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K Number
K182179
Device Name
AdvantageRib Anterior System
Manufacturer
SIG Medical Corp.
Date Cleared
2018-11-16

(95 days)

Product Code
HRS,HWC
Regulation Number
888.3030
Type
Traditional
Panel
OR
Reference & Predicate Devices
K141241,K142823,K151173
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The AdvantageRib Anterior System is intended for the fixation, and fusion of rib fractures and osteotomies of normal and osteoporotic bone.

Device Description

The AdvantageRib Anterior System is composed of commercially pure titanium locking bone plates per ASTM F67 and titanium alloy locking and non-locking screws per ASTM F1472 that provide rigid fixation in instances of fractures and osteotomies in normal and osteoporotic bone. The implant and associated screws are provided to the end user in non-sterile packaging, in a variety of sizes and lengths.

AI/ML Overview

I am sorry, but the provided text does not contain the acceptance criteria and study details as requested. The document is a 510(k) premarket notification letter from the FDA regarding the "AdvantageRib Anterior System." It states that clinical testing is not necessary to demonstrate substantial equivalence and refers to performance evaluation in accordance with ASTM standards and engineering/geometric analysis.

The document does not include:

  1. A table of acceptance criteria and reported device performance.
  2. Sample sizes or data provenance for a test set.
  3. Number or qualifications of experts for ground truth.
  4. Adjudication method for a test set.
  5. Information on a multi-reader multi-case (MRMC) comparative effectiveness study.
  6. Information on a standalone (algorithm only) performance study.
  7. The type of ground truth used.
  8. Sample size for a training set.
  9. How ground truth for a training set was established.

Instead, it focuses on demonstrating substantial equivalence to predicate devices based on intended use, materials, design features, dimensions, function, surgical technique, labeling, and adherence to specific ASTM standards (F382, F543, F2193) through engineering and geometric analysis.

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.