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K Number
K020872
Device Name
SYNTHES 3.5 MM BROAD LC-DCP PLATES
Manufacturer
SYNTHES (USA)
Date Cleared
2002-06-12

(86 days)

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

The Synthes 3.5 mm Broad LC-DCP Plates are intended for use on the diaphysis of the long bones (i.e., humerus, ulna, and tibia).

Device Description

The Synthes 3.5 mm Broad LC-DCP Plate is of a Limited Contact - Dynamic Compression Plate (LC-DCP) design. The plates are 4.2 mm thick, 13.5 mm wide, and available in lengths from 90 mm (7 holes) to 285 mm (22 holes).

AI/ML Overview

The provided document, K020872, is a 510(k) premarket notification for the "Synthes 3.5 mm Broad LC-DCP Plates," which are bone fixation plates. The FDA's review in this document focuses on establishing substantial equivalence to a legally marketed predicate device, rather than requiring performance studies with acceptance criteria to demonstrate safety and effectiveness for a novel medical device.

Therefore, the document does not contain the information requested in the prompt regarding acceptance criteria and a study proving the device meets those criteria. Specifically, the following information is not present:

  1. A table of acceptance criteria and reported device performance.
  2. Sample size used for the test set and data provenance.
  3. Number of experts used to establish ground truth and their qualifications.
  4. Adjudication method for the test set.
  5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
  6. Information about a standalone (algorithm only) performance study.
  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 primarily focuses on regulatory approval based on substantial equivalence and does not detail the technical performance testing typically associated with the type of acceptance criteria mentioned in the prompt.

§ 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.