(89 days)
Intended Use: The Okami Medical LOBO Vascular Occlusion System is intended for use to obstruct or reduce the rate of blood flow in arteries of the peripheral vasculature. The device is not indicated for use in blood vessels where crush or bend forces are anticipated (e.g. joint areas, superficial vasculature).
Not Found
This FDA 510(k) clearance letter for the Okami Medical LOBO Vascular Occlusion System primarily deals with the substantial equivalence determination of a medical device based on its indications for use, without detailing specific performance studies against acceptance criteria in the manner that would be expected for a novel AI/ML-based device.
Therefore, many of the requested elements for an AI/ML device (e.g., sample sizes for training/test sets, expert qualifications, MRMC studies, ground truth establishment) are not applicable to the content provided in this 510(k) letter.
However, I can extract the relevant information from the document as it pertains to the device and its intended use, and indicate where the requested information is absent.
Device Name: Okami Medical LOBO Vascular Occlusion System
Regulation Name: Vascular Embolization Device
Regulatory Class: Class II
Indications for Use: The Okami Medical LOBO Vascular Occlusion System is intended for use to obstruct or reduce the rate of blood flow in arteries of the peripheral vasculature. The device is not indicated for use in blood vessels where crush or bend forces are anticipated (e.g. joint areas, superficial vasculature).
Here's an attempt to answer your questions based solely on the provided text, acknowledging that much of the detailed study information for AI/ML devices is not present.
1. A table of acceptance criteria and the reported device performance
The provided document, a 510(k) clearance letter, does not contain specific acceptance criteria or reported device performance in a measurable format like sensitivity, specificity, accuracy, or other quantitative metrics. The basis for clearance in a 510(k) is "substantial equivalence" to a predicate device, meaning the new device is as safe and effective as a legally marketed device. Performance data, if submitted, would have been part of the 510(k) submission but are not typically detailed in the clearance letter itself.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in this document. The 510(k) clearance is based on substantial equivalence to a predicate device, implying that the device performs as intended and is as safe and effective as the predicate. | Not specified in this document. Performance data (e.g., occlusion rates, complication rates) would have been part of the manufacturer's submission but are not summarized here. |
2. Sample sizes used for the test set and the data provenance
- Sample Size (Test Set): Not mentioned in this document.
- Data Provenance (e.g., country of origin, retrospective/prospective): Not mentioned in this document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable as this is a physical medical device (vascular occlusion system), not an AI/ML diagnostic or image analysis device that requires expert-established ground truth for performance evaluation in the context of an AI model.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as this is a physical medical device, not an AI/ML device requiring expert adjudication of ground truth for performance evaluation.
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 as this is a physical medical device, 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 as this is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For a device like a vascular occlusion system, performance data would likely involve outcomes data from preclinical studies (e.g., animal models) and potentially clinical studies (human trials), focusing on aspects like successful occlusion, patency of collateral vessels, complication rates, and device integrity. However, the specific type and details of ground truth/performance verification are not provided in this clearance letter.
8. The sample size for the training set
This information is not applicable as this is a physical medical device, not an AI/ML model that undergoes training.
9. How the ground truth for the training set was established
This information is not applicable as this is a physical medical device, not an AI/ML model.
§ 870.3300 Vascular embolization device.
(a)
Identification. A vascular embolization device is an intravascular implant intended to control hemorrhaging due to aneurysms, certain types of tumors (e.g., nephroma, hepatoma, uterine fibroids), and arteriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in neurovascular applications are also not included in this classification, see § 882.5950 of this chapter.(b)
Classification. Class II (special controls.) The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices.” For availability of this guidance document, see § 870.1(e).