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K Number
K160978
Device Name
LITe BIO Delivery System
Manufacturer
STRYKER CORPORATION
Date Cleared
2016-07-08

(92 days)

Product Code
FMF
Regulation Number
880.5860
Type
Traditional
Panel
General Hospital
Reference & Predicate Devices
K023074,K133328,K152532,K121124,K140710,K112773
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The LITe® BIO Delivery System is intended to deliver autograft, allograft, or synthetic bone grafting materials to all orthopedic surgical sites.

Device Description

The LITe® BIO Delivery System is a manually operated hand-held device used to facilitate delivery of bone graft material to all orthopedic surgical sites. The LITe® BIO Delivery System consists of a delivery cannula, a delivery plunger, a delivery plunger tip, a loading syringe, and a delivery handle. The cannula is filled with the physician's choice of bone graft material and is then delivered to the intended surgical site.

AI/ML Overview

The provided text describes the 510(k) summary for the LITe® BIO Delivery System, a medical device. This document is a premarket notification for a Class II piston syringe intended to deliver bone grafting materials.

The document does not describe a study involving an AI/Machine Learning device. It refers to a physical medical device for delivering bone graft material. Therefore, the requested information regarding acceptance criteria, performance metrics, sample sizes for test/training sets, ground truth establishment, expert adjudication, or MRMC studies for an AI/ML device is not applicable to this document.

The "Summary of Performance Data" section lists several bench tests conducted to demonstrate the device's performance, but these are engineering performance criteria for a physical device, not an AI/ML algorithm.

Summary of Performance Data Provided:

The document states:
"Testing was conducted to demonstrate performance as intended and included the following bench testing:

  • Functional testing (delivery of graft material through cannula)
  • Life cycle testing
  • Cantilever bending of cannula
  • Radial compression of cannula
  • Retention strength test of cannula
  • Connection strength test of cannula to loading funnel"

This information aims to demonstrate that the LITe® BIO Delivery System is substantially equivalent to other currently marketed bone graft delivery systems and that its technological differences do not raise any new safety or effectiveness issues.

Therefore, I cannot provide the requested information about acceptance criteria and studies for an AI/ML device based on this document.

§ 880.5860 Piston syringe.

(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).