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The Dornier Bipolar Cable is indicated to be used with a compatible electrosurgical generator and an HF electrode for endoscopic treatment in urological applications: Cutting, ablation, resection, vaporization and coagulation with HF current.

The Dornier Bipolar Cable is a sterile, single use, disposable device that allows connection of an electrosurgical generator to an HF electrosurgical resection and vaporization electrode. The outer body of the Dornier Bipolar Cables are constructed of a medical grade thermoplastic elastomer. The cable consists of a double wire zip cord with one plug end which has four (4) banana and one (1) straight pin, style of connector that is then attached to the generator. The other end is separated and has two (2) overmolded connectors, one male pin on a wire and one female pin on a wire which are compatible with the HF Electrode.

The provided text describes the 510(k) summary for the Dornier Bipolar Cable. This is a submission for a medical device that does not involve Artificial Intelligence (AI). The submission focuses on demonstrating substantial equivalence to a predicate device through conventional engineering and safety testing.

Therefore, many of the requested categories related to AI performance, such as sample sizes for test and training sets, expert consensus, adjudication methods, and MRMC studies, are not applicable to this document.

Here's the information that can be extracted or deduced from the provided text:

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

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

This information is not applicable as the device is a physical electrosurgical cable and its evaluation did not involve a "test set" in the context of an AI algorithm or data analysis study. The testing performed was engineering and safety validation. The provenance of test data for physical components is not usually detailed in this manner for 510(k) submissions.

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. "Ground truth" in this context typically refers to the confirmed diagnostic or clinical reality for evaluating an AI model. For a physical medical device, the "ground truth" is established through adherence to engineering standards and validated test methods by qualified engineers and technicians, not through expert consensus on medical images or diagnoses.

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

This information is not applicable as there was no test set requiring expert adjudication in the context of an AI system.

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 electrosurgical cable and does not involve AI assistance for human readers or direct comparative effectiveness in that manner.

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

This information is not applicable as there is no algorithm or AI component in this device.

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

The "ground truth" for this device's performance is based on meeting established engineering standards and validated test methods for its physical and electrical properties. This is typically determined by physical measurements, electrical tests, and adherence to regulatory standards (e.g., IEC 60601 series).

8. The sample size for the training set

This information is not applicable as there is no AI component or training set for this device.

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

This information is not applicable as there is no AI component or training set for this device.

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The Dornier MAGELLAN Ureteral Access Sheath is indicated for use in endoscopic urology procedures where ureteral dilation and ureteral access is desired for injection of fluids and insertion and removal of endoscopes and related instruments. The target population is for adults only (at least 22 years old).

The Dornier MAGELLAN Ureteral Access Sheath is a two component ureteral dilatation system that provides an open conduit to the upper urinary tract to facilitate Ureteroscopy, which contains a single lumen for injection of fluids as well as passage of endoscopes and related instruments. The packaged product includes a Hydrophilic-coated Dilator with a locking mechanism and a Hydrophilic-coated sheath with hub. The Access Sheath is a sterile, single use, disposable device that allows access to the ureter to facilitate scope and urological tool passage. The Dornier MAGELLAN Ureteral Access Sheaths are constructed of a medical grade thermoplastic elastomer (Pebax®). This material has been USP Class VI tested. All colorants used are compliant with FDA standards.

This FDA 510(k) summary describes the Dornier MAGELLAN Ureteral Access Sheath, a medical device, and its substantial equivalence to a predicate device. As such, it does not detail acceptance criteria and a study that proves the device meets specific performance metrics in the way that an AI/ML device submission would. Instead, the submission focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device through a comparison of characteristics and performance tests.

Here's a breakdown of the requested information based on the provided text, and where certain details are not applicable (N/A) because this is a traditional medical device submission, not an AI/ML B.S.E submission:

Acceptance Criteria and Device Performance

The submission states that the Dornier MAGELLAN Ureteral Access Sheath underwent various performance tests, and "All testing was found to be acceptable and substantially equivalent to those of the predicate device." While specific numerical acceptance criteria are not provided in this summary, the implicit acceptance criterion for each test is that the device's performance must be comparable to, or meet the established benchmarks for, the predicate device.

Table of Acceptance Criteria and Reported Device Performance

Study Details

1. Sample size used for the test set and the data provenance:
   This information is N/A for this type of submission. The performance data section lists the types of tests conducted (e.g., kink resistance, tensile strength), which are typically bench tests or material tests, not clinical studies with patient data. Therefore, there isn't a "test set" in the context of patient data, nor is there data provenance in terms of country of origin or retrospective/prospective in the way an AI/ML device would report it.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   This information is N/A. The "ground truth" for these types of mechanical and material tests is defined by engineering specifications and established test methodologies, not by expert medical interpretation.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
   This information is N/A. Adjudication methods are relevant for clinical studies where multiple experts evaluate cases that might have ambiguous findings, which is not applicable to the performance tests listed.

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:
   This information is N/A. This device is a physical ureteral access sheath, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and the concept of "human readers improving with AI" are not relevant.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   This information is N/A. This is a physical medical device, not an algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   For the performance tests described (e.g., sterility, biocompatibility, kink resistance, tensile strength), the "ground truth" is typically based on engineering specifications, material standards, and validated test methods. It's not based on expert medical consensus, pathology, or outcomes data. For example, the ground truth for "kink resistance" would be defined by a specific force or angle at which the sheath begins to kink, as measured by a standardized physical test.

7. The sample size for the training set:
   This information is N/A. This device does not involve a training set as it is not an AI/ML model.

8. How the ground truth for the training set was established:
   This information is N/A. This device does not involve a training set or ground truth establishment in the context of AI/ML.

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The Dornier EQUINOX Balloon Dilatation Catheter is indicated for dilation of the urinary tract.

The Dornier EQUINOX Balloon Dilatation Catheter is a multiple lumen catheter with a dilatation balloon mounted at the distal tip. Dilatation balloon catheters are used to exert radial force to dilate narrow ureteral segments.

The Dornier EQUINOX Balloon Dilatation Catheters are sterile, single-use devices. The EQUINOX Balloon Dilatation Catheters are available in 5.8 French (Fr) diameter, with a catheter length of 80 centimeters (cm). There will be three (3) balloon diameters, (4mm, 5mm and 6mm) and two (2) balloon lengths (4cm and 10cm)

The Dornier EQUINOX Balloon Dilatation Catheters are constructed of a medical grade nylon material. This material has been USP Class VI tested. The base material is compounded with BaSO4 to render the Dornier EQUINOX Balloon Dilatation Catheter radiopaque under x-ray fluoroscopy. The catheter also has radio-opaque marker bands on the proximal and distal ends of the balloon for visualization during use. All colorants used are compliant with FDA standards.

This FDA 510(k) summary describes a medical device, the Dornier EQUINOX Balloon Dilatation Catheter, and its substantial equivalence to a predicate device, rather than providing details of a study on AI or diagnostic performance. Therefore, most of the requested information about acceptance criteria, study details, expert involvement, and ground truth is not applicable.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document lists performance tests but does not provide specific quantitative acceptance criteria or detailed numerical results. Instead, it states that "All testing was found to be acceptable and substantially equivalent to those of the predicate device."

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 a 510(k) summary. The document describes bench testing, not clinical studies with patients or data sets.

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):

Not applicable. This document is about a mechanical device's performance characteristics, not a diagnostic or AI device that requires expert-established ground truth.

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

Not applicable. Adjudication methods are typically used in clinical trials or studies where human expert consensus is needed to determine ground truth for diagnostic accuracy, which is not the subject of this document.

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 document is for a medical device (balloon 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. This document is for a medical device (balloon catheter), not an algorithm.

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

Not applicable. The "ground truth" for this device's performance would be engineering specifications and established test methods (e.g., measuring dimensions, pressure resistance, sterility, biocompatibility standards).

8. The sample size for the training set:

Not applicable. This document does not describe an AI/machine learning device that uses a training set.

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

Not applicable. This document does not describe an AI/machine learning device.

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The Dornier CASCADE Ureteral Stent is indicated to relieve obstruction in a variety of benign, malignant and post-traumatic conditions in the ureter such as presence of stones and/or stone fragments, or other ureteral obstructions such as those associated with ureteral stricture, carcinoma of abdominal organs, retroperitoneal fibrosis or ureteral trauma, or in association with Extracorporeal Shock Wave Lithotripsy (ESWL). The stent may be placed using endoscopic surgical techniques or percutaneously using standard radiographic technique.

The Dornier CASCADE Ureteral Stents are sterile, single-use devices. The stents are available in 4.9 to 8.0 French (Fr) diameter, with lengths ranging from 14.0 to 32.0 centimeters (cm). The stents are constructed of a thermoplastic polyurethane elastomer. The base polyurethane material is compounded with BaSO4 to render the stent radiopaque under x-ray fluoroscopy.

Drainage holes extend along the body of the stent as well as on the pigtails to provide drainage. The stents are secured in the urinary tract with pigtail loops on the proximal and distal ends. A monofilament tether for repositioning and removal of the device is located on the proximal pigtail (bladder end) of the stent. Along the stent are graduation marks to provide visualization during stent advancement and placement. The CASCADE Ureteral Stent includes a pigtail straightener, a small polymer tube to aid in placement over a wire guide. The pigtail straightener is removed prior to use. The CASCADE Ureteral Stents are labeled for a maximum 30day indwell time.

The stents are packaged into a pre-formed tray and sealed within a Tyvek pouch. The individually sealed Tyvek pouches are labeled with identification labeling and then packaged into a corrugated shipping box. The packaged stents are sterilized by a contract sterilizer using ethylene oxide.

The provided text is a 510(k) summary for the Dornier CASCADE Ureteral Stent. It describes the device, its indications for use, and the studies conducted to demonstrate its substantial equivalence to a predicate device. However, it does not contain specific acceptance criteria or detailed results of a study designed to prove the device meets those criteria in a format applicable to evaluating AI/ML models.

The document states: "All testing was found to be acceptable and bench performance testing comparable to the predicate device." This is a general statement of compliance, not a detailed report of acceptance criteria and performance data for a particular device function.

Therefore, many of the requested details about acceptance criteria, specific device performance, sample sizes for test and training sets, expert qualifications, adjudication methods, or MRMC studies are not present in this regulatory document.

However, I can extract the information that is available from the document:

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

The document does not provide a table of specific numerical acceptance criteria or reported device performance values. It generally states that "All testing was found to be acceptable and bench performance testing comparable to the predicate device." The types of tests performed are listed, implying that the device met the requirements of these tests.

Summary of available information for Section 1:

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

Not applicable/Not provided in this document. This document pertains to a physical medical device (ureteral stent), not a software or AI/ML device that operates on a "test set" of data in the common sense of the term for AI/ML. The "testing" refers to physical and biological evaluations of the stent itself.

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

Not applicable/Not provided in this document. Ground truth as typically defined for AI/ML models (e.g., expert consensus on medical images) is not relevant for the types of physical and biological tests described for this ureteral stent.

4. Adjudication method for the test set

Not applicable/Not provided in this document. Adjudication methods are typically for evaluating discrepancies in human or AI interpretations of data, which is not what this document describes.

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. This document does not mention any MRMC study or AI assistance, as it concerns a physical medical device.

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

No. This document does not describe an algorithm or AI performance.

7. The type of ground truth used

Not applicable/Not provided in this document in the context of expert consensus or pathology for data interpretation. The "ground truth" for the physical device would be the validated standards and specifications against which the stent's physical properties and biological interactions were measured (e.g., ISO standards, ASTM standards for material properties, specified biocompatibility limits).

8. The sample size for the training set

Not applicable/Not provided. This concept is for AI/ML models, not for physical device testing.

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

Not applicable/Not provided. This concept is for AI/ML models, not for physical device testing.

In summary, the provided document is a 510(k) summary for a physical medical device, not an AI/ML device. Therefore, most of the requested information regarding AI/ML model evaluation, such as sample sizes for test/training sets, data provenance, expert ground truth, adjudication methods, and MRMC studies, is not present or applicable. The document confirms that the Dornier CASCADE Ureteral Stent underwent standard sterilization, shelf-life, biocompatibility, and bench performance testing, and was found to be acceptable and comparable to its predicate device.

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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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