(24 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 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 describes a 510(k) premarket notification for the Diamondback 360® Peripheral Orbital Atherectomy System. This document focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria and providing detailed study results for a novel AI/software product. Therefore, much of the requested information regarding AI device performance metrics, sample sizes for test/training sets, expert adjudication, MRMC studies, and ground truth establishment is not present in the given text.
However, I can extract the available information regarding performance testing and conclusions:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Mechanical/Functional Performance | 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. Specific tests performed: |
| System Life Testing | Confirmed specifications |
| Stall Testing | Confirmed specifications |
| Introducer Compatibility Testing | Confirmed specifications |
| Temperature Testing | Confirmed specifications |
| Tensile Testing | Confirmed specifications |
| Flexibility Testing | Confirmed specifications |
| Delivered Torque Testing | Confirmed specifications |
| Orbit Testing | Confirmed specifications |
| Guide Wire Brake Testing | Confirmed specifications |
| Saline Flow Testing | Confirmed specifications |
| Track Testing | Confirmed specifications |
| Packaging/Distribution Integrity | Confirmed specifications |
| Biocompatibility | 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. Specific tests performed: |
| Cytotoxicity per ISO 10993-5 | Confirmed specifications |
| Sensitization per ISO 10993-10 | Confirmed specifications |
| Irritation per ISO 10993-10 | Confirmed specifications |
| Acute Systemic Toxicity per ISO 10993-11 | Confirmed specifications |
| Pyrogenicity per ISO 10993-11 | Confirmed specifications |
| Hemocompatibility per ISO 10993-4 | Confirmed specifications |
| Overall Conclusion | The device met all predetermined acceptance criteria of design verification and validation testing as specified by applicable standards, test protocols, and/or customer inputs. Testing results demonstrate substantial equivalence to legally marketed predicate devices and raise no new safety or effectiveness questions. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided text. The testing appears to be primarily bench testing of the device's physical and functional characteristics, not clinical data or image-based test sets.
- Data Provenance: Not applicable in the context of an AI device. The data for this medical device submission is from laboratory bench testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The "ground truth" for this type of device's performance is established by meeting predefined engineering specifications and regulatory standards through bench testing. There's no mention of clinical experts establishing ground truth in this context.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This is not an AI/software device that requires human adjudication of outputs.
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 not an AI device.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done:
- Not applicable. This is not an AI device. It's a physical atherectomy system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For this device, the "ground truth" or acceptability criteria are based on engineering specifications, industry standards (e.g., ISO 10993 for biocompatibility), and regulatory requirements. It's demonstrated through successful completion of bench tests.
8. The sample size for the training set:
- Not applicable. This is not an AI device, so there is no "training set."
9. How the ground truth for the training set was established:
- Not applicable. 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).