(63 days)
The Heavy Double Flexible Tipped Wire Guide is intended to facilitate placement of devices used during diagnostic and interventional procedures.
The Heavy Double Flexible Tipped Wire Guide is constructed of stainless steel coils surrounding a stainless steel mandril. It is a 0.032 inch diameter, 60 cm long wire guide with two flexible tips and four sets of centimeter markings etched at 10 cm intervals along the wire shaft. The device is supplied sterile, packaged within a Tyvek peel pouch.
This document is a 510(k) premarket notification for a medical device called the "Heavy Double Flexible Tipped Wire Guide." It does not describe an AI/ML powered device, therefore the requested information for acceptance criteria and study proving the device meets the criteria is not applicable in the context of AI/ML.
The document discusses various performance tests conducted for the wire guide and states that predetermined acceptance criteria for each test were met. However, it does not provide the specific numerical acceptance criteria or detailed results in a table format as requested for an AI/ML device.
Here's a breakdown of what is available in the document, framed as close as possible to the request, but acknowledging the device type:
Device Type: Medical device (Catheter Guide Wire), not an AI/ML powered device.
1. Table of acceptance criteria and reported device performance:
| Test Name | Acceptance Criterion (General Statement) | Reported Device Performance |
|---|---|---|
| Fracture Testing | No signs of fracture after manipulation (excluding region of fixation and first turn). | Met the predetermined acceptance criterion. |
| Tensile Testing | No sign of loosening of any unions after appropriate force per ISO 11070:1999. | Met the predetermined acceptance criterion. |
| Corrosion Resistance | No signs of corrosion affecting functional performance or biocompatibility. | Met the predetermined acceptance criterion. |
| Flex Testing | No signs of defects or damage after repeated flexing. | Met the predetermined acceptance criterion. |
| Acute Performance Evaluation | Rated as acceptable for normal clinical practice for performance parameters evaluated. | Met the predetermined acceptance criterion. |
| Bubble Leak (Packaging) | No pinholes or imperfect seals (no bubbles from pressurized air leaking). | Met the predetermined acceptance criterion. |
| Seal Strength (Packaging) | Mean seal force exceeds 0.50 lbf. | Met the predetermined acceptance criterion. |
| Biocompatibility Testing | Deemed acceptable per ISO 10993-1:2009 (cytotoxicity, sensitization, irritation/intracutaneous reactivity, systemic toxicity, hemocompatibility). | Deemed acceptable; met the predetermined acceptance criterion. |
Regarding the requested details that are specific to AI/ML studies, none of these are applicable to this document:
- Sample sized used for the test set and the data provenance: Not applicable to a physical device performance study. The "test set" would be the physical samples of the wire guide subjected to the tests.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical device's mechanical and material properties is established through standardized testing procedures and measurements, not expert consensus on interpretations.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): For a physical device, ground truth is based on objective measurements and adherence to specified physical and material properties.
- The sample size for the training set: Not applicable (no "training set" for physical device testing).
- How the ground truth for the training set was established: Not applicable.
In conclusion, this document details the performance testing of a conventional medical device, not an AI/ML product. Therefore, many of the specific questions related to AI/ML acceptance criteria and studies are not relevant. The document states that the device successfully met its predetermined acceptance criteria for various physical and mechanical tests.
§ 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.