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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).

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I am sorry, but the provided text from the FDA 510(k) clearance letter for the LOBO Vascular Occlusion System does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria related to an AI/machine learning device.

The document is a standard FDA clearance letter for a medical device (a vascular occlusion system), confirming that the device is substantially equivalent to legally marketed predicates. It briefly describes the indications for use but does not delve into performance studies, acceptance criteria, sample sizes, expert adjudication, or any details relevant to AI/ML device testing as described in your request.

Therefore, I cannot fulfill your request using the provided text. To answer your query about acceptance criteria and study details for an AI/ML device, you would need to provide a document that specifically details such a study, for example, a clinical study report or a 510(k) summary for an AI/ML-driven device.

Ask a specific question about this device

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

I am sorry, but the provided text from the FDA letter does not contain the information required to answer the questions about the acceptance criteria and the study that proves the device meets those criteria. The letter is a 510(k) clearance letter for the "LOBO Vascular Occlusion System," which is a vascular embolization device. This type of device is a physical medical device, not an AI/software device that would typically undergo the kind of performance studies described in your request (e.g., studies involving AI algorithms, expert readers, ground truth establishment, MRMC studies, etc.).

The letter confirms that the device is "substantially equivalent" to legally marketed predicate devices and outlines the regulatory basis for its marketing, general controls, and other administrative requirements. It provides the device name, regulation number, regulation name, regulatory class, product code, and indications for use.

Therefore, I cannot populate the table or answer the specific questions about AI/software performance studies, sample sizes, expert qualifications, or ground truth methodologies based on the provided document.

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