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The SMART™ Control™ Nitinol Stent Transhepatic Biliary System is intended for use in the palliation of malignant neoplasms in the biliary tree.

The device description of the proposed SMART™ Control™ Nitinol Stent Transhepatic Biliary System is as follows.
• 6 French stent delivery system profile;
• Stent material – Nickel Titanium alloy and tantalum micromarkers;
• Expanded stent diameters 9 and 10 mm;
• Stent lengths: 80 mm;
• Stent delivery system usable length 80 and 120 cm;
• Guidewire lumen 0.035";

The provided text describes a medical device, the SMART™ Control™ Nitinol Stent Transhepatic Biliary System, and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study proving the device meets specific acceptance criteria.

The document is a 510(k) summary and the FDA's response letter, which focuses on regulatory approval based on demonstrating substantial equivalence to existing legally marketed devices. This regulatory pathway typically relies on comparison to predicate devices, and often involves pre-clinical testing, rather than extensive clinical studies with specific performance acceptance criteria as would be seen for new clinical efficacy claims or performance validation.

Here's a breakdown of why this information is missing based on the input provided:

• No specific acceptance criteria are listed. The document states "Performance standards have not been established by the FDA under section 514 of the Food, Drug and Cosmetic Act."
• No detailed study is described that measures performance against acceptance criteria. The document states, "The equivalence was confirmed through pre-clinical testing," but does not detail the methodology, sample sizes, ground truth establishment, or specific results of this testing.

Therefore, I cannot fulfill your request for a table of acceptance criteria, device performance, study details (sample sizes, provenance, expert involvement, adjudication, MRMC, standalone performance, ground truth types), or training set information as this information is not present in the provided text.

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The SMART™ Control™ Nitinol Stent Transhepatic Biliary System is intended for use in the palliation of malignant neoplasms in the biliary tree.

The device description of the proposed SMART™ Control™ Nitinol Stent Transhepatic Biliary System is as follows. 6 French stent delivery system profile; Stent material – Nickel Titanium alloy and tantalum micromarkers; Expanded stent diameters 6, 7, 8, 9, and10 mm; Stent lengths: 20, 30, 40, 60, 80, and 100 mm; Stent delivery system usable length 80 and 120 cm; and Guidewire lumen 0.035". Proximal Deployment Handle

The provided text is a 510(k) summary for a medical device (SMART™ Control™ Nitinol Stent Transhepatic Biliary System) and a letter from the FDA. It does not include information about acceptance criteria or a study proving device performance in the context of the requested details about AI/algorithm performance.

The document discusses:

• Device Name: SMART™ Control™ Nitinol Stent Transhepatic Biliary System
• Predicate Devices: SMART™ Control Nitinol Stent Transhepatic Biliary System (K021898 and K031777)
• Indications for Use: Palliation of malignant neoplasms in the biliary tree.
• Device Description: Stent material (Nickel Titanium alloy and tantalum micromarkers), stent dimensions (diameters, lengths), delivery system (French profile, usable length, guidewire lumen), and proximal deployment handle.
• Biocompatibility: Stated as biocompatible.
• Substantial Equivalence: Confirmed through pre-clinical testing, comparing it to predicate devices.
• FDA Communication: A letter affirming substantial equivalence but requiring specific warnings regarding use in the vascular system and prominent display of the biliary indication.

The document does not contain any information related to:

• Acceptance criteria in the context of an algorithm or AI.
• Reported device performance as would be detailed for an AI.
• Sample sizes for test sets, training sets, or data provenance for an AI study.
• Number of experts, their qualifications, or adjudication methods for ground truth establishment for an AI.
• MRMC comparative effectiveness studies or human reader improvement with AI.
• Standalone algorithm performance.
• Type of ground truth (e.g., pathology, outcomes data) for an AI.

Therefore, I cannot provide the requested table and study details as they pertain to AI/algorithm performance based on the given input. The "study" mentioned is "pre-clinical testing" used to establish substantial equivalence for a physical medical device, not an AI evaluation.

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The SMART™ Control™ Nitinol Stent Transhepatic Biliary System is intended for use in the palliation of malignant neoplasms in the biliary tree.

The device description of the proposed SMART™ Control™ Nitinol Stent Transhepatic Biliary System is as follows. 7 French stent delivery system profile; Stent material – Nickel Titanium alloy and tantalum micromarkers; Expanded stent diameters 12, and 14 mm; Stent lengths: 20, 30, 40, 60, and 80mm; Stent delivery system usable length 80 and 120 cm; Guidewire lumen 0.035" compatible; and Proximal Deployment handle

The provided text is a 510(k) summary for the SMART™ Control™ Nitinol Stent Transhepatic Biliary System. It does not describe a study involving device performance metrics, acceptance criteria, or ground truth establishment in the context of an AI/ML device.

Instead, it focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance. The document highlights the device's technical specifications, indications for use, and a comparison to existing, legally marketed stents.

Therefore, I cannot extract the requested information (acceptance criteria, reported performance, sample sizes, expert qualifications, adjudication methods, MRMC study details, standalone performance, training set information, or ground truth establishment methods) because this information is not present in the provided 510(k) summary.

The document only states:

• Study that proves the device meets acceptance criteria: "The equivalence was confirmed through pre-clinical testing." (Page 2, Summary of Substantial Equivalence). This refers to pre-clinical testing for biocompatibility and mechanical properties, not a clinical study involving specific performance metrics as might be seen for devices like diagnostic AI.

To elaborate on why each requested point cannot be answered:

1. A table of acceptance criteria and the reported device performance: Not present. The approval is based on substantial equivalence to predicate devices, not specific performance metrics against pre-defined acceptance criteria for a new type of device performance (e.g., diagnostic accuracy).
2. Sample size used for the test set and the data provenance: Not applicable to the presented pre-clinical testing for substantial equivalence.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for diagnostic performance is not established here.
4. Adjudication method: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: No, this is not a diagnostic AI device, so MRMC studies are not relevant in this context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No, this is a physical medical device (a stent), not an algorithm.
7. The type of ground truth used: For the pre-clinical testing mentioned, ground truth would relate to material properties, mechanical integrity, and biocompatibility, typically established through standardized in-vitro and in-vivo animal testing, not expert consensus on human data. Specifics are not provided beyond "pre-clinical testing."
8. The sample size for the training set: Not applicable; this is a physical device, not an AI/ML algorithm requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

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The SMART™ Control™ Nitinol Stent Transhepatic Biliary System is intended for use in the palliation of malignant neoplasms in the biliary tree.

The device description of the proposed SMART™ Control™ Nitinol Stent Transhepatic Biliary System is as follows:
6 French stent delivery system profile;
Stent material - Nickel Titanium alloy and tantalum micromarkers;
Expanded stent diameters 9, and 10 mm
Stent lengths: 100 mm;
Stent delivery system usable length 80 and 120 cm; and
Guidewire lumen 0.035".
Proximal Deployment handle

I am sorry, but the provided text describes a medical device (a biliary stent) and its regulatory clearance (510(k) submission). It does not contain information about studies or acceptance criteria that would allow me to populate the requested table and answer the questions about device performance against acceptance criteria, sample sizes, ground truth establishment, or human reader performance with AI assistance. The document is primarily a regulatory summary stating substantial equivalence to predicate devices based on pre-clinical testing, rather than a clinical study report.

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The SMART™ Control™ Nitinol Stent Transhepatic Biliary System is intended for use in the palliation of malignant neoplasms in the biliary tree.

The device description of the proposed SMART™ Control™ Nitinol Stent Transhepatic Biliary System is as follows.
• 6 French stent delivery system profile;
• Stent material - Nickel Titanium alloy and tantalum micromarkers;
• Expanded stent diameters 9 and 10 mm;
• Stent lengths: 80 mm;
• Stent delivery system usable length 80 and 120 cm; Guidewire lumen 0.035";
• Proximal Deployment Handle.

The provided text is related to a 510(k) submission for a medical device (SMART™ Control™ Nitinol Stent Transhepatic Biliary System) and describes its substantial equivalence to predicate devices, rather than a study outlining acceptance criteria and detailed device performance metrics.

Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth for an AI/ML device is not applicable or cannot be extracted from the given document.

However, I can provide the following based on the available text:

Acceptance Criteria and Device Performance (Not Applicable - This document is a 510(k) summary for a substantial equivalence determination for a medical stent, not a performance study with explicit acceptance criteria for a new device's efficacy as per your request's format.)

The document focuses on establishing substantial equivalence to predicate devices through pre-clinical testing, rather than defining and proving specific performance metrics against pre-defined acceptance criteria for a novel AI/ML device.

Here's an attempt to answer the questions based on the type of document provided:

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

   • Not applicable. This document is a 510(k) summary for a medical stent, asserting "substantial equivalence" to predicate devices, not reporting performance against explicit, quantifiable acceptance criteria in the manner typically seen for AI/ML diagnostic devices. The equivalence was confirmed through "pre-clinical testing," but no specific metrics or targets are provided in this summary.

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. This document does not pertain to a study with a "test set" in the context of AI/ML or diagnostic performance. It refers to "pre-clinical testing" for a physical medical device. No sample size, data provenance, or study type (retrospective/prospective) is mentioned.

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 document does not describe a study involving expert-established ground truth for a test set.

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

   • Not applicable. This document does not describe a study involving adjudication for a test set.

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 does not describe an MRMC study or AI assistance.

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

   • Not applicable. This document is not about an algorithm/AI device.

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

   • Not applicable. This document does not describe a study requiring ground truth in the context of an AI/ML device. The "pre-clinical testing" likely refers to bench testing, mechanical stress tests, biocompatibility assessments, and potentially animal studies, which establish performance against engineering specifications or biological responses, not a "ground truth" for diagnostic accuracy.

8. The sample size for the training set

   • Not applicable. This document does not describe a training set as it is not about an AI/ML device.

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

   • Not applicable. This document does not describe a training set or its ground truth.

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The SMARTTM ControlTM Nitinol Stent Transhepatic Biliary System is intended for use in the palliation of malignant neoplasms in the biliary tree.

The device description of the proposed SMARTTM ControlTM Nitinol Stent Transhepatic Biliary System is as follows. 6 French stent delivery system profile; Stent material – Nickel Titanium alloy and tantalum micromarkers; Expanded stent diameters 6, 7, 8, 9, and10 mm; Stent lengths: 20, 30, 40, 60, 80, and 100 mm; Stent delivery system usable length 80 and 120 cm; and Guidewire lumen 0.035". Proximal Deployment Handle

There is no information in the provided text about a study proving the device meets specific acceptance criteria in terms of performance metrics (like sensitivity, specificity, accuracy) that would typically be associated with AI/software devices. The document is a 510(k) summary for a medical device (a biliary stent), not an AI algorithm.

Here's a breakdown based on the categories requested, highlighting the lack of information pertinent to AI device studies:

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

• Acceptance Criteria: Not explicitly stated as performance metrics. The submission is a 510(k) for a physical medical device (stent), not a software/AI device. The "acceptance criteria" here are implicitly related to demonstrating substantial equivalence to predicate devices, primarily through pre-clinical testing for biocompatibility and mechanical properties.
• Reported Device Performance: The document states, "The SMART™ Control™ Nitinol Stent Transhepatic Biliary System is substantially equivalent to the predicate devices. The equivalence was confirmed through pre-clinical testing." No quantitative performance metrics (e.g., accuracy, sensitivity, specificity) are reported, as these are not relevant for this type of device submission.

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. This is a 510(k) for a physical medical device, not a data-driven AI device. There is no mention of a "test set" in the context of data. Pre-clinical testing would involve physical samples of the device.

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 "ground truth" establishment in the context of data for an AI device.

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

• Not applicable.

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 for a physical medical device (stent), not an AI assistance tool for human readers.

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

• Not applicable. There is no algorithm.

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

• Not applicable.

8. The sample size for the training set

• Not applicable.

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

• Not applicable.

Summary of what the document does indicate:

• Device Type: SMART™ Control™ Nitinol Stent Transhepatic Biliary System (a biliary stent).
• Purpose of Submission: 510(k) for demonstrating substantial equivalence to predicate devices.
• Method of Proving Equivalence: Pre-clinical testing (likely mechanical, material, and biocompatibility testing) confirmed the device is substantially equivalent to predicate devices.
• Key Finding from FDA: The device is substantially equivalent, but a specific warning regarding unestablished safety and effectiveness for vascular use, and clear labeling for biliary use, is required.

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