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K Number
K070876
Device Name
STRYKER TWIST DRILLS
Manufacturer
STRYKER CRANIOMAXILLOFACIAL
Date Cleared
2007-04-27

(29 days)

Product Code
HBE
Regulation Number
882.4310
Type
Traditional
Panel
NE
Reference & Predicate Devices
K943541,K954690,K062842
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Stryker® Twist Drills are intended to be used for drilling holes in large and small bone during orthopedic, spinal, neurosurgical, medial sternotomy, and oral and maxillofacial procedures.

Device Description

Not Found

AI/ML Overview

This document primarily concerns the 510(k) summary and FDA clearance letter for the Stryker® Twist Drills. It focuses on establishing substantial equivalence to predicate devices and detailing the intended use and regulatory classification.

Based on the provided text, there is no information available regarding acceptance criteria or a study proving device performance in the context of an AI/algorithm-driven device. The Stryker® Twist Drills are a physical medical device (drills), not an AI or software-based system that would typically have the acceptance criteria and study details you've outlined.

Therefore, I cannot provide the requested information for the following points as they are not applicable to the provided document:

  1. A table of acceptance criteria and the reported device performance
  2. Sample size used for the test set and the data provenance
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
  4. Adjudication method for the test set
  5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done
  6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done
  7. The type of ground truth used
  8. The sample size for the training set
  9. How the ground truth for the training set was established

The document focuses on regulatory clearance for a physical medical tool, asserting its substantial equivalence to existing drills based on design and intended use, rather than demonstrating algorithm performance.

§ 882.4310 Powered simple cranial drills, burrs, trephines, and their accessories.

(a)
Identification. Powered simple cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments used on a patient's skull. The instruments are used with a power source but do not have a clutch mechanism to disengage the tip after penetrating the skull.(b)
Classification. Class II (performance standards).