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The Ultraflex Diamond Biliary Stent is indicated for palliative treatment of patients with malignant biliary strictures.

The Ultraflex Esophageal Stent System is indicated for use in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors.

The Ultraflex Tracheobronchial Stent System is indicated for treatment of tracheobronchial strictures produced by malignant neoplasms.

The proposed Esophageal, Biliary and Tracheobronchial Ultraflex stents are comprised of two components, a metallic expandable stent and a flexible delivery catheter. The stents are mounted on a delivery catheter. The delivery catheter is placed over a guidewire and through the working channel of an endoscope to deliver the stents are available in a variety of diameters and lengths.

This document is a 510(k) summary for the Boston Scientific Ultraflex™ Stent Systems, seeking a labeling claim for MRI safety and compatibility. It is a Special 510(k), which implies modifications to an already cleared device, primarily regarding labeling for performance characteristics rather than changes to the fundamental design or indications for use. As such, the information provided focuses on the MRI safety claim rather than a comprehensive assessment of the stent system's primary clinical performance.

Here's an analysis of the provided information concerning acceptance criteria and study details:

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

The document does not explicitly present a table of acceptance criteria with corresponding device performance for the primary functions of the stents (e.g., esophageal, biliary, or tracheobronchial stricture treatment). The focus of this 510(k) is specifically on MRI safety and compatibility.

For the MRI safety and compatibility claim, the document states:

• Acceptance Criteria (Implied): The stent system must be demonstrated as "MRI safe and MRI compatible." While specific numerical thresholds for aspects like magnetic field interaction, heating, or image artifact are not quantified in this summary, the general acceptance criterion is that the device does not pose an unacceptable risk or degrade image quality significantly in an MRI environment.
• Reported Device Performance: "Bench testing was conducted to support the MRI safety and compatibility claim." No specific quantified results of this bench testing (e.g., deflection angles, temperature rises, artifact sizes) are provided in this summary.

2. Sample size 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 the bench testing. For MRI compatibility testing of medical devices, the "sample size" typically refers to the number of device units tested.
• Data Provenance: The bench testing would have been conducted in a laboratory setting, likely within Boston Scientific or a contract research organization. The document doesn't specify country of origin or whether it was retrospective/prospective, but bench testing is generally considered prospective in its execution for a regulatory submission.

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):

This question is not applicable to the type of study described. Bench testing for MRI safety and compatibility typically involves engineers and physicists conducting standardized tests according to recognized standards (e.g., ASTM F2052, F2182, F2119). Expert clinical interpretation (like from a radiologist) would not be directly involved in establishing "ground truth" for the physical properties measured during MRI bench testing.

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

Not applicable. Adjudication methods like 2+1 or 3+1 refer to a process for resolving discrepancies in expert opinions, typically in clinical studies or image interpretation. Bench testing results are usually objective measurements that do not require such adjudication.

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 submission concerns a physical medical device (stent) and its MRI compatibility, not an AI or imaging diagnostic product. Therefore, MRMC studies or AI assistance are not relevant to this document.

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

Not applicable, as this is not an algorithm or AI device.

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

For MRI safety and compatibility bench testing, the "ground truth" is established by the physical measurements and properties of the device under specific, controlled MRI conditions, following recognized industry standards (e.g., ASTM standards for MRI compatibility). The "truth" is the measured magnetic field interaction, temperature rise, or image artifact extent.

8. The sample size for the training set:

Not applicable. This is not a machine learning or AI device that would have a "training set."

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

Not applicable, as there is no training set for this device.

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The Ultraflex™ Diamond Biliary Stent System is indicated for palliative treatment of patients with malignant biliary strictures.

The Ultraflex™ Diamond Biliary Stent System is a biliary stent system. It is a self-expanding stent made of Nitinol, constructed using a monofilament, twisted method. It has an overall OD of 10 mm and overall lengths of 40-80 mm. The delivery system has a sliding sheath design, a usable length of 194 cm, a shaft OD of 2.7 mm - 3.02 mm, and is compatible with a 0.035" guidewire.

The provided text describes a 510(k) summary for the Ultraflex™ Diamond Biliary Stent System, focusing on its substantial equivalence to a predicate device. This type of submission relies on comparing the new device to a legally marketed predicate device rather than conducting extensive clinical studies with specific acceptance criteria as you might see for novel technologies or higher-risk devices.

Therefore, the information you're requesting regarding acceptance criteria, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details for performance evaluation is not present in this document. The submission focuses on performance characteristics verified through laboratory testing and biocompatibility assessments, and equivalence based on design and materials.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not present a formal table of acceptance criteria for specific performance metrics (like sensitivity, specificity, or reader agreement) and corresponding reported device performance values as would be typical for an AI/CADe device. Instead, the "acceptance criteria" are implied by the substantial equivalence determination, meaning the device must be as safe and effective as the predicate device.

The document states: "Laboratory testing regarding characteristics was performed on Ultraflex™ Diamond Biliary Stem System to verify its safety and performance. A biocompatibility assessment was performed on the patient- and fluid-contact materials of the Ultraflex™ Diamond Biliary Stent System with satisfactory results."

The "performance" described is about the physical characteristics of the stent and delivery system compared to the predicate, as shown in Table 10-1.

The "acceptance criteria" here are that the Ultraflex™ Diamond Biliary Stent System's characteristics and performance verified through in-vitro laboratory testing and biocompatibility assessment demonstrate that it is as safe and effective as the predicate device. The slight differences in material, construction, RO marker location, usable length, and shaft OD were deemed acceptable based on the provided laboratory testing and the overall conclusion of substantial equivalence.

The following information is NOT available in the provided text, as it describes a 510(k) submission for a medical device (stent), not an AI/CADe product. Therefore, no studies of the type you describe were conducted or reported.

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 data is provided. Performance verification was based on in-vitro lab testing and biocompatibility.

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 clinical test set data requiring expert ground truth is provided.

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

• Not applicable. No clinical test set data requiring adjudication is provided.

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/CADe device.

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

• Not applicable. This is not an AI/CADe device.

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

• Not applicable. The "ground truth" for this medical device submission relies on established engineering principles, material science testing standards, and biocompatibility guidelines.

8. The sample size for the training set

• Not applicable. This is not an AI/CADe device, and no training set is mentioned.

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

• Not applicable. No training set is mentioned.

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