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510(k) Data Aggregation
(28 days)
Boston Scientific ChoICE™ PT, PT Graphix™, ChoICE, Luge, and Mailman Guidewires with ICE Hydrophilic Coating are intended to facilitate the placement of balloon dilatation catheters or other therapeutic devices during PTCA or other intravascular interventional procedures. They are not intended for use in the cerebral vasculature.
Boston Scientific CholCE™ PT Magnet, PT Graphix™ Magnet, CholCE Magnet, Luge Magnet, and Mailman Magnet Guidewires with ICE Hydrophilic Coating are intended to facilitate the placement of balloon dilatation catheters or other therapeutic devices during PTCA or other intravascular interventional procedures. They are not intended for use in the cerebral vasculature.
The Boston Scientific CholCE™, Mailman™, Luge™, CholCE™ PT, and CholCE™ PT Graphix Guide Wires with ICE® Hydrophilic Coating are available with a nominal diameter of 0.014 in (0.37 mm) and in nominal lengths of 182 cm or 300 cm. These guide wires contain a 304 stainless steel core wire. The proximal section of the core wire of all models is coated with polytetrafluoroethylene (PTFE) for lubricity. The distal end of the core wire is formed (flattened) to allow for shaping. All models are available with a shapeable Straight Tip or a preformed "J" Tip to address user preference. Varying tapers along the distal core wire and differing tip materials (spring coil or polymer) provide combinations of rail support and tip flexibility to address user requirements. The 182 cm guide wires are designed with an extension section for exchange of Over-the-Wire systems by using either the MAGNET Exchange Device or the AddWire™ Extension Wire. The 300 cm guide wires allow exchange of therapeutic devices without the use of an extension wire or exchange system.
The provided text is a 510(k) Summary for Boston Scientific guide wires. It describes the device, its intended use, and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study that specifically proves the device meets acceptance criteria.
The document primarily focuses on non-clinical testing performed to demonstrate that the new guide wires are "substantially equivalent" to previously cleared predicate devices. Substantial equivalence means that the new device is as safe and effective as a legally marketed device.
Therefore, I cannot extract the requested information regarding acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details, or ground truth establishment relevant to an AI/ML device from this document. This document pertains to a medical device approval that relies on substantial equivalence and non-clinical testing, not on an AI/ML algorithm's performance against specific acceptance criteria in the manner requested.
If you have a document for an AI/ML device submission that includes a performance study, I would be able to extract that information.
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(90 days)
The SCIMED Quest Floppy and Moderate Support Guide Wires are intended to facilitate the placement and exchange of balloon dilatation catheters or other therapeutic devices during PTCA or other intravascular interventional procedures. The Quest Floppy and Moderate Support Guide Wires are not intended for use in the cerebral vasculature. The devices are provided sterile and intended for one procedure only.
The SCIMED Quest Floppy and Moderate Support Guide Wires are steerable guide wires available in a nominal diameter of 0.014 inches and nominal lengths of 182 and 300 centimeters. The available tip flexibilities will be Floppy and Moderate Support. The distal two centimeters of both models are radiopaque and available in either a straight shapeable or a pre-formed J-Tip.
Acceptance Criteria and Study for SCIMED® Quest™ Guide Wires
Based on the provided document, the "performance" of the device is assessed through "Non-Clinical Test Summary" which lists various physical and mechanical properties. The acceptance criteria are implicit in the successful completion of these tests.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Adequate tip tensile strength | Testing and evaluation of the guide wires included tip tensile strength. (Implies successful testing, as the device received clearance.) |
| Adequate tip torsion strength | Testing and evaluation of the guide wires included tip torsion strength. (Implies successful testing, as the device received clearance.) |
| Adequate combined load strength | Testing and evaluation of the guide wires included combined load strength. (Implies successful testing, as the device received clearance.) |
| Adequate tip flexibility | Testing and evaluation of the guide wires included tip flexibility. (Implies successful testing, as the device received clearance.) |
| Acceptable tip prolapse characteristics | Testing and evaluation of the guide wires included tip prolapse. (Implies successful testing, as the device received clearance.) |
| Adequate J-tip curve retention (for J-tip models) | Testing and evaluation of the guide wires included J-tip curve retention. (Implies successful testing, as the device received clearance.) |
| Acceptable torque response | Testing and evaluation of the guide wires included torque response. (Implies successful testing, as the device received clearance.) |
| Adequate proximal spring coil joint shear strength | Testing and evaluation of the guide wires included proximal spring coil joint shear strength. (Implies successful testing, as the device received clearance.) |
| Compatibility with PTCA catheters and wire movement | Testing and evaluation of the guide wires included PTCA catheter compatibility/wire movement. (Implies successful testing, as the device received clearance.) |
| Adequate lubricious coating adherence | Testing and evaluation of the guide wires included lubricious coating adherence. (Implies successful testing, as the device received clearance.) |
| Satisfactory Shelf Life (ongoing) | Shelf Life testing is currently being conducted and will be submitted when it is completed. (This indicates that full shelf life data was not available at the time of this submission but was considered an ongoing requirement.) |
| Use of same materials and construction methods as predicates | The SCIMED Quest Floppy and Moderate Support Guide Wires utilize the same materials and methods of construction as the currently marketed SCIMED Guide Wires (ChoICE, Luge and Sceptor Families of Guide Wires). (This is a key component of substantial equivalence.) |
| Not intended for use in the cerebral vasculature | The device's intended use explicitly excludes the cerebral vasculature. (This is a limiting factor for device application, not a performance metric.) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes for the "Non-Clinical Test Summary." It mentions "testing and evaluation of the guide wires," which generally implies a sufficient number of samples were tested to demonstrate robust performance for each characteristic.
The data provenance is prospective as the testing was conducted on the physical device itself for the purpose of demonstrating its safety and effectiveness for a 510(k) submission. There is no information regarding the country of origin of the data, but it can be inferred that the testing was performed by the manufacturer, SCIMED Life Systems, Inc., which is based in Maple Grove, MN, USA.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This information is not applicable to this type of device and study. The "Non-Clinical Test Summary" describes physical and mechanical property testing, not subjective assessments by experts. The "ground truth" for these tests would be objective measurements against defined engineering specifications.
4. Adjudication Method for the Test Set
This information is not applicable. Since the testing involved objective physical and mechanical measurements, an adjudication method for different expert opinions would not be relevant.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This type of study is typically used for diagnostic devices that involve human interpretation of images or other data. The SCIMED Quest Guide Wires are interventional devices, and their performance is assessed through physical and mechanical testing, not by comparing human reader performance.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
This information is not applicable. The SCIMED Quest Guide Wires are physical medical devices, not algorithms or AI. Therefore, the concept of "standalone performance" for an algorithm is irrelevant in this context.
7. The Type of Ground Truth Used
The ground truth used for the "Non-Clinical Test Summary" was based on objective engineering and material science specifications and established testing methodologies. For example:
- Physical measurements: For parameters like tip flexibility, torque response, etc.
- Mechanical strength standards: For tensile strength, torsion strength, shear strength.
- Material properties: For coating adherence and compatibility.
- Predicate device performance: The document explicitly states that the device "utilize the same materials and methods of construction as the currently marketed SCIMED Guide Wires (ChoICE, Luge and Sceptor Families of Guide Wires)," implying that the predicate devices set a benchmark for acceptable performance.
8. The Sample Size for the Training Set
This information is not applicable. The concept of a "training set" is relevant to machine learning and AI, which are not involved in the development or testing of this physical medical device.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as point 8.
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