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The Ureteral Stents are intended to facilitate urinary drainage from the kidney to the bladder via placement endoscopically or fluoroscopically by a trained physician.

The Urinary Diversion Stent Sets are intended to provide external drainage of urine after urinary diversion surgeries.

The Ureteral Stents are sterile, single use, disposable devices that provide a lumen that allows fluids to move from the kidney to the bladder. The Ureteral Stents are provided in multiple French sizes and lengths.

The Urinary Diversion Stent Sets are sterile, single use, disposable devices that allow internal drainage from the kidney to an external collection system.

Based on the provided FDA 510(k) clearance letter for the Boston Scientific Corporation's Ureteral Stents and Urinary Diversion Stent Sets (K250824), it's important to note that no study or specific performance criteria are detailed in this document.

This 510(k) is a "Special 510(k) ", which is used when changes to a legally marketed device do not affect its safety or effectiveness. The key takeaway from Section J (Performance Testing) and Section I (Substantial Equivalence) is:

• Changes are limited to labeling updates. The submission explicitly states: "The changes proposed within this bundled Special 510(k) are to the labeling for the proposed devices. There are no changes in design, performance, operating principle, or fundamental technology being proposed within this premarket notification."
• No new testing was required: "Therefore, existing test information/data remains valid for the proposed devices. No additional Verification or Validation testing was required for the changes to the labeling."
• Substantial Equivalence based on existing data: The conclusion reiterates that "Based on the intended use/indications for use, operating principle and comparison of key technological characteristics presented in this premarket notification, it is concluded that the proposed Ureteral Stents and Urinary Diversion Stent Set are substantially equivalent to the predicate device (cleared under K190603)."

Therefore, the document does not contain the information required to populate the sections you requested regarding acceptance criteria and a study proving the device meets those criteria, because no new performance testing was conducted for this specific 510(k) submission.

Here is a table explaining why each of your requested points cannot be answered from this specific 510(k) submission:

In summary, the provided 510(k) document (K250824) is a regulatory clearance for minor changes (specifically labeling updates) to existing, already cleared medical devices. It explicitly states that these changes do not require new performance testing, and therefore, it does not contain the details of studies, acceptance criteria, or ground truth establishment that would be present in an original 510(k) submission for a novel device or a device with significant design changes or a software/AI component. The "proof" of meeting acceptance criteria for these devices relies on the data submitted and reviewed for the predicate device (K190603).

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Percuflex™ Ureteral Stent System and Percuflex™ Ureteral Stent System Kit: The Ureteral Stent is intended to provide drainage from the ureteropelvic junction to the bladder and stenting of the ureter for all patients in whom it is desirable to place a drain which does not externally.

Percuflex™ Nephroureteral Stent System: The Percuflex Nephroureteral Stent is intended for use in Percutaneous Drainage to establish internal drainage from the ureteropelvic junction to the bladder while maintaining external access to the stent.

Amplatz Anchor™ Catheter System: The Amplatz Anchor™ Catheter System is intended for use in applications of percutaneous drainage, particularly percutaneous nephrostomy, abscess or external biliary drainage.

The Percuflex™ Ureteral Stent System and Percuflex™ Ureteral Stent System Kit is designed with the classic pigtail shape on each end and is intended to facilitate drainage internally from the renal pelvis to the bladder and stenting of the ureter without external access after placement. The ureteral stent systems contain a suture to adjust the pigtail shape or to remove the stent. These devices are constructed of a proprietary, biocompatible copolymer called Percuflex™ for patient comfort with a radiopaque resin throughout the catheter tube. Designated Percuflex™ Ureteral Stent Systems are also available with a proprietary Glidex™ hydrophilic material for the reduction of surface friction during placement or with a dissolving distal tip (Temp-Tip™). The dissolving tip internal diameter aids in placement, then dissolves soon after placement to allow a larger lumen for drainage.

The Percuflex™ Nephroureteral Stent System is also designed with the classic pigtail shape on each end and facilitates drainage from the internal ureteropelvic junction to the bladder with external access to the stent. The Nephroureteral Stent System also incorporates the Percuflex™ copolymer and a radiopaque resin throughout the catheter tube. Select models are available with a Temp-Tip™ which dissolves soon after placement. A suture is locked in place with a stopcock to retain the pigtail shape. A luer allows for connection to other drainage devices with a conical fitting.

The Amplatz Anchor™ Catheter System is designed with a unique locking Malecot diamond shape to facilitate percutaneous nephrostomy, abscess or external biliary drainage. The Amplatz Anchor™ Catheter Systems also incorporate the Percuflex™ copolymer and a radiopaque resin throughout the catheter tube. A suture is locked in place with a stopcock to retain the 2-winq design. A luer allows for connection to other drainage devices with a conical fitting.

These Percuflex™ Drainage Catheters and Stents are provided sterile, using 100% ethylene oxide (EO) gas sterilization, and are intended for hospital and single use only. Where long-term use is indicated, it is recommended not to exceed 90 days of indwelling time.

The provided text describes a 510(k) premarket notification for the Boston Scientific Percuflex Drainage Catheters and Stents, asserting their substantial equivalence to a predicate device (K924608). The document focuses on non-clinical performance testing conducted to support new Magnetic Resonance (MR) compatibility information and cumulative internal changes to the devices.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics in a pass/fail format, nor does it specify exact numerical thresholds for "acceptance criteria." Instead, it lists the types of non-clinical tests performed and states that these tests demonstrate "the subject devices are as safe and effective as the predicate devices" and that the changes "do not raise new questions of safety or effectiveness."

However, we can infer the categories of acceptance criteria based on the tests conducted:

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

The provided document describes non-clinical performance testing, primarily bench testing and material characterization. It does not mention human subject testing or clinical data. Therefore:

• Sample Size for Test Set: Not applicable in terms of patient samples. The sample sizes for the in vitro or material tests (e.g., number of stent units tested for tensile strength, number of material samples for FTIR) are not specified in this summary.
• Data Provenance: Not applicable in terms of country of origin for clinical data or retrospective/prospective studies, as no clinical studies are presented. The tests conducted are laboratory-based.

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

Not applicable. Ground truth, in the context of diagnostic performance measured against clinical expert consensus or pathology, is not relevant here as this document describes non-clinical, benchtop, and material science testing of a medical device (stent and catheter systems), not a diagnostic algorithm.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1, 3+1) are used to resolve disagreements among human annotators or readers when establishing ground truth for diagnostic studies. Such a process is not described or relevant for the non-clinical testing presented.

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 physical medical device (stents and catheters), not an AI/ML-driven diagnostic or assistive device. Therefore, no MRMC study or assessment of AI assistance to human readers was performed.

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

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

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical tests described is inherent in the material science principles, engineering specifications, and established testing standards (e.g., ASTM, ISO 10993). For instance:

• For MR compatibility, the "ground truth" is compliance with the limits defined by ASTM standards for RF heating, displacement force, and image artifact.
• For material evaluation, the "ground truth" is that the new material performs identically to the old one in terms of chemical and physical properties as measured by standard analytical techniques.
• For biocompatibility, the "ground truth" is that the material elicits no adverse biological reactions based on ISO 10993 guidelines.
• For tensile strength, the "ground truth" is meeting predefined engineering specifications for strength and durability.

8. The Sample Size for the Training Set

Not applicable. This document describes non-clinical testing for a physical medical device, not the development or evaluation of an algorithm or AI system that requires a "training set."

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

Not applicable, as there is no training set mentioned or implied for this physical medical device.

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