(169 days)
The SCIMED ChoICE PT Vision PTCA 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 ChoICE PT Vision PTCA Guide Wires are not intended for use in the cerebral vasculature. The devices are provided sterile and intended for one procedure only.
The ChoICE PT Vision PTCA 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, Intermediate, Extra Support, Standard, Super Support, and Super Support II. The distal two centimeters of all models are straight shapeable or available in a pre-formed J-Tip.
The tapered, distal stainless steel core wire is surrounded by a polyurethane sleeve and is coated with ICE™ Hydrophilic Coating. The Floppy, Intermediate, Extra Support, and Standard guide wires will have the distal 38 centimeters surrounded by the polyurethane sleeve and are available in radiopaque lengths of 2 and 38 cm. The Super Support and Super Support II guide wires will have the distal 10 centimeters surrounded by the polyurethane sleeve, and are available in radiopaque lengths of 2 and 10 cm. The proximal wire is coated with polytetrafluoroethylene (PTFE)
The provided text describes a 510(k) submission for the SCIMED ChoICE PT Vision PTCA Guide Wires. This submission focuses on establishing substantial equivalence to previously marketed devices rather than presenting a study proving a device meets specific acceptance criteria in the context of AI/ML or diagnostic performance. Therefore, many of the requested categories for a study proving device performance against acceptance criteria are not applicable.
Here's an analysis based on the provided text, highlighting what is available and what is not:
1. A table of acceptance criteria and the reported device performance
The document states: "Test results verified that the ChoICE PT Vision PTCA Guide Wires met all of the minimum requirements and are adequate for their intended use." However, it does not provide specific numerical acceptance criteria or the reported performance values for each test. Instead, it lists the types of tests performed.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Tip Tensile | Not specified, but "met all minimum requirements" |
| Tip Torsion | Not specified, but "met all minimum requirements" |
| Combined Load | Not specified, but "met all minimum requirements" |
| Tip Flexibility | Not specified, but "met all minimum requirements" |
| J-Tip Curve Retention | Not specified, but "met all minimum requirements" |
| Polyurethane Shear Strength | Not specified, but "met all minimum requirements" |
| Torque Response | Not specified, but "met all minimum requirements" |
| PTCA Catheter Compatibility | Not specified, but "met all minimum requirements" |
2. Sample size used for the test set and the data provenance
The document does not specify the sample size for the "test set" in terms of the number of guide wires tested for each non-clinical test. The data provenance is "in vitro testing and evaluation" conducted by SCIMED Life Systems, Inc. The country of origin of the data is not explicitly stated but can be inferred to be the USA, given the company's address (Maple Grove, Minnesota).
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 as this is a submission for a physical medical device (guide wire) and the non-clinical tests described are mechanical/physical performance tests, not diagnostic or AI/ML performance tests requiring expert interpretation of results to establish ground truth.
4. Adjudication method for the test set
This information is not applicable for the same reason as point 3.
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. This is a physical medical device (guide wire), not an AI/ML diagnostic device, and no human reader studies are relevant or mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as it's a physical device, not an algorithm.
7. The type of ground truth used
The "ground truth" here would be the established engineering/design specifications and performance thresholds for the physical/mechanical properties of the guide wire. The text indicates that the device "met all of the minimum requirements," implying comparison to these specifications. It is based on engineering and physical measurements rather than expert consensus, pathology, or outcomes data in a clinical sense.
8. The sample size for the training set
This information is not applicable. There is no "training set" in the context of a physical guide wire's non-clinical performance evaluation as described.
9. How the ground truth for the training set was established
This information is not applicable 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.