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The RapidCross™ PTA Rapid Exchange Balloon Dilatation Catheter is intended to dilate stenoses in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilatation in the peripheral vasculature.

The RapidCross PTA Rapid Exchange Balloon Dilatation Catheter (RapidCross catheter) is a rapid exchange (RX) coaxial catheter compatible with 0.014" guidewires, with a distally mounted semi-compliant inflatable balloon and an atraumatic, tapered tip. The distal portion of the catheter has a lubricious coating. The manifold includes an inflation lumen, which is used to inflate and deflate the dilatation balloon with a mixture of

The provided text describes a 510(k) summary for the RapidCross™ PTA Rapid Exchange Balloon Dilatation Catheter, a medical device. This document focuses on demonstrating substantial equivalence to predicate devices through bench testing and biocompatibility testing, not on clinical acceptance criteria or a study proving performance against such criteria in the context of diagnostic or AI-driven systems.

Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert involvement, and MRMC studies is not applicable to this type of device submission. This is a premarket notification for a physical medical device, not a diagnostic algorithm or image analysis software.

Here's a breakdown of the relevant (and non-relevant) information based on the provided text:

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

• Acceptance Criteria: The document states that "The RapidCross catheter met all acceptance criteria for the bench testing with results similar to the predicates." However, specific numerical acceptance criteria for each test (e.g., "Balloon Burst Strength must be > X psi") are not detailed in this summary.
• Reported Device Performance: The document lists the types of tests performed. It doesn't provide specific numerical results, but rather states that the device performed "similar to the predicates" and "met all acceptance criteria."

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: Not specified for any of the bench tests.
• Data Provenance: The testing was "Bench testing" and "biocompatibility testing." This is laboratory/engineering data, not clinical data from patients. Country of origin is not relevant for this type of testing.

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. This relates to physical device performance and biocompatibility, not diagnostic interpretation requiring expert ground truth.

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

• Not applicable. This applies to clinical data interpretation, not bench 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

• Not applicable. This is a physical medical device, not an AI or diagnostic tool.

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

• Not applicable. This is a physical medical device.

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

• Ground Truth: For bench testing, the "ground truth" is typically defined by engineering specifications, validated test methods, and industry standards (e.g., ISO, ASTM). For biocompatibility, it's defined by ISO 10993-1.

8. The sample size for the training set

• Not applicable. This is a physical medical device, not an algorithm that requires a training set.

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

• Not applicable. This is a physical medical device.

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The NanoCross 0.014" OTW PTA Dilatation Catheter is intended to dilate stenoses in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

The NanoCross .014" OTW PTA Dilatation Catheter is an over the wire (OTW) 0.014" coaxial lumen catheter with a distally mounted semi-compliant inflatable balloon and an atraumatic, tapered tip. The distal portion of the catheter shaft and the balloon has a hydrophilic coating. The manifold includes a lumen marked "THRU". This is the central lumen of the catheter that terminates at the distal tip. This lumen is used to pass the catheter over a guidewire with a maximum outer diameter of 0.014". The lumen marked "BALLOON" is used to inflate and deflate the dilatation balloon with a solution of contrast medium and saline. The balloon has two radiopaque markers for positioning the balloon relative to the stenosis. The radiopaque marker bands indicate the dilating or working section of the balloon. The 210mm balloon contains two additional radiopaque marker bands that denote the middle of the balloon body.

The provided 510(k) summary for the "NanoCross™ .014" OTW PTA Dilatation Catheter" indicates that this is a medical device clearance application, not an AI/ML-driven diagnostic device. Therefore, the information requested regarding acceptance criteria, performance metrics like sensitivity/specificity, ground truth establishment, expert adjudication, MRMC studies, and sample sizes for training/test sets is not applicable to this submission type.

Instead, this submission seeks substantial equivalence to a predicate device (NanoCrossTM .014" OTW PTA Dilatation Catheter (K082854)) based on device characteristics and bench testing.

Here's an analysis based on the provided document:

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

The document does not specify quantitative acceptance criteria in terms of performance metrics like sensitivity or specificity, as it's not a diagnostic AI/ML device. Instead, the acceptance criteria are implicitly met by demonstrating substantial equivalence to a legally marketed predicate device (K082854).

The reported device performance is described as conformance to requirements for its intended use through "bench testing."

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

Not applicable. This device is not an AI/ML diagnostic and therefore does not have a "test set" of patient data in the typical sense for performance evaluation. The "testing" refers to bench testing of the physical catheter.

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. There is no concept of "ground truth" established by experts for this type of medical device submission.

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

Not applicable. There is no expert adjudication for a test set in this context.

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-assisted device, so MRMC studies are irrelevant.

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.)

Not applicable. "Ground truth" as a concept for performance evaluation of diagnostic or AI/ML systems is not relevant here. The evaluation relies on engineering principles and similarity to a predicate device.

8. The sample size for the training set

Not applicable. This is not an AI/ML 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 for an AI/ML algorithm, this question is not relevant.

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The HyperGlide™ Occlusion Balloon System is indicated for use in the blood vessels of the peripheral and neuro vasculature where temporary occlusion is desired. The HyperGlide™ Occlusion Balloon offers a vessel selective technique of temporary vascular occlusion, which is useful in selectively stopping or controlling blood flow.

The HyperGlide™ Occlusion Balloon System is a single lumen, open-ended balloon catheter designed for advancement into the vasculature over a .010" quidewire. Balloon inflation is accomplished by advancement of the quidewire through the open distal end, redirecting inflation media to the balloon through side-holes in the catheter wall. The HyperGlide™ Occlusion Balloon System is currently cleared for commercial distribution for sizes 4x10, 4x15, 4x20, and 4x30. The HyperGlide™ Occlusion Balloon System is packaged with a .010" Xpedian™ hydrophilic guidewire, manufactured by Micro Therapeutics, Inc., d/b/a ev3 Neurovascular and cleared under K982543. The device is sold and packaged with a .010" guidewire in a sterile pouch and for single use only.

Here's an analysis of the provided text regarding the HyperGlide™ Occlusion Balloon System, focusing on acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

The submission references compliance with recognized standards rather than specific quantitative acceptance criteria that are often seen for AI/ML devices. Therefore, the table below reflects this approach.

2. Sample Sizes and Data Provenance

This submission is for a medical device (occlusion balloon catheter), not an AI/ML device. Therefore, it does not involve test sets or data provenance in the context of AI/ML algorithm evaluation. The "data" here refers to engineering test results and comparisons to predicate devices. The document does not specify exact sample sizes for each individual engineering test (e.g., how many balloons were burst tested), but indicates a comprehensive battery of tests was performed.

3. Number of Experts and Qualifications

Not applicable. This is a traditional medical device submission, not an AI/ML submission requiring expert ground truth establishment for an algorithm.

4. Adjudication Method

Not applicable for a traditional medical device submission.

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

Not applicable. This is not an AI/ML device, so there's no "human readers improve with AI vs without AI assistance" study.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This is not an AI/ML algorithm.

7. Type of Ground Truth Used

The "ground truth" for this device, in a physical sense, is established by:

• Engineering Standards: Adherence to recognized international standards like ISO 10555.
• Mechanical Properties: Direct measurement and verification of physical and mechanical performance metrics (e.g., burst pressure, tensile strength, fatigue life).
• Predicate Device Equivalence: Direct comparison of design, materials, and performance to previously cleared, similar devices.

8. Sample Size for the Training Set

Not applicable. There is no concept of a "training set" for this type of medical device submission.

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

Not applicable.

Summary of the Study Proving Device Meets Acceptance Criteria:

The study proving the HyperGlide™ Occlusion Balloon System meets its acceptance criteria is described as a series of performance verification and testing activities. These tests were conducted according to established international standards, specifically ISO 10555 (Sterile, Single Use Intravascular Catheters - Parts 1 and 4).

The testing encompassed various critical aspects of the device's functionality and safety, including:

• Dimensional verification
• Balloon fatigue
• Catheter tensile strength
• Torque strength
• Flexibility
• Burst testing

The submission explicitly states that "The test results demonstrated in this submission meet or exceed the requirements of these standards". This statement serves as the primary evidence that the device satisfies its performance acceptance criteria.

Furthermore, a significant part of the "proof" also relies on demonstrating substantial equivalence to predicate devices (the HyperGlide™ Occlusion Balloon family and HyperForm™ Occlusion Balloon System). This involved showing that the new 5mm version shared identical intended use, design, specifications, materials, construction methods, packaging, and sterilization processes with its cleared predecessors. The FDA's issuance of the 510(k) clearance signifies their agreement that these tests and demonstrations are sufficient to establish safety and effectiveness for marketing.

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The EverCross 0.035" OTW PTA Dilatation Catheter is intended to dilate stenoses in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilatation in the peripheral vasculature.

The EverCross Peripheral Dilatation Catheter is an over the wire (OTW) 0.035" dual lumen catheter with a distally mounted semi-compliant inflatable balloon and an atraumatic, tapered tip to aid in crossing tight stenoses. The distal catheter, proximal to the balloon, is covered with a hydrophilic coating. The catheter manifold includes two lumens. The lumen marked "THRU" is the central lumen of the catheter which terminates at the distal tip. This lumen is used to pass the catheter over a guidewire with a maximum outer diameter of 0.035 inches. The lumen, marked "BALLOON" is used to inflate and deflate the dilatation balloon with a solution of contrast medium and saline. The balloon has two radiopaque markers for positioning the balloon relative to the stenosis.

The provided document is a 510(k) Summary for the EverCross™ .035" OTW PTA Dilatation Catheter. It describes the device, its intended use, and its substantial equivalence to predicate devices, focusing on bench testing and biocompatibility testing. The document does not contain information about a study proving the device meets specific acceptance criteria in the context of device performance as one might expect for an AI/ML or diagnostic device.

This is a medical device submission for a physical dilatation catheter, not a software device or diagnostic tool. The "acceptance criteria" here refer to the performance standards met through bench testing and biocompatibility. There is no mention of a clinical study with human subjects, ground truth, or expert review in the way would be described for an AI/ML or diagnostic device.

Therefore, many of the requested fields cannot be filled.

Here's the information that can be extracted or deduced from the provided text:

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

The document states: "Bench testing and biocompatibility testing were performed to support a determination of substantial equivalence. Results from this testing provide assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use."

It does not provide specific quantitative acceptance criteria (e.g., burst pressure tolerance, flexural strength, etc.) nor specific quantitative results. It broadly refers to "conformance to the requirements for its intended use."

Therefore, a table of specific acceptance criteria and reported performance cannot be generated from the given text.

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

Not applicable. The "test set" for this type of medical device refers to the physical units tested in bench and biocompatibility assays. No information is provided about the sample sizes for these tests, nor their provenance.

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. The concept of "experts establishing ground truth" as it applies to diagnostic or AI/ML devices is not relevant for this physical medical device. Performance is assessed through engineering and biological testing.

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

Not applicable. This concept is typically related to expert review of data for diagnostic or AI/ML devices.

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 is a physical medical device (dilatation catheter), not an AI/ML or diagnostic device. An MRMC study is not relevant here.

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)

Not applicable. For a physical medical device like this, performance is validated through bench testing (e.g., mechanical properties, fluid dynamics) and biocompatibility testing (e.g., cytotoxicity, irritation). The "ground truth" would be established by engineering specifications and industry standards for material and device performance.

8. The sample size for the training set

Not applicable. There is no "training set" in the context of this physical medical device submission.

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

Not applicable. There is no "training set" for this physical medical device.

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The Protégé® EverFlex™ Self-Expanding Biliary Stent System is intended as a palliative treatment of malignant neoplasms in the biliary tree.

The PROTÉGÉ® EverFlex™ Self-Expanding Biliary Stent System is a self-expanding nitinol stent system intended for permanent implantation. The self-expanding stent is made of a nickel titanium alloy (nitinol) and comes pre-mounted on a 6F, 0.035" overthe-wire delivery system. The stent is cut from a nitinol tube in an open lattice design, and has tantalum radiopaque markers at the proximal and distal ends of the stent. Upon deployment, the stent achieves its predetermined diameter and exerts a constant, gentle outward force to establish patency.

Here's an analysis of the provided 510(k) summary regarding the Protégé® EverFlex™ Self-Expanding Biliary Stent System, focusing on the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided 510(k) summary, the device's acceptance criteria and performance are primarily established through substantial equivalence to predicate devices rather than explicit, quantitative acceptance criteria for clinical outcomes or device functionality. The summary describes general performance categories rather than specific metrics with defined pass/fail points.

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

• Sample Size for Test Set: Not explicitly stated in the provided document. The summary focuses on bench testing rather than human clinical trials. For bench tests, "sample size" would refer to the number of stents or components tested. This information is not detailed.
• Data Provenance: The data provenance is from bench testing. The document does not specify the country of origin of this testing data. It is retrospective in the sense that it likely compares the new device's bench test results to existing data from predicate devices. There is no mention of prospective clinical trial data.

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

Not applicable. The "ground truth" for this submission is based on engineering specifications, material science, and performance measurements from bench testing, and comparison to predicate devices, not on expert consensus from clinical image interpretation or patient outcomes directly relevant to establishing "ground truth" for a test set in the conventional sense (e.g., for an AI device).

4. Adjudication Method for the Test Set

Not applicable. There's no mention of a human test set requiring adjudication. The assessment is based on physical and mechanical properties measured during bench testing.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. The device is a physical medical device (stent), not a diagnostic AI algorithm. The study described is focused on physical and mechanical performance and comparison to predicate devices for regulatory substantial equivalence.

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

Not applicable. The Protégé® EverFlex™ Self-Expanding Biliary Stent System is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

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

• Engineering specifications and standards: Compliance with ISO 10993 Part 1 for biocompatibility.
• Bench test results: Measured physical and mechanical performance characteristics of the stent (e.g., expansion force, fatigue resistance, radiopacity, etc., though specific details are not provided).
• Predicate device data: The performance of the new device is compared to the established performance of legally marketed predicate devices to demonstrate substantial equivalence.

8. The Sample Size for the Training Set

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

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

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

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The SpideRX Embolic Protection Device is indicated for use as an embolic protection system to contain and remove embolic material (thrombus/debris). The device also acts as the guidewire while performing percutaneous transluminal coronary angioplasty or stenting procedures in coronary saphenous vein bypass grafts with reference vessel diameters of 3.0 to 6.0 mm. The safety and effectiveness of this device as an embolic protection system has not been established in the cerebral or peripheral vasculature.

The SpideRX™ Embolic Protection Device is a percutaneously delivered distal embolic protection system that can be delivered over any 0.014" or 0.018" guidewire. The SpideRX Embolic Protection Device contains a Capture Wire composed of a nitinol mesh filter mounted on a convertible 190/320 cm PTFEcoated 0.014" stainless steel wire, and a dual-ended SpideRX Catheter for delivery and recovery.

The provided 510(k) summary describes the SpideRX™ Embolic Protection Device and its evaluation for substantial equivalence to predicate devices. It states that the device is indicated for use as an embolic protection system to contain and remove embolic material (thrombus/debris) and also acts as a guidewire during percutaneous transluminal coronary angioplasty or stenting procedures in coronary saphenous vein bypass grafts with reference vessel diameters of 3.0 to 6.0 mm.

Here's a breakdown of the acceptance criteria and study details based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The acceptance criteria are implicitly defined by the non-inferiority hypothesis, where the SpideRX device is considered non-inferior if the MACE rate difference from the control group is statistically significantly less than 5.5%.

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

• Sample Size (Randomized Portion):
  • SpideRX/Treatment Arm: 383 patients
  • Control Arm: 364 patients (FilterWire EX™ Embolic Protection System, FilterWire EZ™ Embolic Protection System, or GuardWire® Plus Temporary Occlusion and Aspiration System)
  • Total Randomized: 747 patients
• Data Provenance: The study was a "prospective, randomized, multi-center trial." The specific country of origin is not mentioned, but "multi-center" implies multiple locations, likely within the US, given the FDA submission.

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

The document does not mention the use of experts to establish ground truth for the test set in the context of diagnostic performance or image interpretation. The primary endpoint, 30-day MACE (Major Adverse Cardiac Events), including death, myocardial infarctions (MI), target vessel revascularizations, and emergent CABG (Coronary Artery Bypass Graft) procedures, are clinical outcomes rather than expert-interpreted data points. Myocardial infarctions are determined through lab tests (CK-MB results).

4. Adjudication Method for the Test Set

The document does not explicitly state an adjudication method for the events contributing to the 30-day MACE. However, the nature of clinical endpoints like death, MI (based on biomarkers), and revascularization often involves standardized definitions and potentially an independent clinical events committee for adjudication in a multi-center trial, though this is not explicitly detailed here. The discussion on missing CK-MB data and its statistical imputation suggests a rigorous approach to handling data, but not an "adjudication method" in the sense of reconciling expert opinions.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

No, an MRMC comparative effectiveness study was not done. This study is evaluating the clinical efficacy and safety of an embolic protection device, not a diagnostic AI system or an assistance tool for human readers. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable here.

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

No, a standalone algorithm performance study was not done, as this evaluates a medical device (embolic protection device), not an algorithm or AI system.

7. The Type of Ground Truth Used

The ground truth used for evaluating the device's performance was clinical outcomes data, specifically the 30-day Major Adverse Cardiac Events (MACE), which includes:

• Death
• Myocardial Infarction (defined by CK-MB levels where possible)
• Target Vessel Revascularizations
• Emergent CABG procedures

8. The Sample Size for the Training Set

The document does not mention a "training set" in the context of an AI or algorithm development. The entire study cohort (963 total enrolled patients, 747 in the randomized portion) constitutes the clinical trial data used to evaluate the device. If an internal analysis or model was created to impute missing CK-MB data, it would have been trained on data from within the SPIDER trial that had complete CK-MB values, but this is not a "training set" for the device itself.

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

As no training set for an AI/algorithm was identified, this question is not applicable. The clinical outcomes that served as the "ground truth" for the device's evaluation (MACE) were established using standard clinical definitions and measurements (e.g., CK-MB for MI, clinical events for death, revascularization).

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The Protégé® EverFlex™ Self-Expanding Biliary Stent System is intended as a palliative treatment of malignant neoplasms in the biliary tree.

The Protégé® EverFlex™ Self-Expanding Biliary Stent System is intended for palliation of malignant strictures in the biliary tree.

The Protégé stent is a self-expanding nitinol stent with an open lattice design. The stent is electropolished. The device is provided premounted on a delivery catheter. Upon deployment the constrained stent self-expands to conform to the duct inner luminal surface.

The provided text is a 510(k) Premarket Notification summary for the Protégé® EverFlex™ Self-Expanding Biliary Stent System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a clinical study with detailed performance metrics.

Therefore, the document does not contain the information requested in points 1-9 regarding acceptance criteria and a detailed study proving the device meets them.

Instead, the key takeaway from the provided text is:

• Acceptance Criteria and Device Performance: The document states that "Performance testing (bench) further supports a substantial equivalence claim. The collective evidence therefore provides assurance that the Protégé® EverFlex™ Self-Expanding Biliary Stent System meets the requirements that are considered acceptable for the intended use." However, specific numerical acceptance criteria and the reported device performance against those criteria are not provided.
• Study Type: The study conducted was primarily bench testing to support a claim of "substantial equivalence" to a predicate device, rather than a clinical study evaluating specific performance metrics against pre-defined acceptance criteria.
• No Information on:
  • Sample size for the test set or data provenance
  • Number or qualifications of experts for ground truth establishment
  • Adjudication method
  • Multi-reader multi-case (MRMC) comparative effectiveness study
  • Standalone algorithm performance (this is not an AI device)
  • Type of ground truth
  • Sample size for the training set
  • How ground truth for the training set was established

In summary, the provided submission is a 510(k) for a medical device (biliary stent) that relies on demonstrating substantial equivalence through bench testing. It does not include the detailed clinical study information and acceptance criteria that would typically be found for a novel device or an AI/software as a medical device (SaMD) where performance metrics against a defined ground truth are central to acceptance.

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