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K Number
K083458
Device Name
INTRAMEDULLARY FIXATION ROD (IFS)
Manufacturer
NOVALIGN ORTHOPAEDICS, INC
Date Cleared
2009-02-09

(80 days)

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

The NovaLign™ Intramedullary Fixation System is intended for use in the fixation of long bone fractures, including fractures in the humerus, femur and the tibia.

Device Description

The NovaLign™ Intramedullary Fixation System is a segmented, intramedullary nail intended for long bone fracture fixation. The device is intended to function as a flexible intramedullary nail during device placement, but will be made rigid at the completion of the surgical implantation procedure.

AI/ML Overview

This document is a 510(k) summary for the NovaLign™ Intramedullary Fixation System, which is a device for fixing long bone fractures. It states that the device is substantially equivalent to legally marketed predicate devices.

Here's an analysis of the provided text in relation to your request about acceptance criteria and study details:

The provided text is a 510(k) summary for a medical device (intramedullary fixation system), NOT a study report for an AI/CADe device.

Therefore, it does not contain any of the information you requested regarding acceptance criteria and a study proving device performance for an AI/CADe device. This type of device (an intramedullary fixation system) is a physical implant, not a software or AI-based diagnostic tool.

To explicitly answer each point based on the provided document:

  1. A table of acceptance criteria and the reported device performance: Not applicable. This document is for a physical orthopedic implant. There are no performance metrics like sensitivity, specificity, AUC, or other typical metrics for AI/CADe devices.
  2. Sample sized used for the test set and the data provenance: Not applicable. There is no test set in the context of an AI/CADe device.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no ground truth establishment in this context.
  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. This is not an AI/CADe device.
  6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/CADe device.
  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.

This 510(k) summary primarily focuses on demonstrating substantial equivalence to a predicate device, which is a regulatory pathway for physical medical devices, and does not involve the type of performance studies relevant to AI/CADe systems.

§ 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.