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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 Ultraxx™ Nephrostomy Balloon Catheter is used to dilate the musculofascial tract, renal capsule, and parenchyma to establish and maintain a percutaneous tract. The main components of the subject device set include the Ultraxx™ Nephrostomy Balloon Catheter (Ultraxx catheter) and Amplatz sheath. The patient-contacting materials of this set include the Amplatz sheath and Ultraxx catheter's balloon, catheter tubing, marker band, and adhesive.

The Ultraxx catheter has a dual lumen shaft with a dilatation balloon on its distal end. One of the lumens accepts a wire guide, and the other is used to inflate the balloon. The catheter material is constructed from a polyether block polyamide copolymer and is available in an outer diameter of 6 Fr with a length of 55 cm. The balloon of the catheter is constructed from polyethylene terephthalate (PET) and is available in nominal inflated outer diameters of 6 to 10 mm with a length of 15 cm. A platinum 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 types of sheaths are available in inner diameters ranging from 18 to 32 Fr with a working length of 17 cm. The distal end has a smoothly rounded beveled tip for ease of insertion. The proximal end has a guidewire notch which functions to secure the wire guide and keep it out of the way during a nephrostomy procedure.

The Ultraxx™ Nephrostomy Balloon Catheter is a short-term use device, sterilized by ethylene oxide, and intended for one-time use. The set is packaged in a peel-open pouch with a three-year shelf life.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly detailed in the provided text. However, the document states, "All predetermined acceptance criteria of the testing were met."

The performance tests conducted include:

• Biocompatibility
• Balloon Rated Burst Pressure, Compliance (pressure-diameter relationship characterization), and Deflation Time
• Tensile Testing of Balloon and Sheath Components, Joints and Bonds
• Balloon Protector Removal Force
• Radiopaque Marker Band Location and Radiopacity Verification
• Component Compatibility and Dimensional Verification
• Shelf Life of Three Years Accelerated Aging

Since "All predetermined acceptance criteria of the testing were met," the reported device performance for each of these tests, by implication, aligns with the specified acceptance criteria.

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

The provided text does not specify the sample sizes used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature).

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

The provided text does not mention the use of experts to establish a ground truth for a test set, nor does it specify their number or qualifications. The performance data described appears to be based on engineering and laboratory testing rather than expert-derived ground truth.

4. Adjudication Method for the Test Set

The provided text does not describe any adjudication method for a test set, as the testing appears to be based on objective performance measurements rather than subjective assessments requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document focuses on the technical performance and safety of a medical device (catheter) through a series of engineering and laboratory tests, not on the comparative effectiveness of human readers with or without AI assistance.

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

This question is not applicable. The device is a medical catheter, not an AI algorithm. Therefore, "standalone (algorithm only)" performance is not a relevant concept for this product. The described tests are for the physical device's performance.

7. The Type of Ground Truth Used

The ground truth for the performance testing appears to be based on objective engineering and laboratory measurements against predefined specifications and industry standards for medical devices (e.g., burst pressure, tensile strength, dimensional verification, biocompatibility). It is not based on expert consensus, pathology, or outcomes data in the context an AI/reader study.

8. The Sample Size for the Training Set

This question is not applicable. The document describes the premarket notification (510(k)) for a physical medical device (catheter), not a device involving an AI algorithm which would typically have a training set.

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

This question is not applicable, as there is no mention of a training set or AI algorithm in the provided document.

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The Amplatz Type Renal Sheath is recommended for the establishment of percutaneous access.

The Amplatz Type Renal Sheath Set is recommended for the establishment of percutaneous access.

The Clear Renal Sheath is recommended for the establishment of percutaneous access.

The Amplatz Type Renal Sheaths are manufactured from extruded tubing and are available in 17cm lengths with the following interior diameters in French units (F): 14F, 16F, 18F, 20F, 22F, 24F, 26F, 28F and 30F. A 20cm length renal sheath with a 30F interior diameter is also available. The Amplatz Type Renal Sheaths are constructed of blue PTFE (polytetrafluoroethylene) material, which is bismuth loaded for fluoroscopy. The tip is designed for atraumatic placement and ease of advancement over dilators or balloons.

The Amplatz Type Renal Sheath Set includes four 17cm length (single) Amplatz Type Renal Sheaths (offered in sizes: 24F, 26F, 28F and 30 F). There are no differences between the renal sheaths offered in the Amplatz Type Renal Sheath Set and the abovementioned Amplatz Type Renal Sheaths. Aside from the renal sheaths, the Amplatz Type Renal Sheath Set contains no additional components.

The Clear Renal Sheath is a 30F, 17 cm length sheath with a guidewire notch at the proximal end and a radiopaque marker at the distal tip. Renal sheaths are used to establish percutaneous access for instrumentation.

The provided FDA document (K172929) describes the 510(k) premarket notification for the Amplatz Type Renal Sheaths, Amplatz Type Renal Sheath Set, and Clear Renal Sheath. This document focuses on demonstrating substantial equivalence to a predicate device based on performance testing (bench evaluation), rather than clinical studies involving human patients or complex AI algorithms. Therefore, many of the details requested in the prompt regarding AI performance, human reader studies, and large-scale clinical ground truth establishment are not applicable.

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

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

The document lists the following performance tests conducted for the devices:

Additionally, Biocompatibility Testing was performed in accordance with EN ISO 10993-1: 2009 for the following:

• MEM Elution Cytotoxicity: Met requirements
• Guinea Pig Maximization Sensitization: Met requirements
• Intracutaneous Reactivity: Met requirements
• Acute Systemic Injection: Met requirements

The document explicitly states: "All testing performed met requirements. The proposed Amplatz Type Renal Sheaths, Amplatz Type Renal Sheath Set and Clear Renal Sheath are considered safe and effective for their intended use."

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

• Sample Size: The document states "Boston Scientific has conducted performance testing with representative samples of the Amplatz Type Renal Sheaths, Amplatz Type Renal Sheath Set and Clear Renal Sheath." It does not specify the exact number of samples used for each test.
• Data Provenance: The tests were bench evaluations conducted by Boston Scientific Corporation. The location is implied to be within Boston Scientific's facilities, likely in the USA (given the company's location in Marlborough, MA). These are prospective tests performed on newly manufactured devices for the purpose of this submission, not retrospective analysis of existing data.

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 is not applicable to the type of device and study described. The ground truth for this device is based on engineering specifications and physical measurements/biocompatibility testing, not expert clinical interpretation. Experts involved would be engineers, material scientists, and toxicologists responsible for the design, testing, and interpretation of bench evaluations and biocompatibility assessments, but the document does not specify their number or qualifications as it would for a clinical study.

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

• Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies, particularly for diagnostic devices where multiple readers' interpretations need to be reconciled to establish a ground truth. For bench testing, the results are typically objectively measured against 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 a medical device (renal sheath), not an AI diagnostic algorithm. No MRMC study was performed as it is not relevant to demonstrating the safety and effectiveness of this type of device.

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

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

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

• The ground truth for the performance testing cited is based on engineering specifications (e.g., specific dimensions, material properties, mechanical strength) and established biocompatibility standards (EN ISO 10993-1). For example, a sheath's inner diameter is measured and compared to its design specification, or a biocompatibility test result is compared to a pass/fail threshold defined by the standard.

8. The sample size for the training set

• Not applicable. This is not a machine learning or AI device that requires a training set. The device's design and manufacturing processes are validated through traditional engineering methods and quality controls.

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

• Not applicable. As there is no training set for a physical device, no ground truth was established for one.

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