(20 days)
The Traxcess 0.014" Hydrophilic Guidewire is intended for general intravascular use, including the neuro and peripheral vasculature. The wire can be steered to facilitate the selective placement of diagnostic or therapeutic catheters. This device is not intended for use in coronary arteries.
The Traxcess 0.014" Hydrophilic Guidewire consists of a 0.014" stainless steel shaft and a tapered nitinol tip contained within 0.012" platinum and stainless steel coils. The distal coil section contains a lubricious hydrophilic coating, and the proximal shaft section is coated with PTFE. The Guidewire is available in a variety of coil tip and overall lengths to suit the needs of the clinician.
The provided text describes a 510(k) premarket notification for the Traxcess 0.014" Hydrophilic Guidewire. This type of submission relies on demonstrating substantial equivalence to a predicate device, rather than conducting new clinical studies to prove effectiveness or establish acceptance criteria based on new performance metrics.
Therefore, the information requested in your prompt (acceptance criteria, study details, sample sizes, ground truth, etc.) is not typically part of a 510(k) submission for a guidewire device, as it is not an AI/ML driven device and does not involve diagnostic performance metrics.
Instead, the documentation focuses on:
- Nonclinical Testing: Physical tests to characterize tensile strength, torque strength, torqueability, tip flexibility, coatings, biocompatibility, and catheter compatibility.
- Animal Testing: Performed to confirm guidewire performance.
- Substantial Equivalence: The primary "proof" is that the device's technical and performance attributes are substantially equivalent to cited predicate guidewires (Runthrough NS, Transend EX Platinum Guidewire, Radifocus Glidewire GT with Gold Coil).
To directly answer your questions based only on the provided text, and acknowledging that these questions are more relevant to AI/ML or diagnostic devices:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Reported Device Performance (Summary from Nonclinical Testing) |
|---|---|
| Tensile Strength | Suitable for its intended use |
| Torque Strength | Suitable for its intended use |
| Torqueability | Suitable for its intended use |
| Tip Flexibility | Suitable for its intended use |
| Coatings (Hydrophilic/PTFE) | Suitable for its intended use (lubricity as described) |
| Biocompatibility | Suitable for its intended use |
| Catheter Compatibility | Suitable for its intended use |
| Guidewire Performance | Confirmed via animal testing to be suitable for its intended use |
Note: The document does not provide specific numerical acceptance criteria or performance values for these categories. It only states that the performance was "suitable for its intended use" and confirmed through testing.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: Not specified for physical or animal testing.
- Data Provenance: Not specified, but generally, device manufacturers conduct such tests in-house or through contract labs, typically within the country of manufacture or relevant regulatory jurisdiction. These are prospective tests conducted specifically for the device submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Number of Experts: Not applicable. For physical and animal testing of a guidewire, "ground truth" is established through engineering and scientific measurements and observations, not expert consensus in the diagnostic sense. Animal studies involve veterinarians and other scientific personnel, but they are assessing physiological responses and device function, not diagnostic interpretations.
- Qualifications of Experts: Not specified.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable. Adjudication methods like 2+1 or 3+1 are used for human interpretation of diagnostic images or data. Physical and animal testing results are typically evaluated against pre-defined engineering specifications or observed physiological outcomes.
5. 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, an MRMC study was not done. This device is a medical instrument (guidewire), not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: For nonclinical testing, the "ground truth" would be the direct physical measurements (e.g., force, length, torque values) and visual inspection against engineering specifications. For animal testing, it would be the observed physiological outcomes, successful navigation, and pathological assessment of tissues post-procedure, as observed and recorded by scientific personnel.
8. The sample size for the training set
- Training Set Sample Size: Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
- Ground truth for Training Set: Not applicable. This device is not an AI/ML algorithm.
In summary: The provided document is for a conventional guidewire device seeking 510(k) clearance based on substantial equivalence. The questions posed are primarily relevant to AI/ML or diagnostic devices that require clinical performance studies and ground truth establishment, which are not detailed or required in this specific 510(k) summary.
§ 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.