(50 days)
The 0.035" and 0.025" Guidewire is indicated for use in the peripheral vasculature. The 0.014", 0.016", and 0.018" guidewires are indicated for use in the peripheral and coronary vasculature.
The guidewire is constructed of nitinol (nickel-titanium alloy). The nitinol core extends from the distal tip of the guidewire to the proximal shaft end. The distal tip is a helically coiled coil gold plated tungsten wire. The guidewire is coated with a coating(s)to help facilitate smooth passage.
This document is a 510(k) summary for the Nitrex™ Nitinol Guidewire, submitted to the FDA in 2003. As such, it focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a comprehensive study report for new device performance metrics in the way a modern AI/ML device submission would.
Based on the provided text, here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test / Verification | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|---|
| Biocompatibility | ISO 10993-1 Compliance | Device meets ISO 10993-1 standards for biological evaluation. | "Biocompatibility of the guidewire was verified in accordance with ISO 10993-1, Biological Evaluation of the Medical Devices." |
| In-vitro Performance | Dimensional Inspection | Dimensions are within specified tolerances. | "All testing of the product yielded acceptable results." |
| Tensile Strength Tests | Tensile strength meets specifications for intended use. | "All testing of the product yielded acceptable results." | |
| Torque Strength Tests | Torque strength meets specifications for intended use. | "All testing of the product yielded acceptable results." | |
| Coating Performance Test | Coating adheres and functions as intended, facilitating smooth passage. | "All testing of the product yielded acceptable results." | |
| Performance under Simulated Conditions | Device performs as expected under simulated use conditions. | "All testing of the product yielded acceptable results." |
Explanation: The document states that "All testing of the product yielded acceptable results." However, it does not explicitly list quantitative acceptance criteria for each specific test (e.g., "tensile strength > X N," "coating adhesion > Y score"). The acceptance criteria are implied to be adherence to internal specifications and relevant standards. This is common for predicate-based medical device submissions that focus on substantial equivalence.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify sample sizes for any of the performance tests. It also does not mention data provenance (e.g., country of origin, retrospective or prospective nature). The testing appears to be conducted in a laboratory setting (in-vitro and simulated conditions).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable and not provided in this type of submission. This document describes the testing of a physical medical device (guidewire), not an AI/ML algorithm that requires expert-established ground truth from a dataset.
4. Adjudication Method for the Test Set
This information is not applicable and not provided. As explained above, this is for a physical device, not an AI/ML algorithm requiring expert adjudication of data.
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
There was no MRMC comparative effectiveness study done. This type of study is relevant for AI/ML devices that assist human readers (e.g., radiologists, pathologists). The Nitrex™ Nitinol Guidewire is a physical interventional device, not an AI diagnostic or assistance tool.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
There was no standalone (algorithm only) performance study done. This is not an AI/ML device. The "standalone performance" here refers to the guidewire's physical characteristics and functionality.
7. The Type of Ground Truth Used
The "ground truth" for this device's testing would be defined by engineering specifications, material science standards, and established in-vitro performance test methods. For example, the "ground truth" for tensile strength would be the measured force at which the guidewire breaks, compared against a pre-defined acceptable range. For biocompatibility, the ground truth is adherence to ISO 10993-1 guidelines and testing results.
8. The Sample Size for the Training Set
There is no training set for this device. This is a physical medical device, not an AI/ML algorithm that undergoes training.
9. How the Ground Truth for the Training Set was Established
This question is not applicable as there is no training set mentioned for this physical medical device.
§ 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.