(62 days)
The Xtrak Support catheter is intended to be used in conjunction with a steerable guidewire in order to access discreet regions of the vasculature.
The Xtrak Support catheter shaft consists of a flexible, distal section made of closely-wound coils, and a stiffer and more torqueable mid-section coupled to a proximal handle through a short length of spiraled strain relief. The distal and mid-shaft sections, and the strain relief are constructed from a continuous length of stainless steel wire to maximize catheter integrity. The catheter is provided in various sizes to accommodate .014" and .018" quidewires.
This 510(k) premarket notification for the Xtrak Support Catheter does not contain information about a study proving the device meets acceptance criteria related to AI/ML performance. The provided document details a traditional medical device submission, focusing on mechanical and biocompatibility testing to demonstrate substantial equivalence to a predicate device.
Therefore, many of the requested categories related to AI/ML performance, ground truth, expert opinions, and sample sizes for AI training and testing, cannot be extracted from this document.
Here's a breakdown of the information that can be extracted and an explanation for the missing information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Type | Acceptance Criteria (from document) | Reported Device Performance (from document) |
|---|---|---|
| Material Safety | Materials suitable for intended use, commonly used in cleared products. | "All materials used...are suitable for their intended use and are used commonly in the manufacture of previously cleared products." |
| Mechanical Performance | Compliance with specifications. | "Test results demonstrate conformance...to their specification requirements." |
| Biocompatibility | Compliance with specifications. | "Test results demonstrate conformance...to their specification requirements." |
| Overall Safety & Effectiveness | "as safe and effective as the legally marketed predicated devices." | "Test results...that the Xtrak Support catheter is as safe and effective as the legally marketed predicated devices." |
2. Sample Size for the Test Set and Data Provenance
- Not Applicable / Not Provided: The document discusses mechanical and biocompatibility testing. These tests typically involve a defined number of physical samples of the device and its components, not data from a "test set" in the context of an AI/ML study. The document does not specify the number of units tested.
- Data Provenance: Not applicable in the context of device performance testing of a physical medical device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not Applicable: This device is a physical medical device (catheter), not an AI/ML diagnostic or prognostic tool. Therefore, "ground truth" in the AI/ML sense, established by medical experts for a dataset, is not relevant to this submission.
4. Adjudication Method for the Test Set
- Not Applicable: As there is no "test set" in the AI/ML context, there is no adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No: The document does not mention any MRMC study. This type of study is typically performed for imaging or diagnostic tools where human readers are involved in interpreting results, which is not the case for a support catheter.
- Effect Size of Human Readers with/without AI: Not applicable, as no AI component is described.
6. Standalone (Algorithm Only) Performance Study
- No: This device is a physical medical instrument. There is no AI algorithm to be evaluated in a standalone manner.
7. Type of Ground Truth Used
- Product Specifications / Industry Standards: For mechanical and biocompatibility testing, the "ground truth" is typically defined by the device's own engineering specifications, relevant ISO standards, and FDA guidance documents for medical devices of this type. It's about meeting pre-defined physical and biological criteria, not clinical outcomes or expert consensus on image interpretation.
8. Sample Size for the Training Set
- Not Applicable: There is no AI/ML component, and therefore no "training set."
9. How the Ground Truth for the Training Set Was Established
- Not Applicable: As there is no training set for an AI/ML model, this question is not relevant.
§ 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).