(111 days)
The Wingman Extendable Tip Support Catheter is intended to be used in conjunction with steerable guidewires to access discreet regions of the peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices and provide a conduit for the delivery of saline solutions or diagnostic/therapeutic agents.
The Wingman Extendable Tip Support Catheter is a device intended to provide additional support to a steerable guidewire when accessing discrete regions of the peripheral vasculature. The device consists of a support catheter, with a concealed radiopaque beveled guide-tip, and activating handle. The through-lumen of the device can serve as a conduit for the delivery of diagnostic and therapeutic agents. The Wingman Extendable Tip Support Catheter product line is being extended to add a .035 diameter device configuration.
The provided text describes a medical device, the "Wingman Extendable Tip Support Catheter," and its 510(k) premarket notification for substantial equivalence to a predicate device. However, it does not contain information typically found in a study proving a device meets acceptance criteria related to AI or machine learning performance.
The document is a regulatory submission for a physical medical device (a catheter), not a software or AI/ML-driven device. Therefore, the questions regarding ground truth, expert adjudication, sample sizes for training/test sets, MRMC studies, or standalone algorithm performance are not applicable to this document. The "performance data" section refers to engineering tests on the physical catheter, not AI performance metrics.
Here's the breakdown based on the provided text, indicating what information is not available for an AI/ML context:
1. Table of acceptance criteria and reported device performance:
| Acceptance Criteria Category | Specific Criteria (if available) | Reported Device Performance |
|---|---|---|
| Physical/Mechanical | All specified criteria (implied) | Met all specified criteria |
| Simulated Use | (Not specified) | Performed as intended |
| Tensile Strength | (Not specified) | Met all specified criteria |
| Torque | (Not specified) | Met all specified criteria |
| Pressure Test | (Not specified) | Met all specified criteria |
| Coating verification | (Not specified) | Met all specified criteria |
| Corrosion Test | (Not specified) | Met all specified criteria |
| Dimensional verification | (Not specified) | Met all specified criteria |
| Visual inspections | (Not specified) | Met all specified criteria |
| Sterilization Validation | (Not specified) | Met all specified criteria |
| Biocompatibility | (Not specified) | Met all specified criteria |
| AI/ML Performance | Not Applicable | Not Applicable |
2. Sample sized used for the test set and the data provenance:
- Not applicable for AI/ML. The document states "All testing was performed on test units representative of finished devices." This refers to physical catheter units, not a dataset for an AI model.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. There is no "ground truth" in the context of AI/ML for this physical device.
4. Adjudication method for the test set:
- Not applicable. This relates to AI/ML ground truth establishment.
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 is a physical medical device, not an AI-driven one.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This refers to AI algorithm performance.
7. The type of ground truth used:
- Not applicable. There is no "ground truth" as it pertains to AI/ML for this device. The "truth" for the physical device tests would be conformance to engineering specifications and performance as intended.
8. The sample size for the training set:
- Not applicable. This refers to AI model training.
9. How the ground truth for the training set was established:
- Not applicable. This refers to AI model training.
Summary regarding the provided text's limitations for your request:
The provided document is a 510(k) clearance letter for a physical medical device (a catheter). It details the regulatory approval process based on substantial equivalence to a predicate device and outlines various engineering and biocompatibility tests performed on the physical product.
It does not involve any AI or machine learning components, and therefore, all questions related to acceptance criteria, study design, ground truth establishment, or performance metrics for an AI/ML device are not present and cannot be inferred from this document.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).