Search Results

The Delta III Pro Lithotripter is indicated for the fragmentation of urinary tract stones, i.e., renal calyceal stones, renal pelvic stones, and upper ureteral stones.

The Delta III Pro Lithotripter is a modular urological work station designed for extracorporeal shock wave lithotripsy ("ESWL") and for diagnostic and therapeutic procedures usual in urology.
The Delta III is composed of the following modules:

• . Basic Unit with integrated X-ray C-arm and Therapy Arm with camera for Shockwave Treatment;
• Patient Table: .
• Control Desk/Image Storage (UIMS). .
  The basic unit contains the power supplies, control unit, power electronics for motor drives, components for shockwave generation, and an integrated Therapy C-arm and an X-Ray C-Arm. The housing can be positioned with its back close to the room wall and has wide side doors for easy service.
  The therapy and X-ray C-arm house the shock wave source ("EMSE") and the complete X- ray unit. The X-ray unit consists of the X-ray generator, the X-ray tube, a flat panel image receptor system, and a high resolution imaging chain. This provides the imaging to perform the procedures. The C-arms allow for a wide range of movement to facilitate performing urological procedures. The shock wave circuit supplies the shock wave energy needed for the treatment of kidney stones.
  The Delta III Pro's urological patient table provides longitudinal, lateral and vertical travel range to allow easy positioning of the stone in the shock wave focus for lithotripsy and urological procedures.
  The image processing system (UIMS) with DICOM 3 capability supports PACS connection and offers complete X-rav control and image handling.

The provided text does not contain information about acceptance criteria and a study that proves the device meets those criteria in the context of typical AI/ML device performance studies (e.g., sensitivity, specificity, accuracy against a ground truth).

Instead, the document is a 510(k) submission for a Delta III Pro Lithotripter, which is a medical device for fragmenting urinary tract stones. The submission focuses on demonstrating substantial equivalence to a predicate device (Dornier Delta III Lithotripter, K201074) based on minor modifications.

The "Performance Data" section describes compliance with electrical safety, electromagnetic compatibility, radiation protection, safety of lithotripsy equipment, safety and performance of x-ray equipment, and usability engineering standards (IEC standards), as well as software verification and validation. These are engineering and regulatory compliance criteria, not performance metrics like sensitivity or specificity for a diagnostic AI.

Here's a breakdown of why the requested information for acceptance criteria and related study details cannot be found in the provided text:

• This is not an AI/ML device in the context of diagnostic performance: The device is a lithotripter, which physically breaks down stones. Its performance is measured by its safety, efficacy in stone fragmentation, and compliance with various engineering standards, not by diagnostic accuracy.
• The "Performance Data" section refers to regulatory compliance and non-clinical testing: "Non-clinical functional testing successfully passed and met all design requirements" and compliance with IEC standards are mentioned. This refers to engineering verification and validation, not a clinical study comparing its diagnostic performance against a ground truth with human experts.
• No mention of human readers, AI assistance, or diagnostic metrics: The text does not discuss human interpretation of images/data, AI algorithms for analysis, or metrics like accuracy, sensitivity, specificity, AUC, etc.

Therefore, many of your specific questions are not applicable to the information provided in this 510(k) summary. I cannot create the table or answer the questions the way they are designed for an AI/ML diagnostic device.

However, I can extract the information that is present regarding "performance" in the context of this device and its submission:

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

The document does not explicitly state "acceptance criteria" for diagnostic performance, but it lists standards with which the device complies. The "reported device performance" is primarily stated as successful compliance with these standards and established design requirements.

2. Sample size used for the test set and the data provenance
This information is not provided because it's a non-clinical, engineering verification for a physical device, not an AI/ML diagnostic study.

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" in the diagnostic sense is established for this type of device.

4. Adjudication method for the test set
Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI-assisted diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable in the diagnostic sense. The "ground truth" for this device would be established engineering specifications, safety standards, and performance benchmarks for stone fragmentation, which are not detailed in this summary.

8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set in that context.

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

Ask a specific question about this device

The Dornier Nautilus is an image intensified, fluoroscopic x-ray system that is intended for use in a wide field of applications, including all general examinations in urology and gynecology, as well as endoscopic and contrast examinations, imaging with radiography and/or fluoroscopy on patients in either the horizontal or vertical position.

The Dornier Nautilus is an Image Intensified Fluoroscopic X-ray System with a flat panel image receptor system. The Nautilus consists of the following components: an X- ray generator and tube housing, flat panel detector, monitors and procedure table. An X-ray cabinet contains system elements such as the X-ray generator, power electronics for the imaging chain.

The Dornier Nautilus is a radiographic and fluoroscopy examination table with the X-ray tube housing mounted under the table on a fixed arm. A flat panel detector is mounted above the patient table. The flat panel used is a Varex model 4343DXV. These Varex 4343 series have been used in similar cleared devices (K192541). The Varex flat panel system uses Cesium lodide as the image scintillator which is identical to that used in the predicate device. While the X-ray tube and detector are fixed in their positions relative to each other when the system is in use, the table top and X-ray/detector unit can be moved in a variety of planes to position the patient in the desired imaging position. The captured images are processed and can be stored in the users DICOM system.

The provided text describes the Nautilus, an image intensified fluoroscopic x-ray system. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of device performance metrics like sensitivity, specificity, or accuracy.

The "Performance Data" section primarily addresses adherence to electrical safety and electromagnetic compatibility (EMC) standards, and software verification and validation. These are crucial for the safety and basic functionality of the device, but they are not the typical performance metrics associated with demonstrating the clinical efficacy or diagnostic accuracy of an imaging system compared to a ground truth or a human reader.

Here's a breakdown of what is and isn't present, based on your request:

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

• Acceptance Criteria Mentioned: The text implicitly states acceptance criteria by listing the standards that the Nautilus was tested against (e.g., IEC 60601-1, IEC 60601-1-2). The "Performance Data" states that "Performance testing confirmed that the Nautilus met the requirements of the following standards."
• Reported Device Performance: The document only reports conformance to these safety and software standards, not specific performance metrics in terms of image quality, diagnostic accuracy, or clinical outcomes. There are no numerical results (e.g., contrast-to-noise ratio, spatial resolution, diagnostic sensitivity/specificity) provided.

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

• Not Applicable. No clinical or diagnostic performance test set is described. The testing mentioned is for electrical safety, EMC, and software, which typically involves engineering tests, not patient 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. No ground truth establishment for diagnostic performance is mentioned.

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

• Not Applicable. No diagnostic performance test set requiring adjudication is described.

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: "Clinical testing is not necessary for the subject system Nautilus, based on the same basic technology as the predicate device and based on existing minor differences." This indicates that an MRMC study or any clinical effectiveness study was not performed or deemed necessary for this 510(k) submission. There is no AI assistance mentioned, so no effect size for human readers with AI vs. without AI assistance can be provided.

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

• No. This device is an imaging system (fluoroscopic x-ray system) and not an AI algorithm. Its performance is evaluated fundamentally in conjunction with a human operator / clinician interpreting the images. No standalone algorithm performance is applicable or discussed.

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

• Not Applicable. No diagnostic ground truth is mentioned. The "ground truth" for the non-clinical tests would be the requirements defined by the referenced international standards for electrical safety, EMC, and software quality.

8. The sample size for the training set

• Not Applicable. As no AI algorithm or diagnostic performance study is described, there's no training set for such a purpose.

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

• Not Applicable. See point 8.

Summary of Device Acceptance and Study as Described in the Document:

The Nautilus device's acceptance is based on its substantial equivalence to a predicate device (Dornier Genesis K151485) and its demonstrated conformance to established international standards for:

• Electrical Safety: IEC 60601-1, EN 60601-1-6, IEC 60601-1-3, IEC 60601-2-28, IEC 60601-2-54
• Electromagnetic Compatibility (EMC): IEC 60601-1-2
• Usability: EN 60601-1-6, IEC 62366-2
• Software Verification and Validation: Adherence to FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (Moderate Level of Concern).

The study that "proves the device meets the acceptance criteria" is non-clinical testing (bench testing) against these referenced standards. No clinical studies, human reader studies, or diagnostic performance studies with explicit acceptance criteria (e.g., sensitivity/specificity thresholds) and corresponding test results are provided in this submission document. The rationale provided for not conducting clinical testing is that the device uses "the same basic technology as the predicate device and based on existing minor differences."

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

The Delta III Lithotripter is indicated for the fragmentation of urinary tract stones, i.e., renal calyceal stones, renal pelvic stones, and upper ureteral stones.

The Delta III Lithotripter is a modular urological work station designed for extracorporeal shock wave lithotripsy ("ESWL") and for diagnostic and therapeutic procedures usual in urology. The Delta III is composed of the following modules: Basic Unit with integrated X-ray C-arm and Therapy Arm with camera for Shockwave Treatment; Patient Table; Control Desk/Image Storage (UIMS).

This document is a 510(k) summary for the Delta III Lithotripter, detailing minor changes to an existing device. As such, it focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with acceptance criteria and a human-in-the-loop performance evaluation. The information provided primarily consists of engineering and software validation.

Here's an analysis based on the provided text, addressing your questions to the extent possible:

1. Table of acceptance criteria and the reported device performance

The document does not present a formal table of acceptance criteria for clinical performance in the way one might expect for a new diagnostic or AI device. Instead, the "acceptance criteria" are implied by compliance with standards and functional validation tests, with the reported performance being "does not impact the performance" and "equal to or better than the predicate."

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

The document describes bench testing and standards compliance, not a clinical test set with patient data. Therefore, there is no mention of a "sample size for the test set" in the context of patient data, nor its provenance (country of origin, retrospective/prospective). The tests mentioned are engineering and software validation tests.

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

This type of information is not applicable to the submission described. The described tests are about technical performance, safety, and functionality, not about expert interpretation of medical images or patient outcomes. Ground truth in this context would refer to engineering specifications or validated functional requirements.

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

This is not applicable as the submission describes engineering and software validation, not a clinical study requiring adjudication of diagnoses or findings.

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 comparative effectiveness study was done or is mentioned. The submission is for minor changes to an existing lithotripter, focusing on hardware component replacements and software updates, not AI integration for improved human reading.

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

This is not applicable. The device (Delta III Lithotripter) is a medical device for shock wave lithotripsy. While it includes image processing software (UIMS with AGFA MUSICA), the evaluation described is for the functional performance of these components within the overall system, not a standalone algorithm being evaluated for diagnostic accuracy without human involvement. The AGFA MUSICA software enhances X-Ray image processing, but it's part of the lithotripter system for visual guidance during procedures, not a diagnostic AI algorithm.

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

For the described tests, the "ground truth" would be established by:

• Engineering specifications and regulatory standards: For electrical safety, EMC, radiation protection, and usability.
• Predicate device performance: For the ultrasound image quality and camera image quality, the ground truth for comparison is the performance of the components being replaced.
• Functional requirements: For the UIMS software validation, the ground truth is that the software should perform its intended function (e.g., image processing, PACS connection) without negatively impacting other equipment functions.

There is no mention of expert consensus, pathology, or outcomes data being used as ground truth for these specific validation tests.

8. The sample size for the training set

Not applicable. This submission does not involve a machine learning or AI model that requires a training set in the conventional sense. The UIMS software update involves incorporating the AGFA MUSICA package, which is likely a pre-existing, validated image processing software, not a custom-trained model for this specific application.

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

Not applicable, as there is no mention of a training set.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

The Delta III Lithotripter is indicated for the fragmentation of urinary tract stones, i.e., renal calyceal stones, renal pelvic stones, and upper ureteral stones.

The Delta III Lithotripter is a modular urological work station designed for extracorporeal shock wave lithotripsy ("ESWL") and for diagnostic and therapeutic procedures usual in urology.

The Delta III is composed of the following modules:

• . Basic Unit with integrated X-ray C-arm and Therapy Arm with camera for Shockwave Treatment;
• Patient Table;
• . Control Desk - Image Processing.

The basic unit contains the power supplies, control unit, power electronics for motor drives, components for shockwave generation, and an integrated Therapy C-arm and an X-Ray C-Arm. The housing can be positioned with its back close to the room wall and has wide side doors for easy service.

The therapy and X-Ray C-arm house the shock wave source ("EMSE") and the complete Xray unit. The X-ray unit consists of the X-ray generator, the X-ray tube, an image receptor system, and a high resolution imaging chain. This provides the imaging to perform the procedures. The C-arms allow for a wide range of movement to facilitate performing urological procedures. The shock wave circuit supplies the shock wave energy needed for the treatment of kidney stones.

The Delta III's urological patient table provides longitudinal, lateral and vertical travel range to allow easy positioning of the stone in the shock wave focus for lithotripsy and urological procedures.

The image processing system (UIMS) with DICOM 3 capability supports PACS connection and offers complete X-ray control and image handling.

This document describes a 510(k) submission for the Delta III Lithotripter, which is a modification to a previously cleared device. As such, the submission focuses on demonstrating substantial equivalence to the predicate device rather than conducting extensive new clinical studies to establish absolute performance against defined acceptance criteria for a novel device.

Therefore, the typical structure for reporting acceptance criteria and study details for a new device's performance may not be fully applicable here. However, I can extract the information provided regarding the changes and how their safety and effectiveness were addressed.

Here's an analysis based on the provided text, addressing the points you requested where relevant:

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

The document does not explicitly state quantitative acceptance criteria for clinical performance (e.g., stone free rate, re-treatment rate) for the modified device, as this is a modification to a predicate device. The primary performance demonstration is focused on showing that the changes do not negatively impact safety or effectiveness.

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 describes tests for compliance with electrical, EMC, radiation, and usability standards, as well as software and hardware verification. These are typically engineering and bench tests, not clinical studies with human subjects in the traditional sense. Therefore, the concept of "sample size used for the test set" for patient data, country of origin, or retrospective/prospective does not apply to the provided performance data. The tests performed are on the device itself.

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

This section is not applicable. The performance data provided is based on compliance with international standards and internal engineering verification, not on expert adjudication of clinical outcomes or images.

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

This section is not applicable, as the tests are for engineering compliance and verification, not for clinical outcomes requiring expert adjudication.

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

This section is not applicable. The device is a lithotripter, not an AI-assisted diagnostic tool for human readers. There is no mention of an MRMC study or AI assistance.

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

This section is not applicable. The device is a physical medical device (lithotripter), not an algorithm.

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

For the verification tests mentioned (e.g., electrical safety, software functionality), the "ground truth" is defined by the requirements of the applicable international standards (e.g., IEC 60601 series) and the design specifications of the device. For example, for electrical safety, the ground truth is compliance with the specified voltage limits or isolation requirements in the standard. For software, it's meeting the intended function and not introducing errors.

8. The sample size for the training set

This section is not applicable. The document describes a physical medical device and its modifications, not a machine learning or AI model that requires a training set.

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

This section is not applicable for the same reason as point 8.

Ask a specific question about this device

Dornier's Medilas H RFID Laser Fibers are intended to be used as an accessory for the Dornier Medilas H Holmium Laser ("Laser"). This laser is intended for cutting, vaporization, ablation, and coagulation of soft tissue in conjunction with endoscopic equipment (including laparoscopes, hysteroscopes, bronchoscopes, gastroscopes, and colonoscopes), or for open surgery for contact or non-contact surgery with or without a handpiece for use in incision/excision, vaporization, ablation and coagulation of soft tissue. The Laser is indicated for use in medicine and surgery, in the following medical specialties:

• Arthroscopy,
• Urology,
• Lithotripsy, ●
• Pulmonology,
• Gastroenterology,
• Gynecology,
• o ENT.
• General Surgery.

The Medilas H RFID Laser Fiber is a modification to Dornier's currently cleared Dornier Medilas H RFID Laser Fibers (K152591) to include a rounded, ball tip, distal end. The fiber core and cladding for the subject device are made from silica, which is same material used in the predicate device. Additionally, the fiber is manufactured and tested in the identical fashion as the company's predicate device and functions in an equivalent manner.

The medical device described in the document is the "Dornier Medilas H RFID Gentle Flex Laser Fiber," an accessory for the Dornier Medilas H Holmium Laser. This device is a modification of a previously cleared device (K152591), with the primary change being the addition of a rounded, ball-tip distal end.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the exact sample sizes used for each functional performance test. The data provenance is also not explicitly stated in terms of country of origin, nor whether the studies were retrospective or prospective.

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

This information is not provided in the document. The performance tests appear to be engineering/technical evaluations rather than clinical studies requiring expert consensus on ground truth.

4. Adjudication Method for the Test Set

This information is not applicable or provided, as the tests described are functional performance tests rather than assessments requiring human adjudication of clinical outcomes.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No MRMC comparative effectiveness study was mentioned or performed. The studies were non-clinical functional performance tests comparing the modified device to a predicate device.

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

This question is not applicable as the device is a medical accessory (laser fiber) and not an AI or algorithm-based device.

7. The Type of Ground Truth Used

For the functional performance tests, the "ground truth" was established by comparing the performance characteristics of the modified (subject) device against the established performance characteristics of the predicate device (Dornier Medilas H RFID Laser Fiber - K1525591). These are objective measurements related to physical and optical properties.

8. The Sample Size for the Training Set

This question is not applicable as the device is not an AI or algorithm-based device that requires a training set.

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

This question is not applicable as the device is not an AI or algorithm-based device.

Ask a specific question about this device