(16 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)
Here's an analysis of the provided text regarding the acceptance criteria and study for the Diamondback 360® Peripheral Orbital Atherectomy System:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly list quantitative acceptance criteria with specific numerical targets. Instead, it states that the device "met the established specifications necessary for consistent performance during its intended use" and "met all predetermined acceptance criteria of design verification and validation testing as specified by applicable standards, test protocols, and/or customer inputs."
However, based on the performance bench testing conducted, we can infer the categories of acceptance criteria:
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Biocompatibility | All tests (Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Pyrogenicity, Hemocompatibility) showed materials are non-toxic and non-sensitizing, consistent with intended use. |
| Durability/Life Cycle | System Life Testing met established specifications. |
| Functionality (High Load) | Stall Testing met established specifications. |
| Compatibility | Introducer Compatibility Testing met established specifications. |
| Fluid Management | Contrast Injection Testing met established specifications. |
| Thermal Performance | Temperature Testing met established specifications. |
| Mechanical Strength | Tensile Testing met established specifications. |
| Mechanical Flexibility | Flexibility Testing met established specifications. |
| Power/Movement Delivery | Delivered Torque Testing met established specifications. |
| Operational Mechanism | Orbit Testing met established specifications. |
| Safety Mechanism | Guide Wire Brake Testing met established specifications. |
| Fluid Dynamics | Flow Testing met established specifications. |
| Navigation/Advancement | Track Testing met established specifications. |
| Packaging Integrity | Packaging/Simulated Distribution Testing met established specifications. |
2. Sample Size Used for the Test Set and Data Provenance:
The document describes bench testing and biocompatibility testing, not clinical trials involving human subjects or data sets in the traditional sense of AI/diagnostic device evaluation. Therefore, there is no "test set" of patient data, nor is there information on data provenance (country of origin, retrospective/prospective) for such a test set. The "test set" here refers to the physical devices and materials undergoing various engineering and biological assessments.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
This is not applicable as the study involved bench testing and biocompatibility testing of a physical medical device, not the evaluation of an algorithm against a ground truth established by experts.
4. Adjudication Method for the Test Set:
This is not applicable for the same reasons as #3. The results of the mechanical and biological tests are objective measurements, not subject to expert adjudication.
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 is not applicable. The device is an orbital atherectomy system, a physical interventional medical device, not an AI or diagnostic tool that assists human readers. No MRMC study was conducted or would be relevant for this type of device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable. The device is a physical orbital atherectomy system, not a software algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the performance evaluation of this device is based on established engineering specifications, material science standards, and biological safety standards. For example:
- Biocompatibility: Conformance to ISO standards for biocompatibility, assessed through laboratory tests (cytotoxicity, sensitization, etc.).
- Mechanical Performance: Measurements against predefined engineering specifications for torque, tensile strength, flexibility, etc., derived from industry standards and internal design requirements.
- System Life: Durability testing against a specified number of cycles or operational hours.
8. The Sample Size for the Training Set:
This is not applicable. The device is a physical medical device, not an AI model requiring a training set.
9. How the Ground Truth for the Training Set was Established:
This is not applicable for the same reason as #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).