FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The Vail 1000 Enclosed Bed is a soft-sided enclosed bed for patients who are at risk to harming themselves or others by intentionally or unintentionally leaving the bed unasisted

Device Description

Vail 1000 Enclosed Bed

AI/ML Overview

I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance tables, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, ground truth types, or training set details.

The document is a US FDA 510(k) clearance letter for a device called "Vail 1000 Enclosed Bed". It states that the device is substantially equivalent to a legally marketed predicate device and outlines the general controls provisions of the Act it falls under. It also includes the "Indications For Use" for the device, which describes its intended purpose.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them from this document.

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K Number

K963622

Device Name

VAIL 2000 ENCLOSED BED

Manufacturer

VAIL PRODUCTS, INC.

Date Cleared

1997-05-07

(239 days)