(135 days)
The Merit Hydrophilic Guide Wire is intended to be used in the peripheral vascular system to facilitate the placement of devices during diagnostic and interventional procedures. These guide wires are not intended for Percutaneous Transluminal Coronary Angioplasty use or for use in the neurovasculature.
The Splashwire Hydrophilic guide wire consists of a nitinol core wire with a ground tapered distal section. A polyurethane jacket which contains tungsten for radiopacity is applied over the core wire and a hydrophilic coating is applied over the polyurethane jacket. The surface of the jacket is uniform with both the distal and proximal ends fully coated. The wire is placed inside a multiple loop flush dispenser, also referred to as a hoop. The dispenser has a flush port which facilitates solution flushing through the hoop to hydrate the guide wire. The wire is placed so that the distal end of the wire comes out of the outer portion of the hoop. A J-straightener is placed on the other end of the hoop to introduce the wire into the catheter. The wire is sold sterile and is a single use device. The subject Splashwire Hydrophilic Guide Wire Line Extensions and the predicate Splashwire Hydrophilic Guide Wire share the device characteristics described above, with the subject guide wire incorporating the following additional modifications:
J-Tip Guide Wires:
The J Tip devices incorporate a distal tip formed into a J shape. These guide wires are provided with a 1.5 mm J Tip.
Long Taper Guide Wires:
The Long Taper Guide Wires incorporate an extended core wire taper length providing enhanced flexibility.
The provided FDA 510(k) clearance letter and summary for the Splashwire Hydrophilic Guide Wire (K251181) outlines the regulatory approval process and demonstrates substantial equivalence to a predicate device (K201595). However, it does not contain the specific information required to address your request regarding acceptance criteria and the detailed study that proves the device meets those criteria, particularly for an AI-enabled medical device.
The document describes a traditional medical device (a guide wire) and the non-clinical bench testing performed to ensure its safety and performance. This typically involves physical and mechanical property tests. It does not refer to AI/ML software, algorithms, or any studies involving human readers or ground truth expert consensus in the way you've outlined.
Therefore, I cannot provide a table of acceptance criteria and reported device performance for an AI-enabled device, nor details on sample sizes, expert ground truth establishment, or multi-reader multi-case studies, as this information is not present in the provided text.
Based on the provided document, the device is a physical medical device (a guide wire), not an AI-enabled one. The acceptance criteria and "study" described are standard bench tests for physical properties, not performance metrics for an AI algorithm.
Here's a breakdown of what can be inferred from the document regarding the device's performance, but it does not align with the parameters of an AI/ML study:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states: "Testing was conducted on the subject Splashwire Hydrophilic Guide Wire in accordance with protocols based on requirements outlined in guidance's and industry standards and these were shown to meet the acceptance criteria that were determined to demonstrate substantial equivalence." And "All test results were comparable to the predicate Splashwire Hydrophilic Guide Wire and the subject Splashwire Hydrophilic Guide Wire met the predetermined acceptance criteria."
While specific numerical acceptance criteria and performance data are not provided in this summary, the document indicates that the following categories of non-clinical bench tests were successfully completed and met their predetermined acceptance criteria:
| Acceptance Criteria Category (Test Type) | Reported Device Performance (Implied) |
|---|---|
| Dimensional Verification | Met predetermined specifications (comparable to predicate) |
| Finished Wire Surface | Met predetermined specifications (comparable to predicate) |
| Tip Tensile Strength | Met predetermined specifications (comparable to predicate) |
| Tip Stiffness | Met predetermined specifications (comparable to predicate) |
| Tip Flexibility | Met predetermined specifications (comparable to predicate) |
| Prolapse Test | Met predetermined specifications (comparable to predicate) |
| Torque Strength | Met predetermined specifications (comparable to predicate) |
| Torqueability | Met predetermined specifications (comparable to predicate) |
| Coating Integrity | Met predetermined specifications (comparable to predicate) |
| Catheter Compatibility | Met predetermined specifications (comparable to predicate) |
| Fracture Test | Met predetermined specifications (comparable to predicate) |
| Flexing Test | Met predetermined specifications (comparable to predicate) |
| Simulated Use Testing | Met predetermined specifications (comparable to predicate) |
| Kink Resistance | Met predetermined specifications (comparable to predicate) |
| Ancillary Device Compatibility | Met predetermined specifications (comparable to predicate) |
2. Sample Size Used for the Test Set and Data Provenance:
This information is not available in the provided document. For a physical medical device, "test set" would refer to the number of units tested for each characteristic. The provenance of the data is not applicable in the context of clinical images or patient data; it would refer to the samples of the manufactured guide wire used for the bench tests. These are likely internal lab tests.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This information is not applicable to this type of device and study. "Ground truth" in this context would be derived from the physical properties of the device measured by laboratory instruments, not expert human interpretation of data.
4. Adjudication Method for the Test Set:
This information is not applicable as there are no human interpretations or adjudications involved in the physical bench tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
This information is not applicable. MRMC studies are relevant for software that aids human interpretation (e.g., AI for radiology). This device is a physical guide wire.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This information is not applicable. This describes the performance of a physical device, not an algorithm.
7. The Type of Ground Truth Used:
The "ground truth" for this device is based on measurements of its physical and mechanical properties according to established industry standards and FDA guidance for guide wires (e.g., ISO standards, FDA guidance on guidewire performance). It's not expert consensus, pathology, or outcomes data.
8. The Sample Size for the Training Set:
This information is not applicable. This device is not an AI/ML algorithm that requires a training set. The "design controls" mentioned refer to the engineering and manufacturing process, not data training.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable as there is no training set for a physical device.
In summary, the provided document details the 510(k) clearance for a physical medical device (Premarket Notification: K251181) and its substantial equivalence based on standard bench testing. It does not provide information relevant to the assessment of an AI-enabled medical 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.