LogoFDA 510(k) Search
K Number
K031207
Device Name
SAFETY RELEASE ARCH BAR KIT
Manufacturer
CASEY SURGICAL, LLC
Date Cleared
2003-07-15

(90 days)

Product Code
DYX
Regulation Number
872.4600
Type
Traditional
Panel
DE
Reference & Predicate Devices
K991004,K820944
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Casey Surgical Safety Release ™ Arch Bar Kit is indicated for use in intermaxillary and maxillo-mandibular fixation.

Device Description

The Casey Surgical Safety Release ™ Arch Bar Kit is made of four components which are installed by an oral surgeon or dentist along with ligature wires. The installed device provides temporary jaw immobilization. The device incorporates a safety release mechanism.

AI/ML Overview

The provided text is a 510(k) summary for the Casey Surgical Safety Release™ Arch Bar Kit. It describes the device, its intended use, and comparison to predicate devices. However, this document does not contain any information regarding clinical studies, acceptance criteria, or performance data beyond stating substantial equivalence to predicate devices.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets those criteria, as this information is not present in the provided text. The document focuses on regulatory compliance through substantial equivalence, rather than detailing a specific performance study against defined acceptance criteria.

The 510(k) summary indicates that the device's substantial equivalence is based on:

  • Comparison of Technical Characteristics to Predicate Device: "Similar to predicate devices K991004 Synthes Quick Lock™ IMF system and K8200944 Dental Arch Bar in materials of construction and indications for use. The Casey Surgical Safety Release ™ Arch Bar Kit has the additional safety release feature."

This implies that the acceptance criteria were implicitly met by demonstrating that the device is as safe and effective as the predicate devices, likely through engineering analysis, functional testing, and material characterization, rather than a clinical study with specific performance metrics like accuracy, sensitivity, or specificity.

To directly address your numbered points based on the provided text:

  1. A table of acceptance criteria and the reported device performance: This information is not available in the provided text.
  2. Sample size used for the test set and the data provenance: Not applicable, as no performance study is detailed.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
  4. Adjudication method for the test set: Not applicable.
  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. This device is not an AI-based diagnostic tool.
  6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device, not an algorithm.
  7. The type of ground truth used: Not applicable, as no performance study with ground truth is detailed. The ground for substantial equivalence is comparison to predicate devices and their established safety and effectiveness.
  8. The sample size for the training set: Not applicable, as no machine learning algorithm is involved.
  9. How the ground truth for the training set was established: Not applicable.

§ 872.4600 Intraoral ligature and wire lock.

(a)
Identification. An intraoral ligature and wire lock is a metal device intended to constrict fractured bone segments in the oral cavity. The bone segments are stabilized by wrapping the ligature (wire) around the fractured bone segments and locking the ends together.(b)
Classification. Class II.