(21 days)
The Headway Microcatheter is intended for general intravascular use, including the peripheral, coronary and neuro vasculature for the infusion of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils.
The Headway Microcatheter is a single lumen catheter designed to be introduced over a steerable guidewire to access small, tortuous vasculature. The semi-rigid proximal section transitions to a flexible distal tip to facilitate advancement through vessels. Dual radiopaque markers at the distal end facilitate fluoroscopic visualization. The outer surface of the Microcatheter is coated with a hydrophilic polymer to increase lubricity. A luer fitting on the Microcatheter hub is used for the attachment of accessories.
The provided text describes the 510(k) submission for the Headway 17 Microcatheter, focusing on its substantial equivalence to a predicate device rather than detailing studies with acceptance criteria based on performance metrics like accuracy, sensitivity, or specificity for an AI/device.
Therefore, the information presented does not include the typical elements one would expect when describing the acceptance criteria and a study proving device performance for an AI-powered medical device in the way your prompt requests.
However, I can extract the relevant information from the provided document as it pertains to acceptance criteria for a non-AI medical device (microcatheter) and the study (bench testing) that demonstrated it met those criteria.
Here's the breakdown based on the provided text, structured to align with your request where applicable, but noting the absence of AI-specific elements:
1. A table of acceptance criteria and the reported device performance
For the Headway 17 Microcatheter, the "acceptance criteria" are implied by the "Result" column stating "Met established criteria." The specific quantitative or qualitative criteria for each test are not detailed in this summary but are understood to have been pre-defined and satisfied.
| Bench Testing (Acceptance Criteria Category) | Reported Device Performance (Met Criteria) |
|---|---|
| Separation Force | Met established criteria |
| Unscrewing Torque | Met established criteria |
| Ease of Assembly | Met established criteria |
| Resistance to Overriding | Met established criteria |
| Stress Cracking | Met established criteria |
| Durability/Lubricity of Hydrophilic Coating | Met established criteria |
| Tip Shape and Tip Retention | Met established criteria |
| Simulated Use | Met established criteria |
| Compatibility with Embolic Agents | Met established criteria |
| Dynamic Burst Pressure | Met established criteria |
| Radio-Detectability | Met established criteria |
| Flow Rate | Met established criteria |
| Kink Resistance | Met established criteria |
| Catheter Stiffness | Met established criteria |
| Package Integrity | Met established criteria |
| Catheter Flexural Fatigue | Met established criteria |
| Catheter Particle Measurement | Met established criteria |
| Biocompatibility | Met established criteria |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified in the provided 510(k) summary. These types of bench tests typically use a predefined number of device units or components, but the exact quantity is not disclosed here.
- Data Provenance: The study is "Bench Testing," implying it was conducted in a laboratory setting by the manufacturer (MicroVention, Inc., based in Aliso Viejo, California, U.S.A.). It is prospective in the sense that the tests were performed on newly manufactured devices to demonstrate compliance for regulatory submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not applicable for these types of bench tests. The "ground truth" for mechanical properties, material compatibility, or physical performance in bench tests is typically established through direct measurement, established engineering principles, and validated test methods, rather than expert consensus on medical images or patient data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This concept is not applicable to the bench testing described. Adjudication methods are relevant for studies requiring experts to resolve discrepancies in interpretation, particularly in diagnostic contexts.
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
- No, an MRMC comparative effectiveness study was not done or described. This type of study is specific to evaluating AI's impact on human performance in diagnostic tasks and is not relevant for a microcatheter's physical and mechanical performance evaluation via bench testing.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No, a standalone algorithm performance study was not done or described. The device is a physical microcatheter, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for these bench tests is derived from objective measurements against pre-defined engineering and performance specifications. Examples include:
- Measurement of forces (e.g., separation force).
- Observation of material integrity (e.g., stress cracking).
- Measurement of fluid flow rates.
- Evaluation of biological response in biocompatibility tests.
- Demonstration of compatibility with other agents (e.g., embolic agents).
- Fluoroscopic visualization for radio-detectability.
- Established limits for catheter stiffness and kink resistance.
8. The sample size for the training set
- Not applicable. There is no "training set" as this is a physical medical device, not an AI/machine learning model.
9. How the ground truth for the training set was established
- Not applicable. As there is no training set, this question is not relevant.
In summary, the provided document details the regulatory submission for a physical microcatheter, focusing on its substantial equivalence to a predicate device through bench testing. The evaluation criteria are based on engineering and material performance standards rather than AI-specific metrics.
§ 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).