(29 days)
The Modified Concentric Microcatheter is indicated for use in the selective placement of fluids and/or other devices or agents into the peripheral, coronary and neuro vasculature during diagnostic and/or therapeutic procedures.
The Modified Concentric Microcatheter consists of a single lumen, braided, variable stiffness shaft with a radiopaque marker on the distal end and a luer hub on the proximal end. The catheter shaft has a hydrophilic coating to reduce friction during use.
The provided text, K091961, is a 510(k) summary for a medical device called the "Modified Concentric Microcatheter." This document is a premarket notification to the FDA for a modified version of an already cleared device.
Crucially, this type of 510(k) submission (specifically a "Special 510(k): Device Modification") and the information provided within it are primarily focused on demonstrating substantial equivalence to a predicate device, rather than detailed performance studies with acceptance criteria, ground truth, or human reader studies typically associated with AI/ML device evaluations.
Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes for test/training sets, expert involvement, and ground truth types is not applicable or present in this document. The document specifically states: "The results of verification and validation conducted on the Modified Concentric Microcatheter demonstrate that it performs as designed, is suitable for its intended use and is substantially equivalent to the predicate device." This indicates that the "study" conducted was a series of engineering verification and validation tests, not a clinical performance study with human subjects or experts establishing ground truth in the way described in your request.
Here's a breakdown of what can be extracted from the provided text, and where information is missing or not applicable:
1. A table of acceptance criteria and the reported device performance
- Not explicitly stated in the provided text. The document states that "The results of verification and validation conducted on the Modified Concentric Microcatheter demonstrate that it performs as designed, is suitable for its intended use and is substantially equivalent to the predicate device."
- For a medical device like a microcatheter, acceptance criteria would typically relate to physical and mechanical properties (e.g., burst pressure, tensile strength, lubricity, steerability, trackability, radiopacity, dimensions) and biocompatibility. The document implies these tests were performed and met success criteria but does not detail them.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable/Not provided. This device is a physical medical instrument, not an AI/ML algorithm that processes data. The "test set" would refer to the number of microcatheters or components tested in engineering verification and validation, which is not specified.
- "Data provenance" in the context of clinical data for AI is not relevant here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable/Not provided. As this is a physical device, ground truth for its performance would be established through engineering measurements and established medical device testing standards, not by human experts adjudicating clinical cases.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided. Adjudication methods are relevant for subjective interpretations (like medical images) where expert consensus establishes ground truth. For objective physical device performance, this is not applicable.
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/No evidence. This is a physical medical device, not an AI/ML diagnostic or assistive tool for human readers. Therefore, an MRMC study is not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable/No evidence. This is a physical medical device. There is no algorithm involved in its direct function.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not explicitly stated, but implied to be engineering and performance specifications. Given the nature of a microcatheter, ground truth would be based on:
- Engineering specifications: Conformance to dimensional tolerances, material properties.
- Pre-defined performance criteria: E.g., ability to navigate a tortuous path, resistance to kinking, lubricity, burst pressure, tensile strength.
- Biocompatibility testing results: Adherence to ISO standards for material safety.
8. The sample size for the training set
- Not applicable/Not provided. This is a physical medical device, not an AI/ML algorithm. There is no concept of a "training set" for its development in the context of this 510(k).
9. How the ground truth for the training set was established
- Not applicable/Not provided. As there is no training set for an AI/ML model, this question is not relevant.
In summary, the K091961 document details a 510(k) submission for a modification to a physical medical device (microcatheter). The "study" mentioned refers to engineering verification and validation tests to ensure the modified device meets its design specifications and remains substantially equivalent to a predicate device. It does not involve AI/ML performance evaluation, expert ground truth establishment for clinical data, or human reader studies. Therefore, most of the specific questions asked, which are highly relevant to AI/ML device submissions, are not applicable to this particular document.
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).