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K Number
K150661
Device Name
ST.A.R. 90 F4 External Fixation Screws With Hydroxyapatite
Manufacturer
CITIEFFE s.r.l
Date Cleared
2015-07-07

(116 days)

Product Code
JDW
Regulation Number
888.3040
Type
Traditional
Panel
OR
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Citieffe External Fixator ST.A.R 90 F4 ELBOW is intended for use in upper extremity treatment of bone and soft tissue conditions and other bone conditions amenable to treatment by use of the external treatment modality. Possible applications include:

  • Fracture dislocation with ligaments instability;
  • Comminuted intra-articular fractures;
  • Post traumatic reconstruction for joint stiffness.
    Citieffe External Fixator ST.AR. 90 F4 KNEE is intended for use in the treatment of bone conditions leg lengthening, osteotomies, arthrodesis, fracture fixation and other bone conditions amenable to treatment by use of the external fixation modality.
Device Description

ST.A.R.90 F4 External Fixation Screws With Hydroxyapatite

AI/ML Overview

I apologize, but the provided text from the FDA 510(k) summary for K150661 does not contain information about acceptance criteria, device performance studies, or details relevant to artificial intelligence (AI) or machine learning (ML) models such as sample sizes for test/training sets, expert qualifications, or comparative effectiveness studies.

The document is a standard FDA clearance letter for a medical device (external fixation screws) and focuses on regulatory compliance and substantial equivalence to predicate devices, not on the performance evaluation of a diagnostic AI system against specific clinical acceptance criteria.

Therefore, I cannot fulfill your request for that specific information based on the text provided.

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.