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K Number
K151790
Device Name
PMT Platinum Depthalon Depth Electrode
Manufacturer
PMT CORPORATION
Date Cleared
2016-07-14

(379 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 Platinum Depthalon® Depth Electrodes are intended for temporary (

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) clearance letter from the FDA for a medical device called "PMT Platinum Depthalon Depth Electrodes". This document does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The letter is a regulatory document confirming that the device is substantially equivalent to legally marketed predicate devices. It discusses:

  • The device name and regulation number.
  • The indication for use of the device.
  • General controls provisions and other compliance requirements for the manufacturer.
  • Contact information for FDA divisions.

Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment based on 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).