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K Number
K181540
Device Name
Estremo Citieffe Nailing System
Manufacturer
CITIEFFE S.r.L.
Date Cleared
2019-01-16

(219 days)

Product Code
HSB
Regulation Number
888.3020
Type
Traditional
Panel
OR
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Estremo Citieffe Nailing System is indicated for femoral fracture fixation, which may include the following:

  • · diaphyseal femoral fractures;
  • · supra-condylar femoral fractures:
  • · corrective osteotomies;
  • · pseudoarthrosis:
  • non-unions and mal-unions.

The Estremo Citieffe Nailing System is indicated for tibial fracture fixation, which may include the following:

  • · diaphyseal tibial fractures;
  • · corrective osteotomies;
  • · pseudoarthrosis;
  • · non-unions and mal-unions.

The Estremo Citieffe Nailing System is indicated for tibiotalocalcaneal arthrodesis.

Device Description

Not Found

AI/ML Overview

This document is an FDA 510(k) clearance letter for the Estremo Citieffe Nailing System, which is an intramedullary fixation rod for fracture fixation. It is NOT an AI/ML medical device submission.

As such, the document does not contain the information required to answer the prompt. The prompt asks for details about a study that proves an AI/ML device meets acceptance criteria, including:

  • A table of acceptance criteria and reported device performance (for an AI/ML device, this would typically involve metrics like sensitivity, specificity, AUC, etc.)
  • Sample size for the test set and data provenance
  • Number and qualifications of experts for ground truth
  • Adjudication methods
  • MRMC study details and effect size
  • Standalone AI performance
  • Type of ground truth used
  • Training set sample size and ground truth establishment

None of this information is present in the provided FDA 510(k) clearance letter for a physical medical implant (nailing system). The letter confirms the device's substantial equivalence to a predicate device based on its indications for use and general controls, but it does not describe an AI/ML algorithm's performance study.

§ 888.3020 Intramedullary fixation rod.

(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.