The Reflex™ ACP System is intended for anterior intervertebral screw fixation of the cervical spine at levels C2-T1. The system is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with the following indications: Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), trauma (including fractures), tumors, deformities or curvatures (including kyphosis, lordosis or scoliosis), pseudoarthrosis, failed previous fusion, decompression of the spinal cord following total or partial cervical vertebrectomy, spondylolisthesis and spinal stenosis.

WARNING: This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

Device Description

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Reflex™ Anterior Cervical Plate System, focusing on adding indications to the device. However, it does not contain the detailed information necessary to answer all the questions regarding acceptance criteria and a study proving the device meets those criteria, especially in the context of AI/ML or a clinical study with human readers and ground truth.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (Synthes' Cervical Spine Locking Plate (CSLP) System) through mechanical properties.

Here's an attempt to answer the questions based only on the provided text, highlighting where information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Mechanical Properties	Reflex ACP System demonstrated comparable mechanical properties to the predicate device (Synthes' CSLP System).
Intended Use Equivalence	Substantially equivalent for the stated indications to the predicate device.
Material Equivalence	Both components (bone plates and screws) fabricated from titanium alloy, similar to predicate devices.

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

This information is not provided in the document. The study described is a mechanical test comparing the Reflex ACP System to a predicate device. There is no mention of a "test set" in the context of patient data, nor any data provenance (country of origin, retrospective/prospective).

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

This information is not provided. Ground truth in the context of clinical outcomes or expert consensus is not relevant to the type of study (mechanical testing) described.

4. Adjudication Method for the Test Set

This information is not provided. Adjudication methods are typically used in clinical studies involving interpretation or outcome assessment, which is not the case here.

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. The submission focuses solely on demonstrating substantial equivalence through mechanical testing, not on clinical performance or the impact of AI assistance on human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No, a standalone algorithm performance study was not done. This device is a physical medical implant (anterior cervical plate system), not an AI/ML software device.

7. The Type of Ground Truth Used

The "ground truth" used for this device's evaluation was primarily the mechanical performance and material characteristics of the legally marketed predicate device (Synthes' Cervical Spine Locking Plate (CSLP) System). The stated criterion is "comparable mechanical properties" to the predicate.

8. The Sample Size for the Training Set

This information is not provided. The concept of a "training set" is not applicable to the mechanical testing described for this physical medical device.

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

This information is not provided. The concept of "ground truth for a training set" is not applicable. The basis for comparison was the established mechanical properties of the predicate device.

Summary

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Reflex™ Anterior Cervical Plate System -- Additional Indications

510(k) Premarket Notification

510(k) Summary for Reflex" Anterior Cervical Plate System - Additional Indications

Proprietary Name:	Reflex™ Anterior Cervical Plate System
Common Name:	Anterior Cervical Plate System
Proposed Regulatory Class:	Class II
Classification Name and Reference:	Spinal Invertebral Body Fixation Orthosis21 CFR §888.3060
Device Product Code:	87 KWQ: Appliance, Fixation, Spinal Intervertebral Body
For Information contact:	Karen AriemmaRegulatory Affairs SpecialistHowmedica Osteonics Corp.59 Route 17Allendale, NJ 07401-1677Telephone: (201) 831-5718Fax: (201) 831-6038Email: kariemma@howost.com
Date Summary Prepared:	May 30, 2003

The purpose of this premarket notification is to add indications to the Reflex " Anterior Cervical Plate (ACP) System.

Predicate Device Information:

The Reflex " ACP System consists of bone plates and screws. Both components are available in a variety of lengths in order to accommodate patient physiology. The components are fabricated from titanium alloy. The implants will be provided non-sterile. The following system was already determined substantially equivalent for the desired indications: Synthes' Cervical Spine Locking Plate (CSLP) System.

Intended Use:

WARNING: This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

Performance Data:

Static and fatigue test results show the Reflex ACP System demonstrated comparable mechanical properties to the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 8 2003

Ms. Karen Ariemma Regulatory Affairs Specialist Howmedica Osteonics Corporation 59 Route 17 Allendale, NJ 07401-1677

Re: K031702

Trade/Device Name: Reflex™ Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWO Dated: May 30, 2003 Received: June 2, 2003

Dear Ms. Ariemma:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Karen Ariemma

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

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

Enclosure

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510(k) Number (if known): K ∞ 3 170 x

Device Name: Reflex Anterior Cervical Plate System

The Reflex ACP System is intended for anterior intervertebral screw fixation of the cervical spine at levels C2-T1. The system is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with the following indications:

Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of . the disc confirmed by history and radiographic studies)
Trauma (including fractures) .
Tumors ●
Deformities or curvatures (including kyphosis, lordosis or scoliosis) .
Pseudoarthrosis .
Failed previous fusion .
6 Decompression of the spinal cord following total or partial cervical vertebrectomy.
Spondylolisthesis ●
Spinal Stenosis ●

WARNING: This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

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

Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use OR Over-The-Counter Use

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

Muriam C. Provost

Division of General, Restorative and Neurological Devices

510(k) Number K031702

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.