(141 days)
Courier ST Balloon Dilatation Catheters are recommended for percutaneous transluminal angioplasty of the Iliac, Femoral and Renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
Courier ST Catheters are not indicated for use in coronary arteries or the neurovasculature.
The proposed Courier™ ST Balloon Dilatation catheter is an over-the-wire catheter with three lumens. The Courer™ ST Balloon Dilatation catheters are recommended for percutaneous transluminal angioplasty of the Iliac, Femoral and Renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
The provided document, a 510(k) premarket notification for the Medi-tech Courier™ ST Balloon Dilatation Catheter, describes the acceptance criteria and performance testing conducted. However, it does not contain information typically associated with studies proving device performance against acceptance criteria in the context of diagnostic or AI-assisted devices as outlined in your request.
This document is for a medical device (a balloon dilatation catheter) and focuses on "functional tests" and "biocompatibility tests" rather than diagnostic performance metrics like sensitivity, specificity, or AUC, or studies involving human readers and AI assistance.
Here's an analysis of the provided text in relation to your specific questions:
1. A table of acceptance criteria and the reported device performance
The document lists the types of tests performed, but it does not specify quantitative acceptance criteria (e.g., "Burst pressure > X psi") or the exact numerical results for each test. Instead, it broadly states that "The following in vitro functional tests were performed" and "The following biocompatibility tests were performed."
| Acceptance Criteria Category | Reported Device Performance (as described in the document) |
|---|---|
| In vitro Functional Tests | |
| Balloon Burst Testing | Performed |
| Multiple Inflation Testing | Performed |
| Inflation/Deflation Time Testing | Performed |
| Balloon Compliance Testing | Performed |
| Balloon Proximal Bond Testing | Performed |
| Sheath Withdrawal Testing | Performed |
| Biocompatibility Tests | |
| Intracutaneous Reactivity | Performed |
| Sensitization | Performed |
| Cytotoxicity | Performed |
| Acute Systemic Toxicity | Performed |
| Haemocompatibility | Performed (completed as Hemolysis) |
| Pyrogenicity | Performed |
| Genotoxicity | Performed (completed as Mutagenicity) |
The conclusion states: "Based on the Indications for Use, technological characteristics and safety and performance testing, the Courier® ST Balloon Dilatation Catheter has been shown to be safe and effective for its intended use." This implies the device met the unstated acceptance criteria for these tests.
2. Sample sized used for the test set and the data provenance
The document does not specify sample sizes (e.g., number of catheters tested) for any of the functional or biocompatibility tests. It also does not mention data provenance in terms of country of origin or whether the studies were retrospective or prospective, as these are typically not relevant for in vitro functional and biocompatibility testing of a physical medical device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable to the type of device and testing described. Functional and biocompatibility tests for a balloon catheter do not involve expert interpretation or ground truth establishment in the way diagnostic imaging or AI devices do. The "ground truth" for these tests would be objective measurements (e.g., pressure readings, material analysis).
4. Adjudication method for the test set
Not applicable. There's no human interpretation or subjective assessment that would require an adjudication method.
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 physical medical instrument (a catheter), not a diagnostic AI or imaging device that would involve human readers or AI assistance in a diagnostic capacity.
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 and does not involve an algorithm.
7. The type of ground truth used
For the functional tests, the ground truth would be based on objective physical measurements (e.g., burst pressure, inflation/deflation times, bond strength). For biocompatibility tests, the ground truth would be based on standardized laboratory assays and toxicology principles to assess the material's interaction with biological systems.
8. The sample size for the training set
Not applicable. This device does not use an "algorithm" or a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
In summary, the provided document is a 510(k) summary for a physical medical device, not an AI or diagnostic application. Therefore, many of the questions regarding AI performance criteria, expert adjudication, MRMC studies, and training/test sets are not relevant to the information presented. The document confirms that standard functional and biocompatibility tests were performed and concluded that the device is safe and effective, implying it met the necessary (though unspecified) acceptance criteria for those tests.
§ 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).