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The Brilliant™ Introducer Kits are intended for use to facilitate the introduction of guide wires, catheters and other accessory medical devices through the skin into a vein or artery and minimize blood loss associated with such introduction.

The BrilliantTM Introducer Kit classifies into four types (Type I, II, III, and IV). Type I and II consists of a sheath introducer, a dilator, a guide wire with a guide wire collimator, a puncture needle; Type III consists of a sheath introducer, a dilator, a guide wire with a guide wire collimator; and Type IV consists of a sheath introducer, a dilator, a guide wire with a guide wire collimator, an intravascular catheter with introducer needle, a scalpel and a syringe.

The puncture needle or an intravascular catheter incorporates a lumen, which provides a conduit for the insertion of the guide wire into the vascular system. The various types of guide wires, model dependent, are utilized as a guiding mechanism for the insertion of the introduction sheath into the vascular system. The guide wire contains a wire collimator, which assists in funneling the wire through the lumen of the puncture needle or the intravascular catheter and contains marking that are visible under fluoroscopy, which can determine the length of the guide wire within the vascular system. The sheath introducer provides a conduit for introducing other interventional devices, including guide wires and interventional catheters, into the vasculature. The main components of the sheath introducer assembly are a hydrophilic coated sheath introducer, hemostasis valve housing, and a side port with tubing connected to a 3-way stopcock/valve. The hydrophilic coated dilator is used to provide support and stability to the sheath introducer during deployment into the vascular system. The proximal end of the dilator includes a luer port and has a tapered, atraumatic distal tip. Both the sheath and dilator contain bismuth, making these devices visible under fluoroscopy.

Please find the requested information regarding the acceptance criteria and the study that proves the device meets the acceptance criteria, as extracted from the provided document.

Acceptance Criteria and Reported Device Performance

The provided document describes the "Brilliant™ Introducer Kit," which is a collection of medical devices, not a digital algorithm or AI. Therefore, the acceptance criteria and study details are related to the physical performance and biocompatibility of the medical device components rather than algorithmic or AI-assisted performance metrics (like sensitivity, specificity, or improvement in human reader performance with AI assistance).

The document states that the Brilliant™ Introducer Kit underwent various performance and biocompatibility tests to demonstrate substantial equivalence to its predicate device, the "Shoocin™ Introducer Kit."

1. Table of Acceptance Criteria and Reported Device Performance:

Since the document does not explicitly state numerical acceptance criteria for each specific test but rather states that the device "passed" or "met the requirements," I will present the tests performed and the reported outcome.

2. Sample size used for the test set and the data provenance:

• Test Set Sample Size: The document does not specify explicit sample sizes for the performance or biocompatibility tests in terms of number of devices or data points used. However, testing was conducted on samples of the physical device.
• Data Provenance: The studies were conducted by Lepu Medical Technology (Beijing) Co., Ltd. Given the company's location and the context of a 510(k) submission to the FDA, these tests would be considered prospective studies specifically designed to evaluate the new device for regulatory clearance. The country of origin of the data would be China, where Lepu Medical Technology is based.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This question is not applicable to the provided document. The "ground truth" in this context refers to the direct measurement and observation of the physical properties and biological reactions of the device, typically performed through standardized laboratory and animal testing protocols, rather than expert consensus on diagnostic interpretations. No human experts in the sense of clinicians establishing a "ground truth" for a diagnostic outcome are mentioned or relevant here.

4. Adjudication method for the test set:

Not applicable. Adjudication methods like 2+1 or 3+1 are used in studies involving human interpretation or subjective assessments, which is not the nature of the biocompatibility and performance tests described for this medical device. The results of these tests are typically objective measurements or observations against defined standards.

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. The Brilliant™ Introducer Kit is a physical medical device (catheter introducer kit) and not an AI or imaging algorithm. Therefore, no studies involving human readers, AI assistance, or MRMC analysis were conducted.

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, not an algorithm.

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

The "ground truth" for the device's performance and safety is established through:

• Standardized Test Protocols: Adherence to international standards like ISO 10993 (for biocompatibility) and ISO 11070 (for shelf life) and AAMI/ANSI/11135 (for sterilization).
• Physical Measurements and Chemical Analysis: Direct measurement of device dimensions (ID/OD, length), material properties, fracture strength, corrosion resistance, and observation of defects.
• In Vitro and In Vivo Biological Assays: Laboratory tests (e.g., hemolysis, cytotoxicity, complement activation) and animal studies (e.g., sensitization, systemic toxicity, pyrogenicity, in vivo thromboresistance).

8. The sample size for the training set:

Not applicable. This is a physical medical device, not an algorithm that requires a training set.

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

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

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