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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 Brilliant™ Introducer Kit classifies into four types (Type I, II, III, and IV). Type I consists of a sheath introducer and a dilator. Type II consists of a sheath introducer, a dilator, a guide wire with a guide wire collimator and a puncture needle. Type III consists of a sheath introducer, a dilator, a guide wire with a guide wire collimator. Type IV consists of a sheath introducer, a dilator, a guide wire with a guide wire collimator, an Intravascular catheter (with needle) 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. The guide wire is radio- detective under fluoroscopy. 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 tubing with 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. The sheath introducer contains Barium sulfate (BaSO4), making the device visible under fluoroscopy. There is no radiocontrast agent in the dilator.

The provided text is a 510(k) premarket notification for a medical device called the "Brilliant Introducer Kit." This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study proving the device meets specific performance acceptance criteria for a novel AI/software component within the device.

Therefore, many of the requested points regarding AI/algorithm performance studies cannot be answered from this document.

However, I can extract information related to the device's biocompatibility and performance testing, which are critical acceptance criteria for this type of medical device.

Here's the information that can be extracted and a clear indication of what cannot be derived from the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are demonstrated through biocompatibility testing and general performance testing. The text does not provide quantitative acceptance criteria targets in the way one might for a software algorithm's accuracy, but rather indicates that the device "met the requirements" or "successfully passed" various tests based on established standards.

Table 1: Acceptance Criteria (as implied by successful testing) and Reported Device Performance

Additional Information Requests:

1. 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 in the document for the biocompatibility or performance tests.
   • Data Provenance: The document does not specify the country of origin for the test data, nor whether the studies were retrospective or prospective. The applicant is Lepu Medical Technology (Beijing) Co., Ltd., which is located in P.R. China, implying the studies were likely conducted there or overseen by them.

2. 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 device and testing described. The "ground truth" here is established by standardized laboratory testing procedures (e.g., ISO, ASTM, USP standards) for biocompatibility and engineering performance, not by expert interpretation of clinical images or data.

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

   • This question is not applicable. Adjudication methods are typically for subjective clinical assessments or image interpretations, not for objective laboratory test results.

4. 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/software device that assists human readers.

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

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

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

   • For biocompatibility: Ground truth is established by the specific endpoints and methodologies defined in the referenced international standards (e.g., cell viability for cytotoxicity, skin irritation scores for intracutaneous reactivity, sensitization response for maximization tests, mortality/organ effects for systemic toxicity, complement activation markers for complement assay, hemolytic index for hemolysis, temperature rise for pyrogenicity, clotting times for thromboplastin, and visual/histological assessment for in vivo thromboresistance).
   • For performance testing: Ground truth is established by engineering specifications and measurements (e.g., tensile force measurements, diameter measurements, visual inspection for coating integrity, particulate counts, chemical residue analysis, microbial culture for sterility, endotoxin assays).

7. The sample size for the training set

   • Not applicable. This is not a machine learning/AI device, so there is no "training set."

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

   • Not applicable (no training set).

In summary, the provided document is a 510(k) premarket notification for a conventional introducer kit, primarily demonstrating substantial equivalence through adherence to existing medical device standards for biocompatibility and performance. It does not involve AI/machine learning components, and thus, metrics pertinent to AI/software validation are not present.

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The ShoocinTM 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 ShoocinTM Introducer Kit consists of a puncture needle, a guide wire with a guide wire collimator, a sheath introducer, and a dilator. The Puncture Needle incorporates a lumen, which provides a conduit for the insertion of the Guide Wire into the vascular system. The flexible stainless-steel guide wire is utilized as a guiding mechanism for the insertion of the Introducer 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. The Guide Wire is radio-detective under fluoroscopy. The Sheath Introducer contains Barium sulfate (BaSO4), making the device visible under fluoroscopy and provides a conduit for introducing other interventional devices, including guide wires and interventional catheters, into the vascular system. The main components of this assembly are a non-hydrophilic coated Sheath Introducer, hemostasis valve housing, and a side port tubing with a 3-way stopcock/valve. The 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. There is no radiocontrast agent on the dilator.

The document provided is a 510(k) premarket notification for a medical device called the "Shoocin™ Introducer Kit." This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving that a device meets acceptance criteria related to AI/ML or diagnostic performance studies.

Therefore, the information required to answer the prompt regarding AI/ML acceptance criteria and a study proving device performance (specifically, a diagnostic performance study for an AI/ML device) is not present in this document.

The document primarily focuses on:

• Substantial Equivalence: Comparing the modified device (Shoocin™ Introducer Kit) to its predicate (also Shoocin™ Introducer Kit, K123475) to demonstrate that changes (e.g., adding models, changing radiocontrast agent) do not alter its fundamental nature, intended use, or safety and effectiveness.
• Biocompatibility Testing: Results from tests performed according to ISO 10993 standards (e.g., cytotoxicity, intracutaneous study, sensitization, systemic toxicity, complement activation, hemolysis, pyrogen study, partial thromboplastin time, in vivo thromboresistance). These are biological safety tests.
• Performance Testing (Bench Tests): A list of physical and chemical bench tests performed on components of the introducer kit (sheath introducer, 3-way stopcock/valve, dilator, puncture needle, guidewire, particulate evaluation, chemical performance, biological sterility, bacterial endotoxin). These are engineering/material performance tests.
• Sterilization: The method used and the Sterility Assurance Level.

This document does not describe an AI/ML-based device, a study involving human readers, ground truth establishment for diagnostic images, or any of the other criteria relevant to the prompt's request for AI/ML device performance and acceptance criteria.

To directly answer your numbered points based on the provided document, I must state that the information is absent:

1. A table of acceptance criteria and the reported device performance: Not applicable. The document lists performance tests for physical properties and biocompatibility, not diagnostic or AI performance.
2. Sample sizes used for the test set and the data provenance: Not applicable. The tests are bench tests and biocompatibility studies, not diagnostic studies with test sets of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No diagnostic ground truth is established.
4. Adjudication method: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, this is an introducer kit, not a diagnostic AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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The ULTRASKIN™ Hydrophilic Guide Wire is indicated to direct a catheter to the desired peripheral or coronary anatomical location during diagnostic or interventional procedure.

The ULTRASKIN™ Hydrophilic Guide Wire consists of a Nitinol core wire, a plastic jacket with hydrophilic coating. The wire distal curve comes in different shapes such as straight, J angled and angled. The guide wire is radiopactitive under fluoroscopy.

The provided text describes the ULTRASKIN™ Hydrophilic Guide Wire, a medical device, and its supporting data for FDA 510(k) clearance. The document focuses on demonstrating substantial equivalence to a predicate device through biocompatibility and performance testing.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are largely derived from international standards and internal performance testing, demonstrating safety and effectiveness compared to a predicate device.

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

• Test Set Sample Size: The document does not explicitly state the sample sizes used for each specific biocompatibility and performance test (e.g., number of animals for toxicity tests, number of guide wires for mechanical tests). It generally states that "The ULTRASKIN™ Hydrophilic Guide Wire successfully passed all of the following performance tests" and provides "Results" for each biocompatibility test.
• Data Provenance: The data is generated from testing conducted by Lepu Medical Technology (Beijing) Co., Ltd. The document does not specify the country of origin for the studies themselves (e.g., where the animal studies were conducted), but the manufacturer is based in Beijing, P.R. China. The studies are assumed to be prospective as they were conducted for the purpose of this 510(k) submission.

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

This document describes technical and biological performance testing, not studies requiring expert interpretation of clinical data or images. Therefore, the concept of "experts establishing ground truth for a test set" with qualifications like "radiologist with 10 years of experience" is not applicable here. The "ground truth" for these tests is defined by the objective pass/fail criteria of the specified ISO standards and validated internal engineering tests.

4. Adjudication Method for the Test Set

Not applicable. The tests are objective measurements against predefined criteria in scientific standards, not subjective assessments requiring 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 is a medical device (guide wire), not an AI-powered diagnostic or assistive tool. MRMC studies are used for evaluating diagnostic performance of systems, often involving human readers and AI.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the performance of the ULTRASKIN™ Hydrophilic Guide Wire is based on:

• International Standards: Primarily ISO 10993 series for biocompatibility and ISO 11070 for shelf life, which define the acceptable limits and methodologies.
• Engineering Specifications/Internal Standards: For performance tests like dimension verification, tensile strength, etc., the "ground truth" or acceptance criteria are derived from the device's design specifications and industry safety/performance expectations for guide wires.
• Predicate Device Comparison: The ultimate "ground truth" for FDA 510(k) clearance is demonstrating substantial equivalence to a legally marketed predicate device (Radifocus® Glidewire® Advantage, K063372) by showing that any differences do not raise new questions of safety or effectiveness.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI device that requires a "training set." The device's performance is established through direct physical, chemical, and biological testing.

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

Not applicable, for the same reason as above.

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