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The Boston Scientific/EP Technologies intracardiac introducing sheaths and accessories are designed to facilitate the intracardiac placement of interventional devices.

The intracardiac introducing sheath and accessories consists of: (1) a disposable introducer sheath, (2) a vessel dilator and (3) guidewire. The intracardiac introducing sheath consists of a braided shaft, a soft distal tip, and marker band. The sheath comes with either a Hemostasis valve or a luer fitting. The introducer sheaths are constructed in a range of curve reach configurations, diameters and lengths to respond to physician preferences. The introducer sheath configurations covered under the subject 510(k) Premarket Notification include 8.5F and 9.5F diameter, angles ranging form 0° - 180

The provided text describes a 510(k) premarket notification for an "Intracardiac Introducing Sheath and Accessories." This is a medical device, and the submission aims to demonstrate its substantial equivalence to previously marketed predicate devices, not an AI/ML powered device. Therefore, many of the requested categories (such as sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance, etc.) are not applicable to this type of medical device submission.

However, I can extract the relevant information regarding acceptance criteria and the study performed based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

Study that Proves the Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria is an in vitro testing program designed to demonstrate the "substantial equivalence" of the subject device (Intracardiac Introducing Sheath and Accessories) to its predicate devices. The study involved a series of controlled laboratory tests measuring various physical, mechanical, and functional properties.

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

• Sample Size: The document does not specify the exact sample sizes used for each in vitro test. It generally refers to "manufactured sheaths and dilators" and "packaged units." For in vitro testing, this typically involves a representative number of devices to achieve statistical significance for the specific tests performed, but the exact count is not provided.
• Data Provenance: The data provenance is from laboratory testing (in vitro) conducted by Boston Scientific Corporation/EP Technologies. There is no mention of country of origin for the data (as it's in vitro testing, often performed internally or by contract labs), nor is it retrospective or prospective in the clinical sense.

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

• Number of Experts & Qualifications: Not applicable. For this type of in vitro device performance testing, "ground truth" is typically established by predefined engineering specifications, industry standards (e.g., ISO 11135 for sterilization), and comparison to the performance of predicate devices, rather than expert clinical consensus. The testing engineers and quality control personnel are the "experts" in this context, ensuring adherence to protocols and specifications.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable in the clinical sense. In vitro testing results are compared against predetermined acceptance criteria (e.g., a tensile strength minimum, a leak rate maximum, visual inspection criteria, or direct comparison to predicate device performance). Any discrepancies would be handled by internal quality control and engineering review processes.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging AI/ML devices where human readers interpret medical images. This submission is for a physical medical device (an introducer sheath).

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

• Standalone Performance: Not applicable. This is not an AI/ML algorithm.

7. The Type of Ground Truth Used:

• Ground Truth Type: The "ground truth" or reference standard for this device's performance relies on:
  • Engineering Specifications: Predefined performance metrics (e.g., bond strength, leak rates, friction forces).
  • Industry Standards: Compliance with relevant international standards (e.g., ISO 11135 for sterilization).
  • Predicate Device Performance: Direct comparison of the subject device's performance to that of the legally marketed predicate devices, demonstrating similar safety and effectiveness.

8. The Sample Size for the Training Set:

• Sample Size for Training Set: Not applicable. This is not an AI/ML algorithm that requires a training set. The device itself is manufactured to specifications.

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

• Ground Truth for Training Set: Not applicable.

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