(27 days)
The Interlock-35 Fibered IDC Occlusion System is indicated for obstructing or reducing blood flow in the peripheral vasculature during embolization procedures. This device is not intended for neurovascular use.
The Interlock - 35 Fibered IDC Occlusion System includes a coil manufactured from platinum-tungsten alloy that is mechanically attached to a coil delivery wire. This assembly is contained within an introducer sheath. The platinum coil contains synthetic fibers for greater thrombogenicity. The Interlock - 35 Fibered IDC Occlusion System is designed to be delivered under fluoroscopy through a 5F (1.70 mm) OD (0.035 in [0.89 mm] or 0.038 in [0.97 mm] inner lumen) Imager™ II Selective Diagnostic Catheter without side flushing holes. The interlocking delivery wire design allows the coil to be advanced and retracted before final placement in the vessel, thus aiding in more controlled delivery including the ability to withdraw the coil prior to deployment.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Interlocking Arm to Delivery Wire Tensile Strength | Met predetermined acceptance criteria |
| Delivery Wire Bend Resistance | Met predetermined acceptance criteria |
| Introducer Sheath Deliverability | Met predetermined acceptance criteria |
| Device Preparation | Met predetermined acceptance criteria |
| Corrosion Resistance | Met predetermined acceptance criteria |
| Device Removal From Carrier Tube | Met predetermined acceptance criteria |
| Sterilization | Met predetermined acceptance criteria |
| Biocompatibility | Met predetermined acceptance criteria |
2. Sample sized used for the test set and the data provenance
The document does not specify the exact sample sizes used for each bench test conducted. It generally states that "The following bench testing was conducted for design elements and performance characteristics deemed appropriate to demonstrate equivalence to the predicate device." It also doesn't mention data provenance in terms of country of origin or whether a test set was retrospective or prospective, as the study described is a series of bench tests rather than a clinical study with patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable to the provided document. The study described involves bench testing of a medical device (Interlock™ -35 Fibered IDC™ Occlusion System) rather than evaluating an AI medical device that requires expert-established ground truth from images or patient data.
4. Adjudication method for the test set
This information is not applicable to the provided document, as the study is bench testing and not a clinical study involving human readers or adjudicators.
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
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done (or at least not reported in this document). The device is a vascular embolization system, not an AI software/device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable. The device is a physical medical device for embolization, not an algorithm or AI system.
7. The type of ground truth used
The "ground truth" for the bench tests would have been the established engineering specifications and performance standards for each test (e.g., minimum tensile strength, maximum bend resistance, etc.). The document states the device "met the predetermined acceptance criteria," indicating these criteria served as the ground truth.
8. The sample size for the training set
This information is not applicable. The device is a physical medical device, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable for the same reason as above.
§ 870.3300 Vascular embolization device.
(a)
Identification. A vascular embolization device is an intravascular implant intended to control hemorrhaging due to aneurysms, certain types of tumors (e.g., nephroma, hepatoma, uterine fibroids), and arteriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in neurovascular applications are also not included in this classification, see § 882.5950 of this chapter.(b)
Classification. Class II (special controls.) The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices.” For availability of this guidance document, see § 870.1(e).