(29 days)
The Stealth 360° Orbital PAD System is a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and who are acceptable candidates for percutaneous transluminal atherectomy.
The OAS supports removal of stenotic material from artificial arteriovenous dialysis fistulae (AV shunt). The OAS is a percutaneous orbital atherectorny system indicated as a therapy in patients with occluded hemodialysis grafts who are acceptable candidates for percutaneous transluminal angioplasty.
The Stealth 360° Orbital PAD System is an orbital atherectomy system (OAS) that is intended for use in the treatment of peripheral arteries and A-V graft (shunt) stenosis.
The OAS provides a method of removing stenotic material from peripheral arteries and A-V grafts. The Stealth 360° uses an electrically driven shaft to apply a diamond coated, eccentrically rotating surface to ablate stenotic material. The stenotic particles that are removed are small enough to be absorbed by the body.
The Stealth 360° Orbital PAD System consists of the following components:
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- Orbital atherectomy device (OAD)
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- Atherectomy guide wire
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- Externally operated saline pump
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- Atherectomy Lubricant (e.g. ViperSlide)
The provided text describes the regulatory clearance of the Stealth 360° Orbital PAD System and mentions performance data used to support its substantial equivalence to a predicate device. However, it does not contain the requested information regarding acceptance criteria, a detailed study proving the device meets those criteria, or specific performance metrics in the format requested.
The submission is for a modification to an existing device where the "crown blanks" will be molded instead of machined. The primary goal of the submission is to demonstrate that this modified device is substantially equivalent to the predicate device (K110389, also the Stealth 360° Orbital PAD System).
Here's an analysis based on the provided text, highlighting what is missing for each requested point:
1. A table of acceptance criteria and the reported device performance
- Missing. The document states that "performance bench testing" was conducted, specifically "Life/Stall Testing" and "Orbit Testing," to confirm performance characteristics compared to the predicate device. However, it does not provide specific acceptance criteria (e.g., "device must operate for X hours without failure") nor report any quantitative device performance metrics from these tests. It only states that the testing "demonstrate[s] that the modified Stealth 360° Orbital PAD System is as safe and effective as the predicate device."
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Missing. No information on sample sizes for any test sets is provided. The tests mentioned ("Life/Stall Testing" and "Orbit Testing") appear to be bench tests, not clinical studies on human subjects. Therefore, data provenance related to human subjects (country, retrospective/prospective) is not applicable or provided.
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)
- Missing. This information is relevant for studies involving expert review or interpretation, typically in diagnostic or imaging devices. This document describes an atherectomy device and physical bench testing, not a study requiring expert ground truth establishment in this manner.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Missing. As above, this is not applicable for the type of bench testing described.
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
- Missing. This type of study is completely unrelated to the device described (an atherectomy system) and the type of testing performed (bench testing for substantial equivalence of a manufacturing change). This question is typically relevant for AI-powered diagnostic tools.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Missing. This is also irrelevant to the device and testing described. The Stealth 360° Orbital PAD System is a mechanical atherectomy device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Missing. For the "Life/Stall Testing" and "Orbit Testing," the "ground truth" would likely be engineering specifications or performance baselines established by the predicate device's performance. However, these specific "ground truths" or benchmarks are not detailed.
8. The sample size for the training set
- Missing. There is no mention of a "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
- Missing. This is also irrelevant as there is no "training set."
In summary, the provided 510(k) summary focuses on demonstrating substantial equivalence through bench testing to a predicate device, primarily to address a manufacturing change (molded vs. machined crown blanks). It does not provide the detailed study results, acceptance criteria, or expert review/AI-related information requested.
§ 870.4875 Intraluminal artery stripper.
(a)
Identification. An intraluminal artery stripper is a device used to perform an endarterectomy (removal of plaque deposits from arterisclerotic arteries.)(b)
Classification. Class II (performance standards).