(30 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 atherectomy 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 sarface (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 510(k) summary (K152694) for the Diamondback 360 Peripheral Orbital Atherectomy System details the acceptance criteria via performance bench testing and concludes that the device meets these criteria. However, it does not involve a study in the traditional sense of clinical trials or AI/ML evaluations with human experts. Instead, it focuses on verifying the device's physical and functional properties against established specifications.
Here's an analysis based on the provided text, addressing your questions where possible:
1. Table of Acceptance Criteria and Reported Device Performance
The document lists performance bench testing categories that served as the acceptance criteria. The device performance is generally reported as meeting these criteria, implying successful execution within established specifications.
| Acceptance Criteria (Test Category) | Reported Device Performance |
|---|---|
| - System Life Testing (including guidewire) | "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." |
"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." |
| - Stall Testing | |
| - Introducer Compatibility Testing | |
| - Temperature Testing | |
| - Tensile Testing | |
| - Flexibility Testing | |
| - Delivered Torque Testing | |
| - Orbit Testing | |
| - Guidewire Brake Testing | |
| - Saline Flow Testing | |
| - Track Testing | |
| - Packaging/Simulated Distribution Testing | |
| - Biocompatibility (Cytotoxicity per ISO 10993-5) | |
| - Biocompatibility (ASTM Hemolysis per ISO 10993-4) | |
| - Biocompatibility (Chemical Characterization per ISO 10993-18) | |
2. Sample size used for the test set and the data provenance
The document does not specify exact sample sizes for each bench test. The "test set" in this context refers to the manufactured device components or systems subjected to the various physical and chemical tests. The data provenance is internal to the manufacturer (Cardiovascular Systems, Inc.) as these are internal design verification and validation tests. There's no mention of external data or geographic origin beyond the manufacturer's location in Saint Paul, MN. All testing described is retrospective in the sense that it evaluates a designed product, not prospective observational or interventional studies on human subjects.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This type of information is not applicable to the presented data. The "ground truth" for bench testing is typically defined by engineering specifications, international standards (e.g., ISO 10993 for biocompatibility), and internal quality control criteria. These are established by engineering and quality assurance teams, not clinical experts for diagnostic accuracy.
4. Adjudication method for the test set
Not applicable. Bench testing results are compared against predetermined numerical or qualitative specifications, not adjudicated by a panel in the way clinical diagnostic accuracy studies are.
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 submission for a mechanical atherectomy device, not an AI/ML-driven diagnostic or assistive device where MRMC studies with human readers would be relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a physical, mechanical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the bench testing, the "ground truth" is based on:
- Engineering Specifications: Designed parameters and tolerances for device components and system performance (e.g., tensile strength, flexibility limits, torque values, flow rates).
- International Standards: e.g., ISO 10993 for biocompatibility (Cytotoxicity, Hemolysis, Chemical Characterization).
- Test Protocols: Internally developed experimental procedures to evaluate specific performance characteristics.
8. The sample size for the training set
Not applicable. This device is not an AI/ML product that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this device.
§ 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).