(189 days)
The SCIMED ChoICE Guide Wires are intended to facilitate the placement of balloon dilatation catheters or other therapeutic devices during PTCA or other intravascular interventional procedures. The ChoICE Guide Wire family is not intended for use in the cerebral vasculature.
The ChoICE Super Support and Super Support II Guide Wire models are steerable guide wires available in a nominal diameter of 0.014" and two tip configurations, straight shapeable and pre-formed J-Tip. A polymer sleeve extending from the spring coil to the proximal fluorinated polymer coated core wire, surrounds the tapered core wire and is coated with ICE Hydrophilic Coating. The available lengths for the Super Support and Super Support II Guide Wire will be: ChoICE -190 cm, ChoICE Plus-182 cm, and ChoICE Exchange-300 centimeters.
The provided document is a 510(k) premarket notification for a medical device, specifically PTCA Guide Wires. This type of regulatory submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific performance acceptance criteria through a clinical study with detailed statistical analysis.
Therefore, the input does not contain the kind of information requested for many of your points, such as:
- A table of acceptance criteria and reported device performance (in a quantifiable, statistically analyzed sense).
- Sample sizes for test sets, data provenance, or number/qualifications of experts for ground truth.
- Adjudication methods.
- MRMC comparative effectiveness studies with effect sizes.
- Standalone algorithm performance.
- Training set information.
Instead, the document describes non-clinical (in vitro) testing for the guide wires and states that the results verified that the device met minimum requirements for its intended use. It does not provide specific numerical acceptance criteria or performance metrics.
Here's an analysis based on the information available in the document, and an explanation for what is not present:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Minimum Requirements) | Reported Device Performance |
|---|---|
| Tip Tensile strength | Met minimum requirements |
| Tip Torsion strength | Met minimum requirements |
| Combined Load | Met minimum requirements |
| Tip Flexibility | Met minimum requirements |
| J-Tip Curve Retention | Met minimum requirements |
| Torque Response | Met minimum requirements |
| Proximal Spring Coil Joint Shear Strength | Met minimum requirements |
Explanation: The document states, "Test results verified that the ChoICE Super Support and Super Support II Guide Wire models met all of the minimum requirements and are adequate for their intended use." However, the specific numerical values for these "minimum requirements" (acceptance criteria) and the actual numerical results of the tests are not provided in this summary.
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not specified. The document only mentions "Testing and evaluation of the guide wires included" the listed tests, but does not detail the number of units tested.
- Data Provenance: The tests conducted were "Non-Clinical Test Summary" and "in vitro testing and evaluation." This implies laboratory/bench testing, not data from human subjects or clinical settings. Therefore, country of origin is not applicable in the usual sense (it's manufactured in Maple Grove, MN, USA, as per the submitter's address). The study is non-clinical/in-vitro.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This was a non-clinical/in-vitro engineering performance test. "Ground truth" in the context of expert review for medical imaging or clinical outcomes is not relevant here. The "ground truth" (or standard) for these tests would be established by engineering specifications and test methodologies.
4. Adjudication method for the test set:
- Not applicable. As this was non-clinical/in-vitro testing, there's no "adjudication" in the sense of reconciling human expert opinions. The results would be objectively measured against predefined engineering specifications.
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:
- Not applicable. This device is a PTCA guide wire, not an AI or imaging diagnostic device that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical medical instrument, not a software algorithm.
7. The type of ground truth used:
- Ground Truth: For the non-clinical tests, the "ground truth" would be the engineering specifications and performance standards for guide wires, which dictate the "minimum requirements" mentioned in the results. This is established through materials science, biomechanical engineering principles, and regulatory requirements for medical devices.
8. The sample size for the training set:
- Not applicable. This is a physical medical device, not a machine learning algorithm that requires a "training set."
9. How the ground truth for the training set was established:
- Not applicable. (See #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.