(88 days)
The Boston Scientific Corporation (BSC) Kayak™ Hydrophilic Guide Wires are intended to facilitate the placement of a catheter during diagnostic or interventional procedures. The wire can be torqued to facilitate navigation through tortuous arteries and/or avoid unwanted side branches. This device is not intended for use in the coronary arteries or the neurovasculature.
The Kayak™ Hydrophilic Guide Wires are steerable guide wires available in a nominal diameter of 0.035 and 0.038 inches and nominal lengths of 80, 150 and 180 centimeters. The available tip flexibilities will be • Standard, • Stiff • Long Taper. The distal three centimeters of all models are available in straight and pre-formed angled tip design. The Kayak™ Hydrophilic Guide Wire consists of the following three components: • nickel titanium core • polyurethane jacket • hydrophilic coating. The full length of the guide wire has a polyurethane jacket containing tungsten encasing the core wire. The full length of the guide wire has a hydrophilic coating for lubricity.
Here's an analysis of the provided text, focusing on the acceptance criteria and study information for the Kayak™ Hydrophilic Guide Wires:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Tensile Strength | Not explicitly stated, implied to be sufficient for intended use. | "met all evaluation acceptance criteria" |
| Torque Strength | Not explicitly stated, implied to be sufficient for intended use. | "met all evaluation acceptance criteria" |
| Cantilever Stiffness | Not explicitly stated, implied to be sufficient for intended use. | "met all evaluation acceptance criteria" |
| Tip Prolapse | Not explicitly stated, implied to be sufficient for intended use. | "met all evaluation acceptance criteria" |
| Peel Test | Not explicitly stated, implied to be sufficient for intended use. | "met all evaluation acceptance criteria" |
| Lubricity and Durability | Not explicitly stated, implied to be sufficient for intended use. | "met all evaluation acceptance criteria" |
| Biocompatibility | Not explicitly stated, implied to be sufficient for intended use. | "met all evaluation acceptance criteria" |
| Product Shelf Life | Not explicitly stated, implied to be sufficient for intended use. | "met all evaluation acceptance criteria" |
Note: The document states that the "Test results demonstrate that the Kayak™ Hydrophilic Guide Wires met all evaluation acceptance criteria and are adequate for their intended use." However, the specific quantitative or qualitative acceptance criteria for each test are not detailed in this summary.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for each non-clinical test. It only lists the types of tests performed. The data provenance is described as "in vitro testing and evaluation," meaning the tests were conducted in a laboratory setting, not on human subjects. There is no information regarding the country of origin of the data provided beyond Boston Scientific being located in Maple Grove, Minnesota, USA.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable as the described study is a non-clinical, in vitro performance test of a medical device (guide wire). There is no "ground truth" established by human experts in the context of diagnostic performance or clinical outcomes. The "ground truth" here is the physical and mechanical properties of the device, measured against predefined engineering specifications and standards.
4. Adjudication Method for the Test Set
This information is not applicable as the study is a non-clinical, in vitro performance test. Adjudication methods are typically relevant in clinical studies or diagnostic evaluations where expert consensus is needed to resolve discrepancies in interpretation.
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 conducted. This document describes non-clinical, in vitro testing of a medical device's physical and functional properties, not a study evaluating human reader performance with or without AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No, a standalone algorithm-only performance study was not conducted. This document describes the performance of a physical medical device (guide wire), not a software algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical tests described is based on engineering specifications, material science properties, and performance standards for guide wires. For example, tensile strength would be measured and compared against a specified minimum force the wire must withstand before breaking. Lubricity would be measured against a standard for friction.
8. The Sample Size for the Training Set
This information is not applicable as the study is a non-clinical performance test of a physical device. There is no "training set" in the context of machine learning or AI algorithm development.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the reasons stated in point 8.
§ 862.3550 Lead test system.
(a)
Identification. A lead test system is a device intended to measure lead, a heavy metal, in blood and urine. Measurements obtained by this device are used in the diagnosis and treatment of lead poisoning.(b)
Classification. Class II.