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Tearaway introducer sheath: These introducers are used for the percutaneous introduction of diagnostic or therapeutic devices, such as catheters and pacing leads, into the vasculature.

MicroSlide™ Tearaway introducers are used for the procedures to introduce catheters and other intravascular devices into the coronary and peripheral vasculature of adult and pediatric patients of all ages.

The Galt Medical Tearaway Introducer Sheath assembly consists of an outer peelable sheath and a dilator. The tear-away sheath has a winged hub to initiate the tear in the sheath. The design of the tearaway introducer sheath is unchanged from the current line of Tearaway Introducer Sheaths (K000313), and the pediatric version MicroSlide™ Tearaway Introducer (K123430). The subject and current marketed predicate devices are identical with the exception of the material used in the sheath hub.

The provided text is a 510(k) premarket notification for a medical device called the "Tearaway Introducer Sheath and MicroSlide Tearaway Introducer." The purpose of this submission is to demonstrate that the device with a new hub material is substantially equivalent to previously marketed predicate devices.

Acceptance Criteria and Study for the Device:

The core of this submission revolves around demonstrating that changing the hub material of an already cleared device does not negatively impact its safety and effectiveness. Therefore, the "acceptance criteria" are essentially the established performance specifications of the predicate devices. The study conducted is a series of non-clinical tests to show that the new device meets these specifications.

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present a formal table of "acceptance criteria" with explicit numerical targets, but rather lists the functional tests performed to demonstrate substantial equivalence to the predicate devices. The "reported device performance" is implied to have met these predicate device specifications, as the conclusion states substantial equivalence.

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

The document does not specify the exact sample sizes (e.g., number of units tested) for each non-clinical test. It only states that functional testing was conducted on "aged product."

• Sample Size: Not specified.
• Data Provenance: The tests were conducted internally by Galt Medical Corporation ("Galt Medical requirements") according to protocols "based on international standards." This indicates that the data is from prospective testing performed by the manufacturer to support this specific 510(k) submission. There is no indication of country of origin of the data beyond the manufacturer being in the USA.

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

This is a non-clinical device submission focused on performance and material equivalence. Therefore, there are no "experts" in the clinical sense (e.g., radiologists) used to establish ground truth. The "ground truth" for the test set is established by recognized international standards and the performance specifications of the predicate devices. The expertise involved would be in engineering, materials science, and testing methodology, likely performed by the manufacturer's qualified personnel.

4. Adjudication Method for the Test Set:

Not applicable. This is not a study requiring human interpretation or adjudication for the test set. The tests are objective, measurable physical and chemical properties.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No. This is a non-clinical submission for a physical medical device. MRMC studies are typically for diagnostic imaging devices or software.

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 a software algorithm.

7. The Type of Ground Truth Used:

The ground truth used for these non-clinical tests is based on:

• Device specifications: Established performance parameters for the device (e.g., specific force values for hub break, dimensional tolerances).
• International standards: Adherence to relevant ISO or other recognized standards for medical device testing.
• Predicate device performance: The performance of the previously cleared Galt Tearaway Introducer Sheath (K000313) and Galt MicroSlide™ Tearaway Introducer (K123430) serves as the benchmark.

8. The Sample Size for the Training Set:

Not applicable. There is no "training set" as this is not an artificial intelligence/machine learning device. The "training" for the device, in a manufacturing sense, would be the established manufacturing process and quality control, which is addressed by the quality system regulation (21 CFR Part 820).

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

Not applicable. As there is no training set as understood in AI/ML, there's no ground truth established for it in that context.

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The NexGen Peripheral Expandable Catheter is indicated for percutaneous access to the perioheral vascular system and is designed to assist in the placement and removal of devices. This device is not intended for use in the coronary or cerebral vasculature.

The NexGen Peripheral Expandable Catheter is a sterile single use catheter intended to facilitate the placement or removal of vascular catheters and devices including the NexGen Mechanical Retrieval Device (MRD).

The Device features a Pebax/HDPE catheter shaft attached Nitinol tip that expands as the device is deployed from the lumen of a guide catheter. The Nitinol braid passively expands to the contour shape of the vessel lumen and allows a separate medical device such as a catheter to be retracted into the Nitinol Braid. Both the Nitinol Braid and the other device are then retracted into the Guide Catheter. The retracted Expandable Catheter with the encapsulated device are then removed together via removal of the Guide Catheter.

The Expandable Catheter comes in multiple expanded profiles of 5mm, 7mm, 9mm and 11mm, each having a working length of 43cm and 116cm. The Expandable Catheter is packaged in a Tear Away Sheath (B. Braun 510(k) K000313) that is used to facilitate loading the catheter into a Guide Catheter.

Proximally located on the catheter shaft is a female luer connection for the attachment to a Hemostasis Valve Y Connector, which provides a means of introducing contrast media or other fluids. The Hemostasis Valve Y Connector is separate or a prepackaged component.

The provided text describes a medical device, the NexGen Peripheral Expandable Catheter, and its 510(k) submission to the FDA. However, the document does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in the way typically applied to AI/ML medical devices.

Instead, this document details the regulatory clearance process for a physical medical device (catheter) based on its substantial equivalence to predicate devices. The "testing" mentioned refers to bench-top non-clinical tests to verify the device met design specifications and functional/structural integrity, not clinical performance acceptance criteria in the context of diagnostic accuracy or reader improvement that would be relevant for an AI study.

Therefore, many of the requested categories for AI/ML device studies (like sample sizes, ground truth establishment, expert qualifications, MRMC studies) are not applicable or present in this document.

Below is a table summarizing the information available in the provided text, while explicitly noting where the requested AI-relevant information is not present.

Acceptance Criteria and Device Performance (as presented for a physical medical device)

Study Details (as applicable to a physical medical device submission, not AI)

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

   • Not Applicable / Not Provided for AI-style "test set." The testing described is non-clinical bench testing of the physical device. The documents do not mention clinical studies with human participants that would have a "test set" in the context of an AI/ML device evaluation.

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)

   • Not Applicable / Not Provided. This is a physical device submission, not an AI/ML device requiring expert-established ground truth for performance evaluation in the diagnostic sense.

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

   • Not Applicable / Not Provided.

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

   • No. This document describes a physical medical device, not an AI/ML algorithm that would assist human readers.

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

   • No. This is not an algorithm.

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

   • Not Applicable. For the bench-top tests, "ground truth" was likely defined by engineering specifications and measurements (e.g., a specific tensile strength requirement, a maximum leak rate).

7. The sample size for the training set

   • Not Applicable / Not Provided. This is a physical device, not an AI/ML algorithm requiring a training set.

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

   • Not Applicable / Not Provided.

Conclusion:

The provided 510(k) summary is for a physical medical catheter and details non-clinical bench testing to demonstrate compliance with design specifications and substantially equivalence to predicate devices, as required for FDA clearance of such devices. It does not provide information relevant to the typical acceptance criteria and study designs used for AI/ML-driven medical devices, as it is not an AI/ML device.

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