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K Number
K962853
Device Name
NEOSONO
Manufacturer
L.S. SCIENTIFIC
Date Cleared
1996-09-12

(52 days)

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

Not Found

Device Description

Not Found

AI/ML Overview

The provided text describes the safety and effectiveness of the Neosono XX device, focusing on its design and internal testing rather than a clinical study with acceptance criteria. As such, I cannot extract the requested information. The text does not contain:

  • A table of acceptance criteria and reported device performance.
  • Information about sample sizes for test sets or data provenance.
  • Details on experts used for ground truth establishment or their qualifications.
  • Adjudication methods for a test set.
  • A multi-reader multi-case (MRMC) comparative effectiveness study.
  • Standalone algorithm performance.
  • The type of ground truth used (e.g., expert consensus, pathology, outcomes data).
  • Sample size for a training set.
  • How ground truth for a training set was established.

Instead, the document focuses on internal safety checks (power source, device failure modes like circuitry failure, open/shorted wires, low battery) and the technical approach to effectiveness (impedance measurement, handling environmental variations, and probe wire integrity). It highlights design features and internal self-tests that address potential issues.

N/A