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The Ureteral Catheter is used for temporary urine drainage, delivery of irrigation fluids, injection of contrast agent to the urinary tract, navigation of a tortuous ureter, access, advancement or exchange of wire guides (open-ended catheters only).

Ureteral Catheters are single-use and sterile devices, which consist of catheter, adapter and guide wire. Ureteral Catheters are available in a variety of French sizes and distal tip configurations. Ureteral Catheters have 5 different distal tip configurations, which are closed round tip, open tapered tip, open tip, open soft tip and open cone tip. The adapter and guide wire are optional and the choice of Ureteral Catheter, adapter and guide wire should be based on the physician's preference and clinical situation. The catheter tube is made of Polyvinylchloride (PVC). The catheter is uncoated. Recommend duration of use: less than 24 hours.

The document describes a 510(k) premarket notification for a medical device, the Wellead® Ureteral Catheter (K220036). This type of submission aims to demonstrate that a new device is substantially equivalent to a legally marketed predicate device. While it includes "Test Summary" and "Comparison to predicate device and conclusion" sections, it does not present acceptance criteria or a study design in the way typically expected for assessing AI/ML-based device performance.

This document focuses on the physical and material properties of a non-AI/ML medical device (a ureteral catheter) and its equivalence to a predicate device. Therefore, many of the requested items related to AI/ML device performance (like expert adjudication, MRMC studies, standalone performance, training sets) are not applicable.

Here's an interpretation of the available information in the context of your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative, pass/fail performance metric for the device's intended use. Instead, it relies on demonstrating that the subject device's various characteristics are equivalent to a predicate device and meet relevant industry standards.

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

The document refers to various "lab bench testing" (e.g., for ASTM, ISO standards) but does not provide specific sample sizes for these tests. It indicates that the tests were performed on the "Ureteral Catheter," implying testing was done on samples of the subject device. The provenance of these test results is from the manufacturer, Well Lead Medical Co., Ltd. in China.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

This information is not applicable as the device is a physical medical instrument, not an AI/ML system that requires expert interpretation for a "ground truth" test set. The "ground truth" here is the physical and biological performance as measured by objective engineering and biocompatibility tests against established standards.

4. Adjudication Method for the Test Set

This is not applicable for the same reasons as above. Testing involved objective measurements against standards, not subjective interpretation requiring adjudication.

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

This is not applicable as the device is not an AI-assisted diagnostic or imaging device. There is no human-in-the-loop component for which an MRMC study would be performed.

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

This is not applicable as the device is a physical ureteral catheter, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" used in this submission is based on:

• Compliance with international and national standards (e.g., ISO 10993, ASTM F1929, EN 1618).
• Objective physical and chemical measurements (e.g., tensile strength, leakage, radiopacity, cytotoxicity, sensitization, irritation).
• Demonstrated equivalence to a predicate device (Cook Incorporated's Ureteral Catheters, K171662) which itself was previously cleared based on similar principles.

8. The Sample Size for the Training Set

This is not applicable as the device is a physical medical instrument, not an AI/ML system requiring a "training set."

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

This is not applicable for the same reasons as above. There is no training set for this type of device.

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The Allwin Ureteral Catheters are used for drainage of urine from the ureter and they allow the delivery of contrast media.

Not Found

This document is an FDA 510(k) clearance letter for a medical device (Allwin Ureteral Catheters), not a study report or clinical trial summary. Therefore, it does not contain the information requested regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or multi-reader multi-case studies.

The letter confirms that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory requirements. It doesn't detail the performance validation methods or results for the device itself.

To answer your request, you would need access to the actual 510(k) premarket notification submission (K220730) which would contain the data from performance testing, if such data was required and submitted for this type of device. However, for a Class II device like a ureteral catheter (product code KOD), performance testing might focus on physical properties, biocompatibility, and sterilization rather than image analysis performance metrics.

In summary, the provided text does not contain the information needed to answer your questions about acceptance criteria and study data for device performance.

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The Urinary Catheter is indicated for use to facilitate access to the urinary tract through a retrograde route for the delivery of gels or fluids into the urinary tract.

The Urinary Catheter is a single use 12 Fr or 16 Fr urethral catheter with a fixed female Luer lock hub. The catheter has a Coudé (Tiemann) tip, is 40 cm long. The catheter tube is made of Polyvinylchloride (PVC) and the Luer lock hub is made of Polycarbonate. The catheter is uncoated. The device is designed to assist in access to the urinary bladder using standard technique for drainage and delivery of gels or fluids. The catheter is indicated for use by healthcare professionals for facilitating access to the urinary tract through a retrograde route, for the delivery of gels or fluids into the urinary tract. The catheter is supplied sterile in a Tyvek pouch. The catheter is inserted into the body for a typical duration of less than 1 hour.

I cannot fulfill your request to describe the acceptance criteria and study proving device performance as the provided text is a 510(k) summary for a urinary catheter, which is a physical medical device, not an AI/ML-driven device.

The questions you've asked (e.g., number of experts, ground truth, MRMC study, training data) are relevant to the evaluation of AI/ML-powered medical devices, specifically those that analyze data (like images) to provide diagnostic or prognostic information. The provided document describes the regulatory clearance for a physical urinary catheter based on its substantial equivalence to predicate devices and bench testing for physical characteristics like flow rate, kink resistance, and tensile force.

Therefore, the information required to answer your questions (acceptance criteria for AI performance, clinical study results for AI, ground truth establishment, training set details) is not present in this document.

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The subject device is a tubular device that is inserted through the urethra to pass urine from the bladder.

The Teleflex Rusch®FloCath Quick™ 18 French (Fr.) Coudé Hydrophilic Intermittent Catheter is single use, disposable and sterile. The catheter is made of clear polyvinylchloride (PVC) with vertically cut and softly rounded, polished eyes and has a hydrophilic coating. It is composed of a shaft with a proximal funnel and a tip. The funnel is made of PVC. The shaft size is an 18 French gauge and is identified on the packaging. The funnel is color coded red to facilitate size identification. The catheter is 40 cm in overall length. The FloCath Quick is an integrated package that contains the FloCath catheter with a blue protective catheter sleeve and a packet of sterile 0.9% saline. Before opening, the sterile saline pouch is broken to hydrate the catheter. The protective catheter sleeve allows for touchless insertion. The sleeve can also be pushed back and used as an extension to the catheter. The FloCath Quick packaging has a packaging hole to facilitate opening the catheter. Either the packaging hole or the adhesive patch on the catheter pack can be used to hang up the catheter in an appropriate, convenient location while the catheter is hydrated.

The provided text is a 510(k) summary for a medical device (Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent Catheter), which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria for performance metrics in a clinical context.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of algorithm performance or clinical outcomes are not applicable or cannot be extracted from this document, as it primarily details bench testing and a comparison to a predicate device for regulatory clearance.

However, I can extract the relevant bench testing performance data which serves as the "study" for this type of submission and interpret the "pass" results as meeting implicit acceptance criteria for substantial equivalence.

Here's the information that can be extracted, with explanations for what is not applicable:

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

For a 510(k) submission, the "acceptance criteria" for bench testing are generally that the device performs comparably to the predicate or meets established standards, and in all reported cases, the device "Passed". Specific numerical acceptance thresholds are not explicitly detailed in this summary for each test, but "Pass" indicates they were met.

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 bench tests conducted.
• Data Provenance: The document does not specify the country of origin of the data. The testing described is bench testing, not clinical data, so terms like "retrospective or prospective" do not directly 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 section is Not Applicable (N/A). The "ground truth" concept is usually associated with clinical or image-based studies where expert consensus or diagnostic outcomes are used. This submission focuses on engineering bench tests and material biocompatibility, which do not typically involve experts establishing "ground truth" in this manner. The evaluations are based on compliance with international standards and internal protocols.

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

This section is Not Applicable (N/A). Adjudication methods are relevant for studies involving human interpretation or clinical endpoints, not for objective bench testing of device performance parameters.

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 section is Not Applicable (N/A). This device is a urological catheter, not an AI-powered diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant.

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

This section is Not Applicable (N/A). As stated above, this is a physical medical device, not an algorithm.

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

This section is Not Applicable (N/A) in the traditional sense. For the bench tests, the "ground truth" or reference for assessment is established by the specified international and industry standards (e.g., EN 1616:1997, ASTM F623:2013, ISO 10993 series, ISO 11135-1:2014). Passing these standards serves as verification that the device meets defined engineering and safety specifications.

8. The sample size for the training set

This section is Not Applicable (N/A). This device is not an AI/ML algorithm that requires a training set.

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

This section is Not Applicable (N/A). As this is not an AI/ML device, there is no training set or ground truth in that context.

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The UroGen Ureteral Catheter is indicated for use by physicians for facilitating access to the urinary tract through a retrograde route and may be used in conjunction with a guidewire or for the injection of gels or fluids into the urinary tract.

The device is a single use ureteral catheter, designed to assist in access to the upper urinary tract using standard endoscopic technique for drainage and delivery of gels or fluids. The catheter is indicated for use by physicians for facilitating access to the urinary tract through a retrograde route and may be used in conjunction with a guidewire or for the injection of gels or fluids into the urinary tract.

The catheter is supplied sterile in a Tyvek pouch with a sterilization indicator. The catheter is inserted into the body for a typical duration of less than 1 hour. The catheter is placed over a guidewire of up to 0.038 inches in diameter that is prepositioned through the urological tract.

The UroGen Ureteral Catheter is indicated for use by physicians for facilitating access to the urinary tract through a retrograde route and may be used in conjunction with a guidewire or for the injection of gels or fluids into the urinary tract.

Here's an analysis of the acceptance criteria and the study data provided for the UroGen Ureteral Catheter:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state quantitative acceptance criteria in a dedicated table. Instead, it lists the types of tests performed and indicates that they were "successfully completed" or "addressed by bench testing and validation." The implicit acceptance criterion for each test is that the device must meet the requirements of the referenced standard or, in the case of an internal standard, perform as intended without raising safety or effectiveness concerns.

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

The document does not specify the exact sample sizes used for each individual test. It generally states that "testing was conducted." The provenance of the data is from laboratory testing and not from human patient data (retrospective or prospective). The location of the testing laboratories is not specified, but the applicant's address is Ra'anana, Israel, and New York, NY, USA.

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

This information is not applicable to this submission. The "ground truth" for device performance in this context is established by the technical specifications of the referenced standards and internal engineering specifications, not by expert interpretation of clinical data or images.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods (like 2+1, 3+1) are typically used for clinical study data where multiple experts assess the same cases. For device bench testing, the assessment is based on objective measurements and compliance with predefined technical criteria from standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI/imaging devices where human readers interpret medical images. This submission describes a physical medical device (catheter) and its bench testing.

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

This concept is not directly applicable. The device itself is a standalone physical product. The performance studies described are essentially "standalone" in the sense that they evaluate the device's physical properties and functionality without human patient interaction during the tests described.

7. The Type of Ground Truth Used

The "ground truth" for the performance of the UroGen Ureteral Catheter in these studies relates to:

• Compliance with International Standards: The device's performance is compared against the established specifications and requirements outlined in internationally recognized standards (e.g., ISO 10993, ISO 10555, ASTM F623-99, EN 13868, EN 1616, ISO 594, ANSI/AAMI/ISO 11135, AAMI/ISO 11138, EN 1422).
• Internal Standard Specifications: For the "Instillation force test," an internal standard was used, implying predefined engineering specifications for acceptable performance.
• Safety and Effectiveness Principles: The ultimate "ground truth" for regulatory clearance is that the device is as safe and effective as its predicate device without raising new safety or effectiveness concerns.

8. The Sample Size for the Training Set

This information is not applicable. "Training sets" are relevant for machine learning or AI models. The UroGen Ureteral Catheter is a physical medical device, and its design and manufacturing process do not involve a training set in the context of AI.

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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These devices are intended for access and catheterization of the urinary tract, including the following applications:

• Delivery of contrast media
• Navigation of a tortuous ureter
• Access, advancement, or exchange of wire guides

The Angled Tip Ureteral Catheter is constructed from polyurethane tubing and is designed with a female Luer lock adapter. The catheter is available in 5 and 6 French diameters and a length of 70 centimeters. The distal tip of the catheter has an angle of 20°, sideports, and a taper. The female Luer lock adapter is constructed from polyamide. The subject device also includes a stainless steel wire guide coated with PTFE. The wire guide diameter is 0.035 inches and the length is 145 centimeters

This document, K181144, is a 510(k) premarket notification for the Angled Tip Ureteral Catheter from Cook Incorporated. It determines the device is substantially equivalent to legally marketed predicate devices.

The document does not contain information regarding studies for AI/ML based medical devices or their acceptance criteria. It pertains to a physical medical device (catheter) and its substantial equivalence based on performance testing of the device itself. Therefore, I cannot extract the requested information regarding:

• A table of acceptance criteria and reported device performance for an AI/ML device.
• Sample sizes, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, or ground truth details for an AI/ML test set or training set.

The performance data listed in the document (Biocompatibility, Sterilization, Dimensional and Compatibility, Radiopacity, Kink Radius, Tensile, Blockage and leakage) are standard engineering and material tests for a physical catheter, not typically applicable to the validation of an AI/ML algorithm.

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The Imager II Urology Torque Catheter is indicated for use in facilitating access to the urinary tract, either through a retrograde or antegrade route, and may be used in conjunction with a guidewire or for the infusion of radiopaque contrast material. The Imager II Urology Torque Catheter is also indicated for the infusion of gels, such as BackStop™, intended for use in the urinary tract.

The Imager II Urology Torque Catheter is single lumen, torqueable catheter that is offered with one of a variety of tip configurations, each uniquely designed to facilitate access to the urinary tract. This device is made of a bio-compatible polymer reinforced with a stainless steel braided wire with one hole at the distal tip and a luer lock hub is attached to the proximal end. The catheter may be used with a guidewire up to .038 in. diameter.

The provided FDA 510(k) summary (K180530) for the Imager™ II Urology Torque Catheter describes performance data related to material changes, not diagnostic accuracy. Therefore, many of the requested criteria regarding expert review, specific ground truth methods, and comparative effectiveness with human readers are not applicable or cannot be extracted from this document.

Here's the information that can be extracted or that indicates inapplicability:

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

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

   • The document states "Verification activity has been performed on representative devices of the proposed Imager™ II Urology Torque Catheters." A specific numerical sample size is not provided.
   • Data Provenance: Not explicitly stated, but implies laboratory testing performed on manufactured devices. No information on country of origin of data or whether it's retrospective/prospective in a clinical sense.

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 urological catheter, and the performance testing relates to physical properties and biocompatibility, not diagnostic interpretation requiring expert clinical consensus.

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

   • Not applicable, as no expert adjudication of diagnostic findings is involved for this type of 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

   • Not applicable. This is not an AI-assisted diagnostic device.

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

   • Not applicable. This is not an algorithmic or AI device.

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

   • For mechanical performance: The ground truth implicitly derives from the device's "predefined product specifications." These specifications define what constitutes acceptable shaft and tip bond, and tensile strengths.
   • For biocompatibility: The ground truth for safety and effectiveness is established by the results of standardized ISO biological evaluation tests, indicating whether the material elicits a cytotoxic, sensitization, or intracutaneous reactivity response beyond acceptable limits.

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 this device.

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The Cone Tip Ureteral Catheter is intended for retrograde pyelogram.
The Rutner Universal Wedge Catheter is intended for retrograde pyelogram. The 4.0 Fr Rutner Universal Wedge Catheter is indicated for pediatric population 2 years and older.

Cone Tip Ureteral Catheter: The product consists of a straight, tipped catheter. The distal tip is in a cone formation and intended to temporarily occlude the ureteral orifice. The catheter tip and tubing shaft are made of radiopaque polyvinyl chloride material. The catheter is available in outer diameters of 4.8 and 6.0 French with corresponding tip diameters of 8.0 and 10.0 French respectively. The total working length of the device measures 70 centimeters. All French sizes are available with a closed distal end, except the 4.8 French catheters which are also available with an open end. Catheters with closed distal ends include one side port near the tip, whereas catheters with open distal ends do not include a side port. The radiopaque vinyl tubing shaft has an adapter on the proximal end and incremental graduation marks placed along the distal 50 centimeters of the catheter surface.

Rutner Universal Wedge Catheter: The distal tip is made of polyvinyl chloride radiopaque material and its configuration is designed to occlude the ureteral orifice and stabilize the catheter by temporarily wedging the orifice. The catheter tubing shaft is manufactured from non-radiopaque nylon with an adapter located at the proximal end. The catheter is available in outer diameters of 4.0 or 5.0 French and a total device length of 70 centimeters. The outer diameter of the tip is available in 8.0 and 14.0 French. Based upon the device size, the distal tip may occlude an opening of 3.0 to 8.0 French or 4.0 to 14.0 French, respectively. A single sideport is located in the distal end of the catheter.

The provided document is a 510(k) summary for the Cone Tip Ureteral Catheter and Rutner Universal Wedge Catheter. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving clinical effectiveness in the same way an AI/CADe device would. Therefore, the information typically requested for AI/CADe acceptance criteria and studies (like sample size for test set, number of experts for ground truth, MRMC studies, effect size, etc.) is not present in this document.

However, based on the provided text, I can extract the following information about the performance data that was conducted to ensure the device meets its design input requirements for safety and performance:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists performance tests conducted. The "acceptance criteria" are implied by the successful completion of these tests, leading to the conclusion that the devices "meet the design input requirements based on their intended uses." Specific numerical acceptance criteria are not detailed in this summary.

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

This information is not provided in the document. The performance data section only lists the types of tests conducted.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable/not provided. The tests conducted are primarily engineering and material science evaluations, not clinical performance assessments requiring expert ground truth in the way an AI/CADe device would.

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

This information is not applicable/not provided. The tests conducted are primarily engineering and material science evaluations.

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. This submission is for a medical device (ureteral catheter) and not an AI/CADe device. No MRMC study was mentioned or required.

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

This information is not applicable. This submission is for a medical device (ureteral catheter) and not an AI/CADe device.

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

The "ground truth" for the performance tests would be the established engineering specifications, material standards, and industry best practices for each test (e.g., maximum allowable tensile strength, specific kink radius, biocompatibility standards, etc.). These are objective criteria, not clinical "ground truth" derived from expert consensus, pathology, or outcomes data.

8. The sample size for the training set

This information is not applicable/not provided. This is not an AI/CADe device that uses training data.

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

This information is not applicable/not provided. This is not an AI/CADe device that uses training data.

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Renal Access Cobra Catheter: This device is intended for delivery of contrast media as well as access, advancement, or exchange of wire guides in the renal area.
Kumpe Access Catheter: These devices are intended for access and catheterization of the urinary tract, including the following applications: Delivery of contrast media, Navigation of a tortuous ureter, Access, advancement, or exchange of wire guides

The Renal Access Cobra Catheter consists of tubing with a proximal connector cap and a winged female Luer lock adapter. The catheter has a total length of 65 cm and an outer diameter of 6.0 French. The catheter tubing is composed of a polymer reinforced with braided wire. The distal end of the catheter has a hook shaped curve. The tubing French size and compatible wire guide size are printed on one side of the winged female Luer lock adapter; on the other side is the name of the manufacturer.
The Kumpe Access Catheter consists of tubing with a proximal cap and female Luer lock adapter. The catheter has a total length of 65 cm and an outer diameter of 5.0 French. The catheter tubing is composed of a polymer reinforced with braided wire. The distal tubing configuration is angled at approximately 45 degrees. The tubing French size, compatible wire guide size, and manufacturer are printed on the cap.

The provided text is a 510(k) summary for the Renal Access Cobra Catheter and Kumpe Access Catheter. It outlines the device's indications for use, comparison to a predicate device, and performance data. However, it does not contain specific acceptance criteria or details of a study that proves the device meets those criteria in the format requested.

The document lists the types of testing performed but does not provide:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets or data provenance.
• Number of experts or their qualifications for establishing ground truth.
• Adjudication methods.
• Information on Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance (as this is a physical device, not an AI/software device).
• The type of ground truth used (as this refers to diagnostic accuracy, which is not applicable here).
• Sample size for the training set or how ground truth for a training set was established (again, not applicable to a physical medical device).

Instead, the document states that "The following testing was performed in order to demonstrate that the proposed Renal Access Cobra Catheter and Kumpe Access Catheter met applicable design and performance requirements." and then lists general categories of performance tests:

• Dimensional and Compatibility Testing
• Radiopacity Testing
• Kink Radius Testing
• Blockage and Leakage Testing
• Tensile Testing
• Biocompatibility Testing
• Environmental Testing
• Sterilization Testing
• Accelerated Age Testing

The conclusion drawn is: "The results of these tests support a conclusion that the Renal Access Cobra Catheter and Kumpe Access Catheter will perform as intended. The subject devices do not raise new questions of safety or effectiveness as compared to the predicate device."

Therefore, based on the provided text, it is not possible to fully answer your request. The document describes a traditional 510(k) submission for a physical medical device, which focuses on demonstrating substantial equivalence to a predicate device through a series of engineering and biocompatibility tests, rather than clinical performance studies with specific accuracy metrics like those found with AI or diagnostic devices.

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Ureteral catheters are indicated for access and catheterization of the urinary tract, including applications:

• Delivery of contrast media
• Drainage of fluids from the urinary tract
• Delivery of irrigation fluids to the urinary tract
• Navigation of a tortuous ureter
• Access, advancement, or exchange of wire guides (open-ended catheters only)

The Pediatric Ureteral Catheter is indicated for access and catheterization of the urinary tract in pediatric patients, including the following applications:

• Delivery of contrast media
• Drainage of fluids from the urinary tract
• Delivery of irrigation fluids to the urinary tract
• Navigation of a tortuous ureter

The Ureteral Catheter family is comprised of nine different types of Ureteral Catheters. The types of catheters include: Open-End Ureteral Catheter, Open-End Ureteral Catheter Sof-Flex, EchoTip Open-End Ureteral Catheter, Open-End Flexi-Tip Ureteral Catheter, Flexi-Tip Ureteral Catheter (Closed End), Whistle Tip Ureteral Catheter, Round Tip Ureteral Catheter, Spiral Tip Ureteral Access Catheter, and Pediatric Ureteral Catheter. The Ureteral Catheters range in length from 10 to 125 cm. The catheters may be closed or open-ended. The Ureteral Catheters are sterile, single-use devices.

The provided text describes a 510(k) premarket notification for a family of ureteral catheters. It focuses on demonstrating substantial equivalence to predicate devices, primarily through performance and biocompatibility testing. However, it does not contain the information required to answer your specific questions regarding an AI/algorithm-based device and its acceptance criteria, such as a table of accuracy metrics, sample sizes for test/training sets, expert adjudication methods, MRMC studies, or standalone algorithm performance.

The document is for a traditional medical device (catheters) and not an AI/ML-driven diagnostic or assistive system. Therefore, the concepts of "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to engineering performance tests and biocompatibility, not AI performance metrics.

Specifically, the document states:

• Performance Testing: "Performance - Testing shows that the subject device conforms to the performance testing requirements based on intended use. All predetermined acceptance criteria were met." (Page 6)
• Biocompatibility Testing: "Biocompatibility – Testing shows that the subject device conforms to the biocompatibility requirements based on its intended use. All predetermined acceptance criteria were met." (Page 6)

The tests performed are typical for a physical medical device: Tensile Strength, Leakage and Lumen Blockage, Radiopacity, Kink Radius, Catheter-Hub Bond, Cytotoxicity, Sensitization, and Irritation/Intracutaneous Reactivity.

To directly answer your request based on the provided text, the following information is NOT available:

1. A table of acceptance criteria and the reported device performance (for an AI/ML device): The document lists performance tests for a physical device, not AI performance metrics like sensitivity, specificity, or AUC.
2. Sample size used for the test set and the data provenance: No information on test data, as it's a physical device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable to this type of device.
4. Adjudication method for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a 510(k) summary for physical ureteral catheters and does not contain any information about AI/ML device performance or the study design for such a device.

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