(75 days)
Indications for Use: The Stereotaxis Assert™ Guide Wire is intended to introduce and position over-the-wire catheters and other over-the-wire therapeutic devices within the coronary and peripheral vasculature during PTCA or other intravascular interventional procedures.
The Stereotaxis Assert™ Guide Wire is a steerable guide wire that has a nominal diameter of 0.014 in/ 0.36mm and nominal lengths of 180 cm and 300 cm. The guide wire is designed only for use in conjunction with the Stereotaxis Magnetic Navigation System. The wire is configured with a tapered distal tip and an embedded magnet, which is used for navigating the wire through the vasculature. A hydrophilic coating covers the distal portion of the wire, and a PTFE coating covers the proximal end of the wire. This device is sterilized with 100% ethylene oxide.
The provided document is a 510(k) Summary for the Stereotaxis Assert™ Guide Wire. It describes a medical device, its intended use, technological characteristics, and comparison to a predicate device. It explicitly states that no clinical studies were needed to support the modifications and therefore clinical performance data is not available. This means that the device was not evaluated through a study to meet acceptance criteria in the way envisioned by your request.
Instead, the document details that the device met acceptance criteria based on:
- Physical testing: "The Stereotaxis Assert™ Guide Wire was designed and tested in compliance with the FDA "Coronary and Cerebrovascular Guidewire Guidance" dated January 1995. The device met design input criteria..."
- Preclinical animal performance data: "Testing of the Stereotaxis Assert™ Guide Wire in the swine animal model demonstrated substantial equivalence to the currently marketed predicate device."
Given this, I cannot fill out the requested table for "acceptance criteria and the study that proves the device meets the acceptance criteria" in the traditional sense of a clinical or standalone AI study. The document focuses on demonstrating substantial equivalence to a previously cleared device (K021363) through non-clinical data.
Here's how I can address your request based on the provided text, acknowledging the limitations:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria with reported performance values as would be found in a clinical trial. Instead, it states qualitative criteria and that they were met through non-clinical testing.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Design Input Criteria Compliance | "The device met design input criteria" |
| Compliance with FDA Guidance | "designed and tested in compliance with the FDA 'Coronary and Cerebrovascular Guidewire Guidance' dated January 1995." |
| Substantial Equivalence (Animal) | "demonstrated substantial equivalence to the currently marketed predicate device" in a swine animal model. |
2. Sample size used for the test set and the data provenance
The document mentions "testing of the Stereotaxis Assert™ Guide Wire in the swine animal model" but does not specify the sample size for this animal study. It also does not specify the country of origin or whether it was retrospective or prospective, although animal studies are typically prospective.
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 or provided. The "ground truth" equivalent in this context would be the successful navigation and performance in the animal model, observed by the researchers/veterinarians conducting the study, rather than expert interpretation of images or clinical outcomes.
4. Adjudication method for the test set
This information is not applicable or provided. Adjudication methods are typically relevant for human-read clinical studies or analyses requiring consensus on diagnoses or outcomes.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No, an MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical studies were needed to support the modifications."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not applicable as this is a physical medical device (guide wire), not an AI algorithm. Its performance is inherent in its physical properties and how it functions.
7. The type of ground truth used
For the animal study, the "ground truth" was likely direct observation of the device's performance in vivo within the swine vasculature, assessing its navigability and ability to deliver other devices, in comparison to the predicate device.
8. The sample size for the training set
This is not applicable. There is no "training set" in the context of a physical medical device like a guide wire. Design and engineering principles are applied, followed by non-clinical testing.
9. How the ground truth for the training set was established
This is not applicable for the reasons stated above.
§ 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.