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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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It is used for percutaneous puncture to the renal pelvis, establishing a percutaneous approach and providing access for endoscopes and surgical instruments.

The product consists of a needle tube, a needle hub, a rear end, equipment channel interface E, fiber image channel interface F, irrigation channel interface I, an obturator, a needle-free joint and a two-way water valve, and that primary package of the product contains a protective sleeve which is only used for product protection. The product is sterilized by ethylene oxide and is single use.

The provided text is a 510(k) summary for an "Introducer Needle" device. It outlines the device's comparison to a predicate device and the performance data submitted to demonstrate substantial equivalence. However, it does not describe a study involving an AI/Machine Learning device or a Multi-Reader Multi-Case (MRMC) comparative effectiveness study.

The performance data section (9. Performance Data) details physical and chemical performance testing, biocompatibility testing, and packaging/shelf-life testing, which are standard for medical devices like introducer needles. These tests are to demonstrate the device meets design requirements and performs as intended, but they do not involve acceptance criteria related to algorithmic performance, expert image interpretation, or human reader improvement with AI assistance.

Therefore, I cannot provide the requested information about acceptance criteria, a study proving device meets acceptance criteria, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment in the context of an AI/ML device, as this document pertains to a physical medical device.

Here's what I can extract from the provided text regarding the physical device's "acceptance criteria" and "performance data" if interpreted broadly:

Acceptance Criteria and Reported Device Performance (Physical Device)

The document doesn't explicitly list "acceptance criteria" in a table format with specific quantitative thresholds that need to be met for each test for the "Introducer Needle." Instead, it states that "Performance testing was performed in accordance with applicable clauses in ISO 9626-2016 and ISO 7864-2016" and that the testing was "to demonstrate that the Introducer Needle met applicable design requirements." The conclusion then states, "The results of these tests provide reasonable assurance that the Introducer Needle will perform as intended."

However, based on the performance tests listed, we can infer the "acceptance criteria" are implied by meeting the standards of ISO 9626-2016 (presumably for stainless steel needle tubing for the manufacture of medical devices) and ISO 7864-2016 (likely for sterile hypodermic needles for single use).

Here's a representation of the implied acceptance criteria based on the testing performed, and the "reported performance" is that the device met these criteria.

Other Requested Information (Not Applicable to this Document as it's not an AI/ML Device)

The following points are not applicable to the provided document, as it describes a physical medical device (introducer needle) and not an AI/Machine Learning device. Therefore, information regarding AI/ML-specific testing is absent.

• Sample sizes used for the test set and the data provenance: Not applicable to a physical device performance study of this nature. The "test set" here refers to physical units subjected to tests.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical device refers to engineering specifications and performance standards.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 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.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable in the context of AI/ML. For this physical device, the ground truth is established by the specified engineering standards (ISO 9626-2016, ISO 7864-2016) and biocompatibility standards (ISO 10993 series).
• The sample size for the training set: Not applicable (no ML training).
• How the ground truth for the training set was established: Not applicable (no ML training).

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For short-term (up to 30 days) percutaneous drainage of the upper urinary tract in adult patients.

The Kolibri® Percutaneous Nephrostomy Catheters are available in two configurations based on the tip configuration termed either J or Malecot. The distal end of the J catheter resembles a loop, and the distal end of the Malecot catheter has 4-wings which form an open basket to hold the catheter in place. J and Malecot catheters are single lumen catheters with outer diameters ranging from 6 Fr to 20 Fr. The J and Malecot catheters are manufactured from the material branded Vortek by Coloplast. The catheters are supplied either individually or as part of a kit. The following components are included depending on the specific configuration:

• · Stylet
• · Silicone sleeve
• · Stopcock
• Female Luer
• Urine bag connector
• Guidewire (kits only)
• · Dilator set(s) (kits only)
• · Chiba needles (kits only)
  The dilators. Chiba Needles, and quidewires are all packaged separately. The J and Malecot catheters are supplied sterile via ethylene oxide for single use.

Kolibri Direct Puncture Set
The Direct Puncture Set consists of an 8 Fr or 10 Fr J catheter with a silicone sleeve, stopcock, urine bag connector, transparent reinforced tube, stainless-steel trocar needle, and stainlesssteel stylet. The Direct Puncture Set is supplied sterile via ethylene oxide for single use.

The provided text is a 510(k) summary for the Kolibri® Percutaneous Nephrostomy Catheters, Kolibri® Percutaneous Nephrostomy Kits, and Kolibri® Direct Puncture Sets. This document is a premarket notification to the FDA, demonstrating that the new device is substantially equivalent to a legally marketed predicate device.

However, the document does not describe an acceptance criteria table or a study that proves the device meets specific performance acceptance criteria related to a diagnostic or AI-driven medical device. Instead, it outlines the device's technical characteristics, its comparison to a predicate device, and a list of biocompatibility, sterilization, and bench tests performed to demonstrate substantial equivalence for a mechanical catheter device.

Therefore, I cannot extract the information required for your request in the format you specified, as the input document does not contain data related to a clinical study or performance metrics for a diagnostic or AI-based device. The device described is a medical instrument (catheter), and the "performance data" refers to its physical and material properties, not diagnostic accuracy, sensitivity, specificity, or AI performance.

If you have a document that describes the acceptance criteria and study for a diagnostic or AI-driven medical device, please provide that, and I will do my best to extract the requested information.

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The In-Ka® Percutaneous Balloon Dilatation Catheters are indicated for dilation of the tract to create a percutaneous renal access in patients requiring a percutaneous renal procedure for urine drainage or therapeutic action. The balloon catheter is designed for transient use (for the percutaneous tract dilation).

The Amplatz sheath is used during renal dilation to provide and maintain a nephrostomy tract in patients requiring a percutaneous renal procedure for urine drainage or therapeutic action. It is designed for short-term use (up to 3 hours).

The In-Ka® Percutaneous Balloon Dilatation Catheters are balloon catheters intended for dilation of the nephrostomy tract to create a percutaneous renal access. The catheter is a 7 Fr double lumen catheter supplied with a radiopaque Amplatz sheath. The catheter is supplied with or without an inflation device (manometer) depending on the model. Amplatz sheaths are also sold separately from the catheter. The 30 Fr balloon is equipped with a radiopaque stainless-steel ring on its distal extremity corresponding to the balloon's working length to allow radiographic visualization and positioning. Each In-Ka catheter is supplied sterile for a single use.

The provided text describes a 510(k) premarket notification for the "In-Ka® Percutaneous Balloon Dilatation Catheter and Amplatz Sheath." It does not contain information about acceptance criteria and a study proving the device meets those criteria, as typically seen with AI/ML-driven devices.

This document is a regulatory submission for a physical medical device (catheter and sheath) and primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing, biocompatibility, sterilization, and shelf-life studies. It does not involve any AI components, human reader studies, or ground truth establishment in the context of diagnostic or interpretive performance.

Therefore, the requested information regarding acceptance criteria, reported device performance in those criteria, sample sizes for test/training sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth types is not applicable to this specific document as it pertains to AI/ML device evaluations.

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Cook-Cope Loop Nephrostomy Set: This device is used for percutaneous placement of a loop catheter in the renal pelvis for nephrostomy drainage.

Ultrathane Nephrostomy Set with Mac-Loc: This device is used for percutaneous placement of a loop catheter in the renal pelvis for nephrostomy drainage.

Ultrathane Suprapubic Set with Mac-Loc: The Ultrathane Suprapubic Set with Mac-Loc is used to provide bladder drainage by percutaneous placement of a loop catheter.

The bundled submission includes the Cook-Cope Loop Nephrostomy Set, Ultrathane® Nephrostomy Set with Mac-Loc®, and the Ultrathane® Suprapubic Set with Mac-Loc®

• . Cook-Cope Loop Nephrostomy Set and Catheter: The catheter is placed using standard percutaneous nephrostomy techniques into the kidney. The catheter is then secured in place by pulling the suture taut to create the distal retention loop, wrapping around the catheter shaft and knotting the suture. The latex is then folded over the suture and the excess suture is cut off. The catheter is kept in place within the patient using a retention disc.
• . Ultrathane Nephrostomy Set with Mac-Loc: The catheter is placed using standard percutaneous nephrostomy techniques. The catheter is then secured in place by pulling the suture taut to create the distal retention loop. While maintaining traction on the monofilament, the locking cam lever is pushed down until a distinct "snap" is felt. The catheter's distal loop is now locked into position. The excess suture is trimmed off. The catheter is then kept in place within the patient using a retention disc.
• Ultrathane Suprapubic Set with Mac-Loc: The catheter is placed using standard . suprapubic techniques. The catheter is then secured in place by pulling the suture taut to create the distal retention loop. While maintaining traction on the tether, the locking cam lever is pushed down until a distinct "snap" is felt. The catheter's distal loop is now locked into position. The excess suture is trimmed off. The catheter is then kept in place within the patient using the enclosed StatLock device.

The subject percutaneous drainage catheter sets consist of a flexible tube with an open distal tip and drainage holes. The distal end of the subject devices has either a Mac-Loc locking loop or a cope loop. A Mac-Loc locking loop mechanism secures the distal catheter loop configuration by means of a nylon monofilament. After the catheter is placed in the desired location, the nylon thread is pulled tight to form the distal loop configuration. Then the locking cam lever can be pushed down to snap into position, thereby locking the distal loop in position. The cope loop configuration is formed by pulling back the suture, and then the loop can be locked in place by sliding a latex sleeve over the suture.

Some catheter sets have a radiopaque marker to aid the user in placement. The proximal hub assembly of the devices provides a Luer lock hub to allow the user to connect to a fluid collection device (not subject of this submission). Accessories include introducing catheters, catheter securing devices, needles, cannulas, stylets, dilators, and wire guides.

The provided text is a 510(k) Summary for medical devices and does not contain information about acceptance criteria or a study proving that the device meets such criteria in the context of an AI-powered diagnostic system. Instead, it describes performance testing conducted to demonstrate substantial equivalence to predicate devices for traditional medical devices (catheter sets).

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study proving the device meets them, nor can I provide information regarding sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details. This information is not present in the provided document.

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Used to gain precise percutaneous access to the kidney by means of controlled fine wire puncture from within the collecting system for patients aged 12 years and older.

The Lawson Retrograde Nephrostomy Wire Puncture Set is used to gain percutaneous access to the kidney by means of a controlled fine wire puncture from within the collecting system.

The Lawson Retrograde Nephrostomy Wire Puncture Set is composed of the tipdeflecting wire guide, catheter, sheathed puncture wire, coaxial needle assembly (inner and outer needle cannulae) and working wire guide. The tip-deflecting wire guide is used to direct the catheter into the desired calyx in a retrograde manner using standard access techniques, followed by exchange of the deflecting wire with the sheathed puncture wire. To initiate percutaneous nephrostomy access, the puncture wire is unsheathed and advanced from the catheter through the kidney towards the patient's flank and through the skin. The coaxial needle assembly is then advanced over the puncture wire and into the renal collecting system, and then the puncture wire and inner needle cannula are removed to allow a working wire guide to be placed through the outer needle cannula.

• . The tip-deflecting wire guide has a three-ring handle which twist-locks with the catheter. The tip-deflecting wire guide is made from stainless steel and is available in an outer diameter of 0.045 in.
• . The catheter is available in an outer diameter of 7 Fr with a length of 82.5 cm and made of braided nylon tubing. The sheathed puncture wire can interlock with the proximal portion of the catheter.
• The sheath is made of radiopaque TFE tubing which extends 1 cm from the . catheter when locked together. The sheath is available in an outer diameter of 3 Fr with a length of 85 cm.
• . The puncture wire is made of stainless steel with a plastic pin vise handle. The puncture wire has an outer diameter of 0.43 mm with a length of 145 cm.
• . The needle set has a 22 gage inner needle that is 22.5 cm in length with the outer needle being 18 gage and 14 cm in length.
• . The working wire guide is made of stainless steel and is 0.97 mm in diameter and 145 cm in length.

The set will be supplied sterile and is intended for one-time use. The set is packaged in a peel-open pouch with a three-year shelf life.

The provided text describes a medical device, the Lawson Retrograde Nephrostomy Wire Puncture Set, and its 510(k) submission to the FDA. However, the document does not contain information related to acceptance criteria or a study proving the device meets those criteria in the context of AI/ML or diagnostic performance.

The performance data listed refers to engineering and biocompatibility tests for a physical medical device, not a diagnostic algorithm or AI system. Therefore, I cannot extract the specific information requested in your prompt regarding acceptance criteria, study details, human reader performance, or ground truth for an AI-based device.

The "Performance Data" section lists the following tests:

• Biocompatibility
• Compatibility (likely referring to component compatibility)
• Dimensional
• Tensile Strength (Hub-to-Shaft Bond of Catheter, Sheath, Stylet, Needles; Tip-to-Shaft Bond of Catheter; Distal Tip of Deflecting Wire; Shaft of Puncture Wire)
• Radiopacity
• Shelf Life following Accelerated Aging to Three-year Real-Time Equivalency
• Packaging, Sterility and Stability

These are standard tests for physical medical devices to ensure safety, functionality, and manufacturing quality. The document concludes: "All predetermined acceptance criteria of the testing were met. Therefore, the results of these tests support a conclusion that the Lawson Retrograde Nephrostomy Wire Puncture Set will perform as intended and support a determination of substantial equivalence to the predicate device."

Since the provided text does not describe an AI/ML device or its associated performance study, I cannot fill out the requested table or answer the questions related to AI performance, expert adjudication, or training/test sets for an AI model.

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The Kaye Nephrostomy Tamponade Balloon Catheter and Stent Set is used for nephrostomy drainage, and dynamic tamponade to prevent hemorrhage in nephrolithotomy and percutaneous stone removal procedures.

The Kaye Nephrostomy Tamponade Balloon Catheter Set is used for nephrostomy drainage, and dynamic tamponade to prevent hemorrhage in nephrolithotomy and percutaneous stone removal procedures.

The Kaye Nephrostomy Tamponade Balloon Catheter and Stent Set is comprised of a balloon catheter, ureteral stent, flexible stylet, Y-connecting tube and syringe. The balloon catheter can be sold separately with the stylet and syringe. The radiopaque balloon catheter has an outer diameter of 14.0 French and a tip diameter of 17.0 French, with a working length of 25 centimeters. The clear polyethylene balloon measures 15 centimeters in length and has an inflated diameter of 12 millimeters. The flexible stylet is 8.5 French and is manufactured from polyurethane material. The flexible stylet, designed to be inserted through the proximal end of the balloon catheter, extends 2 millimeters from the balloon catheter tip when assembled. The stent is manufactured from radiopaque polyurethane with an outer diameter of 5.0 French and a length of 75 centimeters. The stent is designed with two adjustable and removable adapters located at the proximal end of the stent. The Y-connecting tube is made of non-radiopaque polyvinylchloride material with an outer diameter of 14.0 French, and a length of 30 centimeters. A 10 mL Luerlock syringe is also provided in the set and is used to inflate the balloon through the inflation check valve.

The Kaye Nephrostomy Tamponade Balloon Catheter and Stent Set is supplied sterile in a Tyvek peel open pouch and labeled with a three-year shelf life. The subject device has a maximum indwell time of 96 hours (4 days) for the stent and 48 hours (2 days) for the balloon catheter and is labeled as a single-use device.

The provided FDA 510(k) premarket notification for the Kaye Nephrostomy Tamponade Balloon Catheter and Stent Set describes various performance tests to demonstrate substantial equivalence to predicate devices, rather than establishing specific acceptance criteria for diagnostic accuracy or clinical effectiveness in the way an AI/ML device study might.

However, based on the information provided, I can infer the "acceptance criteria" and the "study" are the battery of engineering and material tests conducted to ensure the device's physical and functional properties meet expected standards for safety and effectiveness, similar to its predicates.

Here's a breakdown based on your request, interpreting "acceptance criteria" as meeting the performance requirements demonstrated by the listed tests:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is an engineering device, acceptance criteria are typically validated through testing to confirm specific physical and functional properties. The document lists the tests performed, implying that successful completion of these tests (i.e., the device performed as intended during the test) constitutes meeting the acceptance criteria. Specific numerical acceptance values are not provided in this summary, but the conclusion states the device "will perform as intended" and "does not raise different questions of safety and/or effectiveness."

• Dimensions: Conformed to specified dimensions (e.g., 14 Fr outer diameter, 17 Fr tip diameter, 25 cm working length, 12 mm inflated diameter).
• Inflation Volume: Performed as specified for inflation.
• Rated Burst Pressure: Withstood specified pressure (40 psi).
• Tensile Strength: Withstood specified tensile forces.
• Radiopacity: Sufficiently radiopaque for visualization. |
  | Stent Performance | - Compatibility: Compatible with specified accessories/procedures.
• Dimensions: Conformed to specified dimensions (e.g., 5 Fr outer diameter, 75 cm total length, 33 cm working length).
• Tensile Strength: Withstood specified tensile forces.
• Flow Rate: Maintained adequate flow rate.
• Kink & Lumen Patency: Maintained patency and resisted kinking.
• Radiopacity: Sufficiently radiopaque for visualization. |
  | Stylet Performance | - Compatibility: Compatible with the balloon catheter.
• Dimensions: Conformed to specified dimensions (e.g., 8.5 Fr).
• Tensile Strength: Withstood specified tensile forces. |
  | Set (Catheter & Stent) Performance | - Liquid Leakage & Gravity Flow: Performed without leakage and allowed proper gravity flow. |

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

The document does not explicitly state the sample sizes for each specific test mentioned (e.g., how many catheters were burst-tested, how many stents were kink-tested). These are typically standard engineering tests performed on a statistically relevant sample size from manufacturing lots, but the exact numbers are not detailed in this 510(k) summary. The data provenance is from laboratory testing conducted by the manufacturer, Cook Incorporated. Therefore, it is prospective data for the device's performance under specific test conditions.

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

Not applicable in the context of this device. "Ground truth" established by experts is relevant for diagnostic or AI/ML devices where human interpretation or clinical outcomes define the truth. For this medical device, the "ground truth" for the tests is defined by the physical and chemical properties of the materials and the mechanical performance under controlled laboratory conditions, verified by standardized testing methods.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (e.g., 2+1, 3+1) are for resolving discrepancies in expert interpretations, typically in diagnostic studies. Here, the "truth" is determined by objective engineering measurements against predefined specifications.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. MRMC studies are used to assess the impact of a diagnostic tool (often AI-assisted) on human reader performance. This device is a surgical/drainage catheter, not a diagnostic imaging device, and there is no AI assistance involved.

6. Standalone (Algorithm Only) Performance

Not applicable. This is not an AI/ML algorithm or software device. Its performance is entirely physical and mechanical.

7. Type of Ground Truth Used

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

• Engineering Specifications: Defined physical dimensions, material properties, and performance limits (e.g., burst pressure, flow rate, tensile strength).
• Standardized Test Methods: Adherence to recognized industry standards for testing sterility, biocompatibility, mechanical properties, etc.
• Bench Testing Data: Quantitative and qualitative results from laboratory evaluations.

8. Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI/ML system, so there is no "training set."

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

Not applicable, as there is no training set.

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Used to establish a percutaneous tract into the renal pelvis for catheter placement or stone manipulation.
Used under fluoroscopy or ultrasound for initial location and positioning within the renal collecting system during a percutaneous nephrostomy.

The Percutaneous Entry Set is comprised of a Skinny Needle® with Chiba Tip, a Disposable Two-Part Trocar Needle, 8 dilators and a wire guide.
The Skinny Needle® is comprised of a stainless steel stylet inserted through a hubbed stainless steel cannula. The cannula has gauge size of 22 with a length of 20 centimeters. The distal end of the cannula is a Chiba tip, beveled at a 30° angle.
The Disposable Two-Part Trocar Needle is comprised of a stainless steel beveled stylet which can be inserted through a hubbed stainless steel cannula. The cannula comes in a gauge of 18 with lengths in 15 and 20 centimeters. When the beveled stylet is inserted through the cannula, the length from the distal endpoint of the cannula to the proximal starting point of the bevel on the wire is 0-2 millimeters. Needles have an optional Echotip® design, consisting of a series of very small dimples on the surface of the needle tip that enables it to be visible under ultrasound.
The dilators are manufactured from polyethylene tubing in 6.0, 7.0, 8.0, 9.0, 10.0, 12.0, 14.0 and 16.0 French sizes. All dilators measure 20 centimeters in length and have 8 to 15 millimeter taper with a 0.040 inch diameter thru hole.
The wire guide is characterized by a heavy-duty shaft, with a gradual transition to a very flexible distal tip. This wire guide type is manufactured in a 0.038 inch diameter, and measures 80 centimeters in length with a 3 millimeter Safe-T-J tip. This wire guide is constructed of a polytetrafluoroethylene coated stainless steel.
The Percutaneous Entry Set will be supplied sterile and is intended for one-time use. The set is packaged in a peel-open pouch with a 3-year shelf life.
The Skinny Needle® with Chiba Tip is also available for sale individually.
The Skinny Needle® with Chiba Tip will be supplied sterile and is intended for one-time use. The set is packaged in a peel-open pouch with a 3-year shelf life.
The Disposable Two-Part Trocar Needle is also available for sale individually.
The Disposable Two-Part Trocar Needle will be supplied sterile and is intended for onetime use. The set is packaged in a peel-open pouch with a 3-year shelf life.

Here's an analysis of the provided text regarding the acceptance criteria and study for the medical device:

Please note that this document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. It is not a detailed clinical study report evaluating the performance of a new AI algorithm. Therefore, many of the typical questions regarding AI-specific acceptance criteria, test sets, ground truth establishment, or clinical effectiveness studies are not applicable directly to this submission.

The device in question is a Percutaneous Entry Set, Skinny Needle® with Chiba Tip, Disposable Two-part Trocar Needle, which is a physical medical device (needles, dilators, wire guides), not an AI software.

Therefore, the provided document does not contain information to answer questions 1, 2, 3, 4, 5, 6, 7, 8, and 9 in the context of an AI-powered device.

Instead, the document details performance data of the physical device to demonstrate its safety and effectiveness and substantial equivalence to a predicate device.

Acceptance Criteria and Study for the Percutaneous Entry Set and Needles (Physical Device)

This section outlines the performance testing done to ensure the physical device meets its intended design requirements and is substantially equivalent to a predicate device.

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

The document lists types of tests performed but does not provide specific numerical acceptance criteria (e.g., "tensile strength must be > X N") nor the quantitative results ("tensile strength was Y N"). It only states that the devices "met applicable design requirements" and that "the results of these tests provide reasonable assurance that the devices will perform as intended."

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

The document does not specify the sample sizes used for each test. It mentions that testing was performed internally by the manufacturer (Cook Incorporated) and in accordance with recognized standards (ASTM F 623-99 (2013) and FDA's Guidance for the Content of Premarket Notifications for Conventional and Antimicrobial Foley Catheters). There is no mention of external data provenance (e.g., country of origin, retrospective/prospective clinical data) as these are non-clinical, bench-top, and lab-based tests of a physical device.

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

Not applicable. This device is a physical medical instrument, and its performance is evaluated through engineering and materials testing, not by expert interpretation of images or data to establish a "ground truth." The ground truth for these types of tests is generally defined by engineering specifications and recognized test methods.

4. Adjudication method for the test set

Not applicable, for the same reasons as point 3. Testing involves objective measurements against established 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 is not an AI device, and therefore no MRMC study was performed to assess AI assistance.

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

Not applicable. This is a physical device, not an algorithm.

7. The type of ground truth used

For the safety and performance tests (e.g., tensile strength, corrosion, biocompatibility), the "ground truth" is typically defined by:

• Engineering specifications: Pre-defined thresholds and requirements based on the intended use and material properties.
• Recognized standards: Compliance with industry standards like ASTM F 623-99 (2013) and FDA guidance documents.
• Predicate device characteristics: Performance levels comparable to the legally marketed predicate device (K844090).

8. The sample size for the training set

Not applicable. This is not an AI device that requires a training set.

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

Not applicable. This is not an AI device that requires a training set.

Summary for the Substantial Equivalence Determination:

The submission demonstrates substantial equivalence by showing that the subject devices (Percutaneous Entry Set, Skinny Needle® with Chiba Tip, Disposable Two-part Trocar Needle) have:

• Similar indications for use.
• Similar methods of operation.
• Similar fundamental technological characteristics as the predicate device (Percutaneous Nephrostomy Trocar System, American Edward Laboratories, K844090).
• Differences in design specifications, dimensions, and materials are supported by a battery of performance tests that confirm the devices "met applicable design requirements" and "will perform as intended," without raising new questions of safety or effectiveness.

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Percutaneous Neonatal Pigtail Nephrostomy Set: This device is intended for percutaneous placement of a pigtail catheter in the renal pelvis for nephrostomy drainage in neonatal patients.
Pediatric Nephrostomy Stent Set: This device is used as a nephrostomy drainage catheter and ureteral stent in pediatric patients 2 years and older.

The Percutaneous Neonatal Pigtail Nephrostomy Set comprises a 6.0 French (Fr) pigtail drainage catheter, a 22-gauge trocar needle, an 18-gauge trocar needle, a 5.0-Fr dilator, a 6.0-Fr dilator, a 7.0-Fr dilator, a retention disc and pull tie, a 10-Fr connecting tube, and a 0.038-inch (in) diameter, 30-centimeter (cm) wire guide.
The Pediatric Nephrostomy Stent Set comprises an 8.2-Fr pigtail drainage catheter with 4.7-Fr stent tubing, a retention disc and pull tie, and 10-Fr connecting tube.

This document is a 510(k) Pre-market Notification for medical devices, specifically the "Percutaneous Neonatal Pigtail Nephrostomy Set" and "Pediatric Nephrostomy Stent Set." It asserts substantial equivalence to predicate devices and describes various performance tests. However, it does not contain any information about a study proving the device meets specific acceptance criteria related to an AI/ML algorithm or software.

Therefore, I cannot provide the requested information. The document pertains to traditional medical devices (catheters and stents), not an AI-powered one.

Specifically, the following requested information cannot be extracted from the provided text:

1. A table of acceptance criteria and the reported device performance: While performance tests are listed (Sterilization, Packaging, Biocompatibility, etc.), no specific acceptance criteria values or results from these tests are provided. More importantly, these are device manufacturing/material performance criteria, not related to an AI/ML algorithm's clinical performance.
2. Sample size used for the test set and the data provenance: Not applicable as there is no AI/ML algorithm being evaluated.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
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.
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: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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The Ultraxx™ Nephrostomy Balloon Catheter is used to dilate the musculofascial tract, renal capsule, and parenchyma to establish and maintain a percutaneous tract.

The Inflation Device is recommended for use with balloon dilatation catheters to create and monitor the pressure in the balloon and to deflate the balloon.

The Ultraxx™ Nephrostomy Balloon Catheter is a double-lumen catheter indicated for a nephrostomy procedure by dilating the musculofascial tract, renal capsule, and parenchyma to establish and maintain a percutaneous tract. The device is intended for limited duration use, not to exceed 24 hours in the body.

The Ultraxx Nephrostomy Balloon Catheter Set is comprised of the Ultraxx balloon catheter, Amplatz sheath, and inflation device. The Ultraxx Nephrostomy Balloon Catheter is constructed from a radiopaque nylon tubing with a dilatation balloon on its distal end. The outer diameter of the catheter is available in 6 French (Fr) with a working length of 55 centimeters (cm). The balloon of the catheter is constructed from polyethylene terephthalate (PET) and is available in nominal inflated diameters of 6 to 10 millimeters (mm) with a length of 15 cm. A radiopaque marker band is positioned on the distal end of the balloon catheter which confirms accurate placement of the catheter. The maximum rated balloon pressure is 20 atm. The Amplatz sheath is available in either polytetrafluoroethylene (PTFE) or a clear polyvinyl chloride (PVC). Both sheaths are available in inner diameters of 18, 24, or 32 Fr with a working length of 17 cm. The Cook Sphere Inflation Device was cleared on March 3, 2004 under K032840. The inflation device is a one-piece, plastic, disposable inflation device with a lock lever design to control the piston, a manometer, and a connecting tube with a male rotating adapter.

The set will be supplied sterile and is intended for one-time use. The set is packaged in a peel-open pouch with a three-year shelf life.

This document, K181713, is a 510(k) premarket notification for a medical device (Ultraxx™ Nephrostomy Balloon Catheter Set). For this type of submission, the primary goal is to demonstrate "substantial equivalence" to a legally marketed predicate device, rather than proving the device meets specific performance acceptance criteria through a traditional clinical study with a detailed test set, ground truth, and statistical analysis as one might find for a novel class III device or a new AI/ML-based diagnostic.

Therefore, the information typically included in a "Description of acceptance criteria and the study that proves the device meets the acceptance criteria" for a novel device, especially an AI one, is largely not applicable to this submission. This 510(k) explicitly states there were no changes to the subject device that would affect biocompatibility, sterility, or performance compared to the predicate devices.

However, I can extract the relevant information regarding the comparative claims made and the assessment of equivalence:

Device: Ultraxx™ Nephrostomy Balloon Catheter Set

Summary of Acceptance Criteria and Device Performance (as pertains to a 510(k) for substantial equivalence):

Further Details (as per the provided document):

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

   • Not applicable in the typical sense. This submission is based on demonstrating substantial equivalence to pre-existing, cleared devices. The "test set" here refers to the device itself and its components.
   • The document mentions "Packaging integrity testing following simulated distribution was performed." The sample size for this specific test is not detailed, but it would have been an engineering/bench test rather than a clinical or data-driven evaluation of performance against a "test set" of patient data.

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

   • Not applicable. The "ground truth" for a 510(k) for substantial equivalence relies on comparison to a predicate device's known characteristics and performance, not on expert labeling of a dataset.

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

   • Not applicable. No such adjudication process is described or implied for this type of submission.

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

   • No. This device is a physical medical device (catheter set) used in a procedure, not an AI/ML-based diagnostic or imaging device. Therefore, MRMC studies and AI assistance are irrelevant.

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

   • Not applicable. As stated above, this is a physical medical device, not an algorithm.

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

   • Not applicable. The "ground truth" for this 510(k) is the established performance and characteristics of the predicate devices (K171601 and K032840), which presumably met their own regulatory requirements (likely via prior 510(k)s based on bench testing, limited animal/clinical data, and comparison to even older predicates).

7. The sample size for the training set:

   • Not applicable. No training set is used as this is not an AI/ML device.

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

   • Not applicable. No training set is used.

In conclusion, this 510(k) submission (K181713) for the Ultraxx™ Nephrostomy Balloon Catheter Set explicitly states that there were no changes to the device (Ultraxx balloon catheter, Amplatz sheath, and the Cook Sphere Inflation Device) that would affect biocompatibility, sterility, or performance compared to its predicate devices. The only "modification" from the predicate devices was that the two predicate devices (Ultraxx™ Nephrostomy Balloon Catheter and Cook Sphere Inflation Device) are now provided together as a convenience kit.

Therefore, the "study" proving the device meets acceptance criteria is primarily the demonstration of identical characteristics to the already cleared predicate devices, supported by specific bench testing for the new "packaging configuration" (packaging integrity testing following simulated distribution). The success criterion for this submission was demonstrating "substantial equivalence" to the predicates, which was met as indicated by the FDA’s clearance letter.

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