(28 days)
The ASAHI PTCA Guide Wire, X-treme is intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). The Asahi PTCA Guide Wires are not to be used in the cerebral blood vessel.
The Asahi PTCA Guide Wire, X-treme is a steerable guide wire with a maximum diameter of 0.014 inches (0.36mm) and available in 190 cm and 300 cm length. The extension wire is connected to the end of the guide wire outside the body for 190cm wire. The wire is constructed from a stainless steel core wire. The core wire and coil are soldered. The distal tip of the guide wire has a radiopaque tip to achieve visibility, and is made of soft to easy bend with the vessel curve, and is available with a straight tip. There is polyurethane coating covered with hydrophilic coating applied to the distal section of the guide wire and dimethylpolysiloxane (silicone oil – not contacting blood) is applied to gape space in spring-coil in the tip part. The proximal section of this guide wire is coated with PTFE.
The provided text describes a 510(k) summary for the Asahi PTCA Guide Wire, X-treme. However, it does not contain the detailed information typically associated with acceptance criteria and a study that proves a device meets those criteria, especially for AI/ML-driven devices.
The document pertains to a medical device (a guide wire) that is explicitly stated to not be an AI/ML device. The "Performance Data" section briefly mentions "mechanical and functional bench testing that demonstrates that the ASAHI PTCA Guide Wire, X-treme performs as intended." This indicates that the safety and effectiveness were demonstrated through bench tests, not through clinical studies involving human or AI-assisted performance metrics.
Therefore, most of the requested information regarding acceptance criteria, sample sizes for test/training sets, expert adjudication, MRMC studies, standalone performance, and ground truth establishment is not present in this document as it is specific to AI/ML device evaluations.
Here's a breakdown of what can be extracted or inferred from the provided text, and what cannot:
1. A table of acceptance criteria and the reported device performance
The document states: "This 510(k) notice includes mechanical and functional bench testing that demonstrates that the ASAHI PTCA Guide Wire, X-treme performs as intended." It also claims: "The ASAHI PTCA Guide Wire, X-treme is of the same materials as the predicate devices. The dimensional specifications and design of the device ensures compatibility for the intended use."
However, specific numerical acceptance criteria (e.g., tensile strength greater than X, friction coefficient less than Y) and the corresponding measured performance values are not provided in this summary. The "summary/conclusion" states the device "functions as intended" and is "substantially equivalent" to predicate devices, implying it met the criteria, but the criteria themselves are not listed.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in this document (e.g., tensile strength, flexibility, lubricity, torqueability, tip deflection.) | "Performs as intended" based on mechanical and functional bench testing. |
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. The testing was "mechanical and functional bench testing," which would involve physical samples of the guide wire, but the number of samples tested is not stated.
- Data Provenance: Not applicable in the context of clinical data provenance. The testing was conducted by Asahi Intecc Co., Ltd. (Japan).
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 as this is a physical medical device, not an AI/ML diagnostic tool requiring expert ground truth for interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- 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. This is not an AI/ML diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For mechanical/functional bench testing, the "ground truth" would be established engineering specifications, standards (e.g., ISO for medical devices), or predicate device performance characteristics. No expert consensus, pathology, or outcomes data is relevant for this type of device testing.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device that undergoes training.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/ML device that undergoes training.
§ 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.