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The Nanostim™ Introducer Kit is intended to provide a conduit into the venous system for insertion of diagnostic and other interventional devices.

The St Jude Medical Nanostim Introducer Kit is designed to perform as a guiding sheath for introduction of diagnostic and interventional devices. The Nanostim™M Introducer Kit is comprised of an introducer sheath and a dilator. The Introducer Kit is compatible with 0.035" and 0.038" guidewires and is available in one size (18F) and two lengths (30cm and 50cm).

The introducer is fitted with a hemostasis valve to minimize air introduction during insertion and/or exchange, and a sideport with a three-way stopcock. The introducer features a radiopaque tip marker incorporated within the sheath material to identify the location of the distal tip of the sheath. Design modifications were made to the length and packaging of the current device. The changes made to the Nanostim Introducer Kit do not affect the intended use of the device or alter the fundamental scientific technology of the device.

The provided text describes a 510(k) premarket notification for a medical device called the Nanostim Introducer Kit. This document is a submission to the FDA seeking to demonstrate that the modified device is substantially equivalent to a legally marketed predicate device.

Here's an analysis of the acceptance criteria and study information provided, structured as requested:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the specific sample sizes for each non-clinical test (visual, dimensional, torsional, simulated use/kink). It generally refers to "Design verification testing."

• Test Set Sample Size: Not specified for individual tests.
• Data Provenance: The study is reported as "Design verification testing," which implies it was conducted by the manufacturer (St. Jude Medical, Inc.) to verify their modified product. The origin of the data (e.g., country) is not specified beyond being generated by the applicant. It is a retrospective study in the sense that the testing was performed on the manufactured device, not as part of a prospective clinical trial.

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

This information is not applicable to this submission. The tests conducted are non-clinical, design verification tests, not clinical evaluations relying on expert interpretation of medical data (like imaging or pathology). The "ground truth" for these engineering tests would be established by objective measurements and defined specifications, not expert consensus.

4. Adjudication Method for the Test Set

This information is not applicable. Since the tests are non-clinical, objective measurements against pre-defined specifications determine success or failure. There is no human variability in interpreting results that would require an adjudication method.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "Clinical evaluation is not required for this device." This type of study is typically performed for AI/image analysis devices where human reader performance is a key metric.

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 (an introducer kit), not an AI algorithm or software device.

7. The Type of Ground Truth Used

The ground truth used for the non-clinical tests would be based on engineering specifications and industry standards for medical device performance. For example:

• Visual test: Conformance to manufacturing standards, absence of defects.
• Dimensional measurement test: Conformance to specified dimensions (e.g., diameter, length).
• Torsional Strength: Ability to withstand a specified torsional force without breaking or deforming.
• Simulated use/kink test: Ability to perform as intended under simulated use conditions without kinking or failure.

8. The Sample Size for the Training Set

This information is not applicable. This submission is for a physical medical device. There is no "training set" in the context of machine learning or AI models. The device's design is based on engineering principles and prior iterations, not trained on a dataset.

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

This information is not applicable for the same reason as point 8. There is no training set for this device.

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The Nanostim™ Introducer Kit is intended to provide a conduit into the venous system for insertion of diagnostic and other interventional devices.

The St Jude Medical Nanostim Introducer Kit is designed to perform as a quiding sheath for introduction of diagnostic and interventional devices. The Nanostim™ Introducer Kit is comprised of an introducer sheath and a dilator. The Introducer Kit is compatible with 0.035" and 0.038" guidewires and is available in 18F and one length of 30 cm.

The introducer is fitted with a hemostasis valve to minimize air introduction during insertion and/or exchange, and a sideport with a three-way stopcock. The introducer features a radiopaque tip marker incorporated within the sheath material to identify the location of the distal tip of the sheath. Design modifications were made to the current design to improve the manufacturability and to increase the product shelf life. The changes made to the Nanostim Introducer Kit do not affect the intended use of the device or alter the fundamental scientific technology of the device.

The provided text is a 510(k) summary for the Nanostim Introducer Kit, which is a medical device. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving a device meets specific clinical performance criteria for accuracy or diagnostic efficacy in the way an AI or diagnostic imaging device would.

Therefore, many of the requested categories for AI/diagnostic studies (e.g., sample size of test set, ground truth experts, MRMC studies, standalone performance) are not applicable here. This document primarily describes engineering verification and biocompatibility testing.

Here's the information extracted from the document that is relevant to acceptance criteria and device performance:

1. Table of Acceptance Criteria and Reported Device Performance

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The Nanostim™ Introducer Kit is intended to provide a conduit into the venous system for insertion of diagnostic and other interventional devices.

The St Jude Medical Nanostim Introducer Kit is designed to perform as a guiding sheath for introduction of diagnostic and interventional devices. The Nanostim™ Introducer Kit is comprised of an Introducer sheath and a dilator. The Introducer Kit is compatible with 0.035" and 0.038" guidewires and is available in 18F and one length of 30 cm. The introducer sheath is fitted with a hemostasis valve to prevent blood loss and minimize air introduction during introducer insertion and/or exchange. A sideport with a three-way stopcock is provided for air or blood aspiration and fluid infusion. The introducer features a radiopaque tip marker incorporated within the sheath material to identify the location of the distal tip of the sheath.

This document is a 510(k) summary for the St. Jude Medical Nanostim Introducer Kit and does not contain information about a study proving the device meets specific acceptance criteria in the context of AI/ML performance, nor does it involve expert reviews or clinical trials in the way typically associated with AI/ML medical devices. The document concerns a physical medical device (catheter introducer) and its substantial equivalence to predicate devices.

Therefore, I cannot fulfill your request to describe acceptance criteria and a study proving the device meets those criteria, as the provided document does not contain this information in the context you've outlined.

The document discusses:

• The device's intended use and technological characteristics.
• Non-clinical testing (e.g., visual, dimensional, tensile, leak tests, biocompatibility).
• A statement that clinical evaluation is not required.
• A comparison to predicate devices to establish substantial equivalence.

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