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Intended Use: The NOMOS MINICRANE is intended to be used as an accessory to radiation therapy patient support assemblies. The MINICRANE is used to provide a simple method for indexing the patient/table a prescribed distance.
Indications: The indications for the NOMOS MINICRANE are the same as those for the predicate NOMOS CRANE; i.e., to display the prescribed distance of patient indexing.

The MINICRANE is an accessory to radiation therapy patient support assemblies which attaches to the an appropriate part of the radiation therapy table (table) such as the side (hand) rails or a fixation device such as the NOMOGrip. The arm of the MINICRANE is available in a number of lengths to accommodate various treatment positions. The MINICRANE locks onto the table or fixation device. Patient access to the treatment table is not obstructed and the table can be freely adjusted in the X, Y, and Z axes. The arm of the MINICRANE incorporates a batteryoperated digital micrometer which displays, in millimeters, the position of the table with respect to an origin. The micrometer may be set to display the value in inches, however, the Operator's Manual instructs the user to set the micrometer to display millimeters. With the MINICRANE attached to the treatment table, a technologist can move the table to a predefined point in the Y axis. The coordinate of the MINICRANE will identify this point within the limits of accuracy of the stability of the treatment table.

The provided text describes a medical device, the NOMOS MINICRANE, which is an accessory to radiation therapy patient support assemblies. It is used to index the patient/table a prescribed distance. However, the document does not contain any information regarding acceptance criteria, a specific study proving the device meets those criteria, sample sizes, expert involvement, or ground truth establishment.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device (NOMOS CRANE) rather than detailing performance studies with specific metrics. It states: "The indications, design, materials, manufacturing, and specifications of the NOMOS MINICRANE do not raise any new issues relating to safety and effectiveness."

Therefore, I cannot fulfill your request for a table of acceptance criteria, device performance, study details, sample sizes, expert qualifications, adjudication methods, or ground truth information based on the provided text. This information is typically found in detailed performance studies or validation documents, which are not present in this 510(k) summary.

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