Disposable Percutaneous Nephrostomy Dilators:
Dilator for tract preparation and splittable working sheath to protect the parenchyma.

The Disposable Percutaneous Nephrostomy Dilators consists of dilator tube and tearing sheath. The body of the tearing sheath is made of polytetrafluoroethylene (PTFE), the tearing handle is made of acrylonitrile-butadiene-styrene copolymer (ABS).

The body of the dilator tube is made of polypropylene (PP), the connector of the dilator tube is made of polypropylene (PP).

The Disposable Percutaneous Nephrostomy Dilators are sterile single use device. EO sterilization, shelf life of 3 years.

These devices must be used in operating theatre, under aseptic environment.

Duration of use for the different components:
Tearing sheath tube:

This document is a 510(k) clearance letter for a medical device called "Disposable Percutaneous Nephrostomy Dilators." It's not a study report or a publication containing detailed information about acceptance criteria or specific performance studies in the way you've outlined for an AI-powered diagnostic device.

The FDA 510(k) clearance process primarily focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving performance against specific clinical acceptance criteria through extensive clinical trials for new technologies.

Therefore, the input provided does not contain the information requested for an AI-powered device's acceptance criteria and study that proves it meets them. This document is for a Class II medical device (Disposable Percutaneous Nephrostomy Dilators) that is a physical tool, not an AI software.

Here's why the requested information cannot be extracted from this document:

• Acceptance Criteria & Reported Performance: The document does not define specific performance metrics like sensitivity, specificity, or accuracy that would be relevant for an AI diagnostic device. Instead, it lists non-clinical performance tests (e.g., Dimensional Testing, Resistance to Flattening, Biocompatibility tests, Sterility, Shelf-life) for a physical device, and concludes that it is "as safe and as effective" as the predicate device.
• Sample Size (Test Set) and Data Provenance: Not applicable for this type of device and submission. There is no "test set" of patient data for an AI algorithm.
• Number of Experts & Qualifications (Ground Truth): Not applicable. Ground truth for an AI diagnostic would involve expert consensus on medical images or pathology. For this physical dilator, "ground truth" refers to established engineering and biological safety standards.
• Adjudication Method: Not applicable.
• MRMC Comparative Effectiveness Study: Not applicable. There is no human reader component to compare with AI for this physical device.
• Standalone Performance: Not applicable. This is a physical device, not a software algorithm.
• Type of Ground Truth: For the physical device, ground truth for its performance is based on established engineering standards (e.g., ISO for sterility, dimensional accuracy) and biological safety guidelines (e.g., ISO 10993 for biocompatibility).
• Sample Size (Training Set): Not applicable. There is no concept of a "training set" for a physical medical device in this context.
• Ground Truth for Training Set: Not applicable.

In summary, the provided FDA 510(k) clearance letter is for a physical medical device (dilator) and does not describe the kind of acceptance criteria or performance studies relevant to an AI-powered diagnostic device.

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The Optilume® High Pressure Urological Balloon Dilation Catheter is indicated for dilation of the urinary tract.

The Optilume® High Pressure Urological Balloon Dilation Catheter is an 0.038" (0.97mm) guidewire and flexible cystoscope compatible over-the-wire (OTW) catheter with a dual lumen design with a tapered atraumatic tip. The Optilume® High Pressure Urological Balloon Dilation Catheter is used to exert radial force to dilate narrow urinary tract segments (strictures). The distal end of the catheter is a non-compliant inflatable balloon. The 75 cm long Optilume® High Pressure Urological Balloon Dilation Catheter is supplied in five balloon diameters ranging from 4-10mm and balloon lengths ranging from 20-80mm. The balloon catheter is supplied sterile for single use.

This document is an FDA clearance letter for a medical device called the "Optilume® High Pressure Urological Balloon Dilation Catheter." It details the regulatory review process, including the determination of substantial equivalence to a predicate device.

However, the provided text does not contain information about the acceptance criteria or a study that proves the device meets those acceptance criteria in the context of an AI/ML medical device.

The performance data mentioned in the document are solely related to engineering and material performance tests for a physical medical device (a balloon catheter), not an AI algorithm. These tests include:

• Biocompatibility Testing: Ensuring the materials are safe for use in the body.
• Performance Testing: Evaluating physical attributes like balloon diameter, length, inflation/deflation time, burst strength, and compatibility with other medical equipment.
• Sterilization: Validating the sterilization process.
• Packaging and Distribution: Ensuring the device remains sterile and functional during transport and storage.

Therefore, I cannot fulfill your request to describe acceptance criteria and a study proving an AI/ML device's performance, as the provided input does not describe such a device or study.

The questions you've asked (about sample sizes for test sets, data provenance, expert ground truth, MRMC studies, standalone performance, training sets, etc.) are highly relevant for AI/ML medical device clearances but are not addressed in this particular FDA letter, as it's for a traditional hardware device.

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ARMADA Ureteral Dilator Set: Used for step by step dilatation of the intramural and ureter and / or for stone manipulation.
ARMADA Nottingham One Step Dilator: Used for one step dilatation of the intramural portion and ureter.
ARMADA Amplatz Renal Dilator Set: Used for progressive dilatation for tract prior to percutaneous kidney stone removal.
ARMADA Renal Dilator: Used for dilatation of Renal Tract.
Glider Amplatz Sheath: Used to maintain previously established nephrostomy tract.
Fascial Dilator: Fascial Dilators are used for dilatation of percutaneous track over the guidewire.
Introducer Sheath: Used for introducing safety wire during nephrostomy.
Introducer Catheter: Used for guiding renal dilators for establishing nephrostomy tract.

Not Found

I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for "Allwin Dilator & Sets", which specifies the device's indications for use and regulatory information. However, it does not describe any acceptance criteria or a study that proves the device meets specific performance criteria through a rigorous testing process involving AI or human reader performance.

Therefore, I cannot provide:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set or data provenance.
3. Number of experts or their qualifications.
4. Adjudication method for the test set.
5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
6. Information about standalone (algorithm only) performance.
7. The type of ground truth used.
8. The sample size for the training set.
9. How the ground truth for the training set was established.

This document is a regulatory approval letter for a medical device (dilators and sets), not a technical report or study detailing the validation or performance of an AI/ML diagnostic tool.

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In-Ka® ureteral balloon dilatation catheters are intended for:

• . Dilation of ureteral meatus and/or ureteral canal during endoscopic procedures
• . Treatment of ureteral stenosis

The In-Ka Ureteral Balloon Dilatation Catheter is a urinary balloon catheter intended for dilation of the ureteral meatus or the ureteral canal or for treatment of ureteral stenosis. The catheter is a double lumen catheter with a balloon at the distal end and supplied in three balloon diameters ranging from 4 - 6 mm. Each 75 cm long In-Ka catheter is supplied sterile for a single use. Either a manometer or a 10cc syringe is included for balloon inflation.

This document describes the regulatory approval for the In-Ka® Ureteral Balloon Dilatation Catheters and does not provide information about an AI/ML device or its acceptance criteria. Thus, it is not possible to fill out the table and answer the questions related to AI/ML device performance and study as the provided text doesn't contain the relevant details.

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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 Ureteral Dilator Sets are intended for the dilation of the ureter prior to ureteroscopy or stone manipulation.

The Ureteral Dilators are intended for the dilation of the ureteroscopy or stone manipulation.

The Ureteral Dilator Sets, and each individual Ureteral Dilator, are used for dilation of the ureter prior to ureteroscopy and/or stone manipulation. The Ureteral Dilator Sets are available in one of three sets: a set of 6 dilators, a set of 7 dilators and a wire guide, or a set of 9 dilators and a wire guide. The dilators are manufactured from either radiopaque ethylene vinyl acetate (EVA) or fluorinated ethylene propylene (FEP). Dilators manufactured with EVA are also available with hydrophilic coating. Dilators are also available individually. The wire guide is a stainless steel fixed core wire guide. The Ureteral Dilators and the Ureteral Dilator Sets are sterilized by ethylene oxide and intended for one-time use.

All Ureteral Dilators are manufactured with a length of 60 centimeters and range from 6.0 French to 18.0 French in diameter. The distal end of the dilators is tapered to a 0.040inch diameter endhole with the taper measuring 0.8-2.5 centimeters from the distal end, depending on the device French size. Additionally, the French size of each dilator is stamped at the proximal end.

The stainless steel fixed cored wire guide is manufactured with a diameter of 0.038 inches (0.97 millimeters) and a length of 145 centimeters.

The provided document is a 510(k) premarket notification for a medical device (Ureteral Dilator Sets and Ureteral Dilators). This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific performance criteria through a clinical or algorithmic study with defined acceptance criteria for a new, unproven technology.

Therefore, the document does not contain the kind of information requested in your prompt, which pertains to studies proving performance against acceptance criteria for an AI/ML or diagnostic device (e.g., sensitivity, specificity, physician improvement with AI assistance, ground truth establishment).

The "acceptance criteria" discussed in this document refer to bench testing for physical characteristics of the dilators, not clinical performance metrics or AI algorithm performance.

Here's why the document doesn't fit your prompt's requirements:

• Device Type: The device is a physical medical instrument (ureteral dilators), not an AI algorithm, diagnostic tool, or imaging system that would typically have performance metrics like sensitivity, specificity, F1-score, or require MRMC studies.
• Submission Type: A 510(k) for this type of device focuses on demonstrating substantial equivalence in terms of intended use, technological characteristics, and safety/effectiveness profiles compared to a predicate, often through bench testing and material characterization, rather than new clinical efficacy studies.
• Tests Performed: The tests listed (Tensile, Kink Resistance, Dilator Tip Rollback, Lubricity, Dimensional Verification, Radiopacity, Biocompatibility, Sterility, Packaging Integrity) are all bench tests and material/biological compatibility assessments, not performance studies involving human readers or AI output.

If I were to hypothetically interpret the "acceptance criteria" from the bench testing context within the provided document, here's how it would look, but please be aware this is not what your prompt is asking for in terms of AI/diagnostic device performance:

Hypothetical Table of "Acceptance Criteria" for Ureteral Dilators (Based on Bench Testing from Document)

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The Safety Wire Guide Introducer is used for antegrade placement of a safety wire guide prior to endourological procedures.

The Safety Wire Guide Introducer is used for antegrade placement of a safety wire guide prior to endourological procedures. The Safety Wire Guide Introducer includes an obturator and sheath. The radiopaque polyethylene obturator is 7.0 French, 25.7 cm in length, and has a 1 cm taper along the distal tip of the device. It can be inserted through the radiopaque polyethylene introducer sheath that is 12.0 French, 22.2 cm in length, and tapers 6 mm from the distal end of the device.

The provided document is a 510(k) premarket notification for a medical device called the "Safety Wire Guide Introducer." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving clinical effectiveness through extensive studies or defining strict performance acceptance criteria in the same way one might for an AI/ML device.

Therefore, the information required to fully answer the request (especially regarding acceptance criteria, study details, expert involvement, and comparative effectiveness studies for AI) is not present in the provided document. The device is a physical medical instrument, not an AI/ML algorithm.

However, I can extract the available performance data and how it demonstrates "acceptance" in the context of a 510(k) submission:

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

In a 510(k) for a physical device, "acceptance criteria" are typically the successful completion of specified engineering and biocompatibility tests in accordance with recognized standards and FDA guidance. The document states that "All predetermined acceptance criteria were met." Specific numerical criteria are not detailed in this summary, but the categories of testing performed are listed.

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

• Sample size: Not specified. For engineering and biocompatibility tests, sample sizes are typically determined by relevant ISO standards or internal statistical rationale, but these details are not provided in this 510(k) summary.
• Data provenance: Not explicitly stated, but these tests would have been conducted in a controlled laboratory environment by the manufacturer (Cook Incorporated) or a contracted testing facility.

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

This concept is not directly applicable to the testing of a physical device like a wire guide introducer. "Ground truth" in this context would refer to the physical properties measured and assessed against engineering specifications, which are determined by instrumentation and established test methods, not expert consensus in the diagnostic sense.

4. Adjudication method for the test set:

Not applicable in the context of physical device testing. Results are typically quantitative measurements compared against predefined engineering specifications.

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

Not applicable. This device is a physical medical instrument, not an AI-powered diagnostic tool.

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

Not applicable. This device is a physical medical instrument.

7. The type of ground truth used:

For the listed performance tests, the "ground truth" would be the objective measurement of physical properties (e.g., length, tensile strength, radiopacity, biological reaction) compared against predefined engineering specifications and biocompatibility standards.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device, so there is no training set in that sense.

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

Not applicable.

In summary, the provided document is a 510(k) summary for a conventional, physical medical device. It details the engineering and biocompatibility testing performed to demonstrate substantial equivalence to a predicate device, rather than the performance characteristics of an AI/ML system.

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The Cook 810 Set is used for retrograde or antegrade ureteral access and to facilitate wire guide exchange.

The Desilets-Hoffman Introducer Set is used for retrograde or antegrade ureteral access and to facilitate wire guide exchange.

The Ureteral Introducer Sets is a bundle of two Ureteral Introducer Sets, composed of the Cook® 810 Set and Desilets-Hoffman Introducer Set. The Cook 810 Set is composed of a dilator and a delivery sheath, which is used for retrograde or antegrade ureteral access and to facilitate wire guide exchange. To use this device, antegrade (i.e., through a percutaneous tract) or retrograde (i.e., transurethral) access is achieved using a wire guide up to 0.038 inches in outer diameter, using standard access techniques. Next, the dilator is inserted over the wire guide and used to dilate the ureter/ureteral orifice. The physician would then place the delivery sheath over the dilator to dilate the anatomy to 10 French before placing the tip of the sheath into the desired anatomical location. The dilator is withdrawn while maintaining the position of the introducer sheath. Wires may then be placed/exchanged through the sheath, and the delivery sheath is subsequently removed from the patient. The dilator is an outer diameter of 8 French and 88 centimeters (cm) in length. Both ends of the dilator have smooth round tips and both tips are tapered at 5 millimeters (mm) as well. The sheath is an outer diameter of 8.5 French and 30 or 50 cm in length, depending on the selected set.

The Desilets-Hoffman Introducer Set is used for retrograde or antegrade ureteral access and to facilitate wire guide exchange. The Desilets-Hoffman Introducer Set includes a delivery sheath and dilator. The delivery sheath is 10 French and 30 cm in length. The dilator is 8 French and available in 70 or 88 cm in length. One of the sets ("RB" version) has a radiopaque band on the delivery sheath to aid in fluoroscopic visualization during placement.

This document is a 510(k) premarket notification for a medical device and thus does not contain the detailed information necessary to fully answer all aspects of your request regarding a stand-alone study with acceptance criteria and device performance. A 510(k) summary focuses on demonstrating substantial equivalence to a predicate device rather than presenting a comprehensive standalone validation study report with detailed performance metrics against pre-defined acceptance criteria.

However, I can extract the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states: "All predetermined acceptance criteria were met." However, it does not provide a table with specific numerical acceptance criteria or the corresponding numerical device performance results. Instead, it lists the types of tests performed.

Missing Information: Specific numerical acceptance thresholds (e.g., "tensile strength > X N") and specific numerical results for each test (e.g., "tensile strength = Y N").

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

The document does not specify the sample sizes for each of the performance tests conducted. It also does not discuss data provenance in terms of country of origin or whether the data was retrospective or prospective, as these tests are typically bench and lab-based rather than clinical human data.

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

Since the performed tests are primarily bench, mechanical, material, and biological (biocompatibility) tests, the concept of "experts establishing ground truth" in the context of clinical interpretation (like radiologists for image analysis) does not apply. The "ground truth" for these types of tests would be established by validated test methods and reference standards.

4. Adjudication Method for the Test Set:

Not applicable, as this refers to adjudication of expert opinions or clinical outcomes, which are not detailed in the context of these engineering and biocompatibility 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. This device is a ureteral introducer set, a physical medical device, not an AI-powered diagnostic tool requiring MRMC studies for human reader performance.

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

The performance tests listed are standalone tests of the device itself (e.g., tensile strength, biocompatibility), which can be considered "algorithm only" in the sense that they evaluate the device's inherent properties without active human intervention in its function during the test. There is no "human-in-the-loop" aspect to these specific performance validations as they are not AI/diagnostic tools.

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

For the performance tests described, the "ground truth" would be based on:
* Validated test methods and industry standards: For dimensional testing, tensile strength, kinking, rollback, radiopacity, sterilization, package integrity, and shelf-life, results are compared against predefined engineering specifications and relevant ISO or ASTM standards.
* Established biological safety standards: For biocompatibility, the tests (cytotoxicity, sensitization, irritation, acute systemic toxicity, pyrogenicity) results are compared against criteria outlined in ISO 10993 standards.

8. The sample size for the training set:

Not applicable. This device is a physical medical device, not an AI algorithm that requires a "training set" of data.

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

Not applicable. As above, there is no "training set" for this type of device.

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The Balloon Ureteral Dilator and Balloon Ureteral Dilator Set is intended for ureteral dilation prior to ureteral stone manipulation or ureteroscopy and dilation of the intramural ureter.

The Balloon Ureteral Dilator Set includes the balloon ureteral dilator, a wire guide, a 10 mL syringe, an endoscopic cap and a pin-vise handle. Balloon ureteral dilators can be purchased separately. The balloon ureteral dilator is composed of a radiopaque dilator fitted with a polyethylene balloon. The balloon ureteral dilator is available in 5.0 or 7.0 French and is 65 centimeters in length. The balloon is located on the distal end of the dilator and has diameters of 5 or 6 millimeters with lengths of 4 or 10 centimeters when inflated. The balloon has a maximum inflation pressure of 40 or 60 psi, depending on the diameter and length of the balloon. Additionally, radiopaque marker bands are placed at the proximal and distal ends of the balloon to provide fluoroscopic visibility. Additional set components in the Balloon Ureteral Dilator Set include a straight safety wire guide, endoscopic cap, pin-vise handle, and syringe. The wire guide has a diameter of 0.028 or 0.038 inches and a length of 145 centimeters. The endoscopic cap and a pin-vise handle are provided to stabilize the wire guide during introduction. The syringe is a 10 mL luer-lock syringe provided for balloon inflation. The Balloon Ureteral Dilator and Balloon Ureteral Dilator Set is provided sterile for one-time use.

This document is a 510(k) Premarket Notification for a medical device called the "Balloon Ureteral Dilator and Balloon Ureteral Dilator Set." It is not an AI/ML medical device, clinical study, or imaging study, but rather a submission for a physical medical instrument. Therefore, most of the requested information regarding acceptance criteria, sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, and training set details are not applicable in the context of this document.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (Ascend™ Balloon Dilation Catheter (K970041)) through comparison of technical characteristics and performance testing of the physical device.

However, I can extract the closest equivalent information where available:

1. Table of Acceptance Criteria and Reported Device Performance:

The document lists performance tests conducted, implying that the device was considered to "meet the design input requirements" based on these tests. It doesn't present a table with specific numeric acceptance criteria and reported numeric performance values for each test, but rather states that it met the requirements.

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

• Sample Size: Not explicitly stated for each test. For physical device testing, sample sizes are typically determined by relevant ISO standards or internal quality procedures, but are not detailed in this summary.
• Data Provenance: The testing was conducted internally by Cook Incorporated as part of their design verification and validation process for the 510(k) submission. No external clinical data or patient data is mentioned; it's laboratory-based performance testing of the device itself.

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

This is not applicable. Ground truth establishment by experts (e.g., radiologists) is relevant for diagnostic or AI/ML devices that interpret data. This document describes a physical medical instrument (dilator). Its "ground truth" is its physical and functional performance as measured by engineering and material science tests.

4. Adjudication Method for the Test Set:

This is not applicable. Adjudication methods (e.g., 2+1, 3+1) are for resolving disagreements among multiple human readers in studies, typically in diagnostic imaging. The performance testing of this device is based on objective, quantifiable engineering measurements.

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

This is not applicable. MRMC studies are used to evaluate the impact of a diagnostic tool (often AI-assisted) on human reader performance. This device is a therapeutic instrument, not a diagnostic one.

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

This is not applicable. This document is for a physical medical device, not an algorithm.

7. The Type of Ground Truth Used:

The "ground truth" for this device's performance is established by engineering specifications and established test methods (e.g., ISO standards for medical devices, internal design requirements) that define acceptable physical and functional characteristics (e.g., burst pressure, tensile strength, dimensions).

8. The Sample Size for the Training Set:

This is not applicable. This device is not an AI/ML algorithm that requires a training set.

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

This is not applicable. As it's not an AI/ML device, there is no training set or its associated ground truth establishment.

In summary, this 510(k) submission demonstrates the substantial equivalence of a physical medical device. The "acceptance criteria" and "proof" relate to standard engineering and biocompatibility performance testing, rather than clinical study designs typically associated with AI/ML or diagnostic devices.

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Ureteral Dilators: Intended to be used for dilatation of the ureter during ureteroscopic procedures.

Percutaneous Nephrostomy Dilators:

Dilator for tract preparation or splittable working sheath to protect the parenchyma.

Ureteral dilators:

The Ureteral Dilators are hollow rigid tubes made of Polyether Block Amide (PEBA) with tapered tips at the distal and proximal end. Total length is approximately 48 cm.

The dilators are compatible with a 0.038 inch (0.97 mm) guidewire. Outer diameters are either:

• CH FR 08 at one end and CH FR 10 at the other end
• CH FR 12 at one end and CH FR 14 at the other end ●

Percutaneous Nephrostomy (PCN) dilators:

The simple dilators are hollow tubes made in Polyether Block Amide (PEBA), with a tapered distal tip and straight cut proximal end. Total length is approximately 21cm.

The dilators are compatible with a 0.038 inch (0.97mm) guide-wire.

The dilator with splittable sheath consists of a high-density polyethylene (HDPE) dilator fitted with a Polytetrafluoroethylene (PTFE) sheath.

The provided text describes a 510(k) premarket notification for Ureteral Dilators and Percutaneous Nephrostomy Dilators. This document is a regulatory submission for medical devices, where the manufacturer seeks to demonstrate that their new device is "substantially equivalent" to a legally marketed predicate device.

Crucially, the provided text DOES NOT contain information about acceptance criteria or a study that proves the device meets those criteria, as typically found in clinical performance studies for AI/software-as-a-medical-device (SaMD).

Instead, this document focuses on bench testing and biocompatibility testing to establish substantial equivalence for a physical medical device. The "summary and conclusions from the nonclinical tests submitted" only mention these two types of tests.

Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth types, because these elements are not present in the provided 510(k) summary for this type of physical device submission.

The document states: "Substantial equivalence is supported by bench testing comparing Ureteral and Percutaneous Nephrostomy Dilators to the predicate device and biocompatibility testing performed on the Ureteral and Percutaneous Nephrostomy Dilators." This indicates the primary evidence for this submission is related to the physical properties and material safety of the dilators, not an AI algorithm's diagnostic performance.

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