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K Number
K151998
Device Name
TraceIT Tissue Marker - 3mL
Manufacturer
AUGMENIX, INC.
Date Cleared
2015-08-19

(30 days)

Product Code
NEU
Regulation Number
878.4300
Type
Special
Panel
SU
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Not Found

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) clearance letter from the FDA for a device called "TraceIT Tissue Marker." This document does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or multi-reader multi-case studies. It is a regulatory approval letter based on substantial equivalence to predicate devices, not a detailed study report.

Therefore, I cannot extract the requested information from the provided text. The sections of the prompt asking for specifics about acceptance criteria, study details, sample sizes, expert qualifications, and ground truth are not addressed in this type of FDA letter.

§ 878.4300 Implantable clip.

(a)
Identification. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.