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K Number
K963402
Device Name
INNOVASIVE 2.8MM ROC SUTURE BONE FASTENER AND 3.5MM ROC SUTURE BONE FASTENER
Manufacturer
INNOVASIVE DEVICES, INC.
Date Cleared
1996-11-04

(67 days)

Product Code
MBI
Regulation Number
888.3040
Type
Traditional
Panel
OR
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The ROC fastener is intended for bladder neck suspension for female urinary incontinence due to urethral hypermobility.

Device Description

The Innovasive ROC Suture Bone Fastener is an implantable soft tissue fixation device complete with the instrumentation needed to effect soft tissue to bone repair. The devices consist of a high density polyethylene cartridge with an acetyl drive pin which is deployed into a pre-drilled hole in the bone. The Fastener is deployed through the use of a deployment handle made of molded polysulfone. The Fastener also has a stainless steel drive tool inside the cartridge which shears the implantable Fastener when deployed by the handle. The Fastener comes with various non-absorbable suture material.

In addition to the Fastener, a stainless steel drill guide is available to establish the proper hole for in the bone for the Fastener. A stainless steel and polysulfone extractor is included which can be used to remove the deployed Fastener should it be necessary. All of the instrumentation except the Fastener will be offered as reusable devices and can be autoclaved in the sterilization tray provided for this purpose.

The Fastener will be available as a sterile, single use device. Both sutured and sutureless versions will be marketed.

AI/ML Overview

This document describes a medical device called the "Innovasive ROC Suture Bone Fastener" and provides performance data for its 510(k) submission. However, it does not include information about AI/ML device performance, acceptance criteria, or studies for such devices.

The provided text describes a physical medical device used for soft tissue to bone repair, specifically for bladder neck suspension. The performance study mentioned is a cadaver study comparing the ultimate holding strength of the device to a predicate device.

Therefore, I cannot answer your request regarding:

  1. A table of acceptance criteria and reported device performance (for an AI/ML device)
  2. Sample size for the test set and data provenance (for an AI/ML device)
  3. Number of experts for ground truth and their qualifications (for an AI/ML device)
  4. Adjudication method (for an AI/ML device)
  5. MRMC comparative effectiveness study or effect size (for an AI/ML device)
  6. Standalone performance (for an AI/ML device)
  7. Type of ground truth used (for an AI/ML device)
  8. Sample size for the training set (for an AI/ML device)
  9. How ground truth for the training set was established (for an AI/ML device)

The document focuses on mechanical performance of a physical implant, not the performance of an AI/ML algorithm.

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.