POLARUS AF ROD

• 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: Orthopedic
• Reference & Predicate Devices: N/A
• Predicate For: N/A

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.

Summary

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Quality Orthopaedic Instruments and Implants

Enclosure D - 510(k) Summary

This summary regarding 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.93.

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.

The Polarus AF Rod is similar to Smith & Nephew Richards, Inc.'s Intramedullary Rod in design, function, indications and surgical technique and is expected to perform as well as similar devices.

Regulation Number and Section

§ 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.