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K Number
K963433
Device Name
THREADED FIXATION PIN
Manufacturer
ORTHOPAEDIC BIOSYSTEMS, LTD.
Date Cleared
1996-11-06

(68 days)

Product Code
JDW
Regulation Number
888.3040
Type
Traditional
Panel
OR
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Not Found

Device Description

Threaded Fixation Pin

AI/ML Overview

The provided text is a 510(k) summary for a medical device (Threaded Fixation Pin) from 1996. This document is a regulatory submission focused on demonstrating substantial equivalence to a predicate device, not a study report detailing performance data against acceptance criteria.

Therefore, the input does not contain the information necessary to describe acceptance criteria and a study proving a device meets them in the way requested by your prompt.

Here's why and what's missing:

  • Acceptance Criteria & Reported Device Performance (1): The document doesn't define any specific performance metrics (e.g., sensitivity, specificity, accuracy, mechanical strength, displacement limits) nor does it report any numerical performance results for the Threaded Fixation Pin. It only states its intended use and material.
  • Sample Size (Test Set) & Data Provenance (2): There is no mention of a test set, sample sizes, or data provenance as no performance study is described.
  • Number/Qualifications of Experts (3): No experts are mentioned in the context of establishing ground truth for a test set.
  • Adjudication Method (4): Not applicable as no ground truth establishment process is described.
  • MRMC Comparative Effectiveness Study (5): This type of study is not mentioned or implied. The document focuses on material and intended use equivalence.
  • Standalone Performance (6): No standalone performance data is presented.
  • Type of Ground Truth (7): Not applicable as no ground truth is established for device performance.
  • Sample Size (Training Set) (8): No training set is mentioned as no learning algorithm or AI is involved.
  • Ground Truth (Training Set) (9): Not applicable.

In summary, the provided text is an equivalence claim for a rudimentary medical device from 1996 and does not contain the kind of detailed study information (especially concerning AI/algorithm performance) that your prompt is looking for.

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.