(67 days)
The ILT Advancing Mechanism is indicated for use with a guide wire in order to access discreet regions of the vasculature. Once the region has been accessed, the Advancing Mechanism can incrementally advance the guide wire.
The ILT Advancing Mechanism is a detachable handle with a distal luer fitting that can be mated with percutaneous catheters. It is designed to be used in conjunction with percutaneous catheters and steerable guide wires to gain access to locations within the cardiovascular structure that are remote from the site of the insertion. Once accessed, the Advancing Mechanism can incrementally advance or retract the steerable guide wire in an occlusion.
The Advancing Mechanism is approximately five inches in length and can be operated with one hand. When the Advancing Mechanism is engaged, each click of the handle advances or retracts the quide wire an average of 0.26 ± 0.05mm. This mechanism can be disengaged (bypassed) for free movement of the quide wire within the attached catheter.
The ILT Advancing Mechanism is packaged in a Tyvek®/mylar pouch that is heatsealed to form a sterile barrier. The packaged units are sterilized with ethylene oxide gas. The device is provided "STERILE", "Non-Pyrogenic" and is intended for single use only.
The provided document describes the ILT Advancing Mechanism, a medical device for incrementally advancing or retracting a guidewire within the cardiovascular system.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state formal acceptance criteria in a table format. However, it implicitly defines a key performance characteristic:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Incremental advance/retraction of guidewire | Each click advances or retracts the guidewire an average of 0.26 ± 0.05 mm |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document mentions "Performance test results indicate that the device satisfies functional performance requirements when used as indicated." and "in vivo bench studies."
- Sample size: Not specified.
- Data provenance: Not specified, but likely from internal testing at IntraLuminal Therapeutics, Inc. (Carlsbad, CA, USA). The studies appear to be prospective bench studies rather than clinical trials with human subjects for performance evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is a mechanical accessory, not an AI or diagnostic device that requires expert ground truth for image interpretation or diagnosis. The ground truth for its performance would be direct physical measurements (e.g., using calipers or an optical measurement system to quantify guidewire movement per click).
4. Adjudication method for the test set
Not applicable, as expert adjudication is not relevant for the performance testing of this mechanical device.
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
Not applicable. This is a medical device, not an AI system or diagnostic tool for image analysis.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a mechanical device, not an algorithm. The performance described (0.26 ± 0.05 mm per click) is inherently a standalone performance metric of the device itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the device's main performance characteristic (incremental movement) would be based on physical measurement standards. For example, precise physical measurement instruments would be used to quantify the distance the guidewire moves with each "click" of the advancing mechanism.
8. The sample size for the training set
Not applicable. This is a mechanical device, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable due to the reasons stated above.
§ 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.