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The Single-use Ureteral Access Sheath is used to establish a conduit during endoscopic urological procedures facilitating the passage of endoscopes and other instruments into the urinary tract.

The Single-use Ureteral Access Sheath is used to establish a conduit during endoscopic urological procedures facilitating the passage of endoscopes and other instruments into the urinary tract.

The device models are Y-09-40, Y-09-50, Y-10-40, Y-10-50, Y-11-40, Y-11-50, Y-12-40, and Y-12-50.

The device is composed of access sheath and dilator. The access sheath consists of sheath tube and connector. The dilator consists of dilator tube and dilator base. Single-use Ureteral Access Sheath is sterilized by Ethylene Oxide Gas to achieve a SAL of 10-6 and supplied sterility maintenance package which could maintain the sterility of the device during the shelf life of 3 years.

The provided FDA 510(k) clearance letter details the substantial equivalence for a "Single-use Ureteral Access Sheath." This document does not contain information about an AI/ML-driven device or study results proving a device meets acceptance criteria related to AI/ML performance.

The information provided describes a medical device, its intended use, and various performance tests to ensure its safety and effectiveness compared to a predicate device. These tests are standard for a physical medical device (like biocompatibility, sterility, shelf-life, and mechanical bench tests) and are not related to artificial intelligence or machine learning performance metrics found in an AI/ML-driven medical device study.

Therefore, I cannot fulfill your request to describe acceptance criteria and study proving an AI/ML device meets them based on the provided text. The document clearly states "VIII. Clinical study: Not applicable" for this device, which further confirms the absence of data related to human reader performance with or without AI assistance, or algorithm-only performance.

If you have a document describing an AI/ML device, I would be happy to analyze it according to your requested criteria.

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The Single-use Ureteral Access Sheath is used to establish a conduit during endoscopic urological procedures facilitating the passage of endoscopes and other instruments into the urinary tract.

The Single-use Ureteral Access Sheath is a prescription device intended to provide physicians with access to the urinary tract and the capability to serve as a pathway for device exchanges. Similar to all ureteral access sheath sets, this device also safeguards the ureter during device exchanges, thus helping to minimize tissue trauma. The Single-use Ureteral Access Sheath consists of two components: the inner semi-rigid dilator assembly and the outer semi-rigid sheath assembly, both of which have a hydrophilic coating to allow for smooth and easy deployment into the upper tracts over a preplaced ureteral guidewire. The sheath has a locking mechanism that attaches to the luer lock hub of the inner dilator, allowing the sheath and dilator to move as a single unit. To ease the insertion of the Single-use Ureteral Access Sheath into the body orifice, the dilator is advanced over a 0.038 inch guidewire. Since both the sheath and dilator are radiopaque, they can be monitored using X-ray (fluoroscopy) to ensure their accurate positioning during the placement process. The Single-use Ureteral Access Sheath is designed to accommodate endoscopes and other urological instruments with an outer diameter (OD) that is compatible with the sheath's inner diameter (ID) of 10Fr, 11Fr, 12Fr, 13Fr, and 14Fr. The inner layer of the sheath is made of stainless steel to provide radial rigidity that remains patent and intact after the dilator is removed, allowing endoscopes and other urological instruments to pass easily along the lumen of the Access Sheath. The Single-use Ureteral Access Sheath is offered in five French size combinations: 10Fr/12Fr, 11Fr/13Fr, 12Fr/14Fr, 13Fr/15Fr, and 14Fr/16Fr, and four lengths: 35cm, 45cm, 50cm, 55cm. The device is constructed using biologically safe materials and is provided in a sterile condition, intended for single use only.

The provided 510(k) clearance letter is for a "Single-Use Ureteral Access Sheath" (K251599), which is a physical medical device and not an AI or software-based device.

Therefore, many of the requested points related to AI/software performance, such as:

• MRMC comparative effectiveness study
• Standalone (algorithm only) performance
• Sample size and ground truth for training set
• Number of experts and their qualifications for ground truth establishment
• Adjudication method for test set

do not apply to this device and its associated performance data.

The performance data provided in the 510(k) summary focuses entirely on non-clinical performance data for a physical device, including:

• Biocompatibility Testing
• Sterility Testing
• Functional and Mechanical Performance Testing (e.g., appearance, size, patency, breaking force, friction, etc.)

Based on the information provided in the 510(k) clearance letter for the Single-Use Ureteral Access Sheath (K251599), here's a breakdown of the requested information:

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

The document lists various performance tests conducted but does not explicitly state the quantitative acceptance criteria for each test or the specific numerical results obtained. It generally states that "All evaluation acceptance criteria were met" for biocompatibility and implies successful results for performance testing by concluding substantial equivalence.

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The LumenaTM Ureteral Access Sheath is indicated to establish a conduit during endoscopic urological procedures, facilitating the passage of endoscopes and other instruments into the urinary tract.

The LumenaTM Ureteral Access Sheaths are designed to establish a conduit for the treatment of urinary stones or other urinary diseases during the endoscopic procedures. The sheaths are available with both a bendable tip with a Y-shape joint on the proximal end and a straight tip with the outside diameters ranging from 11 to 15 French and lengths ranging from 35 to 45 centimeters. These devices are available in a single lumen configuration and include a sheath tube and a dilator. The bendable-tip sheath is intended to be connected to a negative pressure aspirator for the collection of stones or foreign bodies during the endoscopic procedure.

The provided FDA 510(k) clearance letter and summary for the LumenaTM Ureteral Access Sheath do not contain information about an AI/ML-driven device or study parameters related to AI/ML performance.

Instead, the document describes a traditional medical device (a ureteral access sheath) and the non-clinical bench testing, sterilization, packaging, shelf-life, and biocompatibility evaluations performed to demonstrate its safety and substantial equivalence to a predicate device.

Therefore, I cannot provide information on:

• A table of acceptance criteria and reported device performance specific to AI/ML. The document lists various non-clinical tests but doesn't detail specific acceptance criteria values or quantitative performance metrics in a table for these tests.
• Sample size used for the test set and the data provenance for an AI/ML study.
• Number of experts used to establish the ground truth and their qualifications for an AI/ML study.
• Adjudication method for an AI/ML study.
• Multi-reader multi-case (MRMC) comparative effectiveness study and effect size of human improvement with AI assistance.
• Standalone (algorithm only) performance.
• Type of ground truth used for an AI/ML study.
• Sample size for the training set for an AI/ML study.
• How the ground truth for the training set was established for an AI/ML study.

The document explicitly states: "No clinical study is included in this submission." This further confirms that no studies involving human readers, ground truth establishment, or AI/ML performance evaluations were conducted as part of this submission.

The "acceptance criteria" mentioned in the document refer to the successful completion of the non-clinical performance tests. For example, "All the testing results meet the defined acceptance criteria." However, the specific numerical acceptance criteria and the detailed results for each non-clinical test (Tensile Performance, Hydrophilic Coating Performance, etc.) are not provided in this summary document. They would typically be found in the full 510(k) submission.

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The CoralWell™ Single-use Ureteral Access Sheath is used to establish a conduit during endoscopic urological procedures facilitating the passage of endoscopes and other instruments into the urinary tract. It is designed to establish a conduit for the treatment of urinary stones or other urinary diseases during the endoscopic procedures.

Not Found

This FDA 510(k) clearance letter for the CoralWell™ Single-use Ureteral Access Sheath does not contain any information about acceptance criteria or a study that proves the device meets acceptance criteria.

The letter is a regulatory document confirming that the FDA has reviewed MacroLux Medical Technology Co., Ltd.'s premarket notification and determined the device is substantially equivalent to legally marketed predicate devices. It outlines various regulatory requirements the manufacturer must adhere to (e.g., Quality System regulation, UDI Rule, adverse event reporting), but it does not detail performance testing or clinical studies.

Therefore, I cannot provide the requested information, including:

1. A table of acceptance criteria and the reported device performance: This information is not present in the provided document.
2. Sample sized used for the test set and the data provenance: Not available. The document is about regulatory clearance, not performance testing details.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available, as no performance study is described.
4. Adjudication method: Not available.
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 device is a physical medical instrument (ureteral access sheath), not an AI/software device. Therefore, an MRMC study with AI assistance is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable, as it's not an algorithm.
7. The type of ground truth used: Not available.
8. The sample size for the training set: Not applicable, as this is a physical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

To obtain information about performance criteria and testing for such a device, one would typically need to review the actual 510(k) submission summary or a separate technical document from the manufacturer, which would contain details of bench testing, biocompatibility studies, and potentially animal or clinical performance data if submitted. The clearance letter itself is a summary of the FDA's regulatory decision, not a detailed technical report.

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The Disposable Ureteral Access Sheath is used to establish a continuous conduit during urological endoscopic procedures facilitating the in and out passage of endoscopes and other instruments into the urinary tract.

The proposed device, Disposable Ureteral Access Sheath is used to establish a continuous conduit during urological endoscopic procedures facilitating the in and out passage of endoscopes and other instruments into the urinary tract.

This device is divided into five types:

• Z type Straight joint access sheath
• Y type negative suction Y joint access sheath
• W type negative suction W joint access sheath
• T type Straight joint access sheath
• C type negative suction W joint access sheath

This product consists of access sheath and dilator tube. The access sheath tube consists of access sheath tube body and access sheath joint. The surface of access sheath tube is coated with polyvidone (PVP). The dilator tube consists of dilator tube body and dilator tube connector. The access sheath tube body is made from nylon (PA), stainless steel and polytetrafluoroethylene (PTFE). The access sheath joint is made from polycarbonate (PC), acrylonitrile-butadiene-styrene copolymer (ABS) and silicone. The dilator tube body and dilator tube connector are made from PE.

The proposed devices are sterilized by Ethylene Oxide Gas to achieve a SAL of 10-6 and supplied sterility maintenance package which could maintain the sterility of the device during the shelf life of 3 years.

Based on the provided FDA 510(k) clearance letter for the Disposable Ureteral Access Sheath (K243710), the device is cleared based on non-clinical performance and biocompatibility testing, demonstrating substantial equivalence to a predicate device. There is no information about a study involving human readers or AI assistance.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" alongside specific numerical "reported device performance" values for each criterion. Instead, it lists the types of performance tests conducted and states that the results "met the standard requirements" or that certain characteristics "shall not exceed" or "shall not be less than" a specified value, implying these are the acceptance criteria.

Implied Acceptance Criteria and Performance (Based on "Comparison of Technological Characteristics" and "Non-Clinical Testing" sections):

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

• Sample Size: The document does not specify the exact sample sizes for each non-clinical performance test. It only lists the types of tests performed.
• Data Provenance: The testing was conducted as part of the regulatory submission by Shenzhen Trious Medical Technology Co., Ltd. The document refers to "Performance testing" and "Biocompatibility testing," which are typically done in a controlled laboratory setting. It does not mention retrospective or prospective data in the context of human studies for this device. The manufacturer is based in Shenzhen, China.

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

This request is not applicable to the provided document. The "ground truth" for this device's testing is based on engineering specifications, material science, and established biological safety standards (e.g., ISO and ASTM standards), not on expert clinical interpretation of medical images or data from human patients. Therefore, no human experts (e.g., radiologists) were involved in establishing "ground truth" in the way understood in diagnostic AI/image analysis studies.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods are typically used in clinical studies or expert review processes where there might be disagreements in interpretation (e.g., blinded reads, consensus reads). For non-clinical device performance testing, results are typically objective measurements against predefined specifications.

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

No. The document explicitly states: "No clinical study is included in this submission." Therefore, no MRMC study or AI assistance evaluation was performed or submitted.

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

No. This device is a physical medical instrument (ureteral access sheath), not an AI algorithm or software. Therefore, the concept of "standalone algorithm performance" is not applicable.

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

The "ground truth" for this device's performance is established by:

• Engineering Specifications: Defined physical dimensions, material properties, and mechanical strengths.
• Standardized Test Methods: Adherence to recognized international and national standards (e.g., ISO 11135, ISO 11737-1, ISO 10993-1 for biocompatibility, various ASTM standards for material properties). These standards define how performance is measured and what constitutes acceptable limits.
• Biocompatibility Definitions: Established biological responses to materials as defined by ISO 10993-1.

8. The Sample Size for the Training Set

Not applicable. This is a physical device, not an AI model or software that requires a training set.

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

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

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The Navigator HD Ureteral Access Sheath is indicated for use in endoscopic procedures to facilitate the passage of endoscopes, urological instruments and for the injection of fluids into the urinary tract.

Navigator™ HD Ureteral Access Sheath Set consists of a semi-rigid outer sheath and a semi-rigid inner dilator with interlocking hub. The set permits utilization of a guidewire to assist in device placement.

Sheath: The Navigator™ HD Sheath has a sheath hub which is over-molded onto the sheath shaft has three layers: Outer Pebax layer, Reinforced stainless steel coil enhancing torqueability and maneuverability, Inner PTFE liner. The sheath outer layer contains Barium Sulphate as a radiopacifier. In addition to the stainlesssteel coil, a radiopaque marker band is sandwiched between the Pebax and PTFE layers. The radiopaque marker band is located at the sheath tip and, along with the radiopacifier added to the sheath outer layer, enhances fluoroscopic visualization of sheath placement during the procedure. A hydrophilic coating is applied to the entire length of the shaft to reduce friction and facilitate placement of the device.

Dilator: The Navigator™ HD dilator has a hub with a standard luer lock at the proximal end. The tab on the dilator hub allows it to lock into the sheath hub. The dilator shaft is made of extruded tube Pellethane to allow for dimensional stability, low moisture absorption, and chemical resistance. The dilator tip is made of a softer grade of Pellethane to improve tip flexibility to assist in atraumatic placement. Both the dilator shaft and tip contain Barium Sulfate as a radiopacifier, enhancing visualization under fluoroscopy during the procedure. A hydrophilic coating is applied to the entire length of the dilator to reduce friction and facilitate placement of the device, either when assembled with the sheath or when used separately as a dilatation device.

This is a 510(k) premarket notification for a medical device, not an AI/ML device. Therefore, the questions regarding acceptance criteria and studies that prove the device meets these criteria in the context of AI/ML are not applicable here.

The document discusses the substantial equivalence of the Navigator™ HD Ureteral Access Sheath Set to a previously cleared predicate device.

Here's the relevant information that can be extracted, addressing the spirit of the request as much as possible for a non-AI/ML device:

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

The document doesn't present "acceptance criteria" in the typical AI/ML sense (e.g., specific sensitivity/specificity thresholds). Instead, it relies on demonstrating substantial equivalence to an existing predicate device. The performance is assessed by comparing technological characteristics and performing design verification and usability testing related to a minor change.

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

This is a physical medical device. The "test set" would refer to samples of the device undergoing engineering performance testing. The document does not specify sample sizes for the "Design Verification" or "Summative Usability" testing, nor does it mention data provenance (e.g., country of origin, retrospective/prospective clinical data). These would typically be detailed in internal test reports referenced by the submission but not included in this summary.

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

This is not applicable as this is not an AI/ML device requiring expert ground truth for classification or diagnosis. The "ground truth" for the device's performance relies on engineering specifications and established safety/efficacy profiles of similar devices.

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

Not applicable for a physical medical device. Adjudication methods are relevant for subjective interpretations of data, typically in clinical studies or AI/ML ground truth establishment.

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

Not applicable. This is not an AI/ML device, and no human reader study with or without AI assistance was performed or needed.

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

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

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

The "ground truth" for the device's acceptable performance is based on:

• Engineering specifications and standards: Ensuring the device meets its design requirements.
• Performance testing results: Demonstrating functional equivalence and safety (e.g., mechanical performance, biocompatibility).
• Historical performance of predicate device: The K140323 device, which has a proven track record.

8. The sample size for the training set:

Not applicable. This is a physical medical device, not an AI/ML model that requires a training set.

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

Not applicable, as there is no training set for a physical medical device.

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The Ureteral Access Sheath is used to establish a conduit during endoscopic urological procedures facilitating the passage of endoscopes and other instruments into the urinary tract. It is designed to establish a conduit for the treatment of urinary stones or other urinary diseases during the endoscopic procedures.

Ureteral Access Sheath is used to establish a conduit during endoscopic urological procedures facilitating the passage of endoscopes and other instruments into the urinary tract. The Ureteral Access Sheath provides ureteral dilation and a continuous working channel for the introduction of endoscopes and instruments during ureteral access procedures. Ureteral Access Sheath comes in two models: Tip-unbendable Ureteral Access Sheath and Tip-bendable Ureteral Access Sheath with suction. The Tip-unbendable Ureteral Access Sheath is offered in French size ranging from 10Fr to 14Fr and length 28cm to 45cm. The Tip-bendable Ureteral Access Sheath with Suction is offered in French size ranging from 10Fr to 13Fr and length 33cm to 50cm.

The Seplou (Zhuhai) Co., Ltd. Ureteral Access Sheath (K243025) is a medical device used to create a conduit in the urinary tract for endoscopic urological procedures. The device's acceptance criteria and proven performance are outlined through various tests detailed in the 510(k) summary.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The provided document does not explicitly state the sample sizes used for each specific performance test (biocompatibility, general performance, sterilization, shelf life). It notes that various tests were conducted.

The provenance of the data is not specified in terms of country of origin or whether it was retrospective or prospective. However, given that it is a 510(k) submission for a device manufactured by a Chinese company (SEPLOU (ZHUHAI) CO., LTD.), it is highly probable that the testing was performed in laboratories affiliated with or contracted by the manufacturer, potentially in China or other authorized testing facilities globally.

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

This information is not applicable to this type of device submission. The device is a Ureteral Access Sheath, which is a physical instrument. The "ground truth" for its performance relies on objective measurements against engineering specifications and international standards, not on expert interpretations of data like in an AI/imaging study.

4. Adjudication Method for the Test Set:

This information is not applicable. Adjudication methods (like 2+1, 3+1 consensus) are typically used in clinical studies or studies involving subjective human interpretation (e.g., imaging reviews), which is not the case for the premarket testing of this physical medical device. The tests performed are objective, laboratory-based evaluations.

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 information is not applicable. The device is a physical Ureteral Access Sheath, not an AI or imaging diagnostic tool that would involve human readers or AI assistance.

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

This information is not applicable. The device is a physical Ureteral Access Sheath, not an algorithm or software.

7. The Type of Ground Truth Used:

The "ground truth" for the performance of the Ureteral Access Sheath is established through:

• Compliance with International Standards: ISO (International Organization for Standardization) standards for biocompatibility and sterilization, and ASTM/DIN standards for packaging and shelf-life.
• Engineering Specifications: The manufacturer's own design specifications for dimensions, material properties, mechanical strength (fracture force, bending resistance), and functional aspects (liquid leakage, surface friction).
• Predicate Device Equivalence: The ultimate purpose of the 510(k) submission is to demonstrate substantial equivalence to a legally marketed predicate device (ClearPetra Suction-Evacuation Sheath K161110) in terms of safety and effectiveness, meaning the subject device performs similarly or better than a device already proven safe and effective.

8. The Sample Size for the Training Set:

This information is not applicable. There is no "training set" for a physical medical device like a Ureteral Access Sheath. Training sets are relevant for machine learning algorithms.

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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To establish a continuous conduit during urological endoscopic procedures facilitating the in and out passage of endoscopes and other instruments into the urinary tract.

The ReTrace Ureteral Access Sheath is a sterile, single use device that is inserted over a guidewire into the upper or lower urinary tract of patients requiring ureteroscopic procedure sin a hospital environment. The ReTrace Ureteral Access Sheath consists of:

• Reinforced tube/sheath
• Introducer/dilator
• Connector
• Clip

The reinforced polymeric introducer sheath includes a hydrophilic coating on the exterior and a lubricious inner surface. The sheath is reinforced to provide kink resistance. The distal tip of the sheath is fitted with a radiopaque ring. A white connector is fitted on the proximal end of the sheath and an orange connector is on the proximal end of the introducer to allow the two components to be attached.

The dilator is fitted with a Luer connector on the proximal end and has a hydrophilic coating on the distal end. A guidewire entry and exit eye and exit holes for fluid delivery are located at the distal end of the introducer. The dilator protrudes out the distal end and allows for a gradual enlargement of the passage if needed and improves trackability along the guidewire. Once in the desired location, the dilator is removed to establish a hollow conduit for insertion of endoscopes and other instruments into and out of the urinary tract.

The ReTrace Ureteral Access Sheaths are available in two diameters 10/12 Fr and 12/14 Fr. Lengths range between 28 and 55 cm.

This submission is for modifications to device materials, labeling, packaging, and connector design.

Here's a breakdown of the acceptance criteria and study information based solely on the provided text.

Crucial Note: The provided document is a 510(k) summary for a medical device (Ureteral Access Sheath) that underwent modifications. This means the primary argument for clearance is substantial equivalence to a previously cleared predicate device, rather than proving efficacy from scratch with a new device. Therefore, the details requested in your prompt regarding AI/ML models (e.g., training/test sets, human reader studies, ground truth establishment by experts) are generally not applicable to this type of device clearance. The performance data focuses on demonstrating that the modifications do not negatively impact the device's basic safety and function compared to the original cleared version.

Acceptance Criteria and Reported Device Performance

Given this is a 510(k) for a modified device, the "acceptance criteria" are implicitly that the modified device performs comparably to the predicate device in relevant mechanical, biocompatibility, and sterilization tests, and the modifications do not raise new questions of safety or effectiveness. The reported performance is that the device met these criteria.

Study Details (Based on Provided Text)

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

   • Sample Size: Not explicitly stated as a number of devices for each test. The document lists types of mechanical tests performed (e.g., tensile strength, friction tests) which implicitly involve testing multiple samples, but the exact quantity is not given.
   • Data Provenance: Not specified regarding country of origin. The studies are non-clinical testing (mechanical, biocompatibility, sterilization, packaging) and not human subject data. Thus, the concept of "retrospective or prospective" human data does not apply here.

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

   • Not Applicable. This document describes the clearance of a physical medical device (Ureteral Access Sheath) through non-clinical performance testing for substantial equivalence after modifications. It is not an AI/ML device that requires expert-established ground truth for a test set. The "ground truth" for these tests is defined by the technical specifications, standards (like ISO 10993-1), and acceptable performance parameters for the device.

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

   • Not Applicable. Again, this pertains to expert review of data, typically in AI/ML performance studies. Here, the "adjudication" is whether the device passed specific engineering and performance tests, which would be determined by laboratory results and quality system procedures, not expert consensus on ambiguous data.

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:

   • No. This type of study (MRMC, human readers with/without AI) is specifically for AI-powered diagnostic/interpretive devices. The Retrace Ureteral Access Sheath is a physical, mechanical medical device.

5. 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.

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

   • The "ground truth" for this device's performance testing is defined by engineering specifications, industry standards (e.g., ISO 10993-1), and established test methodologies to ensure the device's physical and functional properties meet design requirements and maintain equivalency to the predicate device.

7. The sample size for the training set:

   • Not Applicable. This is not an AI/ML device with a training set.

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

   • Not Applicable. As above, no training set for an AI/ML model.

Summary of why AI/ML related questions are not addressed:

The provided text is a 510(k) summary for a physical, mechanical medical device (a Ureteral Access Sheath) that underwent modifications. The FDA clearance pathway for such devices, especially when arguing substantial equivalence, relies heavily on non-clinical performance testing (biocompatibility, mechanical integrity, sterilization validation, packaging) to demonstrate that the device is as safe and effective as a legally marketed predicate device. It does not involve AI/ML components, diagnostic interpretation, or human reader studies. Therefore, many of the questions asked in your prompt are not relevant to the content of this specific FDA submission.

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The Single-use Ureteral Access Sheath is used to establish a conduit during endoscopic urological procedures, facilitating the passage of endoscopes and other instruments into the urinary tract.

The Single-use Ureteral Access Sheath is a prescription device intended to provide physicians with access to the urinary tract and the capability to serve as a pathway for device exchanges. Similar to all ureteral access sheath sets, this device also safeguards the ureter during device exchanges, thus helping to minimize tissue trauma. The Single-use Ureteral Access Sheath consists of two components: the inner semi-rigid dilator assembly and the outer semi-rigid sheath assembly, both of which have a hydrophilic coating to allow for smooth and easy deployment into the upper tracts over a preplaced ureteral guidewire. The sheath has a locking mechanism that attaches to the luer lock hub of the inner dilator, allowing the sheath and dilator to move as a single unit. To ease the insertion of the Single-use Ureteral Access Sheath into the body orifice, the dilator is advanced over a 0.038 inch guidewire. Since both the sheath and dilator are radiopaque, they can be monitored using X-ray (fluoroscopy) to ensure their accurate positioning during the placement process. The Single-use Ureteral Access Sheath is designed to accommodate endoscopes and other urological instruments with an outer diameter (OD) that is compatible with the sheath's inner diameter (ID) of 10Fr, 11Fr, 13Fr, and 14Fr. The inner layer of the sheath is made of stainless steel to provide radial rigidity that remains patent and intact after the dilator is removed, allowing endoscopes and other urological instruments to pass easily along the lumen of the Access Sheath. The Single-use Ureteral Access Sheath is offered in five French size combinations: 10Fr/12Fr, 11Fr/13Fr, 12Fr/14Fr, 13Fr/15Fr, and 14Fr/16Fr, and two lengths: 35cm and 45cm. The device is constructed using biologically safe materials and is provided in a sterile condition, intended for single use only.

The device in question is the Single-use Ureteral Access Sheath (K240167). The provided document is a 510(k) summary, which outlines the device's characteristics and the studies performed to demonstrate its substantial equivalence to a legally marketed predicate device.

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

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

The document details performance testing for various attributes. While it states "All evaluation acceptance criteria were met" for specific categories (e.g., Biocompatibility), it does not explicitly list numerical or qualitative acceptance criteria for each functional/mechanical test in a table form, nor does it provide the exact reported performance values. It only lists the tests conducted.

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

The document does not specify the sample sizes used for any of the non-clinical performance tests (biocompatibility, sterility, functional/mechanical testing).
The data provenance is not explicitly stated as retrospective or prospective, nor is the country of origin of the data mentioned for the performance testing. However, the applicant is Hunan Vathin Medical Instrument Co., Ltd., located in China, suggesting the testing was likely conducted by or for the manufacturer.

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 device is a physical medical instrument (Ureteral Access Sheath), not an AI/Software as a Medical Device (SaMD) that requires expert consensus for ground truth establishment. Therefore, this information is not applicable. The "ground truth" for this device is based on objective measurements and compliance with recognized standards.

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

As this is not a clinical study involving human interpretation or subjective assessment necessitating adjudication, this information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in clinical imaging or diagnostic studies.

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 MRMC study was conducted. This device is a physical medical instrument and does not involve AI assistance or human reader interpretation in its intended use.

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

This refers to AI/software performance. This device is a physical medical instrument, so this concept is not applicable.

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

The "ground truth" used for this device's performance evaluation is based on objective measurements and tests against established engineering, material, and biocompatibility standards. For example:

• Biocompatibility: In vitro and in vivo tests according to ISO 10993-1, measured against scientific criteria (e.g., cell viability for cytotoxicity, skin reaction for irritation).
• Sterility: Measured by sterility assurance level (SAL) achieved through validated sterilization processes per ISO 11135.
• Functional/Mechanical: Measured by physical properties (e.g., dimensions, force resistance, patency, leakage) against pre-defined specifications derived from engineering principles and comparison to the predicate device.

8. The sample size for the training set

This device does not involve a "training set" in the context of machine learning or AI. It is a physical medical device.

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

As there is no training set for this physical device, this question is not applicable.

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