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K Number
K971609
Device Name
SCULPTURE
Manufacturer
SERVIZI MEDICO ESTETICI ITALINAI SRL.
Date Cleared
1997-08-14

(105 days)

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

The SCULPTURE is designed for use in fragmentation, emulsification and aspiration of soft ussue in the following Surgical Specialties: plastic and reconstructive surgery, general surgery

Device Description

Not Found

AI/ML Overview

This appears to be a 510(k) clearance letter from the FDA for a device called "Sculpture." The letter confirms that SMEI, Inc. can market the device because it has been determined to be substantially equivalent to devices marketed prior to May 28, 1976.

However, the provided text does not contain any information regarding acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or expert qualifications. This document is a regulatory approval letter, not a clinical study report.

Therefore, I cannot provide the requested information from the given text. To answer your questions, I would need access to the actual 510(k) submission document or a clinical study report for the Sculpture device.

N/A