The Highgate Curved Rod System is intended for unilateral screw fixation of the anterolateral thoracolumbar spine from To to L5. The Highgate Curved Rod System is intended to provide stabilization of a spinal segment as an adjunct to spinal fusion. Indications for the use of this device include spondylolisthesis (Grades 1 and 2), spinal stenosis, pseudarthrosis, failed fusion or degenerative disc disease (DDD) defined as back pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies. The Highgate Curved Rod System is not intended for patients having severe spondylolisthesis (Grades 3 and 4), deformities or curvatures, tumor or trauma i.e. vertebral fracture.

Device Description

The Highgate Curved Rod System is available in titanium alloy (Ti6A14V, ASTM F136) and includes rods and screws. Lateral and end screws are used to attach the rod to the thoracolumbar spine. Rods are offered in two curvatures and have circular openings accommodate the screws.

AI/ML Overview

The provided text describes the Highgate Curved Rod System, a medical device for spinal fixation, and its approval through a 510(k) premarket notification. However, it does not contain information about acceptance criteria, a specific study proving the device meets those criteria, or details regarding performance evaluation with human readers or standalone AI performance. The document primarily focuses on the device's description, materials, intended use, and substantial equivalence to existing devices.

Therefore, many of the requested details cannot be extracted from the given text. Below is an attempt to answer the questions based only on the provided information, noting where information is absent.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not specified in the document	"Static and fatigue mechanical testing were supplied in support of the Highgate Curved Rod System 510(k) premarket notification." (Specific performance metrics or comparison against a benchmark are not provided in the summary.)
Substantial Equivalence to predicate devices	"The Highgate Curved Rod System was determined to be substantially equivalent to several commercially available systems." (Specific criteria for 'substantial equivalence' are not detailed in this summary for performance.)
Indications for Use (correct application conditions)	The device is intended for "unilateral screw fixation of the anterolateral thoracolumbar spine from T10 to L5" as an adjunct to spinal fusion for conditions like "spondylolisthesis (Grades 1 and 2), spinal stenosis, pseudarthrosis, failed fusion or degenerative disc disease (DDD)." It is not intended for "severe spondylolisthesis (Grades 3 and 4), deformities or curvatures, tumor or trauma i.e. vertebral fracture."

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

Sample Size (Test Set): Not specified. The document refers to "mechanical testing" but does not detail the number of units tested.
Data Provenance: Not specified.

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

Not applicable. The provided text describes mechanical testing and a 510(k) submission, not a study involving expert-established ground truth for a diagnostic device.

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

Not applicable. This information is not relevant to the type of device and study described (mechanical testing for spinal implants).

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:

No. The document describes a spinal implant (mechanical device) and its mechanical testing, not an AI-based diagnostic tool that would undergo an MRMC study.

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

Not applicable. This is a mechanical spinal implant, not an algorithm.

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

For the mechanical testing, the "ground truth" would be engineering standards and specifications for material strength, fatigue life, and structural integrity. Specific standards or methods are not detailed beyond "Static and fatigue mechanical testing were supplied."
For the clinical indications, the ground truth would be established medical diagnoses and the medical literature supporting the use of such devices for those conditions, referred to in the substantial equivalence comparison.

8. The sample size for the training set:

Not applicable. This is a mechanical device, not a machine learning model.

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

Not applicable. This is a mechanical device, not a machine learning model.

Summary

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MAR 1 2 2002

Sponsor:

Proposed Proprietary Trade Name: Device Description:

Indication/Intended Use:

Materials:

Substantial Equivalence:

Performance Characteristics:

510(k) SUMMARY of Safety and Effectiveness

K012045
page 1 of 1

Highgate Orthopaedics One Walnut Street Boston, MA 02108

Highgate Curved Rod System

The Highgate Curved Rod System is intended for fixation of the anterolateral unilateral screw thoracolumbar spine from To to L5. The Highgate Curved Rod System is intended to provide stabilization of a spinal segment as an adjunct to spinal fusion. Indications for the use of this device include spondylolisthesis (Grades 1 and 2), spinal stenosis, pseudarthrosis, failed fusion or degenerative disc disease (DDD) defined as back pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies. The Highgate Curved Rod System is not intended for patients having severe spondylolisthesis (Grades 3 and 4), deformities or curvatures, tumor or trauma i.e. vertebral fracture.

The Highgate Curved Rod System components are manufactured from titanium alloy (Ti6A14V, ASTM F136).

The Highgate Curved Rod System was determined to be substantially equivalent to several commercially available systems.

Static and fatigue mechanical testing were supplied in support of the Highgate Curved Rod System 510(k) premarket notification.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle or bird with three curved lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the bird. The text is in all caps and is evenly spaced around the circle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 2 2002

Highgate Orthopaedics c/o Ms. Karen E. Warden, MEBE Representative/Consultant 8202 Sherman Road Chesterland, Ohio 44026-2141

Re:

Highgate Curved Rod System Regulation Number: 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: II Product Code: KWQ Dated: February 13, 2002 Received: February 20, 2002

Dear Ms. Warden:

K012045

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bection of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule) to regars) and entirent date of the Medical Device Amendments, or to conmerce proc to Hiley 20, 2017, in accordance with the provisions of the Federal Food, Drug, de MCS that have been rocuse in avere approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. 1 ou may, dicierore, market the Act include requirements for annual registration, listing of The general vontable proving 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 II your device is classified (500 above) and Existing major regulations affecting your device can may be subject to such additions, 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 I loase be advisou that I Dr o resuarted on our device complies with other requirements of the Act that I Dri has made a sond regulations administered by other Federal agencies. You must of any I cachi statutes and regulanents, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFR Part 6077, laboring (21 CFR Part 820); and if applicable, the electronic 10.11 m the quality bysellis (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Karen E. Warden, MEBE

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will anow you'le begin maing of substantial equivalence of your device to a legally promatics notication: "The PDF Intentigstification 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 11 you desire specific ad 1809.10 for in vitro diagnostic devices), please contact the Office of additionally 21 OF Far 859. 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 Outer general 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,

Mule N Mule

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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4. Indications for Use Statement

510(k) Number (if known): K012045

Device Name: Highgate Curved Rod System

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Over-the-Counter Und 0(k) Number

L. Mark Miller

Sign-Off vision of General. Restorative and Neurological Devices

Prescription Use (Per 21 CFR 801.109)

Confidential: Highgate Curved Rod Premarket Notification

012045

Regulation Number and Section

N/A