The Envision™ Anterior Cervical Plate System is intended for the treatment of the cervical spine in skeletally mature patients receiving fusion by autogenous and/or allogenic bone graft. The implants are attached to the anterior cervical spine (C2-T1) with removal of the implant after the attainment of a solid fusion mass. The Envision Anterior Cervical Plate System is intended for use under the following indications:

Degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
Spondylolisthesis
Trauma (i.e., fracture)
Tumor
Deformity (i.e., kyphosis, lordosis, and scoliosis)
Spinal stenosis
Pseudarthrosis
Failed previous fusion

Device Description

The Ortho Development Envision Anterior Cervical Plate System system is a cervical spinal fixation device, which consists of a variety of bone plates and bone screws. Fixation is provided by the insertion of bone screws thought the openings at each end of the plate into the anterior portion of vertebral bodies of the cervical spine. The devices are manufactured from Ti-6Al-4V alloy per ASTM F-136. The Envision Anterior Cervical Plate System functions to provide a means to fuse the cervical spine.

AI/ML Overview

The provided text describes a submission for the Ortho Development Envision Anterior Cervical Plate System. This is a medical device designed for cervical spinal fixation.

Here's an analysis of the acceptance criteria and study information, based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria/Test	Reported Device Performance
Biomechanical Performance	Static and fatigue compression testing per ASTM F1717-96	Similar to the performance of previously cleared spinal systems with similar indications.
	Static torsion testing per ASTM F1717-96	Similar to the performance of previously cleared spinal systems with similar indications.
Material Composition	Manufactured from Ti-6Al-4V alloy	Meets ASTM F-136 standard for Ti-6Al-4V alloy.

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

The provided documentation describes non-clinical performance testing (mechanical testing), not a test set based on patient data. Therefore, the concept of a "test set" in the context of clinical data provenance or sample size doesn't apply directly here. The testing was conducted on manufactured devices.

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

This question is not applicable. The assessment was based on mechanical testing results against an ASTM standard, not expert consensus on clinical cases.

4. Adjudication Method for the Test Set

This question is not applicable. The assessment was based on mechanical testing results, not a clinical adjudication process.

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

No, an MRMC comparative effectiveness study was not done. The submission explicitly states: "Clinical data and conclusion were not needed for this device."

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

This question is not applicable. The device is a physical medical implant, not a software algorithm.

7. The Type of Ground Truth Used

The ground truth used for the device's performance was compliance with a recognized industry standard (ASTM F1717-96 for mechanical testing). This standard defines accepted biomechanical performance characteristics for spinal fixation devices.

8. The Sample Size for the Training Set

This question is not applicable. The device is a physical medical implant, not an AI/ML algorithm. There is no concept of a "training set" in this context.

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

This question is not applicable for the same reason as above. There is no training set for this type of device.

Overall Context of the Submission:

It's important to note that this document is a 510(k) premarket notification for a medical device. The primary method for demonstrating "substantial equivalence" in a 510(k) is often through comparison to legally marketed predicate devices and non-clinical testing (like biomechanical), rather than extensive new clinical trials, especially when the technology is well-established. The FDA's letter explicitly states that they found the device "substantially equivalent" to predicate devices and that clinical data was not needed for this particular submission.

Summary

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SUMMARY OF SAFETY AND EFFECTIVENESS:

This safety and effectiveness summary for the Ortho Development Envision Anterior Cervical Plate System is provided as required per Section 513(i)(3) of the Food, Drug, and Cosmetic Act.

Submitter: 1.
Ortho Development Corporation 12187 South Business Park Drive Draper, Utah 84020
Contact Person: 2. Carol Freasier Telephone: (801) 553-9991 Fax: (801) 553-9993
Date Prepared: 3. February 27, 2002
Name of the Device 4...
খ Trade Name: Proprietary Name: Common Name: Classification Name: Product Code: Reference:

Ortho Development Envision Anterior Cervical Plate System Envision Anterior Cervical Plate System Appliance, Fixation, Spinal Intervertebral Body Orthosis Spinal Fixation System KWQ (888.3060)

Description of the Device: 5.
The Ortho Development Envision Anterior Cervical Plate System system is a cervical spinal fixation device, which consists of a variety of bone plates and bone screws. Fixation is provided by the insertion of bone screws thought the openings at each end of the plate into the anterior portion of vertebral bodies of the cervical spine.

The devices are manufactured from Ti-6Al-4V alloy per ASTM F-136. Materials:

The Envision Anterior Cervical Plate System functions to provide a means to fuse Function: the cervical spine.

Intended Use: 6.
The Envision Anterior Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine at levels C2-T1. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with :
Degenerative disc disease (defined as neck pain of discogenic origin with degeneration . of the disc confirmed by patient history and radiographic studies)
Spondylolisthesis ●
Trauma (i.e., fracture) .
Tumer .
Deformity (i.e., kyphosis, lordosis, and scoliosis) .
Spinal stenosis .
Pseudarthrosis .

Page 1 of 2

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Failed previous fusion .
1. Predicate or legally marketed devices which are substantially equivalent:
- Synthes Anterior CSLP System (Synthes) .
- . EBI Vuelock Anterior Cervical Plate System (EBI)
- Window Cervical Dynamic Plate System (Advanced Spine Technology) .
Comparison of the technological characteristics of the device to predicate and legally marketed 8. devices:

There are no significant differences between the components of the Ortho Development Envision Anterior Cervical Plate System and other commercially available cervical plating systems currently being marketed, which would adversely affect the use of the product.

Mechanical testing shows the biomechanical performance of the subject device to be similar to the performance of previously cleared spinal systems with similar indications. It is substantially equivalent to these other devices in design, function, material and intended use.

ഗ് Non-clinical Performance and Conclusions:
The Food and Drug Administration have established no performance standards applicable to anterior cervical plating systems. However, static and fatigue compression and static torsion testing of the Envision Anterior Cervical Plate System were performed according to ASTM F1717-96. Data regarding the functional performance of the proposed Envision Anterior Cervical Plate System has been generated.
1. Clinical Performance and Conclusion:
  Clinical data and conclusion were not needed for this device.

Page 2 of 2

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Carol Freasier Regulatory Affairs Ortho Development Corporation 12187 S. Business Park Drive Draper. Utah 84020

APR = 5 2002

Re: K020649 Envision Anterior Cervical Plate System Regulation Number: 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: II Product Code: KWQ Dated: February 27, 2002 Received: February 28, 2002

Dear Ms. Freasier:

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 (OS) 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. Carol Freasier

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 and additionally 21 CFR Part 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» (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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 vours.

Sincerely yours,

for Mark A Millikan

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):

K020649

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Device Name: Envision Anterior Cervical Plate System

Indications for Use

The Envision™ Anterior Cervical Plate System is intended for the treatment of the The Envical - Antenor our noal : receiving fusion by autogenous and/or cervical spine in okelotally matare pare attached to the anterior cervical spine (C2-T1) allogenie bono grant: "plants after the attainment of a solid fusion mass. The with removal of the implical Plate System is intended for use under the following indications:

Degenerative disc disease (defined as neck pain of discogenic origin with . degeneration of the disc confirmed by patient history and radiographic studies)
Spondylolisthesis .
Trauma (i.e., fracture)
Tumor
Deformity (i.e., kyphosis, lordosis, and scoliosis)
Spinal stenosis
Pseudarthrosis
Failed previous fusion

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mach. N. Miller

(Division Sien-Off) Division of General, Restorative and Neurological Devices

510(k) Number K020694

Prescription Use
(Per 21 CFR 801.109)

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.