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The Mustang™ Balloon Dilatation Catheters are intended for dilatation of strictures in the biliary system. The Mustang Balloon Dilatation Catheters with balloons up to 120 mm in length are indicated for the treatment of biliary strictures.

The Boston Scientific Mustang™ Balloon Dilatation Catheter is an over-the-wire balloon catheter with a dual lumen shaft design. One lumen is used to pass the catheter over 0.035" guidewires. The second lumen communicates with the balloon and is used to inflate and deflate the balloon during the procedure. The guidewire lumen and the balloon lumen terminate at the proximal end of the catheter in a Y-connector manifold with luer lock fittings. There are radiopaque marker bands located under the balloon to aid in positioning the system during the procedure. A silicone coating is applied to the balloon to enhance insertion and withdrawal performance. The Mustang™ Balloon Dilatation Catheter will be available with balloon diameters 3.0 mm to 12.0 mm, balloon lengths 2 cm to 12 cm and with shaft lengths of 40 cm, 75 cm, and 135 cm.

This document is a 510(k) summary for the Boston Scientific Mustang™ Balloon Dilatation Catheter, a medical device intended for the dilatation of strictures in the biliary system. It is a premarket notification for a Class II device, seeking to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the provided information, focusing on acceptance criteria and the study that proves the device meets those criteria:

1. Table of Acceptance Criteria and the Reported Device Performance:

The document does not explicitly present a table of quantitative acceptance criteria with corresponding performance values for the Mustang™ Balloon Dilatation Catheter. Instead, it describes various tests performed and states that "The results of these tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use. No new safety or performance issues were raised during the testing."

However, we can infer the types of acceptance criteria indirectly from the tests conducted. The underlying acceptance criterion for all these tests is that the device performs equivalently or better than the predicate device without raising new safety concerns, and meets relevant standards for medical devices of its type.

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

The document describes "bench testing" and "biocompatibility testing." These are laboratory-based studies, not clinical studies involving human patients. Therefore, the concept of a "test set" in the context of clinical data (like patient cases) is not directly applicable here.

• Sample Size: The specific number of devices or material samples used for each bench test or biocompatibility test is not disclosed in this summary.
• Data Provenance: The data provenance is laboratory testing ("bench testing and biocompatibility testing"). Given that Boston Scientific Corporation is based in Maple Grove, MN, USA, it's highly probable that these tests were conducted in the USA, likely at internal Boston Scientific labs or by contracted testing facilities. These are prospective tests performed specifically to support this submission.

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

Since this submission relies on bench and biocompatibility testing, there is no "test set" of clinical cases that would require expert adjudication for ground truth. The "ground truth" for these tests are the established scientific and engineering principles, material specifications, and validated test methods. The "experts" involved would be the engineers, scientists, and technicians who designed, conducted, and analyzed these tests, following recognized standards (e.g., ISO for biocompatibility). Their qualifications would be in engineering, materials science, toxicology, and other relevant scientific disciplines, but specific numbers and qualifications are not stated in this summary.

4. Adjudication Method for the Test Set:

Not applicable, as there is no clinical test set requiring expert adjudication.

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

No, an MRMC comparative effectiveness study was not done. This 510(k) submission primarily relies on non-clinical (bench and biocompatibility) data to demonstrate substantial equivalence for a medical device. MRMC studies are typically performed for diagnostic devices where human readers interpret medical images, often with and without AI assistance, to assess performance improvement.

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

Not applicable. This device is a physical medical instrument (a balloon dilatation catheter), not an algorithm or AI system. Therefore, the concept of "standalone algorithm performance" does not apply.

7. The type of ground truth used:

• For biocompatibility tests: The ground truth is based on established biological safety standards and validated test methodologies (e.g., ISO 10993 series). The "truth" is whether the materials elicit specific biological responses per the standard.
• For in-vitro performance tests: The ground truth is based on engineering specifications, design requirements, and validated test methods (e.g., measuring dimensions, burst pressures, fatigue cycles against predefined limits). The "truth" is whether the device meets those quantifiable engineering parameters.

8. The sample size for the training set:

Not applicable. This device is a physical medical instrument, not an AI/ML algorithm that requires a "training set" of data.

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

Not applicable. As above, there is no training set for this type of device.

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The Boston Scientific Express™ Biliary LD Premounted Stent System is intended for the palliation of malignant neoplasms in the biliary tree.

The Express Biliary LD Stent is a balloon expandable metallic stent intended to maintain patency of biliary strictures produced by malignant neoplasms. The stent will be available in a variety of sizes to address clinician needs. The Express Biliary LD Stent is made from 316L surgical grade stainless steel tubing. The seamless tubing is initially extruded to a cylindrical shape, and is then drawn down in a series of steps to the final tubing dimension. The stent is formed by laser cutting the pattern from the tube, after which it is cleaned and electropolished to obtain smooth rounded struts. The geometry is a continuous pattern consisting of large and small sinusoidal bands connected by axial struts. The deployed stent provides excellent radial strength while conforming to the natural curvature of the anatomy. The stent provides a ghost like image using conventional radiographic imaging equipment. The Express Biliary LD Stent will be offered in Small Vessel (SV) and Large Vessel (LV) models. The SV model will be used for vessel diameters ranging from 6 mm through 8 mm, with lengths of 17 mm, 37 mm, and 57 mm. The LV model will be used for vessel diameters of 9 mm and 10 mm with lengths of 25 mm, 37 mm, and 57 mm.

The Express Biliary LD balloon delivery catheter will be substantially equivalent to the legally marketed Boston Scientific Ultra-thin SDS Balloon Dilatation Catheter (K011889 and K011909). The delivery catheter is identical to the predicate catheter with the exception of one minor component and material change and one design change associated with the number of balloon folds. The hub utilized for the delivery catheter will be the hub design currently used on the Boston Scientific Synergy Balloon Dilatation Catheter (submitted under the name SC 35 Balloon Dilatation Catheter), cleared to market under K993303 and K993305. The Balloon Delivery Catheter is an over-the-wire catheter offered in a two lumen catheter shaft design. One lumen is used to pass the catheter over a guidewire. The proposed device is designed to be placed over guidewires which have outer diameters of 0.035" or smaller. This lumen can also be used for infusion of contrast medium. The second lumen communicates with the balloon and is used to inflate and deflate the balloon during the stenting procedure. The guidewire lumen and the balloon lumen terminate at the proximal end of the catheter by means of a bifurcated hub with luer lock fittings.

The provided document does not contain acceptance criteria for device performance in the traditional sense of a study with quantitative metrics and statistical analysis. Instead, it describes a 510(k) premarket notification for a medical device (Boston Scientific Express Biliary LD Premounted Stent System), which focuses on demonstrating substantial equivalence to a predicate device already on the market.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes, expert involvement, and ground truth are not applicable to this type of regulatory submission.

However, I can extract information related to the non-clinical testing performed to establish this substantial equivalence.

Here's a breakdown of the available information:

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

The document does not provide a table of specific numerical acceptance criteria alongside quantifiable reported device performance in the typical scientific study format. Instead, it lists various functional tests and concludes that the test results "verified that the Express Biliary LD Premounted Stent System is adequate for its intended use and is considered substantially equivalent to the legally marketed Johnson & Johnson Corinthian IQ Transhepatic Biliary Stent with Delivery Catheter." Essentially, the "acceptance criteria" here implicitly mean passing these functional tests to demonstrate similar performance to the predicate device.

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: The document does not specify the sample sizes (e.g., number of stents or catheters tested) for any of the functional or biocompatibility tests.
• Data Provenance: The tests are described as "Non-clinical Test Summary" and "in-vitro testing and evaluation." This indicates that the tests were conducted in a laboratory setting, likely by the manufacturer (Boston Scientific Corporation, One Scimed Place, Maple Grove, Minnesota), rather than involving human clinical data. Therefore, country of origin related to patient data, retrospective/prospective, are not applicable.

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 information is not applicable as the tests described are functional and biocompatibility bench/in-vitro tests, not clinical evaluations requiring expert interpretation of patient data or images to establish a "ground truth" for a test set.

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

• This information is not applicable for the same reasons as point 3. These are non-clinical engineering and biological tests, not clinical studies with subjective evaluation that would require 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

• An MRMC comparative effectiveness study was not done. This document describes a 510(k) submission for a physical medical device (stent system), not an AI/software device that would involve human readers or AI assistance.

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

• This is not applicable, as the device is a physical medical stent system, not an algorithm.

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

• For the non-clinical tests, the "ground truth" would be established by objective, verifiable engineering and scientific standards (e.g., direct measurements of dimensions, standardized material property tests, established biocompatibility protocols). There's no "expert consensus" or "pathology" in the human diagnostic sense involved.

8. The sample size for the training set

• This is not applicable. There is no "training set" as this is not a machine learning or AI-based device. The device itself is what was tested.

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

• This is not applicable for the same reason as point 8.

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