The Osteonics® ACCP System components are intended to provide stabilization at single or multiple levels of the cervical spine, thus aiding in the development of a solid spinal fusion. Additionally, the Osteonics® ACCP System may be used to aid in the restoration of disc height in the presence of a tumor, vertebral trauma, or degenerative disease, pseudarthrosis, or previously failed fusions.

The indications for the use of the 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 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 Osteonics® ACCP is placed longitudinally on the long axis of the cervical spine and is affixed by unicortical bone screws. All Osteonics® ACCP System components are manufactured from ASTM F-136-98 (ISO 5832/3) titanium alloy.

AI/ML Overview

The provided text is a 510(k) Premarket Notification Summary for the Osteonics® ACCP System - Line Extension. This document focuses on demonstrating substantial equivalence to an existing predicate device rather than presenting a study with specific acceptance criteria, device performance, and detailed methodologies typically associated with new device efficacy or safety studies.

Therefore, many of the requested points regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth are not present in this type of submission. This document aims to show that the new device line extension is as safe and effective as the original Osteonics® ACCP System.

Here's an analysis of what can be extracted from the provided text according to your request:

1. A table of acceptance criteria and the reported device performance

The document does not specify quantitative acceptance criteria or detailed performance metrics from a dedicated study. The primary "acceptance criterion" for a 510(k) submission is demonstrating substantial equivalence to a predicate device. This is typically achieved by comparing design, material, intended use, and safety/effectiveness considerations.

Acceptance Criteria	Reported Device Performance (as implied by 510(k))
Substantial Equivalence to Predicate Device	The Osteonics® ACCP System Line Extension components are substantially equivalent in design and intended use to the monoblock cervical plates in the predicate Osteonics® ACCP System. Both are manufactured from ASTM F-136-98 (ISO 5832/3) titanium alloy.

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 provided. 510(k) submissions for line extensions or devices demonstrating substantial equivalence often leverage existing data or generally accepted engineering principles rather than conducting new clinical trials with specific test sets and patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided. The concept of "ground truth" as it relates to expert consensus on clinical data is not applicable in this 510(k) summary. The "ground truth" for a substantial equivalence claim revolves around engineering specifications, material properties, and intended use as compared to a predicate device.

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

This information is not provided. Adjudication methods are typically relevant in clinical trials where expert review of patient outcomes or imaging is required. This 510(k) summary does not describe such a 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

No such study is mentioned or implied. This document is not about AI-assisted diagnostics or interpretation.

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

This is not applicable, as the device is a spinal implant, not an algorithm.

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

The "ground truth" in the context of this 510(k) summary is the established safety and efficacy of the predicate device, the original Osteonics® ACCP System. The manufacturer asserts that the line extension shares the same fundamental design, materials, and intended use, and therefore can be considered equally safe and effective.

8. The sample size for the training set

This information is not provided. "Training set" is a concept typically used in machine learning or AI development, which is not relevant to this device submission.

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

Not applicable for the reasons stated above.

Summary

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510(k) PREMARKE T NOTIFICAT SUMMARY OF SAFETY AND EFFECTIVENESS OSTEONICS® ACCP SYSTEM - LINE EXTENSION

Submission Information
Name and Address of the Sponsorof the 510(k) Submission:	Howmedica Osteonics Corp.59 Route 17Allendale, NJ 07401-1677201-825-4900
Contact Person:	Kate SuttonRegulatory Affairs Consultant
Date Summary Prepared:	July 12, 1999
Device Identification
Proprietary Name:	Osteonics® Anterior Cervical CompressionPlating System - Line Extension
Common Name:	Anterior Cervical Compression Plate
Classification Name and Reference:	Spinal Invertebral Body Fixation21 CFR §888.3060

Predicate Device Identification

The subject Osteonics® ACCP System Line Extension components are substantially equivalent to the anterior cervical plates in the Osteonics® ACCP System.

Device Description

Intended Use

The Osteonics® ACCP System components are intended to provide stabilization at single or multiple levels of the cervical spine, thus aiding in the development of a solid spinal fusion.

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Additionally, the Osteonics® ACCP System may be used to aid in the restoration of disc height in the presence of a tumor, vertebral trauma, or degenerative disease, pseudarthrosis, or previously failed fusions.

Statement of Technological Comparison

The subject Osteonics® ACCP System Line Extension components are substantially equivalent in design and intended use to the monoblock cervical plates in the predicate Osteonics® ACCP System. The subject and predicate anterior cervical plates 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 Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 30 1999

Ms. Kate Sutton Regulatory Affairs Consultant Howmedica Osteonics Corporation 59 Route 17 Allendale. New Jersey 07401-1677

Re: K992344 Trade Name: Osteonics® ACCP System Regulatory Class: II Product Code: KWQ Dated: July 12, 1999 Received: July 14, 1999

Dear Ms. Sutton:

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 control provisions of the Act. The general control 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 regulations affecting your device can be found in the Code of Federal Regulations, 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 Regulation (QS) for Medical Devices: General Regulation (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 action. In addition, FDA may publish further announcements 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 regulations.

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.

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Page 2 – Ms. Kate Sutton

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 at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D. 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): K___________________________________________________________________________________________________________________________________________________

Device Name: Osteonics® ACCP System - Line Extension

Indications For Use:

. 13:40

The indications for the use of the 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	K992344
Prescription Use(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.