(100 days)
The Diamondback 360° Orbital Atherectomy System is a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries are who are acceptable candidates for percutaneous transluminal atherectomy.
The Diamondback 360° Orbital System (OAS) is intended for use in the treatment of peripheral artery stenosis also referred to as Peripheral Artery Disease (PAD). PAD is the result of a stenosis of peripheral arteries, typically in the legs. The OAS provides a method of removing stenotic material from peripheral arteries. The OAS applies a diamond coated, eccentrally rotating cutting surface to ablate stenotic material. The resulting particles of removed stenotic material are very small and can be absorbed by the body. The Diamondback 360° Orbital Atherectomy System consists of the following three significant components: 1) Orbital Atherectomy Device, 2) Guide Wire, and 3) Controller.
The provided document is a 510(k) summary for the Diamondback 360° Orbital Atherectomy System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed acceptance criteria and studies in the same way a PMA (Pre-Market Approval) submission for a novel device would.
Therefore, much of the requested information regarding acceptance criteria, study methodologies, sample sizes, and expert adjudication for an algorithm's performance is not present in this document because the device in question is a physical medical device (an atherectomy system), not an AI/ML algorithm or a diagnostic tool that would typically have such performance metrics.
However, I can extract the information that is present and indicate where the requested information is not applicable or not provided.
1. Table of Acceptance Criteria and Reported Device Performance
This document does not specify quantitative acceptance criteria or a "reported device performance" in terms of specific numerical thresholds for a device's diagnostic or predictive accuracy. Instead, the "performance" shown is that the device was deemed "substantially equivalent" to predicate devices based on safety and effectiveness.
| Acceptance Criteria (Not explicitly stated as such for a performance algorithm) | Reported Device Performance (Summary of Conclusion) |
|---|---|
| Safety: Device comparable to predicates in terms of potential risks and complications. | "Laboratory animal and clinical data were provided to support the safety of the Diamondback 360° Orbital Atherectomy System." The FDA concluded, "No new questions of safety... are raised." |
| Effectiveness: Device achieves intended therapeutic purpose comparably to predicates. | "Laboratory animal and clinical data were provided to support the... effectiveness of the Diamondback 360° Orbital Atherectomy System." The FDA concluded, "No new questions of... effectiveness are raised." The device was found "substantially equivalent" to predicate atherectomy devices for treating peripheral artery stenosis. |
| Technological Characteristics: Similarities in design, materials, and operational principles to predicates. | The device uses a "diamond coated, eccentrically rotating cutting surface to ablate stenotic material," which is stated to be the same technology as a previously cleared device (CSI A-V Graft System, K041630) but with modified indication for use and disposable device variations. It's composed of an orbital atherectomy device, guide wire, and controller, similar in concept to predicate atherectomy systems. |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "Laboratory animal and clinical data" were provided but does not specify the sample size for the clinical study or the test set (if referring to a dataset for an algorithm, which is not the case here).
- Sample Size for Test Set: Not specified in the provided document.
- Data Provenance: "Laboratory animal and clinical data." No mention of specific countries of origin or whether the clinical data was retrospective or prospective is present.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to this 510(k) submission as it concerns a physical medical device, not a diagnostic algorithm that requires "ground truth" derived from expert consensus on images or data. Clinical studies for devices like this typically involve assessment of patient outcomes by physicians, but this is different from establishing a diagnostic ground truth for an AI system.
- Number of Experts: Not applicable/not specified for an AI ground truth.
- Qualifications of Experts: Not applicable/not specified for an AI ground truth.
4. Adjudication Method for the Test Set
This is not applicable for a physical atherectomy device. Adjudication methods like 2+1 or 3+1 refer to how multiple expert opinions are combined to establish a ground truth for an AI algorithm's test set.
- Adjudication Method: Not applicable.
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 as the device is an atherectomy system, not a diagnostic AI tool that would assist human readers in interpreting medical images or data.
- MRMC Study: Not applicable.
- Effect Size of AI Assistance: Not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a physical medical device, not an algorithm.
- Standalone Performance Study: Not applicable.
7. The Type of Ground Truth Used
The concept of "ground truth" as typically discussed for AI algorithms (expert consensus, pathology, outcome data for diagnosis) does not directly apply to the performance evaluation of an atherectomy device in the same way. The studies focused on "safety" and "effectiveness," which would involve clinical endpoints like reduction in stenosis, complication rates (e.g., vessel dissection, distal embolization), and patient outcomes, rather than a diagnostic "ground truth."
- Type of Ground Truth: Clinical endpoints related to safety (e.g., adverse events, complications) and effectiveness (e.g., patency rates, reduction of stenosis), rather than a diagnostic "ground truth."
8. The Sample Size for the Training Set
This is not applicable. The device is a physical medical device, not an AI/ML algorithm that requires a "training set."
- Sample Size for Training Set: Not applicable.
9. How the Ground Truth for the Training Set Was Established
This is not applicable, as there is no "training set" or "ground truth" in the context of an AI algorithm for this physical device.
- Ground Truth for Training Set: Not applicable.
§ 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).