(44 days)
Intended for use in small vessel or superselective anatomy for diagnostic and interventional procedures including peripheral use.
The Cxi Support Catheter consists of a 2.6 French catheter with hydrophilic coating. The catheter includes four (4) radiopaque markers to assist in fluoroscopic visualization of the catheter during use. The inner diameter allows acceptance of a 0.018-inch (0.45mm) wire guide. The catheter is available in two lengths, 90 and 150 cm, with a straight or angled distal tip.
The provided text is a 510(k) Premarket Notification for the Cxi Support Catheter. It describes the device, its intended use, and its substantial equivalence to predicate devices, but does not describe an AI/ML powered device, an algorithm, or a study involving human readers or expert ground truthing.
Therefore, I cannot provide information on:
- Acceptance criteria for an AI/ML device or its reported performance. The "acceptance criteria" discussed in the document refer to design verification tests for a physical medical catheter.
- Sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC comparative effectiveness study, standalone performance, type of ground truth for an AI/ML device. These concepts are not applicable to the physical catheter described.
- Sample size for training set or how ground truth was established for a training set. Again, these relate to AI/ML development, which is not the subject of this document.
However, I can extract the information relevant to the medical device (Cxi Support Catheter) as presented in the document, which pertains to its physical and functional characteristics.
Here's the relevant information from the document regarding the device's testing:
1. Table of Acceptance Criteria (Test Performed) and Reported Device Performance (Implied as "Met")
The document lists the tests performed, implying that the device met the requirements for these tests to assure reliable design and performance. Specific numerical acceptance criteria or detailed performance metrics are not provided in this summary.
| Test Category | Specific Test Performed | Reported Device Performance |
|---|---|---|
| Performance Testing | Freedom of Leakage | "assure reliable design and performance" (implies met criteria) |
| Performance Testing | Burst Pressure | "assure reliable design and performance" (implies met criteria) |
| Performance Testing | Tensile Strength | "assure reliable design and performance" (implies met criteria) |
| Performance Testing | Bending | "assure reliable design and performance" (implies met criteria) |
| Performance Testing | Flow Rate | "assure reliable design and performance" (implies met criteria) |
| Biocompatibility | Biocompatibility | "assure reliable design and performance" (implies met criteria) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the sample size used for any of the listed tests.
- Data Provenance: The tests were conducted by Cook Incorporated. The document does not specify the country of origin of the data beyond that it was generated internally by the manufacturer for regulatory submission in the USA. These appear to be retrospective tests conducted on manufactured product samples.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This concept is not applicable. The tests performed are engineering and biocompatibility tests on a physical device, not interpretative tasks requiring expert consensus for ground truth.
4. Adjudication Method for the Test Set
This concept is not applicable. Adjudication is typically for interpretative clinical data, not for objective engineering or material property tests.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance, not for a physical catheter.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not applicable. The device is a physical catheter, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the tests involved engineering specifications, material standards, and possibly biological safety standards. For example:
- Freedom of Leakage, Burst Pressure, Tensile Strength, Bending, Flow Rate: These would be compared against pre-defined engineering design specifications and performance limits.
- Biocompatibility: This would be assessed against recognized biocompatibility standards (e.g., ISO 10993 series), potentially using in vitro or in vivo testing to determine lack of toxicity, irritation, etc.
8. The Sample Size for the Training Set
This concept is not applicable. There is no AI/ML model or "training set" for a physical catheter.
9. How the Ground Truth for the Training Set was Established
This concept is not applicable.
§ 870.1210 Continuous flush catheter.
(a)
Identification. A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.(b)
Classification. Class II (performance standards).