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K Number
K984458
Device Name
DEPUY ACE SPIDER PLATE
Manufacturer
DEPUY ACE MEDICAL CO.
Date Cleared
1998-12-31

(16 days)

Product Code
HRS
Regulation Number
888.3030
Type
Traditional
Panel
OR
Reference & Predicate Devices
K965028
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
  • · Fixation of Metaphyseal Fractures of the Distal Tibia
  • · Proximal Metaphyseal Tibial Fractures
  • · Calcaneus Body Fractures
  • · Proximal Humeral Head/Shaft Fractures
  • · Distal Femur Fracture -- Comminuted Shaft Fractures
Device Description

The DePuy ACE Spider Plate is a low profile, "one-hole plate" design with a family of diameters to account for various fracture locations and spiked projections to engage the metaphyseal bone in any anatomic region. Five different overall diameters (three small, two large) have been designed to provide adequate clinical flexibility. The top profile has an overall diameter with a central hole for screw fixation; two of the washers have an offset screw hole with an additional k-wire hole. There are eight radiused cutouts producing eight arms that are designed to engage the metaphyseal bone.

AI/ML Overview

The provided text describes a 510(k) submission for a medical device called the "DePuy ACE Spider Plate." This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving the device meets specific performance criteria through a study with acceptance criteria.

Therefore, the input does not contain information about:

  1. A table of acceptance criteria and reported device performance.
  2. Sample size used for a test set or data provenance.
  3. Number of experts used to establish ground truth or their qualifications.
  4. Adjudication method for a test set.
  5. Multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
  6. Standalone (algorithm only) performance.
  7. Type of ground truth used (expert consensus, pathology, outcomes data).
  8. Sample size for a training set.
  9. How ground truth for the training set was established.

The document focuses on establishing substantial equivalence to a predicate device (Acumed Suture Washer) based on similar design and function, rather than presenting a performance study against predefined acceptance criteria.

§ 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.