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K Number
K100146
Device Name
EVOLVE EPS ORTHOLOC
Manufacturer
WRIGHT MEDICAL TECHNOLOGY, INC.
Date Cleared
2010-02-02

(14 days)

Product Code
HRS,HWC
Regulation Number
888.3030
Type
Special
Panel
OR
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The EVOLVE® EPS ORTHOLOC™ System is intended for fixation of fractures, osteotomies and nonunions of the olecranon, humerus, radius, ulna.

Device Description

The EVOLVE® EPS ORTHOLOC™ System consists of plates manufactured per ASTM F138 or F139 and screws manufactured per ASTM F138 or F2229. The plates are precontoured with compression slots and locking screw holes. The screws will be available in both locking and non-locking designs.

AI/ML Overview

The provided text is a 510(k) summary for a bone plate system (EVOLVE® EPS ORTHOLOC™ System). This type of submission focuses on demonstrating substantial equivalence to a predicate device for mechanical devices, not on proving clinical efficacy or diagnostic accuracy through studies involving AI or human readers.

Therefore, the input document does not contain the information requested regarding acceptance criteria related to device performance in an AI or diagnostic context, nor does it describe a study that would demonstrate such performance.

Specifically, the following requested information cannot be extracted from this document:

  1. A table of acceptance criteria and the reported device performance: This document does not define performance metrics in the way that would apply to a diagnostic AI device (e.g., sensitivity, specificity). It focuses on mechanical properties demonstrated by substantial equivalence to predicate devices and materials testing.
  2. Sample size used for the test set and the data provenance: No test set involving patient data is described.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no diagnostic test set is described.
  4. Adjudication method for the test set: Not applicable.
  5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable.
  6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
  7. The type of ground truth used: Not applicable.
  8. The sample size for the training set: Not applicable as there is no mention of an AI algorithm or training data.
  9. How the ground truth for the training set was established: Not applicable.

The document states: "The safety and effectiveness of the EVOLVE® EPS ORTHOLOC™ System are adequately supported by the substantial equivalence information, materials information, and analysis data provided within this 510(k)." This refers to engineering analyses and comparisons to existing devices, not clinical studies in the context of AI or diagnostics.

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.