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The Glidesheath consists of an introducer (sheath and dilator), which are packaged together with a mini guide wire. Some product configurations also include an entry needle, guide wire inserter and a flushing syringe. The Glidesheath is used to facilitate placing a catheter through the skin into a vein or artery. The sheath is coated with hydrophilic coating to minimize frictional resistance when inserting or removing the sheath from the patient's blood vessel. In addition, the sheath and dilator contain bismuth, making these devices visible under fluoroscopy.

The entry needle (cannula) is used to gain access to the vein or artery for placement of the mini guide wire. The entry needle is offered in either stainless steel (SS) version or the Surflo (SR) IV catheter (which includes a needle) (K891087). There are two different types of stainless steel entry needles that are available in various gauges and lengths.

The mini guide wire is inserted through the cannula into the patient's blood vessel and is used for placement of the sheath and dilator into the vein or artery. A guide wire inserter is provided to assist in insertion of the mini guide wire into the cannula. The mini guide wire is offered in three versions, either a stainless steel spring coil model (stainless steel), a nitinol model with palladium tipped (nitinol) or a polyurethane plastic model with a nitinol core (plastic).

Following guide wire insertion, the cannula is removed and the sheath and dilator are then inserted over the mini guide wire and into the blood vessel. The mini guide wire is then withdrawn from the vessel. The dilator maintains the integrity of the sheath and dilates the blood vessel during insertion. Once the sheath is situated in the vessel, the dilator is removed and an appropriate catheter can then be inserted through the sheath. The flushing syringe is used to prime the dilator with heparinized saline.

The entry needle, the mini guide wire, the guide wire inserter and flushing syringe, are all accessories to the Glidesheath. Depending on the product code, certain accessories may or may not be contained within the kit. All of the accessories for a given product code are provided in an individual package with the Glidesheath and sterilized together.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device called Glidesheath™. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets a specific set of acceptance criteria through a clinical study with primary performance endpoints.

For medical devices seeking 510(k) clearance, the primary goal is to show that the new device is as safe and effective as a legally marketed predicate device. This is typically done through non-clinical performance testing and comparison of design, materials, and indications for use. Clinical studies (with human subjects) are often not required for 510(k) submissions if non-clinical data is sufficient to demonstrate substantial equivalence.

Based on the provided text:

A table of acceptance criteria and the reported device performance

The document provides extensive tables (Table 5.4 to 5.9) detailing the non-clinical performance tests conducted on the proposed Glidesheath™. These tables list the component, test description, and the standard (e.g., ISO, ASTM, or Internal) against which the test was performed. The blanket statement "The components tested met the predetermined acceptance criteria and results support a determination of substantial equivalence" (Page 16) serves as the reported device performance, indicating that all listed tests passed their respective internal or external standard requirements.

Since this is a 510(k) for substantial equivalence, the "acceptance criteria" are generally the standards set forth by the referenced ISO/ASTM documents or internal specifications, with the performance being that the device passed these tests.

Example Excerpt from Table 5.4 (Sheath Performance Testing):

Component Test Description Standard Reported Device Performance (Implied)
Sheath Visual Inspection – Extraneous

Component	Test Description	Standard	Reported Device Performance (Implied)
Sheath	Visual Inspection – Extraneous

*(This table would be much longer if all tests were listed, but this demonstrates the format.)*

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

The document does **not explicitly state the sample sizes** used for each non-clinical performance test (e.g., number of sheaths, dilators, or needles tested). It refers to the tests being conducted on "the proposed TMC Glidesheath."

The data provenance is from **non-clinical tests** performed by Terumo Medical Corporation (Elkton, MD, USA) as the manufacturing site for the proposed device. The tests are prospective in the sense that they were specifically conducted for this 510(k) submission, testing the new device manufactured at the new site. The country of origin for the data generation would primarily be the USA (Elkton, MD).

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** to this 510(k) submission. The document describes non-clinical performance and biocompatibility testing of a physical medical device. "Ground truth" and expert adjudication are concepts typically associated with diagnostic AI/imaging studies where human interpretation is being compared against an AI system. For the physical performance tests listed, the "ground truth" is defined by the objective metrics and standards referenced (e.g., a certain force for tensile strength, or a specific leakage rate). The experts involved would be the engineers and technicians performing and verifying these laboratory tests, following the specified standards.

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

This is **not applicable** as the document describes non-clinical performance testing of a physical medical device, not a diagnostic study requiring adjudication of interpretations.

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

This is **not applicable**. The document does not describe an AI device or a diagnostic imaging study. It pertains to a catheter introducer sheath.

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

This is **not applicable**. The device is a physical catheter introducer sheath, not an algorithm or AI system.

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

For the non-clinical performance tests, the "ground truth" is established by adherence to **predefined, objective metrics and standards** such as:
*   ISO 11070: 1998 (Sterile single-use intravascular introducers, dilators and accessories)
*   ASTM F640-12 (Standard Practice for Radiopacity of Medical Photographic Films)
*   ISO 594-1:1986, ISO 594-2: 1998 (Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment)
*   ISO 7886-1: 1993 (Sterile hypodermic syringes for single use – Part 1: Syringes for manual use)
*   ISO 10993 series (Biological evaluation of medical devices)

These standards define what constitutes acceptable performance for various physical and biological properties of the device components. Visual inspections would also follow internal quality standards based on these principles.

8. The sample size for the training set

This is **not applicable**. The Glidesheath™ is a physical medical device, not an AI or machine learning model that requires a "training set."

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

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

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