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.

Summary

{0}------------------------------------------------

0CT 22 1999

K993181

SPECIAL 510(k) PREMARKET NOTIFICATION SUMMARY OF SAFETY AND EFFECTIVENESS HOWMEDICA OSTEONICS® ACCP SYSTEM - CORTICAL SCREWS

Submission Information

Name and Address of the Sponsor of the 510(k) Submission:	Howmedica Osteonics Corp.59 Route 17Allendale, NJ 07401-1677201-825-4900
Contact Person:	Mary-Catherine DillonRegulatory Affairs Team Member
Date Summary Prepared:	September 22, 1999

Device Identification

Proprietary Name:	Howmedica Osteonics® Anterior Cervical Compression Plating System - Cortical Screws
Common Name:	Anterior Cervical Compression Plate
Classification Name and Reference:	Spinal Invertebral Body Fixation21 CFR §888.3060

Predicate Device Identification

The Howmedica Osteonics® ACCP System Cortical Screws are substantially equivalent to the cortical bone screws in the Howmedica Osteonics® ACCP System.

Device Description

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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 vertebrectorny .
trauma (fractures) ●
. tumors
pscudarthrosis
failed previous fusions ●

Statement of Technological Comparison

The subject Howmedica Osteonics® ACCP System Cortical Screw components are substantially equivalent in design and intended use to the cortical bone screws in the predicate Osteonics® ACCP System. The subject and predicate bone screws are manufactured from ASTM F-136-98 (ISO 5832/3) titanium alloy.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is a stylized image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 22 1999

Ms. Elizabeth A. Staub Vice President - Quality Assurance, Regulatory Affairs, Clinical Reasearch Howmedica Osteonics Corporation 59 Route 17 Allendale, New Jersey 07401-1677

K993181 Re: Howmedica Osteonics® ACCP Trade Name: System Cortical Screws Requlatory Class: II Product Code: KWQ September 20, 1999 Dated: Received: September 23, 1999

Dear Ms. Staub:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

{3}------------------------------------------------

Page 2 - Ms. Elizabeth A. Staub

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten Ph.D. M.D.

Ph.D., M.D. Celia M. Witten, Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K99318/

Device Name: Howmedica Osteonics® ACCP System Cortical Screws

Indications For 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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number	K993181
Prescription Use	X
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)

Regulation Number and Section

§ 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.