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 plate that incorporates a one-piece monoblock design, or a two- or three-piece modular design, depending on plate length, which is measured from end to end. Modular end plate sections are secured to each other using locking screws, and are provided preassembled. Optional bone graft screws are also available for insertion through the center screw hole of the modular plate designs. The Osteonics® ACCP is placed logitudinally on the long axis of the cervical spine and is affixed by unicortical bone screws. The Osteonics® ACCP is available in lengths ranging from 24mm to 100mm. A slotted locking screw hole on the proximal and distal end of each preassembled plate allows the surgeon to adjust the plate in order to apply compression to a specific area along the cervical spine, thus optimizing the compressive forces which aid in achieving a successful fusion. Locking screws are firmly tightened after the surgeon has adjusted the plate to the desired level of compression. All Osteonics® ACCP System components are manufactured from ASTM F-136-96 titanium alloy.

AI/ML Overview

The provided text indicates that the Osteonics® ACCP System (Anterior Cervical Compression Plating System) was cleared through the 510(k) pathway by demonstrating substantial equivalence to a predicate device, specifically anterior cervical plates offered by Synthes. This means the primary "acceptance criteria" and the "study that proves the device meets the acceptance criteria" largely revolve around this concept of substantial equivalence rather than a detailed performance study with quantitative metrics for the Osteonics® ACCP System itself.

Here's a breakdown of the requested information based on the provided text, highlighting what is implicitly or explicitly stated:

1. Table of Acceptance Criteria and Reported Device Performance

The core acceptance criterion for a 510(k) submission is substantial equivalence to a predicate device.

Acceptance Criteria (Implicit for 510(k) Substantial Equivalence)	Reported Device Performance (Osteonics® ACCP System)
Intended Use Equivalence:	The Osteonics® ACCP System is intended for anterior intervertebral screw fixation of the cervical spine for the same indications as legally marketed anterior cervical plates (e.g., degenerative disc disease, decompression, trauma, tumors, pseudarthrosis, failed previous fusions). This explicitly matches the indications for use of the predicate device.
Technological Characteristics Equivalence:	The Osteonics® ACCP System (titanium alloy, one-piece monoblock or modular design, locking screws, compression adjustment) is considered substantially equivalent in design and intended use to the predicate anterior cervical plates offered by Synthes. The only noted material difference is the use of ASTM F-136-96 titanium alloy for the subject device versus commercially pure titanium (CPT) for the predicate.
Safety and Effectiveness Equivalence:	The FDA's clearance letter ("We have determined the device is substantially equivalent...") signifies that, based on the information provided, the device is considered as safe and effective as the legally marketed predicate device. No specific clinical performance metrics (e.g., fusion rates, complication rates) are reported for the Osteonics® ACCP System in this submission summary.

Note: For 510(k) submissions, the acceptance criteria are not typically expressed as numerical performance targets (e.g., "fusion rate > 90%") for the new device, but rather as demonstrating that the device is as safe and effective as a legally marketed predicate device (which presumably met such standards in its own approval process).

2. Sample Size Used for the Test Set and Data Provenance

The provided document does not describe a clinical performance study with a distinct "test set" and sample size for the Osteonics® ACCP System. The submission relies on a comparison to a predicate device to establish substantial equivalence. Therefore, there is no information on:

Sample size for a test set
Country of origin of data
Retrospective or prospective nature of data

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Since no clinical "test set" or performance study for the Osteonics® ACCP System is described, there is no information on:

Number of experts used to establish ground truth
Qualifications of those experts

4. Adjudication Method for the Test Set

As no clinical "test set" or performance study is described, there is no information on an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or described in this submission. This type of study is more common for diagnostic imaging AI devices, whereas this submission is for a medical implant (anterior cervical plate).

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. The Osteonics® ACCP System is a physical medical implant, not an algorithm or AI-driven device.

7. The Type of Ground Truth Used

For this 510(k) submission, the "ground truth" essentially comes from the established safety and effectiveness of the predicate device (Synthes anterior cervical plates) and clinical experience with similar devices. The regulatory pathway relies on demonstrating that the new device is sufficiently similar to the predicate that it can be assumed to operate with the same level of safety and effectiveness, leveraging the existing "ground truth" of the predicate. No specific pathology, outcomes data, or expert consensus was directly established for a new clinical trial concerning the Osteonics® ACCP System within this submission.

8. The Sample Size for the Training Set

The provided document does not describe a training set in the context of an algorithm or AI. It describes a physical medical device.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set mentioned for this physical device.

Summary

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3/25/99

ATTACHMENT 10

11982798

510(k) PREMARKET NOTIFICATION SUMMARY OF SAFETY AND EFFECTIVENESS OSTEONICS® ACCP SYSTEM

Submission Information
Name and Address of the Sponsorof the 510(k) Submission:	Osteonics Corporation59 Route 17Allendale, NJ 07401-1677201-825-4900
Contact Person:	Kate SuttonRegulatory Affairs Specialist
Date Summary Prepared:	February 5, 1998
Device Identification
Proprietary Name:	Osteonics® Anterior Cervical CompressionPlating System
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 components are substantially equivalent to similar anterior cervical plates offered by Synthes.

Device Description

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Intended Use

The Osteonics® ACCP System is intended for anterior intervertebral screw fixation of the cervical spine for the following indications:

· 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

Statement of Technological Comparison

The subject Osteonics® ACCP System components are substantially equivalent in design and intended use to the predicate anterior cervical plates offered by Synthes. The subject anterior cervical plate is manufactured from ASTM F-136-96 titanium alloy, and the predicate anterior cervical plate is manufactured from commercially pure titanium (CPT).

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 5 1999

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

K982798 Re: Osteonics® Anterior Cervical Compression Trade Name: Plating (ACCP) System Regulatory Class: II Product Code: KWQ Dated: February 5, 1999 February 8, 1999 Received:

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 controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, qood 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. ਜੋ 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 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 regulations.

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Page 2 - Ms. Kate Sutton

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.
Director
Division of General and
Restorative Devices
Office of Device Evaluation
Center for Devices and
Radiological Health

Enclosure

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ATTACHMENT 9

510(k) Number (if known): K 982 7 9 &

Device Name: Osteonics® ACCP System

Indications For Use:

The indications for use of the Osteonics® ACCP System, in keeping with those of other legally marketed anterior cervical plates, are as follows.

The Osteonics® ACCP System is intended for anterior intervertebral screw fixation of the cervical spine for the following indications:

degenerative disc disease (neck pain of discogenic origin with degeneration of the disc . confirmed by patient history and radiographic studies)
t 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)

Prescription Use Y

Over-The-Counter Use

(Optional Format 1-2-96)

Diode

(Division Sign-Off)
Division of General Restorative Devices K9827
510(k) Number

(Per 21 CFR 801.109)

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.