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K Number
K962091
Device Name
POLARUS AF ROD
Manufacturer
ACUMED, INC.
Date Cleared
1996-07-24

(56 days)

Product Code
HSB
Regulation Number
888.3020
Type
Traditional
Panel
OR
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Polarus AF Rod is an intramedullary rod which addresses tibiocalcaneal arthrodesis procedures (ankle fusions).

Device Description

The Polarus AF Rod is an intramedullary rod which addresses tibiocalcaneal arthrodesis procedures (ankle fusions). The rod's dimensions are 11 mm x 150 mm and it is interlocked in place by 4.5 mm cortical screws. The Polarus AF Rod is manufactured from 6AL/4V ELI per ASTM F 136. This device is provided pre-sterile. Sterility is achieved by gamma radiation. Validation of sterility is maintained on site. Sterility level is 104. Information regarding implantation, packaging, and labeling have been provided.

AI/ML Overview

I am sorry, but the provided text describes a medical device (Polarus AF Rod) and its general characteristics, such as material, sterilization, and intended use for tibiocalcaneal arthrodesis procedures. However, the text does not contain any information about acceptance criteria, device performance studies, or clinical evaluations.

Therefore, I cannot provide the requested information regarding:

  1. A table of acceptance criteria and reported device performance.
  2. Sample sizes, data provenance, number of experts, adjudication methods for test sets.
  3. Multi-reader multi-case (MRMC) comparative effectiveness studies or standalone performance studies.
  4. Type of ground truth used or how it was established.
  5. Training set sample size or how its ground truth was established.

The provided document is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a predicate device based on design, materials, and intended use, rather than detailed performance study results that would include acceptance criteria and specific performance metrics.

§ 888.3020 Intramedullary fixation rod.

(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.