LogoFDA 510(k) Search
K Number
K961976
Device Name
THE BIOPLATE FIXATION SYSTEM
Manufacturer
BIOMEDICS
Date Cleared
1996-08-16

(88 days)

Product Code
JEY
Regulation Number
872.4760
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Not Found

Device Description

The Bioplate Fixation System is manufactured of commercially pure titanium and a titanium 6A1-4V ELI alloy, materials that have been implanted safely for many years.

AI/ML Overview

This document (K961976) is a 510(k) premarket notification for a medical device called the "Bioplate Fixation System." It's focused on demonstrating substantial equivalence to predicate devices rather than providing a detailed study proving the device meets specific acceptance criteria in the way a clinical trial would for a diagnostic or AI-driven device.

Therefore, most of the requested information regarding acceptance criteria and a study to prove meeting those criteria is not applicable or cannot be extracted from this document. This 510(k) is a regulatory submission, not a research paper.

Here's a breakdown of why and what can be inferred:

1. A table of acceptance criteria and the reported device performance

  • Not Applicable/Cannot be extracted. This document does not present acceptance criteria for performance metrics (like accuracy, sensitivity, specificity) because it's a fixation system, not a diagnostic tool. Its "performance" is primarily about material biocompatibility, mechanical strength, and design equivalence to existing, legally marketed devices.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

  • Not Applicable/Cannot be extracted. This 510(k) does not describe a "test set" in the context of clinical or diagnostic performance. The substantial equivalence argument relies on material composition and design similarity to predicate devices, not on a clinical "test set" of patients or data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

  • Not Applicable/Cannot be extracted. "Ground truth" in this context (fixation system) would relate to things like "does it adequately hold bone fragments together?" This is not assessed through expert consensus on a dataset in a 510(k) for this type of device. The "truth" is established through engineering specifications and the history of safe use of similar materials and designs.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

  • Not Applicable/Cannot be extracted. No clinical "test set" or adjudication process described.

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 Applicable/Cannot be extracted. This is a fixation system, not an AI-driven diagnostic device. MRMC studies are completely irrelevant in this context.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

  • Not Applicable/Cannot be extracted. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

  • Not Applicable/Cannot be extracted. The "ground truth" for this type of device relates to its fundamental properties:
    • Material Composition: Commercially pure titanium and titanium 6A1-4V ELI alloy. The "truth" here is that these materials are known, accepted, and described in device classifications (e.g., 21 CFR 888.3030) as safe for implantation.
    • Design Equivalence: The plates and screws are "substantially equivalent in construction and design" to predicate devices manufactured by Howmedica, Medicon, Inc., KLS, and W.L. Lorenz. The "ground truth" is that these predicate devices are already legally marketed and have a history of safe and effective use.

8. The sample size for the training set

  • Not Applicable/Cannot be extracted. There is no "training set" for this type of device.

9. How the ground truth for the training set was established

  • Not Applicable/Cannot be extracted. No training set.

Summary derived from the provided text for K961976:

This 510(k) submission establishes the safety and effectiveness of the Bioplate Fixation System by demonstrating substantial equivalence to predicate devices. The key arguments are:

  • Materials: Manufactured from commercially pure titanium and titanium 6A1-4V ELI alloy, which are recognized as safe and acceptable for implantation (referencing 21 CFR 888.3030).
  • Design: Plates and screws are substantially equivalent in construction and design to predicate devices from Howmedica, Medicon, Inc., KLS, and W.L. Lorenz.

The "acceptance criteria" in this context are implicitly met by demonstrating that the device is made of safe materials and its design is equivalent to already cleared devices, thereby implying it performs at least as safely and effectively as those predicate devices. No new clinical performance data in the typical sense is presented or required for this type of 510(k).

§ 872.4760 Bone plate.

(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.