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K Number
K993181
Device Name
HOWMEDICA OSTEONICS ACCP SYSTEM CORTICAL SCREWS
Manufacturer
HOWMEDICA OSTEONICS CORP.
Date Cleared
1999-10-22

(29 days)

Product Code
KWQ
Regulation Number
888.3060
Type
Special
Panel
OR
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The indications for the use of the Howmedica Osteonics® ACCP System are as follows:

  • degenerative disc disease (neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies).
  • decompression of the spinal cord following total or partial cervical vertebrectomy .
  • . trauma (fractures)
  • . tumors
  • pseudarthrosis .
  • . failed previous fusions
Device Description

The Howmedica Osteonics® ACCP System is an anterior cervical single or multi-level plate that incorporates either a monoblock or modular design, which is measured from end to end. Modular end plate sections are secured to each other using locking screws, and are provided preassembled. The Howmedica Osteonics® ACCP is placed longitudinally on the long axis of the cervical spine and is affixed by cortical bone screws. All Howmedica Osteonics® ACCP System components are manufactured from ASTM F-136-98 (ISO 5832/3) titanium alloy.

AI/ML Overview

The provided document is a 510(k) Premarket Notification Summary for the Howmedica Osteonics® ACCP System - Cortical Screws. This document focuses on the substantial equivalence of a new device to a predicate device, rather than providing details on a study performed to meet specific acceptance criteria for a novel device.

Therefore, most of the requested information regarding acceptance criteria and a study proving the device meets those criteria cannot be extracted from this document, as it describes a regulatory submission for a device component based on equivalence, not a new device requiring extensive performance testing against defined metrics.

Here's a breakdown of what can be inferred or stated from the provided text based on your request:

1. Table of acceptance criteria and the reported device performance:

This information is not present in the document. The submission is a 510(k) for a component (cortical screws) of an existing system (ACCP System). The primary "acceptance criteria" here is substantial equivalence to a predicate device, not performance metrics from a new study.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

This information is not present. The document does not describe a performance study with a test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not present. There is no "test set" described as part of a performance study.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This information is not present. There is no "test set" described as part of a performance study.

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:

This information is not present. The device is a physical medical implant (cortical screws), not an AI-assisted diagnostic or therapeutic tool. Therefore, an MRMC study related to AI assistance would not be applicable.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This information is not present. The device is a physical medical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

This information is not present. There is no "ground truth" mentioned as part of a performance study. The ground for the submission is the substantial equivalence to an existing, legally marketed predicate device.

8. The sample size for the training set:

This information is not present. The document does not describe a machine learning algorithm or a training set.

9. How the ground truth for the training set was established:

This information is not present. The document does not describe a machine learning algorithm or a training set.

Summary of Device and Regulatory Basis (from the document):

  • Device Name: Howmedica Osteonics® Anterior Cervical Compression Plating System - Cortical Screws
  • Common Name: Anterior Cervical Compression Plate
  • Classification Name and Reference: Spinal Invertebral Body Fixation (21 CFR §888.3060)
  • Predicate Device: Cortical bone screws in the Howmedica Osteonics® ACCP System.
  • Basis for Acceptance: Substantial equivalence in design, intended use, and material (ASTM F-136-98 (ISO 5832/3) titanium alloy) to the predicate device.
  • Intended Use/Indications: Degenerative disc disease, decompression of the spinal cord (following total or partial cervical vertebrectomy), trauma (fractures), tumors, pseudarthrosis, and failed previous fusions.

§ 888.3060 Spinal intervertebral body fixation orthosis.

(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.