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K Number
K060545
Device Name
UNITY HUMERAL PLATE
Manufacturer
TORNIER
Date Cleared
2006-04-21

(51 days)

Product Code
KTT
Regulation Number
888.3030
Type
Traditional
Panel
OR
Reference & Predicate Devices
K041860,K041709
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Tornier humeral plate is indicated for simple or complex fractures, fracture dislocations, osteotomies, and non-unions of the proximal humerus.

Device Description

The Unity Humeral plate is intended to provide a temporary fixation of proximal humerus fractures. It is pre-contoured to fit the anatomical profile of the proximal humerus. The plate combines orientable screws, locking screws and cortical screws to provide compression and angular stable locking.

AI/ML Overview

The provided text is a 510(k) Premarket Notification for the "Unity Humeral Plate" and does not contain information about acceptance criteria or a study proving device performance against such criteria.

The document establishes substantial equivalence to predicate devices (Synthes LCP Proximal Humerus Plates, Long, K041860; Numelock II System (Lateral Proximal Humerus Plate), Howmedica Osteronics Corporation, K041709) based on device description, materials, and intended use.

Therefore, I cannot provide the requested information, including:

  1. A table of acceptance criteria and reported device performance.
  2. Sample size and data provenance for a test set.
  3. Number and qualifications of experts for ground truth.
  4. Adjudication method for the test set.
  5. MRMC comparative effectiveness study details.
  6. Standalone algorithm performance.
  7. Type of ground truth used.
  8. Sample size for the training set.
  9. How ground truth for the training set was established.

This type of 510(k) submission generally focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than presenting novel performance studies against specific acceptance criteria like those expected for AI/ML-driven devices.

§ 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.