(63 days)
The Diamondback 360 Peripheral Orbital Atherectomy 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 Diamondback 360 Peripheral Orbital Atherectomy System (OAS) 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 Diamondback 360 uses an eccentrically rotating sanding surface (crown) to remove stenotic material on the vessel wall. The stenotic particles that are removed are small enough to be absorbed by the body.
The Diamondback 360 Peripheral Orbital Atherectomy System consists of the following components:
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- Orbital Atherectomy Device (OAD)
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- Atherectomy Guide Wire (e.g., ViperWire Advance)
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- Saline Infusion Pump (SIP)
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- Atherectomy Lubricant (e.g., ViperSlide)
The provided text is a 510(k) Summary for a medical device and does not contain the detailed information typically found in a clinical study report. Therefore, I cannot fully answer all aspects of your request as the information is not present in the document.
However, I can extract the available information regarding acceptance criteria and the type of evaluation performed.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document states that the device was evaluated using performance bench testing and that "All test results demonstrate that the materials chosen, the manufacturing process, and the design utilized for the Diamondback 360 Peripheral Orbital Atherectomy System met the established specifications necessary for consistent performance during its intended use." It also states, "The Diamondback 360 Peripheral Orbital Atherectomy System met all predetermined acceptance criteria of design verification and validation testing as specified by applicable standards, test protocols, and/or customer inputs."
However, the specific numerical acceptance criteria for each test and the corresponding reported performance values are not provided in this summary.
Here's a table summarizing the tests performed, as listed in the document, and the general statement of performance:
| Test Name | Acceptance Criteria (Not detailed in document) | Reported Device Performance |
|---|---|---|
| System Life Testing D | Established specifications for consistent performance | Met established specifications and predetermined acceptance criteria |
| Stall Testing | Established specifications for consistent performance | Met established specifications and predetermined acceptance criteria |
| Introducer Compatibility Testing | Established specifications for consistent performance | Met established specifications and predetermined acceptance criteria |
| Contrast Injection Testing | Established specifications for consistent performance | Met established specifications and predetermined acceptance criteria |
| Temperature Testing | Established specifications for consistent performance | Met established specifications and predetermined acceptance criteria |
| Tensile Testing | Established specifications for consistent performance | Met established specifications and predetermined acceptance criteria |
| Flexibility Testing | Established specifications for consistent performance | Met established specifications and predetermined acceptance criteria |
| Delivered Torque Testing | Established specifications for consistent performance | Met established specifications and predetermined acceptance criteria |
| Orbit Testing | Established specifications for consistent performance | Met established specifications and predetermined acceptance criteria |
| Flow Testing | Established specifications for consistent performance | Met established specifications and predetermined acceptance criteria |
| Track Testing | Established specifications for consistent performance | Met established specifications and predetermined acceptance criteria |
| Packaging/Simulated Distribution Testing | Established specifications for consistent performance | Met established specifications and predetermined acceptance criteria |
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 describes bench testing, not human clinical studies. Therefore, concepts like "test set sample size" in the context of human data, country of origin, or retrospective/prospective study design are not applicable and not provided. The "sample size" would refer to the number of devices or components tested during the bench tests, which is not specified.
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)
This information is not applicable and not provided. The evaluation involved bench testing against established engineering specifications, not expert interpretation of medical data where "ground truth" is established by medical professionals.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided. Adjudication methods are relevant in clinical studies where expert consensus is needed.
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
This information is not applicable and not provided. This summary describes a physical medical device (orbital atherectomy system) and its mechanical performance through bench testing, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable and not provided. This is for a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the bench testing, the "ground truth" would be the established engineering specifications, standards, and test protocols.
8. The sample size for the training set
This information is not applicable and not provided. As this is a physical device undergoing bench testing, there is no "training set" in the context of machine learning or AI models. The design and manufacturing processes are iterative, but a formal "training set" as you'd find in AI development is not relevant here.
9. How the ground truth for the training set was established
This information is not applicable and not provided for the reasons stated in point 8.
§ 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).