(10 days)
The SpideRX™ Embolic Protection Device is indicated for use as an embolic protection system to contain and remove embolic material (thrombus/debris). The device also acts as the guidewire while performing percutaneous transluminal coronary angioplasty or stenting procedures in coronary saphenous vein bypass grafts with reference vessel diameters of 3.0 to 6.0 mm. The safety and effectiveness of this device as an embolic protection system has not been established in the cerebral or peripheral vasculature.
The SpideRX™ Embolic Protection Device is a percutaneously delivered distal embolic protection system that can be delivered over any 0.014" or 0.018" guidewire. The SpideRX Embolic Protection Device contains a Capture Wire composed of a nitinol mesh filter mounted on a convertible 190/320 cm PTFEcoated 0.014" stainless steel wire, and a dual-ended SpideRX Catheter for delivery and recovery.
The provided text is a 510(k) summary for the SpideRX™ Embolic Protection Device. It describes the device, its intended use, and the FDA's substantial equivalence determination. However, the document does not contain information on acceptance criteria, a study proving the device meets those criteria, or any details related to device performance metrics typically found in clinical trials or validation studies.
The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (SpideRX Embolic Protection Device K053195) based on the device description and intended use, particularly the modification to reflect compatibility with drug-eluting stents.
Therefore, I cannot provide the requested table and study details as they are not present in the input text.
To directly answer your numbered points based on the provided text's limitations:
- A table of acceptance criteria and the reported device performance: Not provided in the text.
- Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not provided in the text.
- 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): Not provided in the text.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not provided in the text.
- 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 relevant to this device, as it is a physical medical device (embolic protection system), not an AI-assisted diagnostic tool. No such study information is provided.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not relevant, as this is not an algorithm or AI device. No such study information is provided.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not provided in the text. The 510(k) process for this type of device typically relies on bench testing, animal studies, and clinical data showing safety and effectiveness comparable to a predicate, but specifics are not in this summary.
- The sample size for the training set: Not applicable/not provided. This is a physical device, not a machine learning model.
- How the ground truth for the training set was established: Not applicable/not provided. This is a physical device, not a machine learning model.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).