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K Number
K112982
Device Name
ANATOMIC ANKLE ARTHRODESIS INTERLOCKING NAIL(A3 INTERLOCKING NAIL )
Manufacturer
SMALL BONE INNOVATIONS INC.
Date Cleared
2012-04-02

(179 days)

Product Code
HSB
Regulation Number
888.3020
Type
Traditional
Panel
OR
Reference & Predicate Devices
K051590,K051678
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The SBi Anatomic Ankle Athrodesis Interlocking Nail System is indicated for tibiotalocalcaneal arthrodesis of the ankle following:

  • Post traumatic and degenerative arthritis involving both ankle and subtalar joints,
  • Rheumatoid arthritis,
  • Osteoarthritis,
  • Pseudoarthrosis,
  • Severe foot/ankle deformity, or
  • Instability and skeletal defects after tumor resection.
    These include neuro-osteoarthroplasty (Charcot's foot), avascular necrosis of the talus, failed joint replacement, failed ankle fusion, and for distal tibia fracture non-unions when used concomitantly with tibiotalocalcaneal pathology.
Device Description

The SBi Anatomic Ankle Arthrodesis Interlocking Nail System consists of implants, associated instruments, and trays. The implants are made of implantable grade titanium while the instrument components and trays are made of several materials: Aluminum, stainless steel, PEEK, POM, and composite materials. The implants are intended for single use only and will be offered sterile and non-sterile.

AI/ML Overview

The provided text is a 510(k) Premarket Notification Summary for a medical device called the "SBi Anatomic Ankle Arthrodesis Interlocking Nail System." This documentation describes a surgical implant, not an AI/ML-based device or a diagnostic tool that would typically have acceptance criteria and a study proving its performance in the way your request outlines (e.g., accuracy, sensitivity, specificity, human reader improvement, standalone performance).

Therefore, I cannot extract the information you requested about acceptance criteria and studies demonstrating device performance related to AI or diagnostic metrics because this document does not contain such information.

Specifically, the document focuses on:

  • Device Description: What the device is made of and how it functions.
  • Intended Use: The medical conditions it is designed to treat (tibiotalocalcaneal arthrodesis of the ankle for various forms of arthritis, deformity, etc.).
  • Substantial Equivalence: Comparing the device to already legally marketed predicate devices (Stryker T2 Ankle Arthrodesis Nail and Synthes Titanium Cannulated Hindfoot Arthrodesis Nail Expert System). This is the primary method of approval for 510(k) devices.
  • Non-clinical data: Fatigue testing, cadaver implantation evaluations, literature search and evaluation, finite element analysis, and engineering/dimensional analysis. These are engineering and mechanical performance tests, not clinical studies in the diagnostic/AI sense.

There is no mention of:

  • Acceptance criteria for diagnostic performance (e.g., sensitivity, specificity, AUC).
  • A "study that proves the device meets the acceptance criteria" in the context of diagnostic accuracy.
  • Sample sizes for test sets or training sets for an algorithm.
  • Data provenance, experts establishing ground truth, adjudication methods.
  • Multi-reader multi-case (MRMC) comparative effectiveness studies.
  • Standalone algorithm performance.
  • Any AI/ML components.

In summary, the request is not applicable to the provided document.

§ 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.