The ArcTecTM Semi-Rigid Plating System is intended for posterior, noncervical, pedicle fixation in order to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine, including degenerative spondylolisthesis with objective evidence of neurological impairment; fracture; dislocation; scoliosis; spinal tumor; and failed previous fusion (pseudarthrosis).

In addition, when used as a pedicle screw fixation system, the ArcTec™ Semi-Rigid Plating System is intended for skeletally mature patients with severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra, who are receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 and below), with removal of the implants after the attainment of solid fusion.

Device Description

The ArcTec™ Semi-Rigid Plating System includes plates, bolts, washers and locking nuts in addition to standard surgical instrumentation. The semi-rigid low profile plate has a low stiffness and is easy to contour. The patent pending washer design incorporates a unique polyaxial bandclamp feature that allows unlimited range of placement on the plate and screw angulation of up to 10 degrees in any plane. The system combines the simplicity of a plate with the adaptability of a polyaxial screw connection.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the ArcTec™ Semi-Rigid Plating System. This is a medical device for spinal fixation, not an AI/ML-based device. Therefore, many of the requested criteria related to AI/ML device performance and testing (such as effect size of human readers with AI, standalone algorithm performance, training set details, and ground truth establishment for AI models) are not applicable to this document.

However, I can extract information regarding the device's performance justification based on the mechanical testing described.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion	Reported Device Performance
Mechanical performance	Mechanical testing in accordance with ASTM F1717 was conducted.
Substantial equivalence	Sufficient information is included to reach a determination of substantial equivalence to predicate devices based on intended use, function, design, material, and mechanical performance.

2. Sample size used for the test set and the data provenance

Test set: Not applicable in the context of an AI/ML device. For this mechanical device, the "test set" refers to the physical devices subjected to mechanical testing. The document does not specify the number of samples used for ASTM F1717 testing.
Data provenance: Not applicable. The testing is described as mechanical testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Experts: Not applicable. This device is evaluated through mechanical testing, not by human experts establishing ground truth for diagnostic accuracy.

4. Adjudication method for the test set

Adjudication method: Not applicable. This concept is relevant for reconciling expert disagreements in diagnostic studies, which is not the case here.

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

MRMC study: No. This is a mechanical spinal implant, not an AI-assisted diagnostic tool for which MRMC studies would be conducted.
Effect size: Not applicable.

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

Standalone performance: Not applicable. This device does not have an "algorithm only" component.

7. The type of ground truth used

Ground truth: For mechanical performance, the "ground truth" is defined by the standards and metrics outlined in ASTM F1717 for spinal implant testing. The document does not specify which particular aspects of ASTM F1717 were evaluated (e.g., static compression, fatigue, etc.), but it refers to the standard generally.

8. The sample size for the training set

Training set sample size: Not applicable. This is not an AI/ML device that requires a training set.

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

Ground truth for training set: Not applicable.

Summary of Device Performance Justification:

The ArcTec™ Semi-Rigid Plating System demonstrates its performance and safety through mechanical testing in accordance with ASTM F1717. This testing serves as the basis for establishing substantial equivalence to legally marketed predicate devices, considering its intended use, function, design, material, and overall mechanical performance. The FDA reviewed this information and found the device substantially equivalent.

Summary

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

K a51044 p 1/2

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (21CFR 807.92)

OCT 7 - 2005

I. DATE PREPARED: October 03, 2005
II. SUBMITTED BY: Altiva Corporation 9800 Southern Pines Blvd. Suite I Charlotte, NC 28273
III. CONTACT PERSON: John Kapitan

Director of Regulatory Affairs & Quality Assurance (704) 409-1754

IV. DEVICE NAME: Trade/Proprietary Name: ArcTecTM Semi-Rigid Plating System
V. DEVICE CLASSIFICATION NAME: Pedicle screw spinal system 21 CFR 888.3070, Class II MNH, MNI
PREDICATE DEVICE INFORMATION: VI.

Simmons Stainless Steel Plating System (K930353) Ultium Plating System (K962784) HydraLok System (K051216) Rogozinski Spinal System (K983899) Titanium Moss Miami Spinal System (K964024)

VII. DEVICE DESCRIPTION:

The ArcTec™ Semi-Rigid Plating System includes plates, bolts, washers and locking nuts in addition to standard surgical instrumentation.

{1}------------------------------------------------

KOSIO44 p½

The semi-rigid low profile plate has a low stiffness and is easy to contour. The patent pending washer design incorporates a unique polyaxial bandclamp feature that allows unlimited range of placement on the plate and screw angulation of up to 10 degrees in any plane. The system combines the simplicity of a plate with the adaptability of a polyaxial screw connection.

VIII. MATERIALS:

The implant components are manufactured from titanium alloy (Ti-6Al-4V per ASTM F136). The implant components are for single use only.

IX. INDICATION FOR USE:

The ArcTec™ Semi-Rigid Plating System is intended for posterior, noncervical, pedicle fixation in order to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine, including degenerative spondylolisthesis with objective evidence of neurological impairment; fracture; dislocation; scoliosis; spinal turnor; and failed previous fusion (pseudarthrosis).

X. SAFETY INFORMATION:

Only surgeons trained and experienced in spinal decompression and bone grafting techniques should use the Arc Tec TM Semi-Rigid Plating System. In addition, thorough familiarization with the implants, instrumentation, and surgical technique is essential. Federal law (U.S.A.) restricts this device to sale by or on the order of a physician.

XI. PERFORMANCE DATA

Mechanical testing in accordance with ASTM F1717 was conducted to evaluate performance as a basis for substantial equivalence.

XII. CONCLUSION

Altiva believes sufficient information is included to reach a determination of substantial equivalence to the predicate devices based on intended use, function, design, material and mechanical performance.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized eagle with three stripes forming its body and wings. The eagle is enclosed within a circle, and the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is written around the upper portion of the circle.

OCT 7 - 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

John Kapitan Director of Regulatory Affairs and Quality Altiva Corporation 9800 Southern Pine Boulevard, Suite 1 Charlotte, North Carolina 28273

Re: K051044

Trade/Device Name: ArcTec™ Semi-Rigid Plating System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: II Product Code: MNH, MNI Dated: September 9, 2005 Received: September 12, 2005

Dear Mr. Kapitan:

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.

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

Page 2- John Kapitan

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 logal|y marketed predicate device results in a classification for your device and thus, permits wourderice 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 (240) 276-0120. Also, please note the regulation onitible, "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/industry/support/index.html .

Sincerely yours,

Mark N. Melkerson, Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Indications for Use

510(k) Number (if known): KOS1044

Device Name: ArcTecTM Semi-Rigid Plating System

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

"Caution: Federal law restricts this device to sale by or on the order of a "physician"

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
---------------------

Division of General, Restorative,
and Neurological Devices

510(k) Number	K051044
---------------	---------

Page 1 of 1

Regulation Number and Section

N/A