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The EndoGator Endoscopy Irrigation Tubing (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 (or cautery unit).

The ENDOGATOR Endoscopy Irrigation Tubing is composed of the following: 1) EndoGator™ Irrigation Tubing, and 2) EndoGator™ Irrigation Accessories. The ENDOGATOR Endoscopy Irrigation Tubing is indicated for irrigation during endoscopic procedures by using it in conjunction with an irrigation pump or cautery units, irrigation accessory, endoscope and disposable sterile water bottle. All tubing sets contain a back flow valve at the distal tip that allows irrigation water to travel in one direction, and therefore the risk of cross contamination is significantly reduced. The irrigation tubing sets are for twenty-four hour use and are to be discarded daily. The accessories are single-use devices and are to be discarded between patients. Tubing sets do not come into direct contact with patient tissue.

The provided text describes the 510(k) Summary for the ENDOGATOR Endoscopy Irrigation Tubing. This document details a medical device and its comparison to a predicate device for substantial equivalence with the FDA. It does not contain information about the acceptance criteria and study design for an AI/ML powered device.

Therefore, I cannot provide the requested information about acceptance criteria for an AI/ML powered medical device, nor can I describe a study proving the device meets said criteria from this document. The document pertains to non-clinical performance testing of irrigation tubing, not an AI/ML diagnostic or therapeutic device.

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The AquaShield CO2 System is intended to be used with an air or carbon dioxide (CO2) source with the purpose of supplying sterile water to the endoscope procedures. It is compatible with U.S. commercially available water bottles.

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I apologize, but the provided text from the FDA 510(k) clearance letters and "Indications for Use" document does not contain the specific information required to describe the acceptance criteria and the study proving the device meets those criteria.

The documents primarily focus on:

• Administrative corrections to trade names (Document 0).
• Substantial equivalence determination for the AquaShield System (Document 1).
• General regulatory information and compliance requirements for medical devices (Document 1 & 2).
• Indications for Use of the AquaShield System (Document 3), which states its purpose is to supply sterile water to endoscope procedures and its compatibility with US commercially available water bottles.

There is no mention of:

• A table of acceptance criteria or reported device performance.
• Sample sizes for test sets, data provenance, or details on training sets.
• Number or qualifications of experts, establishment of ground truth, or adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.

Therefore, I cannot fulfill your request using the provided text. To answer your questions, I would need a different type of document, such as a summary of safety and effectiveness data (SSED) or a clinical study report.

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The AquaShield CO2 System is intended to be used with an air or carbon dioxide (CO2) source with the purpose of supplying sterile water to the endoscopic procedures. It is compatible with U.S. commercially available water bottles.

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I am sorry, but the provided text only contains an FDA clearance letter for a medical device called "AquaShield System CO2." It specifies the device's intended use and regulatory classification but does not include information regarding acceptance criteria, performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth establishment, or training set details.

Therefore, I cannot provide the requested information based on the input text.

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The AquaShield CO2 System is intended to be used with an air or carbon dioxide (CO2) source with the purpose of supplying sterile water to the endoscope procedures. It is compatible with U.S. commercially available water bottles.

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The provided document is an FDA 510(k) clearance letter for the "AquaShield System CO2- Fujifilm." This letter indicates that the device has been cleared for marketing based on substantial equivalence to a predicate device. However, this document does not contain information about acceptance criteria, a specific study proving those criteria, or details regarding performance metrics for a diagnostic or AI-driven device.

The AquaShield System CO2- Fujifilm is described as a system "intended to be used with an air or carbon dioxide (CO2) source with the purpose of supplying sterile water to the endoscope procedures." This suggests it is an accessory for endoscopy procedures, likely for irrigation or insufflation, rather than a diagnostic device with performance metrics typically associated with AI or imaging analyses.

Therefore, I cannot extract the requested information as it is not present in the provided text. The questions regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details are relevant for AI/ML-driven diagnostic devices, but not for the type of device described in this 510(k) clearance.

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The AquaShield CO2 System is intended to be used with an air or carbon dioxide (CO2) source with the purpose of supplying sterile water to the endoscope procedures. It is compatible with U.S. commercially available water bottles.

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I am sorry, but the provided text is a 510(k) clearance letter from the FDA for the AquaShield System. It does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment. This document is a regulatory approval notice, not a study report. Therefore, I cannot fulfill your request based on the given input.

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Erbe's CO2 Tubing/Cap Sets provide sterile water and CO2 or air (if CO2 is not used) to an endoscope for endoscopic procedures.

In general; Erbe's CO2 Tubing/Cap Sets will be manufactured with medical grade materials or agents used in the medical device industry such as plastics, silicone, nitrile rubber, acrylic, nylon, ink, solvent, adhesive, etc. The ERBEFLO CleverCap® CO2 devices provide a conduit for water for endoscopic irrigation and lens cleaning as well as air or CO2 for insufflation; whereas, the ERBEFLO AeroRinse® CO2 devices provide a conduit for water for endoscopic lens cleaning as well as air or CO2 for insufflation. There are three (3) types of Erbe's CO2 Tubing/Cap Sets for each group (i.e., ERBEFLO CleverCap® CO2and ERBEFLO AeroRinse® CO-) which each respectively interfaces with a specified brand of scope (i.e., Pentax, Olymous, and Fujinon Gastrointestinal video Endoscopes). There are two subsets of Sets for the Olympus scope in aech group; one that attaches to standard CO2 sources and the other which specifically attaches to an Olympus CO2 Unit Model UCR. The Sets consist of multiple tubing segments and a cap. The cap of a Set attaches with an air tight seal to a water source (i.e., a sterile water bottle). Then from the water bottle cap, irrigation tubing of a Set (as applicable- only for the ERBEFLO CleverCap® CO2 Sets) interfaces with a designated pump and via ERBEFLO 2 single use connector accessories to the specified endoscope for endoscopic lavage. The next segment, the air/water tubing (also coming from the same water bottle cap), connects to an air/water port of a specified scope for air insufflation as well as lens cleaning [Note: The air/water tubing is a tube within a tube in which the endoscope's processor or CO2 Source (if used) is used to pressurize the bottle for functionality (air and water to the endoscope). Also, for the Pentax Set there is an additional air inlet tube that directs air for endoscope functional use. Or if CO2 is used, pressurization (air and water function) occurs via a CQ2 Source through the Set's CO2 segment.]. The third and final segment for both the Olympus and Fujinon Sets is for connecting to a CO2 Source for CO2 insufflation. For each Set, both the irrigation (as applicable) as well as the air/water tubing segments has a backflow valve. The CO2 segment of the Sets have a standard female luer connector for access a CO₂ Source or in the case of specified Olympus Sets there is a connector on the CO2 segment designed to accessing the Olympus CO3 Unit Model UCR. All of the CO2 segments have a hydrophobic air/gas filter which filters particulates from the CO, Source and keeps fluid from flowing into the CO2 Source. The irrigation (as applicable), air/water, and CO2 segments of the Sets have a clamp to close off the tubing while not in use. Additionally, each Set has an air/water connector(s) for its specified endoscope. Erbe's CO2 Tubing/Cap Sets are provided sterile and are disposable.

This document is a 510(k) premarket notification for a medical device (Erbe's CO2 Tubing/Cap Sets), and as such, it does not describe a study involving an AI/Machine Learning device or a diagnostic accuracy study with expert readers and ground truth establishment. Instead, it demonstrates substantial equivalence to a predicate device through a series of engineering tests and evaluations.

Therefore, many of the requested elements for describing the acceptance criteria and the study that proves an AI device meets them (e.g., sample size for test set, data provenance, number of experts, MRMC studies, standalone performance, ground truth types for AI models, training set details) are not applicable to this type of regulatory submission.

The document discusses performance testing for a physical medical device (tubing and cap sets) rather than an AI algorithm.

However, I can extract information related to the device's performance evaluation and acceptance criteria as presented in this 510(k) summary, interpreting "acceptance criteria" as meeting performance specifications for substantial equivalence.

Here's a breakdown of the device performance evaluation based on the provided document, addressing the relevant points from your request:

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

The document doesn't provide a quantitative table of specific acceptance criteria values and measured performance results in the way one would for an AI model's accuracy. Instead, it lists the types of tests performed and states that the proposed products "met established performance specifications" or "demonstrated safety and efficacy."

• Package integrity testing
• Visual inspection
• Flow testing
• Back flow pressure testing
• Pressure decay testing
• Tensile strength testing
• Durability testing (ensuring no leaks and connectability upon stressing Sets)
• Clamp testing |
  | Packaging Evaluation | Demonstrated adequacy and integrity of the packaging. |
  | Sterilization Evaluation | Demonstrated product sterility and met ethylene oxide residual requirements per recognized standards. |

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

• Sample Size: Not specified in the document. The document refers to "evaluations and tests" but does not give the number of units tested for each evaluation.
• Data Provenance: Not applicable in terms of country of origin or retrospective/prospective for this type of device testing. These are engineering and sterilization validation tests performed on manufactured units.

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

• Not Applicable. This document is for a physical medical device (tubing/cap sets), not an AI/ML diagnostic device that requires expert-established ground truth. Performance is evaluated against engineering specifications and recognized standards.

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

• Not Applicable. See point 3.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not Applicable. This is not an AI diagnostic device.

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

• Not Applicable. This is not an AI diagnostic device.

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

• Not Applicable. The "ground truth" for this device's performance is adherence to established engineering specifications, material biocompatibility standards, and sterility assurance levels, as verified through various physical and chemical tests (e.g., pressure measurements, flow rates, sterility tests, material compatibility tests).

8. The sample size for the training set

• Not Applicable. There is no "training set" as this is not an AI/ML device.

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

• Not Applicable. There is no "training set" or its associated ground truth.

Summary of the Study (Device Performance Evaluation):

The "study" described in the 510(k) summary is a series of engineering and biological evaluations performed on the Erbe's CO2 Tubing/Cap Sets to demonstrate their safety and efficacy and establish substantial equivalence to a legally marketed predicate device (ERBEFLO CleverCap* Hybrid CO₂ Tubing/Cap Sets and Connector Tube, K132340).

The evaluations focused on:

• Biocompatibility: Ensuring materials used are safe for patient contact.
• Sterilization Validation: Proving the device can be consistently sterilized and that residuals are within limits.
• Packaging Integrity: Verifying the packaging maintains sterility and protects the device.
• Functional Performance: Testing various physical attributes like flow, pressure, tensile strength, durability, and leak prevention to ensure the device performs its intended function (providing sterile water, CO2/air to an endoscope) reliably.

The approach taken is purely for a traditional-hardware medical device and does not involve AI or machine learning components, human reader studies, or diagnostic performance metrics common in AI/ML submissions.

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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 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 AquaShield CO2 System is intended to be used with an air or carbon dioxide (CO2) source with the purpose of supplying sterile water to the endoscope procedures. It is compatible with U.S. commercially available water bottles.

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The provided document is a 510(k) premarket notification letter for a device called "AquaShield System CO2, AquaShield System-Pentax." This document itself does not contain the acceptance criteria or a study proving the device meets those criteria.

The letter from the FDA confirms that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory requirements. The "Indications for Use" section describes the intended purpose of the device (supplying sterile water to endoscope procedures compatible with CO2 or air source).

To answer your request, a detailed performance study with acceptance criteria would typically be found in an accompanying submission document, clinical trial report, or biocompatibility/performance testing reports, none of which are provided in this extract.

Therefore, based solely on the provided text, I cannot furnish the requested information. The document focuses on regulatory approval and indications for use, not on specific performance data or acceptance criteria derivation.

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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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