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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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The Ureteral Stent is intended to facilitate drainage from the kidney to the bladder via placement endoscopically, fluoroscopically or during an open surgical procedure by a trained physician.

The Tria Firm Ureteral Stent consists of the following:

• Tria™ Firm Ureteral Stent with retrieval line
• Ureteral Stent Positioner
• Pigtail Straightener

The provided text is a 510(k) Summary for a medical device (Tria Firm Ureteral Stent) seeking substantial equivalence to a predicate device. This document describes performance testing of the device itself (a ureteral stent), not a diagnostic algorithm or AI system.

Therefore, the requested information (acceptance criteria for an AI system, study details like sample size for test/training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for AI) cannot be extracted from this document because it is not relevant to the type of device being described.

The document discusses performance testing related to the physical properties of the stent, such as:

• Removal Force
• Renal Coil Strength
• Tapered Renal Tip
• Retrieval Line to Stent Shaft Tensile Strength
• Appearance and Cleanliness
• Reversibility of Tip Configuration
• Column Strength
• Stent Softens at Body Temperature
• Surface Roughness
• Stent Identification Markers
• Guidewire Compatibility
• Biocompatibility

These tests ensure the physical device functions as intended and is biocompatible. They are not metrics for an AI system's diagnostic accuracy or performance.

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The Ureteral Stent is intended to facilitate drainage from the kidney to the bladder via placement endoscopically, fluoroscopically or during an open surgical procedure by a trained physician.

The Tria™ Firm Ureteral Stent is intended to facilitate drainage from the kidney to the bladder via placement endoscopically or fluoroscopically or during an open surgical procedure. It is constructed of the same Percuflex polymer as other stents currently marketed by BSC. Tria Firm utilizes a modified extrusion process to provide ureteral stents with an ultra-smooth surface topography.

The Tria™ Firm stent has a double pigtail design and utilizes the same monofilament retrieval lines that are used on other BSC ureteral stents. Tria Firm is packaged with a standard straight stent positioner and a pigtail straightener that are currently provided with other ureteral stents marketed by Boston Scientific.

The purpose of the Tria™ Firm Ureteral Stent is to provide physicians with a product that is aimed at addressing accumulation of urine salt deposits during indwelling. The proprietary surface technology on both the outside and inside of the stent provides maximum coverage from calcium and magnesium salt deposition.

This document is a Premarket Notification (510(k)) for a medical device, the Tria™ Firm Ureteral Stent. It describes the device, its intended use, and why it is considered substantially equivalent to existing devices.

Crucially, this type of FDA submission (510(k)) primarily focuses on demonstrating substantial equivalence to a predicate device rather than proving clinical effectiveness through extensive clinical trials with acceptance criteria for specific outcomes, especially in the context of an AI/algorithm-driven device performance study.

Therefore, most of the requested information regarding acceptance criteria, sample sizes for test/training sets, expert adjudication, MRMC studies, and ground truth establishment for an AI/algorithm is not applicable or present in this document.

The document does mention performance testing for the physical device itself (ureteral stent) and an in vitro study related to a claim about reduced salt accumulation.

Here's an analysis based on the provided document, with explanations for why much of your query cannot be answered:

Analysis of the Provided Document Regarding Device Acceptance and Study

This document describes the regulatory submission for a physical medical device (Tria™ Firm Ureteral Stent), not an AI/algorithm. Thus, the "acceptance criteria" discussed are primarily regulatory in nature (e.g., demonstrating substantial equivalence, biocompatibility, structural integrity, and flow rate of the stent), rather than performance metrics for an AI's diagnostic or predictive capabilities.

The study mentioned is an in vitro test, not a clinical study on human subjects or an AI performance study.

Information Extracted from the Document:

1. A table of acceptance criteria and the reported device performance:
   • The document does not provide a clear, quantifiable table of acceptance criteria for "device performance" in the way you'd expect for an AI/algorithm (e.g., sensitivity, specificity, AUC). Instead, it lists types of performance tests for the physical stent.
   • The closest to a quantifiable performance statement is for the in vitro test on salt accumulation.

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

   • Test Set Sample Size: Not specified for any of the performance tests (e.g., how many stents were tested for flow rate or tensile strength). For the in vitro salt accumulation study, the "sample size" of stents tested is not provided, only that it was a "statistically significant" finding.
   • Data Provenance: Not applicable in the context of patient data for an AI/algorithm. All studies appear to be bench (laboratory) tests performed by Boston Scientific or third parties.

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

   • Not applicable. This is for a physical medical device. Ground truth for most tests (e.g., tensile strength, flow rate) is established by physical measurement standards, not expert consensus interpretation of images or clinical data.
   • For the in vitro salt accumulation study, ground truth would be based on lab measurements of salt deposits, not expert readings.

4. Adjudication method for the test set:

   • Not applicable. This is not an AI/imaging interpretation study. Adjudication methods like 2+1 or 3+1 are used for expert consensus on clinical diagnoses/interpretations, not for physical device testing.

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

   • No, this was not done. MRMC studies are specific to evaluating AI in diagnostic imaging (human-in-the-loop performance). This document is for a physical ureteral stent.

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

   • No, this was not done. This is not an algorithm.

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

   • For the physical/mechanical performance tests, the "ground truth" is based on engineering measurements and material science standards.
   • For the biocompatibility tests, it's based on established ISO/USP standards for biological reactivity.
   • For the in vitro salt accumulation study, the "ground truth" refers to laboratory measurements of calcium and magnesium salt deposition. No human expert or pathology report is involved in establishing this ground truth.

8. The sample size for the training set:

   • Not applicable. This document is not describing an AI/machine learning model, so there is no training set in that context. Device design and manufacturing process optimization would be an analogous "training" phase but without a formal "training set" of data points in the AI sense.

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

   • Not applicable for the same reason as #8.

Key takeaway concerning the in vitro claim:

The document explicitly states: "In vitro testing conducted on the Tria™ Firm Ureteral Stent showed a statistically significant lower level of urine calcium and magnesium salt accumulation on the stent surface compared to competitive devices. Correlation of in vitro data to clinical outcomes have not been established." This is a critical disclaimer, indicating that while the lab test showed a positive result, it has not been proven to translate to better patient outcomes in terms of reduced encrustation or longer stent patency in actual human use.

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