(84 days)
The ASAHI Treasure guide wire is intended to facilitate the placement and exchange of diagnostic and therapeutic devices during intravascular procedures. This device is intended for peripheral vascular use only.
The Asahi Treasure peripheral guide wire is a steerable guide wire with a diameter of 0.018" and available in 180 cm and 300 cm lengths. The extension wire is connected to the end of the guide wire outside the body for 180 cm wire. The wire is constructed from a stainless steel core wire with spring. The core wire and coil are soldered together. The distal nod of the guide wire has a radiopaque tip that is straight and is soft to easily bend with the vessel curve. The hydrophilic coating is applied to the distal portion of the guide wire. The proximal section of the guide wire is coated with PTFE.
This is a medical device 510(k) summary for a guide wire, not an AI/ML device. Therefore, the requested information regarding acceptance criteria, study details, ground truth, and AI/ML specific performance metrics is not available in the provided text. The submission focuses on substantial equivalence to predicate devices based on materials, dimensional specifications, and bench testing.
Here's an analysis of what is provided, in relation to your questions, and why AI/ML specific information is absent:
1. A table of acceptance criteria and the reported device performance
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Acceptance Criteria: Not explicitly stated as a table with numerical targets. Instead, the acceptance is based on demonstrating "substantial equivalence" to predicate devices and performing "as intended" through bench testing.
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Reported Device Performance: The document states:
- "The ASAHI Treasure guide wire is made of the same materials that have been used in other predicate devices that are labeled for the similar indications."
- "The dimensional specifications are equivalent to those listed for the currently cleared predicate devices."
- "mechanical and functional bench testing that demonstrates that the ASAHI Treasure guide wire performs as intended."
- "Bench testing demonstrates that the device functions as intended."
Table (Reconstructed from text, but not explicit in the document):
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Material Composition | Same materials as predicate devices with similar indications, proven biocompatible. |
| Dimensional Specifications | Equivalent to cleared predicate devices. (0.018" diameter, 180cm/300cm lengths mentioned in description) |
| Functional Performance (Bench Testing) | Functions as intended (details of specific tests or quantitative results are not provided in this summary, only the conclusion that it performs). |
| Biocompatibility | Components have a long history of use and are proven biocompatible. |
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. The study is described as "mechanical and functional bench testing" which typically involves laboratory testing of physical samples of the device itself, rather than data from human patients. Therefore, concepts like data provenance or retrospective/prospective don't apply in the same way.
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. "Ground truth" in the context of this device's evaluation would refer to the established performance standards or safety profiles against which the bench test results are compared. There is no mention of experts establishing a "ground truth" for the test set, as this is a physical device evaluation, not an image analysis or diagnostic AI tool.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods are relevant for studies involving human interpretation (e.g., radiologists reviewing images). This document describes bench testing, which is objective and mechanistic.
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 is not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For this type of device, the "ground truth" is implicitly defined by the regulatory standards and the performance of the legally marketed predicate devices. The device is being evaluated against established engineering specifications and historical performance of similar devices. There is no mention of "expert consensus," "pathology," or "outcomes data" being used as ground truth for its performance.
8. The sample size for the training set
- Not applicable. This is not an AI device, so there is no "training set."
9. How the ground truth for the training set was established
- Not applicable. This is not an AI device, so there is no "training set."
Summary of why AI/ML specific information is absent:
The document describes a conventional medical device (a guide wire) seeking 510(k) clearance based on "substantial equivalence" to existing predicate devices. This regulatory pathway primarily focuses on comparing material composition, dimensional specifications, and fundamental functional performance through bench testing. It does not involve AI/ML technology, imaging analysis, or diagnostic capabilities that would necessitate the study design and evaluation metrics typically associated with AI/ML device submissions.
§ 870.1330 Catheter guide wire.
(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.