(95 days)
The 14 Wire is indicated for general intravascular use to aid in the selective placement of catheters in the peripheral and cerebral vasculature during diagnostic and/or therapeutic procedures. The device is not intended for use in the coronary arteries.
The Guidewire Torque Device is intended to facilitate guidewire manipulation during interventional procedures.
The Guidewire Introducer is intended to facilitate guidewire insertion into a catheter hub or through a hemostasis valve.
The 14 Wire is a stainless steel guidewire with a radiopaque distal segment. The distal portion of the guidewire is hydrophilically coated. Included within the sterile pouch is a torque device to assist in guidewire manipulation and a guidewire introducer to ease the introduction of the guidewire into the catheter hub and/or hemostasis valve.
The provided text describes a 510(k) submission for a medical device (14 Wire Standard Hydrophilic Guidewire & 14 Wire LS Hydrophilic Guidewire). This type of submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing. It does not involve studies demonstrating AI performance against acceptance criteria in the way described in your request (e.g., sample sizes for AI, expert reader studies, MRMC studies, training sets, etc.).
Therefore, I cannot provide the information you requested regarding acceptance criteria and a study proving a device meets those criteria in the context of AI performance for this specific document. The document describes a traditional medical device (a guidewire) and its evaluation through extensive bench testing and biocompatibility assessments, not an AI software component.
Here's a breakdown of why this document doesn't fit your request:
- No AI Component: The device is a physical guidewire, not an AI algorithm or software.
- No "Test Set" or "Training Set": These terms apply to AI/ML model development and validation, which is not relevant here.
- No "Experts" for Ground Truth (in the AI sense): While engineers and scientists evaluated the guidewire performance, this is not analogous to radiologists or pathologists establishing ground truth for AI algorithms.
- No "Acceptance Criteria" for AI Performance Metrics: The "acceptance criteria" for this device would be its performance against engineering specifications (e.g., tensile strength, lubricity), not metrics like sensitivity, specificity, or AUC for an AI model.
The "Non-Clinical Tests" section lists the types of tests performed. These are all bench tests of the physical properties and performance of the guidewire.
However, to directly address the structure of your request, and clarify what is present in the document versus what is not, I will populate the table and subsequent points based on the provided text, indicating "Not Applicable" or explaining the absence of information where appropriate for an AI-centric request.
Acceptance Criteria and Device Performance (Non-AI Context)
The document does not explicitly present a table of quantitative acceptance criteria alongside performance for each test in a pass/fail format. Instead, it lists the types of non-clinical tests performed and then concludes that based on these tests, the device is substantially equivalent to predicates. The "performance" is implicitly deemed acceptable if it meets the standards demonstrated by the predicate devices and overall safety/effectiveness for its intended use.
Here's an interpretation based on the provided text, framed to align with your table request, acknowledging the non-AI nature:
| Acceptance Criteria Category (Implicit) | Reported Device Performance (Implicit) |
|---|---|
| Mechanical Performance | Demonstrated through testing of: |
| Tip Flexibility | (Performance not quantified, but deemed acceptable) |
| Tip Buckling Force | (Performance not quantified, but deemed acceptable) |
| Torque Response | (Performance not quantified, but deemed acceptable) |
| Tip Shapeability | (Performance not quantified, but deemed acceptable) |
| Tip Shape Retention | (Performance not quantified, but deemed acceptable) |
|
| Flexing Test | (Performance not quantified, but deemed acceptable) |
| Kink Resistance | (Performance not quantified, but deemed acceptable) |
| Torque Strength | (Performance not quantified, but deemed acceptable) |
| Tensile Strength | (Performance not quantified, but deemed acceptable) |
| Fracture Test | (Performance not quantified, but deemed acceptable) |
| Material/Coating Performance | Demonstrated through testing of: |
| Coating Adherence | (Performance not quantified, but deemed acceptable) |
| Coating Lubricity | (Performance not quantified, but deemed acceptable) |
| Corrosion Resistance | (Performance not quantified, but deemed acceptable) |
| Physical/Dimensional Characteristics | Demonstrated through: |
| Visual Inspection | (Performance not quantified, but deemed acceptable) |
| Dimensional Inspection | (Performance not quantified, but deemed acceptable)
| Functional Performance | Demonstrated through: |
| Navigation | (Performance not quantified, but deemed acceptable) |
| Biocompatibility | Biocompatibility testing performed. (Performance deemed acceptable) |
| Sterility & Shelf-Life | Shelf-life testing, assessment of bioburden, pyrogen, EtO residuals, and sterility performed. (Performance deemed acceptable) |
1. Sample sizes used for the test set and the data provenance:
- Sample Size (Test Set): Not specified in terms of number of guidewires or test repetitions for each non-clinical test. The document states "extensive bench testing" and "an in vitro design validation study."
- Data Provenance: Not specified (e.g., country of origin). The studies appear to be internal, non-clinical laboratory tests.
- Retrospective or Prospective: Not applicable in the AI/clinical study sense. These are prospective, controlled bench tests and in vitro studies.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable in the context of ground truth for an AI algorithm. The tests were performed by engineers/technicians in a laboratory setting.
- Qualifications of Experts: Not specified. Standard practice for such tests implies qualified engineering and lab personnel.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Adjudication Method: Not applicable. This is a physical device undergoing objective bench testing, not subjective interpretation. Test results would be compared against internal specifications or predicate device performance.
4. 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:
- MRMC Study: No. This is not an AI device.
5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Standalone Study: Not applicable. This is not an AI algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Type of Ground Truth: Not applicable in the AI sense. The "ground truth" for guidewire performance comes from engineering specifications, established scientific principles, and comparison to the performance of legally marketed predicate devices through objective physical measurements.
7. The sample size for the training set:
- Sample Size (Training Set): Not applicable. This is not an AI device.
8. How the ground truth for the training set was established:
- Ground Truth Establishment (Training Set): Not applicable. This is not an AI 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.