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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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Advanix™ Double Pigtail Biliary Stent is intended for drainage of the bile ducts, for splinting of a bile duct during healing, or for providing bile duct patency in a stricture or past a stone.

The proposed Advanix™ Double Pigtail Biliary Stent consists of a biliary plastic stent. The Advanix double pigtail stent will be sold in a single stent configuration. The double pigtail stent has proximal and distal pigtails, lateral drainage holes in the pigtails, and a tapered tip. The Advanix Double Pigtail Stent will be offered in 7Fr and 10Fr. diameters. The stent lengths for each diameter vary from 3cm-15cm stent lengths. The Advanix Double Pigtail Stent is constructed of a Styrene Butadiene Styrene material.

This document describes the Advanix™ Double Pigtail Biliary Stent, a Class II medical device intended for drainage of the bile ducts, splinting, or providing patency in strictures or past stones. The device is constructed of Styrene Butadiene Styrene material and is offered in 7Fr and 10Fr diameters and 3cm-15cm lengths. The stent is substantially equivalent to the predicate devices, Microvasive® Drainage Stent (K834468) and Microvasive® Biliary Stent and Delivery System (K965147).

Acceptance Criteria and Device Performance:

The provided document does not explicitly present a table of acceptance criteria with corresponding performance metrics in a pass/fail format for specific functional benchmarks. Instead, it broadly states that "all components, subassemblies, and/or full devices met the required specifications for the completed tests" and "all device bench test results were acceptable."

However, based on the tests conducted, the implicit acceptance criteria would be that the device performs within established engineering and biocompatibility standards for biliary stents. The reported performance is that the device met these implied requirements.

Here is a summarized table based on the information provided:

Study Details:

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

   • The document does not specify a sample size for the test set used in the performance or biocompatibility studies. It refers to "components, subassemblies, and/or full devices."
   • The data provenance is not explicitly stated (e.g., country of origin, retrospective/prospective). Given the nature of bench and in-vitro testing, it is generally conducted in a controlled laboratory environment.

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

   • This information is not provided in the document. The tests performed are primarily engineering and laboratory-based, not involving human expert assessment for "ground truth" in the way a diagnostic imaging study would.

3. Adjudication Method for the Test Set:

   • This information is not applicable as the tests are objective, laboratory-based evaluations against specifications, not subjective human assessments requiring adjudication.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No, an MRMC comparative effectiveness study was not conducted. This type of study is typically relevant for diagnostic imaging devices or algorithms that involve human interpretation. This device is a therapeutic stent.

5. Standalone Device Performance (Algorithm Only without Human-in-the-Loop):

   • Yes, the performance data detailed ("Performance Data: In-vitro testing," "All biocompatibility tests," "All device bench test results") represents standalone performance of the physical device. There is no "algorithm" in the context of this device that would involve a human-in-the-loop interaction for performance evaluation.

6. Type of Ground Truth Used:

   • The "ground truth" for the performance evaluation was based on pre-defined design specifications, engineering standards, and established biocompatibility guidelines (EN ISO 10993-1:2009). For example, a stent length test would compare the measured length to the specified manufacturing tolerance.

7. Sample Size for the Training Set:

   • This is not applicable as this is a physical medical device, not a machine learning algorithm that requires a "training set."

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

   • This is not applicable as there is no training set for this type of device.

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The New Microvasive® Biliary Stent and Delivery System is intended for delivery of the stent to the biliary tract for drainage of the bile ducts, for splinting of a bile duct during healing, or for providing bile duct patency in a stricture or past a stone.

The New Microvasive® Biliary Stent and Delivery System is a device intended for delivery of a stent to the biliary tract. The stent is of the Amsterdam type, made of Flexima material, and is available in diameters from 7 to 11.5 Fr and lengths from 5 to 15 cm. The delivery system has a preloaded stent, a working length of 200 cm, and is compatible with a 0.035 inch guidewire.

The provided document is a 510(k) summary for a medical device, the New Microvasive® Biliary Stent and Delivery System. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study for a new AI/software-as-a-medical-device (SaMD) product.

Therefore, most of the requested information regarding acceptance criteria, study details, expert involvement, and ground truth for a performance study is not applicable or not present in this type of submission.

Here's a breakdown of the information that can be extracted and what cannot:

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

• Not Applicable. This document does not present acceptance criteria for a performance study in the way an AI/SaMD submission would. Instead, it demonstrates "substantial equivalence" based on descriptive and technological characteristics compared to predicate devices. The "performance characteristics" mentioned refer to laboratory testing for safety and basic function, not clinical efficacy or diagnostic accuracy.

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

• Not Applicable. No clinical test set or data provenance is mentioned as this is a device based on substantial equivalence, not a new performance evaluation study.

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. No ground truth establishment by experts is mentioned in the context of a performance study.

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

• Not Applicable. No adjudication method for a test set is mentioned.

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 a comparative effectiveness study involving human readers or AI assistance.

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, so "standalone performance" in that context is not relevant.

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

• Not Applicable. No ground truth is established in the context of a performance study. For this device, "ground truth" for its design and safety is implicitly based on established engineering principles and biocompatibility standards for similar devices already on the market.

8. The sample size for the training set

• Not Applicable. This is not a machine learning or AI device, 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, this question is not applicable.

Information that is available from the document related to "performance" in the context of this 510(k) submission:

The document states:

• Performance Characteristics: "Laboratory testing regarding characteristics was performed on New Microvasive® Biliary Stent and Delivery System to verify its safety and performance."
• Biocompatibility: "A biocompatibility assessment was performed on the patient- and fluid-contact materials of the New Microvasive® Biliary Stent and Delivery System with satisfactory results."
• Sterilization & Pyrogenicity: "The New Microvasive® Biliary Stent and Delivery System will be sterilized using ethylene oxide gas using the AAMI protocol for ethylene oxide sterilization. Pyrogenicity testing will be performed on a periodic basis to monitor bacterial endotoxin levels."

The "study" that "proves" the device meets acceptance criteria in this 510(k) context is primarily through:

1. Bench Testing/Laboratory Testing: Mentioned for "characteristics" relating to safety and performance (specific details not provided in the summary).
2. Biocompatibility Assessment: To ensure the materials are safe for patient contact.
3. Sterilization Validation: Using the AAMI protocol for ethylene oxide sterilization.
4. Pyrogenicity Testing: To monitor bacterial endotoxin levels.
5. Substantial Equivalence Argument: The core of the 510(k) is the comparison in design, materials, and intended use to the predicate devices (Solopas™ Percuflex Biliary Stent and Flexima™ Biliary Drainage Catheter), implying that because the predicate devices are safe and effective, and the new device is substantially similar, it too will be safe and effective.

The provided document is a regulatory submission for a physical medical device (a biliary stent) seeking clearance based on substantial equivalence, not a clinical study report for an AI/SaMD product. Therefore, the specific questions about AI/SaMD study design are not addressed.

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