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510(k) Data Aggregation
(260 days)
STRIDE MICROCATHETER
The ASAHI Stride Microcatheter is intended to provide support to facilitate the placement of guide wires in the coronary and peripheral vasculature and can be used to exchange one guidewire for another. The Asahi Stride Microcatheter is also intended to assist in the delivery of diagnostic agents, such as contrast media and therapeutic agents, such as occlusion coils into the coronary and peripheral vasculature.
Asahi Stride Microcatheter consists of catheter (soft tip tube and shaft tube), protector tube, strain relief, hub connector, and radiopaque marker in the soft tip tube. The proximal shaft is reinforced with a stainless steel braid wire to enhance pushability. The device is provided in a 2.2 Fr size with lengths ranging from 105 cm to 150 cm. The device also comes with both straight and angled tips.
The provided text describes a 510(k) premarket notification for the Asahi Stride Microcatheter. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive clinical studies to establish novel performance criteria or improvements with AI.
Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/ML device are not applicable to this submission. The document emphasizes bench testing and biocompatibility testing to show the device performs as intended and is safe, focusing on equivalence to existing devices.
Here's an analysis based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria with reported device performance in the way one might expect for a new AI-powered diagnostic tool. Instead, it refers to:
| Area of Performance | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Technical Characteristics | Equivalent to predicate devices; made of similar materials. | "made of the same materials that have been used in other predicate devices" and "dimensional specifications are equivalent to those listed for the currently cleared predicate devices." |
| Biocompatibility | Safe for patient contact (non-toxic, non-irritating, etc.). | "All components that come in direct contact with the patient have a long history of use in medical devices and are proven to be biocompatible for use in the vasculature." and "submission contains biocompatibility testing conducted on the subject device." |
| Mechanical & Functional Bench Testing | Performs as intended (e.g., pushability, deliverability, ability to facilitate guidewire placement and deliver agents). | "mechanical and functional bench testing that demonstrates that the ASAHI Stride Microcatheter performs as intended." |
| Overall Equivalence | Substantially equivalent to predicate devices for stated indications. | "The ASAHI Stride Microcatheter characteristics are substantially equivalent to the specified predicate devices and other currently marketed devices for the same indication for use." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document as it refers to bench and biocompatibility testing, not clinical studies with "test sets" in the context of an AI/ML device.
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)
This information is not provided and is not applicable to the type of testing described (bench and biocompatibility).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided and 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
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic devices, which is not the nature of the Stride Microcatheter.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as the Stride Microcatheter is a physical medical device, not a standalone algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the biocompatibility testing, the "ground truth" would be established by scientific standards for material safety and patient interaction. For mechanical and functional bench testing, the "ground truth" would be established by engineering specifications and performance benchmarks against predicate devices, based on objective physical measurements.
8. The sample size for the training set
This information is not provided and is not applicable.
9. How the ground truth for the training set was established
This information is not provided and is not applicable.
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