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K Number
K201091
Device Name
V-Print splint
Manufacturer
VOCO GmbH
Date Cleared
2020-11-06

(197 days)

Product Code
MQC,EBI
Regulation Number
N/A
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
  • Therapeutic splints
  • Auxiliary parts and functional parts for diagnostics
  • Manufacturing of patient-matched night guards/splints
Device Description

Not Found

AI/ML Overview

This FDA 510(k) letter for the V-Print splint (K201091) does not contain the information requested to describe the acceptance criteria and the study proving the device meets those criteria.

The provided text only includes:

  • The FDA's decision regarding substantial equivalence.
  • General information about FDA regulations for medical devices.
  • The Indications for Use statement for the V-Print splint.

There is no information within this document about:

  1. Acceptance criteria (e.g., specific performance metrics and thresholds).
  2. Reported device performance data.
  3. Sample size used for testing, or data provenance.
  4. Number/qualifications of experts for ground truth establishment.
  5. Adjudication method.
  6. MRMC study information or effect size.
  7. Standalone performance details.
  8. Type of ground truth used.
  9. Training set sample size.
  10. Ground truth establishment for the training set.

To provide the requested information, a different document, such as a summary of safety and effectiveness (SSE), a detailed test report, or a clinical study report, would be required.

N/A