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The Introducer Assembly with Rotator Lock is intended to provide access to the venous system for device entry, when used in conjunction with additional percutaneous entry devices.

The Introducer Assembly with Rotator Lock consists of a dilator and a split sheath introducer that is used to provide access to the venous system for device entry, when used in conjunction with additional percutaneous critry devices.

Here's the analysis of the provided text regarding the acceptance criteria and study for the "Introducer Assembly with Rotator Lock":

Based on the provided document, the device described is a physical medical device (an introducer assembly) and not an AI/Software as a Medical Device (SaMD). Therefore, the typical acceptance criteria and study methodologies applicable to AI/SaMD (such as performance metrics like sensitivity, specificity, AUC, human reader studies, ground truth establishment with experts, etc.) are not present or relevant in this submission.

The document is a 510(k) Summary of Safety and Effectiveness for a a Class II medical device, which focuses on demonstrating substantial equivalence to a predicate device and adherence to biological safety and verification/validation testing for physical design and materials.

Here's a breakdown of the requested information based on the provided text, acknowledging the nature of the device:

1. Table of Acceptance Criteria and Reported Device Performance

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

This information is not applicable or provided in the context of this 510(k) submission for a physical introducer assembly. The testing mentioned (biological safety, verification, and validation) would typically involve laboratory and engineering bench testing of device samples, rather than human data or clinical studies with a "test set" in the AI/SaMD sense.

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 information is not applicable or provided. Ground truth in the context of AI/SaMD (e.g., diagnostic accuracy) is not relevant for this physical device. Verification and validation testing for a physical device would be executed by engineers, quality control personnel, and potentially in simulated environments or animal models for certain aspects, but not for establishing "ground truth" to train or test an algorithm.

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

This information is not applicable or provided. Adjudication methods are typically used in clinical studies or expert review processes, which are not detailed or implied for the device testing described.

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, a multi-reader, multi-case comparative effectiveness study was not done. This type of study is specifically relevant for AI-assisted diagnostic devices, which the "Introducer Assembly with Rotator Lock" is not.

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. The device is a physical medical instrument, not an algorithm.

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

The document does not describe the use of "ground truth" in the way it's understood for AI/SaMD. The "truth" for this device's performance would be derived from successful completion of engineering tests, material biocompatibility assessments, and functional verification against design specifications and intended use. For example:

• Biocompatibility: In vitro and in vivo tests confirming non-toxicity and compatibility with biological systems.
• Mechanical Performance: Bench testing to ensure physical properties (e.g., strength, flexibility, lubricity) meet specifications.
• Functional Performance: Confirmation that the device can successfully facilitate the introduction of other devices into the venous system without failure or undue difficulty.

8. The sample size for the training set

This information is not applicable or provided. The device is not an AI/SaMD and therefore does not have a "training set" in that context.

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

This information is not applicable or provided for the same reasons as #8.

Summary of the Study and Conclusion from the Document:

The study performed focused on biological safety testing (in accordance with ISO 10993 Part 1) and verification and validation testing of the device's design and materials. The results indicated that the materials passed biological safety standards and that the design and materials were acceptable for the intended use. The primary basis for market clearance was the demonstration of substantial equivalence to a predicate device (TFX Medical Introducer Assembly (K931911)) in terms of functionality, design, placement, and use. The FDA reviewed these submissions and determined that the device was substantially equivalent to legally marketed predicate devices, allowing it to proceed to market.

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