The Olsen Medical Dynamic and Semiconstrained Plates are intended for anterior screw fixation of the cervical spine (C2 to C7) for the following indications: degenerative disc disease (neck pain of discogenic origin with degeneration of the disc, confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis and tumors (primary and metastatic), deformities or curvatures (i.e., scoliosis, kyphosis, and lordosis), pseudoarthrosis and failed previous fusions.

Device Description

The Olsen Medical Anterior Cervical Vertebrae Plate System consists of plates and locking screws. The plate attaches to the anterior portion of the vertebral body of the cervical spine (levels C2 to C7). The Olsen Medical Dynamic and Semiconstrained Plate Systems each come in lengths ranging from 23mm to 109mm. All of the plates, regardless of the length, are 16mm and 19mm wide at the cephalad and caudal ends of the plate, respectively. The Dynamic Plates have slots to receive the screws and the Semiconstrained Plates have round holes to receive the screws. All other plate dimensions are the same. Both plates each have tack holes and drill guide holes at the cephalad and caudal ends of the plate. Both plates are curved both in the longitudinal and lateral planes. The implants of these systems are manufactured from medical grade titanium alloy Ti6 Al4 V meeting the requirements of ASTM F136 or ASTM 1472.

AI/ML Overview

The provided text describes a 510(k) summary for the Olsen Medical Anterior Cervical Vertebrae Plate System, which is a medical device. It is important to note that a traditional acceptance criteria table and a study proving device performance as typically understood for an AI/CADe device (e.g., sensitivity, specificity, AUC) are not applicable to this type of device submission.

This 510(k) submission is for a spinal intervertebral body fixation orthosis, which is a physical implant. The "performance data" section clearly states: "Testing for substantial equivalence to the Synthes CSPL Variable Angle device is done per ASTM 1717 in accordance with FDA Guidance for Spinal System 510(k)s, May 3, 2004." This indicates that the performance evaluation focuses on mechanical properties and biocompatibility, as per established engineering standards for orthopedic implants, rather than diagnostic accuracy or algorithmic performance.

Therefore, many of the requested fields related to AI/CADe device studies (like sample size for test sets, expert ground truth, MRMC studies, standalone performance, training set details) are not relevant to this document.

However, I can extract the relevant information regarding the "acceptance criteria" (which in this context refers to the standards met for substantial equivalence) and the "study" (referring to the testing conducted).

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Standard Met for Substantial Equivalence)	Reported Device Performance (Reference)
Substantial equivalence to Synthes CSKP Variable Angle Cervical Plate Locking System (K031276)	Testing done per ASTM F1717
Adherence to FDA Guidance for Spinal System 510(k)s, May 3, 2004	Compliant with FDA Guidance
Material requirements for Ti6 Al4 V	Implants manufactured from medical grade titanium alloy Ti6 Al4 V meeting the requirements of ASTM F136 or ASTM F1472
Intended Use: Anterior screw fixation of cervical spine (C2-C7) for specified indications (degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, tumors, deformities, pseudoarthrosis, failed fusions)	"The Olsen Medical Dynamic and Semiconstrained Plates are intended for anterior screw fixation of the cervical spine (C2 to C7) for the following indications: degenerative disc disease... [and other listed indications]."

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

Sample Size: Not specified in terms of patient/case count. For mechanical testing of implants, "sample size" typically refers to the number of test articles (e.g., plates, screws) subjected to mechanical loads. This specific quantity is not detailed in the provided summary, but ASTM F1717 would define the required number of samples.
Data Provenance: Not applicable in the context of clinical patient data. The testing is laboratory-based mechanical testing.

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

Not applicable. Ground truth in this context is defined by objective engineering measurements (e.g., fatigue strength, pull-out force) as per ASTM standards, not expert medical consensus.

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

Not applicable. Adjudication methods are relevant for clinical endpoints or diagnostic accuracy, not mechanical device testing.

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:

Not applicable. This is not an AI/CADe device.

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

Not applicable. This is not an AI/CADe device.

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

Ground Truth: Objective mechanical properties and material specifications as defined by engineering standards (ASTM F1717, ASTM F136, ASTM F1472). These standards outline quantifiable metrics for performance (e.g., stiffness, strength, durability) and material composition.

8. The sample size for the training set:

Not applicable. This is not a machine learning device.

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

Not applicable. This is not a machine learning device.

Summary of the study that proves the device meets the acceptance criteria:

The study proving the device meets the acceptance criteria is a bench-top mechanical performance testing study conducted in accordance with ASTM F1717, and raw material verification against ASTM F136 or ASTM F1472. This testing demonstrates that the Olsen Medical Anterior Cervical Vertebrae Plate System possesses comparable mechanical and material properties to the predicate device (Synthes CSKP Variable Angle Cervical Plate Locking System, K031276) and is suitable for its indicated use. The specific details of the individual test results (e.g., ultimate tensile strength, fatigue life cycles) are not provided in this summary but would have been part of the full 510(k) submission to the FDA. The submission states compliance with "FDA Guidance for Spinal System 510(k)s, May 3, 2004," further solidifying the methodology used to establish substantial equivalence.

Summary

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510(k) Summary

SUBMITTED BY

Doug Mc Whorter Olsen Medical 3001 W Kentucky Street Louisville, KY 40211

Date Submitted: July 20, 2004

CLASSIFICATION, COMMON OR USUAL NAME, DEVICE NAME

Trade/Proprietary Name: Common/Usual Name: Device Product Code: Classification:

Olsen Medical Anterior Cervical Vertebrae Plate System Cervical Plating Instrumentation KWO 888.3060 Spinal Intervertebral Body Fixation Orthosis

PREDICATE DEVICE

Classification Name:

Synthes CSKP Variable Angle Cervical Plate Locking System (K031276)

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR §807.92

DEVICE DESCRIPTION AND MATERIALS OF CONSTRUCTION

The Olsen Medical Dynamic and Semiconstrained Plate Systems each come in lengths ranging from 23mm to 109mm. All of the plates, regardless of the length, are 16mm and 19mm wide at the cephalad and caudal ends of the plate, respectively. The Dynamic Plates have slots to receive the screws and the Semiconstrained Plates have round holes to receive the screws. All other plate dimensions are the same. Both plates each have tack holes and drill guide holes at the cephalad and caudal ends of the plate. Both plates are curved both in the longitudinal and lateral planes.

The implants of these systems are manufactured from medical grade titanium alloy Ti6 Al4 V meeting the requirements of ASTM F136 or ASTM 1472.

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INDICATIONS FOR USE

PERFORMANCE DATA

Testing for substantial equivalence to the Synthes CSPL Variable Angle device is done per ASTM 1717 in accordance with FDA Guidance for Spinal System 510(k)s, May 3, 2004.

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Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is an emblem of an abstract bird-like figure, which is the symbol of the Department of Health & Human Services.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB - 7 2005

Mr. Larry D. Potts Olsen Medical 3001 West Kentucky Street Louisville, Kentucky 40211

Re: K042073

Trade/Device Name: Anterior Cervical Vertebrae Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWQ Dated: January 13, 2004 Received: January 13, 2004

Dear Mr. Potts:

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.

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Page 2 - Mr. Larry D. Potts

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. 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 (240) 276-0120. 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/industry/support/index.html.

Sincerely yours.

Mark H. Milken

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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Indications for Use:

510(k) Number (if known): K042073

Device Name:

Indications For Use:

Page 1 of 1

Olsen Medical Anterior Cervical Vertebrae Plate System The Olsen Medical Dynamic and Semiconstrained Plates are

intended for anterior screw fixation of the cervical spine (C2 to C7) for the following indications: degenerative disc disease (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis and tumors (primary and metastatic), deformities or curvatures (i.e., scoliosis, kyphosis, and lordosis), pseudoarthrosis and failed previous fusions.

Prescription Use V (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A. Melkeson

and New

K042073
510(k) Number

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.