(32 days)
The NEUROSCOUTTM Steerable Guidewires are intended for selective placement of microcatheters and other devices within the neuro and peripheral vasculature.
The hydrophilically coated NEUROSCOUT 0.014 guidewires consist of a stainless steel wire core and a radiopaque platinum/tungsten coil on the distal tip. The basic principle of the guidewires is to act as a monorail that catheters can track over to reach a particular area of the neuro and peripheral vasculature. They have a nominal outside diameter of 0.014 inch and nominal overall length of up to 300 cm.
The provided text describes the 510(k) summary for the NEUROSCOUT™ Steerable Guidewire. This is a medical device submission, and the content focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with acceptance criteria in the typical sense of AI/ML performance evaluation (e.g., sensitivity, specificity, AUC).
Instead, the "acceptance criteria" here refer to meeting engineering performance standards and demonstrating safety and effectiveness comparable to existing devices. The "study" refers to a series of preclinical tests validating these physical and functional properties.
Here's an analysis based on the provided text, addressing your questions where applicable and indicating when information is not present:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the conformance to FDA Guidance and the performance of the predicate devices. The reported device performance is that it met these criteria through preclinical testing.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Mechanical Performance: | |
| Tensile Strength | Testing conducted; device performs according to description. |
| Torque Strength | Testing conducted; device performs according to description. |
| Torqueability | Testing conducted; device performs according to description. |
| Tip Flexibility/Linear Stiffness | Testing conducted; device performs according to description. |
| Kink Radius | Testing conducted; device performs according to description. |
| Lubricity and Catheter Compatibility | Testing conducted; device performs according to description. |
| Material/Coating Integrity: | |
| Coating Integrity | Testing conducted; device performs according to description. |
| Biocompatibility | Screening confirmed modifications did not affect biocompatibility. |
| Functionality: | |
| Simulated Use | Testing conducted; device performs according to description. |
| Adequately address user needs (via animal studies) | Animal studies conducted to ensure user needs addressed. |
| Overall Equivalence: | |
| Same intended use as predicate device | Confirmed. |
| Same operating principle as predicate device | Confirmed. |
| Same materials as predicate device | Confirmed. |
| Similar device dimensional specifications as predicate device | Confirmed. |
| Same shelf life and sterilization process as predicate device | Confirmed. |
| Similar manufacturing process as predicate device | Confirmed. |
2. Sample Size Used for the Test Set and the Data Provenance
This document does not describe an "AI/ML test set" in the conventional sense. The "test set" here refers to the guidewire samples used for various preclinical tests.
- Sample Size for Test Set: Not specified in the document. The tests like tensile, torque, lubricity, etc., would have involved a sufficient number of device samples per test to generate statistically sound data, but the exact numbers are not provided.
- Data Provenance: The preclinical testing was conducted by Codman & Shurtleff, Inc. This is prospective testing of the device itself, not data from patients or a specific country. Animal studies were also conducted, implying live subject data (animals), but specific information on the type of animal or location is not given.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not applicable and not provided. The "ground truth" for this medical device submission involves objective physical and mechanical measurements, and direct observation of performance in simulated and animal use. It does not rely on expert interpretation of data like images for AI/ML models.
4. Adjudication Method for the Test Set
This information is not applicable and not provided. Adjudication methods like "2+1" or "3+1" are relevant for resolving discrepancies in expert interpretations (e.g., radiologists reading images). The preclinical tests described here yield objective measurements or observations of physical performance.
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 information is not applicable and not provided. An MRMC study is relevant for evaluating the impact of AI on human reader performance, particularly in diagnostic imaging. The NEUROSCOUT Steerable Guidewire is a physical medical device, not an AI/ML product designed to assist human interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable and not provided. This device is a physical guidewire, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance evaluation refers to:
- Engineering Specifications/Standards: Performance measured against predefined acceptable ranges derived from regulatory guidance (FDA Guidance for Coronary and Cerebrovascular Guidewires, 1995) and the performance characteristics of the predicate devices.
- Objective Measurements: Results from tests for tensile strength, torque strength, flexibility, kink radius, lubricity, coating integrity.
- Observed Functional Performance: During simulated use and in animal studies to ensure user needs are met.
8. The Sample Size for the Training Set
This information is not applicable and not provided. There is no mention of a "training set" as this is not an AI/ML device. The device itself is manufactured based on design specifications; it is not "trained" on data.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable and not provided for the same reason as point 8.
§ 870.1330 Catheter guide wire.
(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.