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K Number
K221346
Device Name
Stryker VariAx 2 MIS Calcaneus
Manufacturer
Stryker GmbH
Date Cleared
2022-07-08

(60 days)

Product Code
HRS
Regulation Number
888.3030
Type
Traditional
Panel
OR
Reference & Predicate Devices
K063875,K132898
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Stryker VariAx 2 MIS Calcaneus is indicated for fractures of the calcaneus.

Device Description

This Traditional 510(k) submission is submitted to the U.S. FDA to provide authorization to market the VariAx 2 MIS Calcaneus plates. The goal of the Subject Device VariAx 2 MIS Calcaneus is to offer a comprehensive range of calcaneal implants and instruments in one system utilizing the VariAx 2 platform technology and SOMA database for the design of the plates.

The Subject Device VariAx 2 MIS Calcaneus has an equivalent Intended Use and Indications for Use as the Predicate Device and shares the same principle of operation.

Stryker VariAx 2 MIS Calcaneus is a non-active implant(s) intended to provide temporary stabilization for bones or bone fragments.

AI/ML Overview

The provided text describes a 510(k) submission for a medical device called "Stryker VariAx 2 MIS Calcaneus." This document does not include information about AI/ML device performance or clinical studies typically associated with evaluating AI/ML models. Instead, it focuses on the substantial equivalence of a bone fixation appliance to an existing predicate device.

Therefore, I cannot provide the requested information regarding acceptance criteria and studies that prove an AI/ML device meets them, as the provided text is for a traditional medical device (metallic bone fixation appliances) and explicitly states:

"Clinical testing was not required for this submission." (Page 4)

Here's why the specific points you asked for cannot be extracted from this document:

  1. A table of acceptance criteria and the reported device performance: This document specifies non-clinical testing for mechanical properties (ASTM F382-17) and MRI compatibility, but it does not present a table of performance metrics for an AI/ML device.
  2. Sample size used for the test set and the data provenance: Not applicable.
  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.
  6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
  7. The type of ground truth used: Not applicable.
  8. The sample size for the training set: Not applicable.
  9. How the ground truth for the training set was established: Not applicable.

§ 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.