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The Merit S-MAK XL™ is intended for percutaneous placement of up to a 0.038" (.097mm) guide wire or catheter into the vascular system.

The S-MAK XL TM utilizes a small diameter coaxial introducer/dilator pair and guide wire for placement of larger diameter guide wires into the vasculature system when a small needle stick is preferred. The S-MAK XL TM consists of the following components: One (1) 4F Coaxial Introducer/Dilator Pair (30 cm length) One (1) 21 gauge Introducer Needle One (1) 0.018" (0.46mm) 80cm Nitinol/Palladium Guide Wire

The provided text describes the 510(k) summary for the S-MAK XL™ device. Based on the information available, a study was conducted to demonstrate the device's substantial equivalence to predicate devices, focusing on performance and biocompatibility.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

The document does not explicitly state "acceptance criteria" in a quantified table format for each test. Instead, it lists the types of performance and biocompatibility tests conducted and states that "Passing results were demonstrated on all tests above." We can infer the acceptance criterion for each test was a "passing result" according to the specified international standards and guidance documents.

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

The document does not explicitly state the sample sizes used for each performance and biocompatibility test set. The provenance of the data is implied to be from laboratory testing conducted according to the listed international standards (e.g., ISO, ASTM, USP). There is no information about the country of origin of the data or whether it was retrospective or prospective.

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

This information is not applicable to the type of testing performed for the S-MAK XL™. The tests are primarily physical, chemical, and biological evaluations, not requiring expert human interpretation to establish a ground truth in the way medical imaging or diagnostic studies might. The "ground truth" is inherently defined by the technical specifications and standards (e.g., a device either passes a tensile strength test or it doesn't).

4. Adjudication method for the test set

Not applicable. The tests are objective and based on established international standards, not requiring adjudication by multiple experts.

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 S-MAK XL™ is a medical device (vessel dilator/introducer sheath), not an AI-powered diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers or AI assistance would not be relevant.

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

Not applicable. The S-MAK XL™ is a physical medical device, not an algorithm or software. Therefore, standalone algorithm performance testing is not relevant.

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

The ground truth for the performance tests and biocompatibility tests is based on adherence to the specified international standards and guidance documents (e.g., ISO, ASTM, USP). For instance, for cytotoxicity, the ground truth is whether the device extract causes a cytotoxic effect within defined parameters. For physical performance, the ground truth is whether the device meets its design specifications (e.g., correct length, ability to insert guide wire).

8. The sample size for the training set

Not applicable. As a physical medical device, the S-MAK XL™ does not involve machine learning algorithms that require a "training set."

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

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

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The Micropuncture® Introducer Set is intended for the placement of wire guides up to 0.038 inch diameter into the peripheral vascular system when a small 21 gage needle stick is desired.

The Micropuncture® Introducer Set is intended for the placement of wire guides up to 0.038 inch diameter into the peripheral vascular system when a small 21 gage needle stick is desired. The device is utilized to gain access to the vasculature using the Seldinger technique. These introducer sets are comprised of either 4.0 French outer introducer and 3.0 French inner dilator coaxial pair, a 21 gage percutaneous entry needle, and a 0.018 inch mandrel wire guide with a distal coil tip. The dilator of these sets can come with a stainless steel stiffening cannula embedded in the shaft. These sets are supplied sterile and are intended for one-time use.

Here's a breakdown of the acceptance criteria and study information for the Micropuncture Introducer Set, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the exact sample sizes used for each individual test. It only states that "Testing verified..." and "The predetermined acceptance criteria were met."

The data provenance is from benchtop testing conducted by Cook Incorporated. The country of origin for the data is not explicitly stated, but Cook Incorporated is located in Bloomington, Indiana, USA, suggesting the testing likely occurred in the US or under the company's direct supervision. The studies are retrospective in the sense that they are laboratory tests performed on finalized device designs rather than prospective clinical trials.

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

This information is not provided in the document. The tests described are primarily engineering and material science tests, not clinical evaluations requiring expert interpretation of ground truth in the same way an AI diagnostic device would. The "ground truth" for these tests is based on established engineering standards and specifications.

4. Adjudication Method for the Test Set

This information is not applicable as the tests performed are objective physical and material performance tests, not subjective interpretations 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?

No, an MRMC comparative effectiveness study was not done. This document describes the clearance of a physical medical device (introducer set), not an AI diagnostic or assistive technology. Therefore, there is no discussion of human reader improvement with or without AI assistance.

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

No, a standalone algorithm performance study was not done. This device is a physical medical instrument, not a software algorithm.

7. The Type of Ground Truth Used

The ground truth used for these tests is based on established engineering standards, material specifications, and regulatory requirements (e.g., ISO standards). For example, for biocompatibility, the ground truth is conformance with ANSI AAMI ISO 10993-1. For leakage, it's conformance with BS EN ISO 11070:2014.

8. The Sample Size for the Training Set

This information is not applicable. This device is not an AI/ML product and does not involve a "training set" in the computational sense. The testing described is verification and validation for a manufactured product.

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

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

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