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The RocaTub ureteral catheter is intended for use during ureteral catheterization for drainage, opacification of the upper urinary tract (retrograde ureteropyelography) and flushing procedures for diagnostics or interventional endourology procedures (stone management, stricture management) on adults.

The Rocamed RocaTub Catheters consist of a flexible tube, tapered, perforated and with position marks. It is radio-opaque and hydrophilic coated. The device includes a stylet for easing insertion into the patient if needed and a connector for syringe for flushing procedures. The device is offered in various sizes, from 4 to 7 Fr in 80cm length, and with various tip shapes.

The provided text is a 510(k) summary for the RocaTub Ureteral Catheter, a medical device. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of the device's performance against specific acceptance criteria in the manner typically seen for AI/ML-driven diagnostic devices.

Therefore, for this specific submission, many of the requested fields regarding AI/ML study design are not applicable.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state quantitative acceptance criteria for device performance in the form of a table that would be common for diagnostic algorithms (e.g., accuracy, sensitivity, specificity). Instead, it focuses on demonstrating that the device meets "necessary specifications" through bench testing and compliance with recognized standards.

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

This information is not applicable in the context of this 510(k) summary, as it describes a non-AI/ML medical device (a ureteral catheter). The "test set" for this type of device refers to units of the manufactured product subjected to various bench tests, not a dataset of patient cases or images. The provenance would be the manufacturing facility.

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

This is not applicable. Ground truth, in the context of an AI/ML diagnostic device, refers to definitive diagnoses often established by expert clinicians or pathological findings. For a physical medical device like a catheter, "ground truth" relates to material properties, design specifications, and functional performance measured through standardized tests, not expert interpretation of cases.

4. Adjudication Method for the Test Set:

This is not applicable. Adjudication methods like 2+1 or 3+1 are used in studies involving expert interpretation discrepancies, typically for diagnostic imaging or clinical assessment. This device's evaluation relies on objective measurements from bench testing.

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

This is not applicable. The RocaTub Ureteral Catheter is a physical medical device, not an AI-assisted diagnostic tool.

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

This is not applicable. This is not an algorithm.

7. The Type of Ground Truth Used:

For this device, the "ground truth" is established through:

• Standardized Test Methods: Adherence to recognized industry standards (e.g., EN 1618:1997 for catheter properties, ASTM F640-12 for radiopacity, ASTM D412A:2015 for polymeric geomembranes).
• Biocompatibility Testing: Conducted in accordance with ISO 10993.
• Validated Manufacturing Processes: Sterilization validation and shelf-life validation.
• Design Specifications: The inherent design parameters of the catheter (e.g., diameter, length, material, tip shape).

8. The Sample Size for the Training Set:

This is not applicable. This device does not involve a "training set" in the context of AI/ML.

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

This is not applicable. This device does not involve a "training set" in the context of AI/ML.

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The Dornier MINNOW Ureteral catheter is indicated for access and catheterization of the urinary tract, 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 Access, advancement, or exchange of wire quides

The target population is for adults only (at least 22 years old).

The MINNOW Ureteral Catheter is a sterile single lumen medical grade thermoplastic elastomer (Pebax®) catheter. It is designed to assist in access to the upper urinary tract using standard endoscopic technique for drainage and delivery of gels or fluids. The device is offered without side holes and is available in 5 and 6 Fr. Sizes, which are common to the industry. 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 quidewire or for the injection of gels or fluids into the urinary tract. The catheter tip is radiused and has a .041" ID that allows for a smooth transition and passage when placed over a guidewire of up to 0.038" inches in diameter that is pre-positioned through the urological tract. The MINNOW Ureteral Catheters are packaged with a standard Touhy-Borst adapter that allows for injection or aspiration of fluids, but removable to allow for scope exchange without having to remove the catheter. The MINNOW Ureteral Catheters are available in 5 and 6 French (Fr) diameter, with a catheter length of 70 centimeters (cm).

This document describes a 510(k) submission for the Dornier MINNOW Ureteral Catheter, aiming to demonstrate its substantial equivalence to a predicate device. The information provided outlines the performance testing conducted to support this claim, rather than a clinical study evaluating the device's diagnostic performance or effectiveness in a "with AI vs without AI" scenario.

Therefore, many of the requested categories regarding acceptance criteria, study details, human reader performance, ground truth, and training sets are not applicable to this type of regulatory submission, as it focuses on demonstrating equivalence through engineering and biocompatibility testing for a physical medical device, not a diagnostic AI system.

Here's an analysis based on the provided text, addressing the applicable points and indicating when information is not relevant to this type of device and submission:

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

The document does not explicitly provide a table of acceptance criteria with specific numerical targets and matching reported performance values. Instead, it lists the types of tests performed and states that "All testing was found to be acceptable and substantially equivalent to those of the predicate device."

Note: Specific numerical acceptance criteria and performance values are not detailed in this summary. The "acceptable" status implies compliance with relevant standards and/or equivalence to the predicate device's performance within acceptable ranges.

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 testing described (sterility, biocompatibility, mechanical properties) would typically involve specific sample sizes for each test according to established standards. Data provenance (country, retrospective/prospective) is not applicable, as this is laboratory testing of a manufactured physical device.

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. For this type of physical medical device (catheter), "ground truth" as it pertains to expert consensus on diagnostic images or clinical outcomes is not relevant. The "ground truth" for the performance tests would be defined by the specifications and standards for each physical or chemical property being measured. Expert involvement for physical/chemical testing is usually in the form of qualified laboratory personnel conducting the tests and engineers/scientists reviewing the results against specifications.

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

This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving human interpretation or subjective assessments, often for diagnostic devices. The testing described here involves objective physical and chemical property measurements.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging AI devices where human performance with and without AI assistance is being evaluated. The Dornier MINNOW Ureteral Catheter is a physical medical device (catheter) for access and fluid management in the urinary tract, not a diagnostic AI system.

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 catheter, not an algorithm or AI system.

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

For the physical and material integrity tests conducted (Sterility, Packaging, Biocompatibility, Radiopacity, Effective Working Length, Catheter Shaft ID, Catheter Tensile Strength, Catheter Stiffness), the "ground truth" is defined by established engineering specifications, material standards (e.g., USP Class VI for biocompatibility), and relevant ISO/ASTM testing standards. There is no "expert consensus," "pathology," or "outcomes data" in the traditional sense for these types of tests in this context. The aim is to meet predefined technical requirements and demonstrate equivalence to the predicate device's performance.

8. The sample size for the training set

This information is not applicable. The Dornier MINNOW Ureteral Catheter is a physical medical device, not an AI model or software algorithm that requires a training set.

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

This information is not applicable. As stated above, this device does not involve a training set.

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Used to temporarily occlude the ureteropelvic junction to prevents from entering the ureter during percutaneous lithotripsy, and for injection of contrast medium.

The UPJ Occlusion Balloon Catheter is composed of a balloon catheter, a removable inflation/injection adapter, a 1 mL syringe, and a wire guide assembly. The UPJ Occlusion Balloon Catheter is manufactured from a double lumen polyurethane radiopaque tubing with a working length of 75 centimeters. The smaller lumen is designed for balloon inflation, while the larger lumen fits over the wire guide assembly. The distal balloon is manufactured from silicone and has an approximate inflation volume of 4 mL. The inflation/injector adapter is removable, allowing for a cystoscope to be removed after the catheter is in place. The wire guide assembly is manufactured in 0.028- or 0.038-inch diameter stainless steel coils. The stainless-steel coils are coated with polytetrafluoroethylene and measure 80 centimeters. The wire guide assembly is designed to be placed through the small lumen of the balloon catheter. The UPJ Occlusion Balloon Catheter is supplied sterile, intended for one-time use only, and packaged in a peel-open pouch with a shelf-life of 3 years.

This document describes the Cook Incorporated UPJ Occlusion Balloon Catheter (K183323). This is a physical medical device, not an AI/ML powered device. As such, the information you requested about acceptance criteria and studies is not applicable in the context of an AI/ML device.

Here's a breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a table with specific acceptance criteria and reported device performance in the manner typically seen for AI/ML models (e.g., sensitivity, specificity, AUC). Instead, it lists performance data in the form of engineering and material testing.

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

This information is not explicitly provided. The "testing" mentioned is for a physical device, and typically involves a certain number of manufactured units or material samples. The document does not specify quantities or data provenance (e.g., country of origin, retrospective/prospective) because these concepts are not applicable to the engineering tests described.

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

This information is not applicable. For physical devices, "ground truth" is established through engineering and material standards, not expert consensus on medical images or clinical data.

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

This information is not applicable as the testing involves physical device properties, not diagnostic interpretations.

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 as the device is a physical catheter, not an AI/ML diagnostic or assistive tool.

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

This information is not applicable as the device is a physical catheter, not an AI/ML algorithm.

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

The "ground truth" for this physical device is based on established engineering and material standards, and compliance with the device's design specifications and intended use. This is demonstrated through various physical and material performance tests.

8. The sample size for the training set:

This information is not applicable as the device is a physical catheter and does not involve an AI/ML training set.

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

This information is not applicable as the device is a physical catheter and does not involve an AI/ML training set.

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Indicated for drainage or irrigation in the urinary tract as well as access, advancement, or exchange of wire guides.

The Pigtail Ureteral Catheter Sets consist of a catheter and wire guide. The catheters are constructed from polyurethane tubing and have a proximal female Luer lock adapter constructed from polyamide. The catheters are available in 5, 6, and 7 French (Fr) and a length of 70 centimeters (cm). The distal end of the catheter has a single pigtail loop with six sideports. The catheter has ink marks denoting depth and body orientation. The stainless steel wire guides are coated with polytetrafluoroethylene (PTFE) and available in diameters of 0.038 and 0.045 inches (in) with a length of 145 cm.

The Pigtail Ureteral Catheter Sof-Flex® AO® is a catheter with a hydrophilic coating. The catheters are constructed from polyurethane tubing and have a female Luer lock adapter constructed from polyamide. The catheters are available in 8.2 and 10 Fr and have a length of 56 cm. The distal end of the catheter has a single pigtail loop with 5 evenly spaced sideports around the pigtail loop. There are also 6 sideports spaced at 1 cm intervals just proximal to the pigtail loop on the same side of the catheter. For the next 10 cm after the sideports, on the straight portion of the catheter, there are no sideports. After which, there are 9 sideports placed at 1 cm intervals spiraled around the catheter across 8 cm.

The subject devices are provided sterile and are intended for one time use.

The provided document is a 510(k) Premarket Notification from the FDA for a medical device (Pigtail Ureteral Catheter Set and Pigtail Ureteral Catheter Sof-Flex® AQ®). This type of document focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a standalone study with acceptance criteria and device performance in the way a clinical trial or AI/ML study would.

Therefore, the requested information, which pertains to acceptance criteria and performance data for an AI/ML device or a full clinical study with ground truth established by experts, sample sizes for training/test sets, etc., is not directly applicable to this FDA submission for a ureteral catheter.

The "Performance Data" section in the document lists various engineering and biocompatibility tests conducted to demonstrate that the physical device meets applicable design and performance requirements. These are not clinical efficacy or diagnostic performance studies that would involve a "test set" with expert-established ground truth or a multi-reader comparative effectiveness study.

Here's a breakdown of why each requested point cannot be fully addressed by this document:

1. A table of acceptance criteria and the reported device performance: The document lists types of performance tests (e.g., Biocompatibility, Sterilization, Flow Rate, Tensile Strength) but does not provide specific numerical acceptance criteria (e.g., "flow rate must be > X ml/min") or the actual quantitative results for the device against those criteria. It only states, "The results of these tests support a conclusion that Pigtail Ureteral Catheter Sets and the Pigtail Ureteral Catheter Sof-Flex® AQ® will perform as intended."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for engineering bench testing. These tests are conducted on manufactured samples, not patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for catheter performance is defined by physical measurements and material properties, not expert clinical interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable to engineering tests.

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, as this is not an AI/ML device or a medical imaging interpretation device.

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 (expert consensus, pathology, outcomes data, etc): For the listed "Performance Data" (e.g., flow rate, tensile strength), the "ground truth" would be established by standardized measurement methods and reference standards for material properties and device function.

8. The sample size for the training set: Not applicable. There is no training set in the context of this device.

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

In summary: The provided FDA 510(k) document is for a physical medical device (ureteral catheter), not an AI/ML diagnostic or prognostic system. The performance data discussed relates to engineering and biocompatibility characteristics, not clinical performance based on expert interpretation of data or AI model evaluation metrics.

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Ureteric catheters for retrograde ureteropyelography are intended for injection of contrast medium or saline during endourological procedures.

The Ureteric Catheters for retrograde ureteropyelography are flexible tubular devices designed with open proximal and distal ends. The bulb shaped distal end permits the catheter to enter the lowest part of the ureter maintaining water tightness when injecting contrast or saline. The Ureteric Catheters are made from a polyvinyl chloride (PVC) material and have soft bulbous tip to help position the device in the ureter meatus. The devices are provided sterile and are intended for single use. The Ureteric Catheters have a Chevassu open tip, do not have side eyes, and range in diameter from 3 Fr to 7 Fr for the catheter body and 4 Fr to 10 FR for the Chevassu bulb. They are supplied with a metal stylet to facilitate insertion and a Luer-lock syringe connector. They are provided in two lengths, 69.5 and 73 cm. The longer version is intended to be compatible with a 0.035" guidewire. The shaft is marked at one centimeter increments along the length to aid in advancement and is radiopaque for fluoroscopic visualization.

The provided document is a 510(k) summary for a medical device (Ureteric catheter) and does NOT contain information about acceptance criteria or a study proving that an AI/ML powered device meets acceptance criteria. It primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing.

Therefore, I cannot extract the requested information from this document. The document details:

• Device Name: Ureteric catheter
• Regulation Number: 21 CFR § 876.5130 (Urological Catheter and Accessories)
• Product Code: EYB
• Predicate Devices: PORGES™ Ureteral Catheters (K021856) and Floppy Tip Hydro-Coated Ureteric Catheter (K171043)
• Non-Clinical Performance Data: Biocompatibility testing (Cytotoxicity, Sensitization, Irritation), Performance testing (Visual Evaluation, Compatibility with Guidewire or Stylet, Compatibility with Connector, Compatibility with Liquid, Tensile Strength on Catheter Bulb, Tensile Strength on Catheter Tube, Flow Rate, Simulation of Use, Radiopacity), Sterilization, and Packaging and Distribution testing.
• Absence of Clinical Studies: Explicitly states "No animal studies or clinical testing were provided to support substantial equivalence between the subject and predicate devices."

No AI/ML software is mentioned, nor are any acceptance criteria or studies related to AI/ML performance.

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This device is intended for injection of contrast medium and/or safety wire guide placement during percutaneous and transurethral access. The catheters that are 24 cm and 40 cm in length can be used in pediatric patients 12 years and over.

The Dual Lumen Ureteral Access Catheter is constructed from a dual-lumen, polyurethane tubing with ink marks and a tubing manifold with extension tubes. The catheter has a working length of 50 cm. The outer diameter of the catheter is 10.0 Fr and both lumens' inner diameter is 0.050 inches. The distal tip is notched to expose one lumen and create a 5.0 Fr tip with the other lumen. This device is manufactured both with and without a hydrophilic coating.

The Flexi-Tip® Dual Lumen Ureteral Access Catheter is constructed from a dual-lumen, polyurethane tubing with ink marks and a tubing manifold with extension tubes. The catheter is available in lengths of 24, 40, and 50 cm. The outer diameter of the catheter is 10.0 Fr and both lumens' inner diameter is 0.050 inches. The distal tip is notched to expose one lumen and a flexible polyurethane tip is bonded to the tip of the other lumen. The Flexi-Tip® Dual Lumen Ureteral Access Catheter is available with hydrophilic coating and a radiopaque urethane tungsten marker. The Dual Lumen Ureteral Access Catheter and the Flex-Tip® Dual Lumen Ureteral Access catheters are sterilized by ethylene oxide and are packaged in peel-open pouches for single use.

This document is a 510(k) summary for the Cook Incorporated Dual Lumen Ureteral Access Catheter and Flexi-Tip® Dual Lumen Ureteral Access Catheter. It is a premarket notification for a medical device seeking clearance from the U.S. FDA, not a study report. Therefore, this document does not contain acceptance criteria or a study that proves the device meets specific performance criteria in the way a clinical trial or performance study would for an AI/CADe device.

The information provided describes the device, its intended use, comparison to a predicate device, and the types of non-clinical testing performed to demonstrate substantial equivalence. It does not include details on:

• A table of acceptance criteria and reported device performance: This document lists the types of tests performed (e.g., Biocompatibility, Sterilization, Dimensional, Lumen Patency), but it doesn't provide specific quantitative acceptance criteria for these tests nor does it report the detailed results of these tests against any defined criteria.
• Sample size for the test set, data provenance, number of experts, adjudication method, MRMC study, standalone study, type of ground truth, training set information: These are all terms typically associated with studies evaluating the performance of AI/CADe systems or diagnostic devices where human interpretation or machine learning is involved. This document is for a physical medical device (catheter) and therefore these concepts are not applicable.

However, based on the context of a 510(k) submission for a physical device, we can infer some general information about "acceptance criteria" and the "study" demonstrating performance:

Inferred Acceptance Criteria and "Study":

For a physical device like a catheter in a 510(k) submission, "acceptance criteria" are typically defined by engineering specifications, recognized national or international standards (e.g., ISO standards for medical devices, ASTM standards), and comparison to the predicate device's established performance. The "study" refers to a series of non-clinical, bench-top, and sometimes animal studies designed to show that the new device meets these specifications and is substantially equivalent to the predicate.

Here's how we can address your request within the limited scope of this document:

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

The remaining points (2-9) are not applicable to this type of device and document:

• 2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective) - This applies to clinical data or AI/CADe performance data, not bench testing of a physical catheter.
• 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 applies to diagnostic interpretation studies, not physical device engineering tests.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set - Applies to expert review in 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 - Applies to AI/CADe systems.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done - Applies to AI/CADe systems.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc) - Applies to AI/CADe systems or diagnostic accuracy studies.
• 8. The sample size for the training set - Applies to AI/Machine Learning models.
• 9. How the ground truth for the training set was established - Applies to AI/Machine Learning models.

This document is a regulatory submission for a Class II medical device (catheter) based on substantial equivalence to a predicate device, focusing on engineering, material, and performance characteristics rather than diagnostic accuracy or AI performance.

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Ureteric catheters are intended for endourological procedures, to restore or maintain drainage of the upper urinary tract and to inject contrast medium or saline.

Duration of use: Ureteric catheters are intended for temporary use during surgical procedure.

Ureteric catheters are ethylene oxide sterilized, single use devices intended to restore or maintain drainage of the upper urinary tract and to flush or inject contrast medium or saline during an endoscopic procedure. All ureteric catheters include a connector nut with a Luer fitting. The connector nut is inserted into the proximal end of the catheter allowing the Luer fitting to connect to collecting or injection devices. Ureteric catheters are open at the distal end (farthest away from the surgeon) to allow use over a guidewire.

Flush Ureteric Catheters and Ureteric Catheters come in three different tip configurations (straight, open coudé with side eyes, open coudé without side eyes). A stylet in included with the catheters to aid during the catheter insertion. The Flush Ureteric Catheters and Ureteric Catheters are supplied in a 74 cm length and diameters range from 3 Fr. to 8 Fr. The Floppy Tip Hydro-coated Ureteric catheters are 70 cm long and have 5,6, and 7 Fr. diameters.

The Flush Ureteric Catheters and Ureteric Catheters are made from polyether block amide materials. The Floppy Tip Hydro-coated Ureteric catheters are made from polyvinyl chloride (PVC), have a hydrophilic coating over the distal tip (farthest away from the surgeon), and a soft tip which allows for easier insertion and advancement of the catheter. The materials have a radiopaque filler to allow for fluoroscopic visibility.

This document describes the performance testing and acceptance criteria for Ureteric catheters, Flush Ureteric catheters, and Floppy Tip Hydro-Coated Ureteric Catheters.

1. Table of Acceptance Criteria and Reported Device Performance:

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The Occluder™ Occlusion Balloon Catheters are indicated for use for temporary Ureteral occlusion and applications including, renal opacification, dislodgment of calculi and preventative calculi migration.

Occluder Occlusion Balloon Catheters are designed for use for temporary occlusion of the ureter and applications including renal opacification, dislodgement of calculi and preventative calculi migration. The devices are provided sterile and are intended for single use. The Occluder Occlusion Balloon Catheters are constructed of a soft compliant latex balloon mounted on the tip of a catheter shaft. Catheter shafts are radiopaque, maximizing fluoroscopic visibility. The Occluder Occlusion Balloon Catheters have two lumens that are marked and color-coded. The balloon tubing, marked BALLOON is a balloon inflation lumen. The tubing marked DISTAL, is the essential lumen of the catheter, which terminates at the distal tip. This lumen is used to pass the catheter over a guidewire. This lumen can also be used for infusion of contrast medium.

This document describes the Boston Scientific Occluder™ Occlusion Balloon Catheter, which is cleared through the 510(k) pathway as substantially equivalent to a predicate device. As such, the study focuses on demonstrating this substantial equivalence rather than establishing new acceptance criteria or conducting a multi-reader multi-case comparative effectiveness study in the way one might for an AI/ML diagnostic device.

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

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a "test set" in the context of clinical data or patient samples. The performance testing mentioned is a bench evaluation.

• Sample Size: The document mentions "samples aged at T=0 and 7-months Accelerated Aging." The specific number of samples tested is not provided.
• Data Provenance: The data is from "Boston Scientific" and is generated through "performance testing (Bench Evaluation)." There is no mention of country of origin of data or whether it is retrospective or prospective, as it does not involve human subjects or historical patient data.

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

This information is not applicable to this submission. The "ground truth" for a substantial equivalence claim based on bench testing does not involve expert consensus on clinical findings. Instead, the "truth" is established by direct measurement against engineering specifications and comparison to the predicate device's known performance/specifications.

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

This information is not applicable. Adjudication methods are typically used in clinical studies or when interpreting complex images/data to establish ground truth for diagnostic devices, which is not the case here.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices involving human interpretation, not for a medical device like an occlusion balloon catheter, especially when seeking 510(k) clearance based on substantial equivalence.

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

No, a standalone algorithm-only performance study was not done. This device is a physical medical instrument, not an AI algorithm.

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

The "ground truth" for this submission is based on engineering specifications and direct measurements/observations from bench testing. The goal was to show that the new device's physical and functional characteristics (e.g., balloon inflation, shaft properties, radiopacity) meet predetermined criteria and are equivalent to the predicate device. This essentially means the "ground truth" is adherence to design specifications and performance metrics established from the predicate.

8. The sample size for the training set

This information is 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

This information is not applicable as there is no training set.

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Medline's urethral catheter is a flexible tubular device that is intended for use in the drainage of fluid from the urinary tract.

flexible tubular device

The provided text is a 510(k) premarket notification letter from the FDA to Medline Industries, Inc. regarding their Red Rubber Urethral Catheter. This document indicates the device has received clearance and is "substantially equivalent" to predicate devices.

However, this document does not contain any information regarding specific acceptance criteria, a study proving device performance against those criteria, or details typically found in a clinical or performance study report.

Therefore, I cannot fulfill your request for the following information based on the provided text:

1. A table of acceptance criteria and the reported device performance: The document does not define any specific acceptance criteria or report performance metrics for the device.
2. Sample sizes used for the test set and the data provenance: There is no mention of a test set, sample sizes, or data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Ground truth establishment is not discussed as no study is detailed.
4. Adjudication method for the test set: No adjudication method is mentioned.
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 is mentioned, and the device described is a physical catheter, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as this is a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth is not discussed.
8. The sample size for the training set: No training set is mentioned.
9. How the ground truth for the training set was established: Not applicable as no training set is discussed.

This FDA letter is a regulatory clearance document, not a detailed scientific study report. To find the information you're looking for, you would typically need to consult the original 510(k) submission summary or a separate clinical study report, if such a study was performed and made public.

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The Stonebuster Endoscopic System for Stone Removal (SESSR) Catheter for Endoscopy is intended to provide access to the ureteral canal and to be used to guide the currently available visualization devices and accessory devices such as bionsy forceps, cytology brushes, stone retrieval baskets, etc. during endoscopic procedures.

The indications for use of the catheter are in urological applications.

The Stonebuster Endoscopic System for Stone Removal (SESSR) Delivery Catheter is a sterile, single-use device comprised of one main component: a flexible triple lumen delivery catheter with three Luer-Lock delivery ports. This device is intended to provide access to the ureteral canal and to be used to guide the currently available visualization devices and accessory devices such as biopsy forceps, cytology brushes, stone retrieval baskets, etc. during endossopic procedures.

The SESSR Delivery Catheter is introduced into the desired anatomical location through the SESS sheath with a minimum working channel diameter of 4.3mm. The distal tip of the SESSR is straight or benefit at minimum of 6.5 mm from the distal tip of 10 degrees providing the physician with (when using visualization devices) a wider field of view.

The provided document (K083788) describes the Stonebuster Endoscopic System for Stone Removal (SESSR) and its substantial equivalence to predicate devices, but it does not contain details about acceptance criteria, a specific study proving device performance against those criteria, or clinical trial data as requested.

The basis for clearance is demonstrating substantial equivalence to legally marketed predicate devices, not through a study proving predefined acceptance criteria. Therefore, most of the requested fields cannot be directly answered from the provided text.

Here's a breakdown of what can be extracted and explanations for what cannot:

1. Table of Acceptance Criteria and Reported Device Performance
The document does not specify quantitative acceptance criteria or report device performance against such criteria. The "performance" assessment is based on a comparison to predicate devices, focusing on design, materials, and intended use.

2. Sample size used for the test set and the data provenance
Not applicable. This was a 510(k) submission based on substantial equivalence, not a clinical study with a "test set" in the context of AI/algorithm performance. The data provenance includes material specifications and sterilization validation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No "ground truth" was established by experts for a test set in this 510(k) submission.

4. Adjudication method for the test set
Not applicable. No test set requiring adjudication was used.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a medical instrument (catheter), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study or AI-related performance metrics are irrelevant.

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

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable in the context of an algorithm's ground truth. The "truth" for this submission was demonstrating that the device's design, materials, and intended use were comparable to existing, legally marketed predicate devices, and that it met relevant standards for sterility.

8. The sample size for the training set
Not applicable. No training set was used, as this is not an AI/algorithm-based device.

9. How the ground truth for the training set was established
Not applicable. No training set was used.

Summary of what the document does provide regarding device evaluation:

• Sterility Testing: A full cycle, single lot batch validation was completed to ensure sterility using ethylene oxide (EtO) gas, contracted with STS Life Sciences Division of Ethox. The reports of these results were included in Section 14.1 of the submission.
• Shelf Life: Currently set at six months, with ongoing monitoring of samples to ensure sterility and functionality, with plans to adjust the shelf life based on these observations.
• Bench Testing: The conclusion mentions "bench test results conducted with the Stonebuster Endoscopic System for Stone Removal (SESSR)." However, the document does not detail these bench tests, their methodologies, or specific quantitative results beyond stating they support substantial equivalence.
• Comparison to Predicate Devices: The primary "proof" of meeting safety and effectiveness is through a detailed comparison (Table 1) to two predicate devices:
  • Boston Scientific Corporation UASS Ureteral Access Sheath (K022135)
  • Bard Dual Lumen Ureteral Catheter (K032521)
    This comparison covers indications for use, shaft material, hub material, sterility, single-use nature, and number of lumens. The sponsor argues that any differences are "insignificant with respect to safety and effectiveness."

In essence, for a traditional 510(k) such as this, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to predicate devices, supported by foundational tests like sterility validation and general engineering/material specifications, rather than a clinical trial or algorithm performance study.

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