Search Results

The ASAHI PTCA Guide Wire, Fielder J 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, Fielder J shape is steerable guide wire with a maximum diameter of 0.014 inches (0.36mm) and available in 180 cm and 300 cm length. The extension wire is connected to the end of the guide wire outside the body for 180cm 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 available as a pre shape "J" and made flexible to bend easily at the vessel curve. There is polyurethane coating covered with hydrophilic coating applied to the distal section of the guide wire. The proximal section of this guide wire is coated with PTFE.

The provided document describes a medical device, the ASAHI PTCA Guide Wire, Fielder J, and its substantial equivalence to predicate devices, supported by bench testing. However, it does not contain the level of detail requested for a comprehensive description of acceptance criteria and the study proving it.

Based on the provided text, here's what can be extracted and what is missing:

Description of Acceptance Criteria and Study Findings for ASAHI PTCA Guide Wire, Fielder J

The provided 510(k) summary indicates that the ASAHI PTCA Guide Wire, Fielder J demonstrated substantial equivalence to predicate devices through mechanical and functional bench testing. The acceptance criteria are implicitly met by demonstrating that the device "performs as intended" and its "characteristics are substantially equivalent to the specified predicate devices." No specific quantitative acceptance criteria or detailed study results are provided in the summary.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not specified.
• Data Provenance: Not specified, but generally, bench testing data would be generated in a laboratory setting, likely at the manufacturer's location in Japan, or a designated testing facility. This is a retrospective analysis of the device's physical properties.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Number of Experts: Not applicable, as this was mechanical and functional bench testing, not a clinical study involving human assessment.
• Qualifications: Not applicable.

4. Adjudication Method for the Test Set

• Not applicable, as this was mechanical and functional bench testing, not a study requiring adjudication of expert opinions.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned or performed based on the provided document. The submission relies solely on bench testing for substantial equivalence.

6. Standalone (Algorithm Only) Performance

• No, this refers to a medical device (guide wire), not an algorithm or AI. Therefore, standalone algorithm performance is not applicable.

7. Type of Ground Truth Used

• Bench Testing Standards/Specifications: The ground truth for the bench testing would be established by pre-defined engineering and performance specifications and standards for guide wires, which dictate acceptable mechanical and functional properties (e.g., tensile strength, flexibility, lubricity, torque transmission, etc.). Comparison to predicate devices also serves as a "ground truth" for substantial equivalence.

8. Sample Size for the Training Set

• Not applicable. This submission is for a physical medical device (guide wire), not an AI algorithm that would require a training set.

9. How the Ground Truth for the Training Set Was Established

• Not applicable. (See point 8)

Summary of Limitations Based on Provided Text:

The document serves as a 510(k) summary for regulatory clearance, focusing on demonstrating substantial equivalence to predicate devices through bench testing. It does not provide the detailed level of information (e.g., specific quantitative ranges for performance metrics, detailed study protocols, sample sizes for specific tests, or clinical data) that would be present in a comprehensive study report or a publication detailing a clinical trial. The "acceptance criteria" are implied by the claim of functioning as intended and substantial equivalence.

Ask a specific question about this device