(35 days)
The ASAHI Astato XS 20 Peripheral 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 Astato XS 20 Peripheral Guide Wire is a steerable guide wire with a maximum diameter of 0.014 inches (0.36mm) and available in 180 cm and 300 cm length. The quide wire is constructed from a stainless steel core wire with platinumnickel coil. The coil part (distal end) of the guide wire is radiopaque to achieve visibility. The distal end of the coil part is a straight configuration and is easily bendable with the vessel curvature. A hydrophilic coating is applied to the coil part (distal portion) of the guide wire. The proximal section of the guide wire is coated with PTFE, and the PTFE in the proximal coating is available in two types - PTFE type I and type II.
The provided text describes a 510(k) summary for the ASAHI Astato XS 20 Peripheral Guide Wire, which focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria for AI/ML device functionalities. Therefore, most of the requested information regarding acceptance criteria, study type (MRMC, standalone), ground truth, and sample sizes for training/test sets is not applicable or cannot be extracted from this document, as it pertains to a traditional medical device submission for a physical guide wire, not an AI/ML product.
However, I can extract information relevant to the device's performance demonstration for its 510(k) clearance.
Here's a breakdown of the available information based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not specify quantitative acceptance criteria with numerical targets. Instead, it refers to "predetermined performance criteria" and lists the types of tests conducted. The "reported device performance" is a general statement that the device "meets all predetermined performance criteria."
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Tensile Strength | Met predetermined performance criteria |
| Turns to Failure (Torque Strength) | Met predetermined performance criteria |
| Torqueability (Torque Response) | Met predetermined performance criteria |
| Tip Flexibility | Met predetermined performance criteria |
| Coating Adhesion | Met predetermined performance criteria |
| Slipping Ability of Guide Wire in PTA Balloon Catheter | Met predetermined performance criteria |
| Particulate testing | Met predetermined performance criteria |
| Biocompatibility (Systemic Toxicity, Hemolysis, etc.) | Met predetermined performance criteria and proven biocompatible |
2. Sample Size Used for the Test Set and Data Provenance
The document states that "in vitro bench testing and shelf-life testing" were conducted. However, it does not specify the sample size for these tests. Data provenance (country of origin, retrospective/prospective) is not applicable or mentioned, as the tests are "in vitro bench testing" rather than clinical trials with patient data.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. This is a physical device, and its performance was assessed through engineering bench tests and biocompatibility studies, not by expert interpretation of data or images.
4. Adjudication Method for the Test Set
Not applicable, as no expert adjudication was involved in the "in vitro bench testing."
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This is a traditional device submission, not an AI/ML device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical guide wire, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the performance tests would be the established engineering specifications and biocompatibility standards relevant to guide wires. For example, a certain tensile strength value would be the "ground truth" against which the device's measured tensile strength is compared. The document states that the components "have a long history of use in medical devices and are proven to be biocompatible."
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI/ML product that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set for this type of device.
§ 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.