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

Mustang Balloon Dilatation Catheters are over-the-wire balloon catheters 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.

This document describes Boston Scientific Corporation's Mustang™ Balloon Dilatation Catheter (K141597) for the treatment of biliary strictures. The device is being compared to its predicate devices, the Mustang™ Balloon Dilatation Catheter (K110122) and the Gladiator Elite™ Balloon Dilatation Catheter (K132810).

Here's an analysis of the provided information regarding acceptance criteria and supporting studies:

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

The document does not explicitly present a table of acceptance criteria with specific numerical thresholds. Instead, it states that "No new safety or performance issues were raised during the testing and therefore, these devices may be considered substantially equivalent to the predicate devices." This implies that the acceptance criteria were met if the performance of the new device was comparable to or better than the predicate devices and did not introduce new safety concerns.

The performance data listed consists of a series of in-vitro performance tests. The implicit "reported device performance" is that the device successfully passed these tests without raising new safety or performance issues, demonstrating substantial equivalence to the predicate devices.

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

The document mentions "Bench testing was performed" and lists "in-vitro performance tests." This indicates that the testing was conducted on samples of the device in a laboratory setting, rather than in human subjects.

• Sample Size: The specific number of devices or components used for each individual in-vitro test is not provided in this summary.
• Data Provenance: The tests are in-vitro bench tests, meaning they were conducted in a controlled laboratory environment. The country of origin of the data is not explicitly stated, but given Boston Scientific Corporation's address (Maple Grove, MN) and the FDA submission, it can be inferred that the testing likely took place in the USA or within the company's global testing facilities dedicated to satisfying US regulatory requirements. The data is prospective for these specific tests as it was generated to support the 510(k) submission for this 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)

This section is not applicable to the provided document. The study described is a series of in-vitro bench tests, not a clinical study involving human patients or expert assessment of medical images/diagnoses. The "ground truth" for these tests would be established by validated test methods, calibration of equipment, and adherence to industry standards, rather than expert consensus on medical conditions.

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

This section is not applicable. Adjudication methods like 2+1 or 3+1 typically refer to the process of resolving discrepancies among multiple human readers or experts in clinical studies, particularly when establishing ground truth. Since the reported studies are in-vitro bench tests, such adjudication methods are not relevant. The results of the tests would be objectively measured without requiring human judgment beyond the execution of the test protocols.

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

This section is not applicable. The document describes a medical device (balloon catheter) for treating biliary strictures, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant to this submission.

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

This section is not applicable. The device is a physical medical instrument (catheter), not an algorithm or software. Therefore, there is no "standalone" algorithm-only performance to assess.

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

For in-vitro bench testing, the "ground truth" is defined by the objective physical and material properties of the device and its performance under specified mechanical conditions. This is established through:

• Standardized Test Methods: Adherence to recognized industry standards (e.g., ISO, ASTM) for testing medical devices.
• Measurement Equipment: Calibrated instruments providing quantitative data (e.g., pressure gauges for Rated Burst Pressure, optical systems for balloon diameter).
• Material Specifications: Compliance of components with predefined material properties.
• Design Specifications: The device's physical dimensions and characteristics as per its engineering design.

The "ground truth" is not derived from human expert consensus, pathology, or patient outcomes in this context, but rather from reproducible scientific and engineering measurements.

8. The sample size for the training set

This section is not applicable. The development described is for a physical medical device (catheter) and involves bench testing for performance and safety, not the training of a machine learning model. Therefore, there is no "training set."

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

This section is not applicable, as there is no training set for this type of device submission.

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