set and Data Provenance:

• Sample Size: Not specified quantitatively. The "benchtop functional performance testing" and "biocompatibility testing" would have involved a certain number of device units, but this specific number is not disclosed in the summary.
• Data Provenance: The testing was "non-clinical testing" and "benchtop," meaning it was conducted in a laboratory/engineering environment, not on human patients. The country of origin for the testing facilities is not specified but would typically be where the manufacturer (EndoChoice, Inc. in Alpharetta, GA) conducts its R&D or uses contract labs. It is prospective testing performed on the modified device.

3. Number of Experts and Qualifications for Ground Truth:

• For this type of device, "ground truth" isn't established by medical experts in the way it would be for an AI diagnostic device. Instead, the "truth" is determined by engineering and material science standards (e.g., a pump correctly delivers water, a material does not cause a toxic reaction).
• The experts involved would be engineers, material scientists, and quality control personnel who conducted and evaluated the benchtop and biocompatibility tests. Their specific number and qualifications are not mentioned in this summary but are implicit to the conduct of these types of tests under regulatory standards.

4. Adjudication Method:

• Not applicable in the context of this 510(k) submission for a non-diagnostic accessory. Test results would be objectively measured against predefined engineering specifications and ISO standards; there's no "adjudication" by multiple human reviewers for interpretation.

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

• No, an MRMC study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical images or data, and the device (often AI) is intended to assist or replace that interpretation. The EndoChoice Water Bottle Cap System is a physical accessory, not an interpretive diagnostic tool.

6. Standalone (Algorithm Only) Performance:

• No, a standalone performance study in the context of an algorithm or AI was not done. This device does not contain an algorithm or AI. It is a mechanical accessory.

7. Type of Ground Truth Used:

• For functional performance, the "ground truth" is adherence to engineering specifications for flow rate, pressure capability, leak prevention, and durability (post-aging). This is determined by objective physical measurements against established design requirements.
• For biocompatibility, the "ground truth" is conformance to ISO 10993-1 standards, meaning the materials do not elicit an unacceptable biological response. This is determined by specified laboratory tests (e.g., cytotoxicity, sensitization, irritation).

8. Sample Size for the Training Set:

• Not applicable. There is no AI or algorithm that requires a "training set" for this device.

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

• Not applicable, as there is no training set for this device.

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The EndoChoice Select injection needle is intended for endoscopic injection into the gastrointestinal mucosa.

The EndoChoice Select Injection Needle mainly consists of a cap, needle, boosting tube, and positioning ring, all made of 304 stainless steel. It also contains an outer tube and nut made of PTFE. The spring and spring tube are made of 302 stainless steel. The shell and injection handle are made of ABS. The bushing is made of TPE (SBS), the inner tube is made of nylon, and the color band indicator is made of CNBR.

The products are intended for single use; an individual device is packed in a sealed pouch following ETO sterilization. The device is used for local injection via endoscope, with the average contact time of the products and the mucosa of the human digestive tract of less than 1 hour.

The provided text describes a Special 510(k) Summary for the EndoChoice Select Injection Needle, which is a medical device. This type of submission is for modifications to a previously cleared device. The document primarily focuses on demonstrating "substantial equivalence" to a predicate device, rather than providing detailed acceptance criteria and a study to prove a device meets those criteria for a novel device.

Therefore, many of the requested data points (like specific performance metrics, sample sizes for test and training sets, number and qualifications of experts, adjudication methods, MRMC studies, and detailed ground truth establishment) are generally not found in this type of submission. The focus is on showing the modified device performs as safely and effectively as the original, cleared device.

However, I can extract the information that is present and indicate where the requested information is not typically presented in a 510(k) summary focused on substantial equivalence.

1. Table of acceptance criteria and the reported device performance

For the modified EndoChoice Select Injection Needle, the "acceptance criteria" are predominantly related to the equivalence of its characteristics and safety to the predicate device. The "reported device performance" is essentially that it passed these equivalence-based tests.

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

The document does not specify sample sizes for individual tests. The "test set" here refers to the samples of the modified device used for the mentioned non-clinical tests (biocompatibility, accelerated aging, sterilization). The data provenance is internal to EndoChoice, Inc.

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

This information is not provided. Ground truth, in the context of device performance, would typically refer to established standards or verifiable performance metrics against which the device is measured. For a K151475 submission, the "ground truth" for "substantial equivalence" is the performance and safety profile of the predicate device (K132065).

4. Adjudication method for the test set

Not applicable/Not specified in this document. Adjudication methods are more relevant for human-read evaluations, not typically for non-clinical engineering tests of medical devices like injection needles.

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 device is an injection needle, not an AI-powered diagnostic tool, so MRMC studies involving human readers and AI are not relevant.

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

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

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

The "ground truth" for this substantial equivalence submission is the established safety and efficacy profile of the predicate device (EndoChoice Injection Needle K132065). The non-clinical tests conducted on the modified device (biocompatibility, sterilization, accelerated aging) were designed to demonstrate that the changes did not negatively impact these established characteristics of the predicate.

8. The sample size for the training set

Not applicable. This is a physical device, not an AI/machine learning model that would require a training set.

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

Not applicable, as there is no training set for a physical injection needle.

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The Fuse Gastroscopy System is intended for diagnostic visualization of the digestive tract. The system also provides access for therapeutic interventions using standard endoscopy tools. The Fuse Gastroscopy System is indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum). The Fuse Gastroscopy System consists of camera heads, endoscopes, video system, light source and other ancillary equipment.

The Fuse Gastroscopy System is a GI platform indicated for diagnostic visualization and therapeutic intervention of the upper digestive tract. The purpose of this submission is to propose new biopsy channel supplier and also to present several design changes that enhance device usability and robustness. The indications for use, fundamental technology and operation principals of the legally marketed device were not changed. The system labeled for healthcare facilities/hospitals enables physicians to view a high-resolution wide field of view of up to 245° (measured diagonally), or 210° (measured horizontally)

The provided text describes a 510(k) premarket notification for the "Fuse® Gastroscopy System" by EndoChoice Inc. This document focuses on demonstrating substantial equivalence to a predicate device (Fuse PeerScope HG, K131422) after making modifications to the existing device. It does not contain information about a study proving the device meets specific acceptance criteria in the context of diagnostic performance or a comparative effectiveness study with human readers.

The performance testing described here is focused on engineering verification and validation of design changes, ensuring safety and effectiveness after modifications, rather than establishing diagnostic performance acceptance criteria for a new AI or image analysis algorithm.

Therefore, many of the requested sections about acceptance criteria, diagnostic performance, sample sizes for test/training sets, expert ground truth establishment, MRMC studies, and standalone algorithm performance cannot be extracted from this document.

Here's a breakdown of what can be extracted or inferred based on the provided text, and what cannot:

1. Table of acceptance criteria and the reported device performance:
This information is not explicitly provided in terms of diagnostic performance metrics like sensitivity, specificity, or AUC against specific acceptance criteria. The performance testing section states: "All test results passed, demonstrating that the device is safe and effective in comparison with the predicate device." This refers to internal engineering/safety testing, not diagnostic accuracy.

2. Sample sized used for the test set and the data provenance:
Not applicable. The document discusses performance testing for mechanical, electrical, and reprocessing aspects, not a clinical diagnostic test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. Ground truth for diagnostic performance is not mentioned as this is not a diagnostic performance study.

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

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. The device is a gastroscopy system (an endoscope), not an AI or image analysis system intended to assist human readers in diagnosis.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI or algorithm-based device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable, as it's not a diagnostic performance study.

8. The sample size for the training set:
Not applicable, as it's not an AI or algorithm-based device requiring training data.

9. How the ground truth for the training set was established:
Not applicable.

Summary of available information:

The document describes the modifications made to an existing medical device (Fuse® Gastroscopy System) and the engineering-focused performance testing conducted to ensure these modifications did not negatively impact the device's safety and effectiveness.

• Acceptance Criteria & Performance (General): The general acceptance criterion was that "All test results passed," demonstrating the device is "safe and effective in comparison with the predicate device." This relates to bench tests (functional, performance, software), laboratory safety/EMC compatibility, biocompatibility, and reprocessing testing. Specific numerical acceptance criteria for these tests are not provided in this summary.
• Study Type: This was a series of engineering verification and validation tests rather than a clinical diagnostic study. It aimed to demonstrate that design modifications (e.g., new biopsy channel supplier, angulation knob brake, umbilical cord plug, locking lever, 90-degree umbilical cord orientation, updated reprocessing methods) maintained the device's safety and effectiveness compared to the predicate.
• Sample Size/Data Provenance for these engineering tests: Not explicitly stated, though implicitly the tests would have involved a number of manufactured devices or components. Data provenance is "within EndoChoice's laboratory or by accredited third parties."
• Ground Truth for these engineering tests: Established by predefined engineering specifications, regulatory standards (listed in the document), and comparison to the performance of the predicate device. For example, reprocessing testing would have had objective criteria for efficacy.

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The retrieval net is intended for use in endoscopic retrieval of foreign objects, food bolus, tissue fragments and excised tissue such as polyps.

The EndoChoice Retrieval Net is a disposable, single-use sterile device comprised of a flexible wire cable and snare loop with net which can be extended and retracted form the flexible outer sheath using a three ring handle. Objects are retrieved by advancing the finger rings of the handle to open the retracted net. The net is then endoscopically manipulated over the foreign object, food bolus, tissue fragment or excised tissue, in which the finger rings of the handle are retracted to close the net once the article has been retrieved.

This document, a 510(k) premarket notification, describes the "EndoChoice Retrieval Net," a retrieval device intended for use in endoscopic procedures. The document aims to demonstrate the device's substantial equivalence to a legally marketed predicate device.

Acceptance Criteria and Device Performance:

The document focuses on demonstrating substantial equivalence to a predicate device, the Roth Net® retriever product line (K122462). The core acceptance criterion is that the new device performs at least as safely and effectively as the predicate, based on comparable characteristics.

While a formal table of "acceptance criteria" with specific quantitative targets and reported performance isn't explicitly provided, the substantial equivalence table (Section 7.5) serves this purpose by comparing key characteristics of the new device to the predicate. The "reported device performance" is implicitly that the device meets or matches the predicate in the listed attributes.

Study Information:

1. Sample size used for the test set and the data provenance:
   The document does not describe a clinical performance study with a "test set" in the traditional sense of evaluating diagnostic accuracy or a specific outcome. Instead, it relies on non-clinical testing (sterilization, shelf-life, biocompatibility, and general performance testing) to demonstrate that the device functions as intended and is safe. No specific sample sizes for these tests are provided in the summarized information, nor is data provenance (country of origin, retrospective/prospective) for a clinical test set.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   Not applicable. This submission does not involve a "test set" requiring expert ground truth in the context of diagnostic or interpretive performance. The non-clinical tests rely on established scientific methods and standards.

3. Adjudication method for the test set:
   Not applicable. There is no clinical "test set" or expert review process described for adjudication.

4. 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. The device is a physical retrieval tool, not an AI-assisted diagnostic or interpretive product. Therefore, an MRMC study related to AI assistance for human readers is not relevant.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   Not applicable. This device is a physical medical instrument, not an algorithm, and intrinsically requires human operation.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   For the non-clinical tests:

   • Sterilization and Shelf-Life: Ground truth is established by adherence to recognized international standards (ISO 11135:2014, AAMI ANSI ISO 11737-2:2009, AAMI ANSI ISO 11138-1:2006).
   • Biocompatibility: Ground truth is established by adherence to AAMI ANSI ISO 10993-1:2009.
   • Performance Testing: While details are not given, this would typically involve engineering tests against internal specifications or industry standards to confirm functional performance (e.g., net opening/closing, retrieval capability, material integrity).

7. The sample size for the training set:
   Not applicable. As this is not an AI/machine learning device, there is no "training set."

8. How the ground truth for the training set was established:
   Not applicable, as there is no training set.

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The EndoChoice water bottle cap system is intended to be used with an air source or carbon dioxide (CO2) with the purpose of supplying sterile water to the endoscope during endoscopic procedures. It is compatible with commercially available sterile water bottles.

The EndoChoice water bottle cap system is a sterile disposable device designed to fit commercially available sterile water bottles for providing sterile water during endoscopic procedures. The water bottle cap system is designed with a clip that is placed on the tubing to stop water flow from the water bottle when the endoscope is not in use.

The device attaches via a connector to the air/water port of an endoscope. The water bottle cap itself is attached to a standard sterile water bottle. Air supplied from the processor unit then pressurizes the water bottle, providing water flow when then air/water valve of the endoscope is depressed. Some models provide a feature that provides an option to use a CO2 air source. Instructions state that the device is to be used by trained endoscopy professionals.

This document is a 510(k) premarket notification for the EndoChoice Water Bottle Cap System. It details the device, its intended use, and its substantial equivalence to a predicate device.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document mentions "Benchtop functional performance testing" and "Laboratory validation testing of sterilization" without specifying exact sample sizes for each test. It also states "Biocompatibility testing in conformance with ISO 10993-1." The nature of these tests (benchtop, laboratory) suggests that they would likely use a dedicated number of device units or components for each specific test, rather than a broad "test set" like clinical trials.

The document does not detail the provenance of data (e.g., country of origin, retrospective/prospective). Given these are non-clinical hardware tests, such details are typically not relevant or included.

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

This section is not applicable to this document. The document describes non-clinical performance and safety testing (functional, sterilization, biocompatibility). These tests do not involve human interpretation or the establishment of ground truth by clinical experts in the same way, for example, an imaging diagnostic device would. Performance is measured against engineering specifications and industry standards (e.g., ISO 10993-1) by qualified laboratory personnel.

4. Adjudication Method for the Test Set:

This section is not applicable. Adjudication methods like 2+1 or 3+1 are used to resolve discrepancies in expert interpretations (e.g., in clinical trials for diagnostic devices). Since the testing described is non-clinical and objective (functional, sterilization, biocompatibility), there is no need for such adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs. without AI assistance:

This section is not applicable. The device (water bottle cap system for endoscopes) is a medical accessory, not an AI-assisted diagnostic or therapeutic device. It does not involve human readers interpreting data, nor does it have an AI component to assist human performance in diagnosis or treatment.

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

This section is not applicable. As mentioned above, the device is a medical accessory and does not involve an algorithm or AI.

7. The Type of Ground Truth Used:

For the non-clinical testing:

• Benchtop functional performance testing: Ground truth would be established by the functional specifications and design requirements of the device (e.g., water flow rate, pressure resistance, connection integrity).
• Laboratory validation testing of sterilization: Ground truth is established by validated sterilization methods and industry standards (e.g., microbial load reduction, sterility assurance level).
• Biocompatibility testing in conformance with ISO 10993-1: Ground truth is established by the requirements of the ISO 10993-1 standard for biological evaluation of medical devices.

8. The Sample Size for the Training Set:

This section is not applicable. As a hardware medical accessory, this device does not utilize a "training set" in the context of machine learning or AI development.

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

This section is not applicable for the same reasons as #8.

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The BONASTENT® Tracheal/Bronchial Stent System is indicated for the treatment of tracheobronchial strictures caused by malignant neoplasms.

The BONASTENT® Tracheal/Bronchial (BTB) is a self-expanding tubular prosthesis designed to maintain patency of tracheobronchial strictures caused by malignant tumors. The stent is made of Nitinol wire and is weaved using a hook & cross wire construction; a silicon membrane covers the stent and is designed to prevent stent migration. Stent sizes range in diameter from 10mm to 20mm and in length from 50mm to 80mm.

The BONASTENT® Tracheal/Bronchial is available on two types of delivery devices. The Y-Shape Handle Delivery Device is used for stents with an outer diameter of 10Fr and less. The I-Shape Handle Delivery Device which is used for stents with an outer diameter larger than 10F.

The provided text describes the 510(k) Summary for the BONASTENT® Tracheal/Bronchial device. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with explicit acceptance criteria and device performance metrics in the typical sense of a clinical trial. However, it does outline performance characteristics compared to its predicate.

Here's an analysis based on the information provided, framed to address your request for acceptance criteria and supporting studies where possible, while noting limitations due to the nature of a 510(k) summary for a stent:

1. Table of Acceptance Criteria and Reported Device Performance

For this specific device (a tracheal/bronchial stent), the "acceptance criteria" are implicitly defined by demonstrating equivalence to a legally marketed predicate device (AERO Tracheobronchial Stent System). The performance data supplied are comparative benchmarks rather than direct acceptance criteria against a defined threshold.

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

The "test set" in this context refers to the samples used in bench testing.

• Sample Size: Not explicitly stated for each test, but implied to be sufficient for the validation and comparative testing performed on the stent models (e.g., 10x20 and 20x80 stents) and deployment systems.
• Data Provenance: The studies are described as "Bench Testing" and "in-vitro tests," meaning they were conducted in a laboratory environment. There is no information regarding country of origin for the data or whether it's retrospective or prospective.

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

Not applicable for this type of submission. This document pertains to bench testing and substantial equivalence, not a clinical study requiring expert ground truth for interpretation of medical data.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 refer to clinical data review, typically by medical experts for diagnoses or outcomes, which is not part of this bench testing summary.

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 medical device (stent) submission, not an AI diagnostic or assistive device.

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

Not applicable. This is a medical device (stent) submission, not an algorithm.

7. The Type of Ground Truth Used

For the bench tests, the "ground truth" is defined by the physical properties measured against established engineering and material standards, or by direct comparison to the predicate device's measured performance. For instance, expansion force measurements are compared directly to the predicate's measurements. Biocompatibility relies on standardized tests.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" as this is not a machine learning or AI device.

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

Not applicable.

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