(30 days)
To facilitate the placement of ballon dilation Catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). The Asahi PTCA Guide Wire, J Shape series is not to be used in the cerebral vasculature.
The Asahi PTCA Guide Wire, ] Shape series is steerable guide wire with a maximum diameter of 0.014" and available in 180 cm and 300 cm length. The extension wire is connected to the end of the guide wire ourside the body. The wire is constructed from a stainless steel core with varying core lengths and diameter for each design. The core wre and coil are soldered, for some items welding is used for up parts instead of soldering. The distal end of the guide wire has a radiopaque up that is available as a pre shaped ""[" and is made soft to easily bend with the vessel curve. The coanng (hydrophilic and silicone) is applied to the distal portion of the wire guide wire. The proximal section of the guide wire is coated with PTFE. H on the product code indicates hydrophilic coating, and J indicates pre shaped "J" tip of the guide wire.
The provided text describes a 510(k) premarket notification for the Asahi PTCA Guide Wire, J Shape series, and focuses on establishing substantial equivalence to predicate devices, rather than a study proving specific acceptance criteria for a new AI/software device. Therefore, much of the requested information (like AI-specific criteria, sample sizes for test/training sets for AI, expert adjudication, MRMC studies, standalone performance, and ground truth for AI) is not applicable or present in this document.
However, I can extract the relevant information regarding the device's acceptance criteria and the study performed, framed within the context of a medical device submission:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Bench Testing | Met acceptance criteria |
| Biocompatibility Testing | Met acceptance criteria |
| Performance Similarity | Performed similarly to predicate devices |
Explanation: The document states that "Bench and biocompatibility testing were conducted according to the recommendations from relevant FDA guidance to demonstrate that the Asahi PTCA Guide Wire, J Shape series met the acceptance criteria and performed similarly to the predicate devices." It also explicitly mentions that "No new safety or effectiveness issues were raised during the testing."
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. The document refers to "bench and biocompatibility testing" but does not specify the sample sizes used for these tests or the data provenance (e.g., country of origin, retrospective/prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable as the document describes a physical medical device (guide wire) and its performance, not an AI/software device requiring expert-established ground truth for a test set.
4. Adjudication Method for the Test Set
This information is not applicable as the document describes a physical medical device and its performance, not an AI/software device requiring an adjudication method for a test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its Effect Size
This information is not applicable as the document describes a physical medical device and its performance, not an AI/software device that would typically undergo an MRMC study.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done
This information is not applicable as the document describes a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the device's performance was established through bench testing (evaluating physical properties and functions against predefined specifications) and biocompatibility testing (evaluating biological safety according to established standards). These tests inherently define the "truth" of whether the device meets its design and safety requirements.
8. The Sample Size for the Training Set
This information is not applicable as the document describes a physical medical device, not an AI/software device that requires a training set.
9. How the Ground Truth for the Training Set was Established
This information is not applicable as the document describes a physical medical device, not an AI/software device that requires a training set and its associated ground truth establishment.
§ 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.