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K Number
K012908
Device Name
BIOPLATE RESORBABLE BONE SCREW
Manufacturer
BIOPLATE, INC.
Date Cleared
2001-11-28

(90 days)

Product Code
DZL
Regulation Number
872.4880
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Bioplate® Resorbable Bone Screws are intended for use in conjunction with Codman Craniosorb™ plates and meshes in the treatment of fractures and reconstructive oranioon's of the craniomaxillofacial skeleton in which resorbable fixation is desired. The plates and screws are used to align and stabilize fractures of bony tissue while normal tissue healing occurs.

The Bioplate® Resorbable Bone Screws are intended for minimally load bearing fixation for the following indications:

  • Reconstructive procedures of the craniomaxillofacial skeleton ●
  • . Repair of Craniofacial fractures
  • Cranial bone fixation .
  • Brow lift procedures
Device Description

The Bioplate® Resorbable Bone Screws are resorbable implants made from a Poly(L-The Dioplates I Rosofbable Bons are provided pre-sterilized by gamma radiation and are not intended to be resterilized by the user.

AI/ML Overview

The provided text is a 510(k) summary for the Bioplate® Resorbable Bone Screw, and it primarily focuses on establishing substantial equivalence to predicate devices rather than presenting a study demonstrating the device meets specific acceptance criteria based on performance metrics like accuracy, sensitivity, or specificity.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth types cannot be extracted from the provided text because such information is not present. This type of document is a regulatory submission for a medical device that often relies on existing data or similarities to previously approved devices, rather than a de novo performance study like those conducted for AI-driven diagnostic tools.

Here's a breakdown of why each point cannot be addressed:

  1. A table of acceptance criteria and the reported device performance: Not present. The document focuses on "substantial equivalence" of design, material, intended use, and principles of operation to predicate devices, not on quantifiable performance metrics.
  2. Sample sized used for the test set and the data provenance: Not present. There is no mention of a "test set" in the context of performance evaluation.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present. Ground truth is not discussed in the context of device performance evaluation.
  4. Adjudication method for the test set: Not present.
  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 relevant. This device is a bone screw, not an AI-assisted diagnostic tool.
  6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not relevant. This device is a bone screw, not an algorithm.
  7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not present.
  8. The sample size for the training set: Not relevant. There is no "training set" as this is not an AI/ML device.
  9. How the ground truth for the training set was established: Not relevant. There is no "training set" as this is not an AI/ML device.

In summary, the provided 510(k) submission is for a physical medical device (bone screw) and does not contain the kind of performance study data and acceptance criteria information that would be expected for a diagnostic device or an AI/ML product.

§ 872.4880 Intraosseous fixation screw or wire.

(a)
Identification. An intraosseous fixation screw or wire is a metal device intended to be inserted into fractured jaw bone segments to prevent their movement.(b)
Classification. Class II.