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K Number
K981015
Device Name
PALI-TRODE
Manufacturer
PREFERRED INSTRUMENTS
Date Cleared
1998-06-16

(90 days)

Product Code
GZL
Regulation Number
882.1330
Type
Traditional
Panel
NE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Pali-Trode™ Depth Electrode is indicated where intra-operative, short-term recording of multi-unit neural activity is required.

Device Description

Semi-Micro Depth Electrode

AI/ML Overview

I am sorry, but the provided text describes a 510(k) clearance letter from the FDA for a device called "Semi-Micro Depth Electrode." This document is a regulatory approval, and it does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or any of the other specific details requested in your prompt.

The letter confirms that the device is substantially equivalent to a predicate device and can be marketed. It lists the trade name, regulatory class, product code, and indications for use.

Therefore, I cannot fulfill your request as the necessary information is not present in the provided text.

§ 882.1330 Depth electrode.

(a)
Identification. A depth electrode is an electrode used for temporary stimulation of, or recording electrical signals at, subsurface levels of the brain.(b)
Classification. Class II (performance standards).