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K Number
K972219
Device Name
ORTHOPEDIC PLATE SYSTEM
Manufacturer
FERGUSON MEDICAL
Date Cleared
1997-11-20

(161 days)

Product Code
HRS
Regulation Number
888.3030
Type
Traditional
Panel
OR
Reference & Predicate Devices
K770128,K782123,K792291,K862224,K864924,K890641,K903252,K912936,K914803,K921338,K922167,K923861,K924085,K930480,K930592,K930966,K931687,K933112,K953644
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The device is intended to be implanted for use in the fixation of long bone fractures and for long bone reconstructions.

Device Description

The device is an assortment of various sizes and configurations of stainless steel bone plates.

AI/ML Overview

I am sorry, but the provided text only contains a 510(k) summary and FDA clearance letter for an "Orthopedic Plate System." This document primarily focuses on establishing "substantial equivalence" to previously marketed devices rather than detailing specific performance acceptance criteria or a dedicated study proving performance against such criteria.

Therefore, I cannot extract the requested information about acceptance criteria, study details, sample sizes, ground truth establishment, or MRMC studies from the given text.

The document states:

  • The device is an assortment of various sizes and configurations of stainless steel bone plates.
  • The device is intended to be implanted for use in the fixation of long bone fractures and for long bone reconstructions.
  • The Orthopedic Plate System is a standardly used device.
  • The FDA determined the device is "substantially equivalent" to predicate devices, implying it meets the same general safety and effectiveness standards as those products.

To provide the requested information, a different type of document, such as a clinical study report, a scientific publication, or a more detailed technical file, would be needed.

§ 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.