The Cadence PEEK Cement Restrictor System is intended for use as a cement restrictor in orthopedic surgeries such as those involving the femoral canal and tibial plateau in hip stem and total knee replacement.

This device is not intended for any spinal indications. The safety and effectiveness of this device when implanted in the spine have not been established.

Device Description

The Cadence™ PEEK Cement Restrictor is a hollow device with teeth on two opposing flat sides, offered in a tapered style of various sizes. The device is crafted of PEEK (ASTM F136). The device is used to hold bone cement (PMMA) in the diaphyseal canal in patients requiring a cemented arthroplasty device.

AI/ML Overview

The provided text is related to a 510(k) premarket notification for a medical device called the Cadence™ PEEK Cement Restrictor. It primarily discusses the device description, intended use, and the FDA's determination of substantial equivalence to a predicate device.

Crucially, this document does NOT contain information about acceptance criteria for device performance or a study demonstrating the device meets such criteria.

The 510(k) process for this type of device (a cement restrictor) relies heavily on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical trials with pre-defined performance acceptance criteria and associated studies for the new device itself.

Therefore, many of the requested categories of information cannot be extracted from the provided text.

Here is a summary of what can be inferred or stated based on the document:

1. A table of acceptance criteria and the reported device performance

Not applicable / Not provided. The document does not define specific performance acceptance criteria for the Cadence™ PEEK Cement Restrictor, nor does it present data from a study against such criteria. The FDA's 510(k) clearance in this case is based on substantial equivalence to a predicate device.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Not applicable / Not provided. No specific test set or associated data are mentioned for the Cadence™ PEEK Cement Restrictor.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not applicable / Not provided. As no test set data is discussed, there's no mention of experts establishing ground truth.

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

Not applicable / Not provided.

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 / Not provided. This device is a cement restrictor, not an AI-powered diagnostic tool. MRMC studies would not be relevant in this context.

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

Not applicable / Not provided. This is not an algorithm-based device.

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

Not applicable / Not provided.

8. The sample size for the training set

Not applicable / Not provided.

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

Not applicable / Not provided.

Summary of what the document DOES state regarding substantial equivalence:

Predicate Device: The Spinal Concepts, Inc. Cadence™ PEEK Cement Restrictor was demonstrated to be substantially equivalent to the Spinal Concepts Cadence™ Titanium Cement Restrictor (K022218).
Regulatory Classification: The device is classified under 21 CFR 878.3300, a "Prosthesis, Hip, Cement Restrictor" (Product Code: JDK). The FDA also noted "Surgical mesh" as a regulation name, which appears to be a broader classification under which this type of device might fall, but "Cement Restrictor" is more specific.
Intended Use: The Cadence™ PEEK Cement Restrictor System is intended for use as a cement restrictor in orthopedic surgeries such as those involving the femoral canal and tibial plateau in hip stem and total knee replacement.
Warning/Limitation: The FDA required a specific warning to be added: "WARNING: THIS DEVICE IS NOT INTENDED FOR ANY SPINAL INDICATIONS. THE SAFETY AND EFFECTIVENESS OF THIS DEVICE WHEN IMPLANTED IN THE SPINE HAVE NOT BEEN ESTABLISHED." This indicates that while the device was found substantially equivalent for specified orthopedic uses, its safety and effectiveness for spinal applications were not established.

Summary

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Submitted By:	Spinal Concepts, Inc.12012 Technology Blvd., Suite 100Austin, TX 78727512-918-2700October 25, 2002	NOV 27 2002
Contact Person:	Audrey SwearingenRegulatory Affairs Specialist
Trade Name:	Cadence™ PEEK Cement Restrictor
Proposed Classification Name:	Prosthesis, Hip, Cement Restrictor
Product Code:	JDK (21CFR 878.3300)

510(K) Summary of Safety and Effectiveness

Device Description: The Cadence™ PEEK Cement Restrictor is a hollow device with teeth on two opposing flat sides, offered in a tapered style of various sizes. The device is crafted of PEEK (ASTM F136). The device is used to hold bone cement (PMMA) in the diaphyseal canal in patients requiring a cemented arthroplasty device.

Intended Use: The Cadence™ PEEK Cement Restrictor System is intended for use as a cement restrictor in orthopedic surgeries such as those involving the femoral canal and tibial plateau in hip stem and total knee replacement.

This device is not intended for spinal indications. The safety and effectiveness of this device when implanted in the spine have not been established.

Substantial Equivalence: The Spinal Concepts, Inc. Cadence™ PEEK Cement Restrictor was demonstrated to be substantially equivalent to the Spinal Concepts Cadence™ Titanium Cement Restrictor (K022218).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure, represented by three curved lines forming a silhouette. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

. Dr. David Hooper Manager, Clinical & Regulatory Affairs Spinal Concepts Incorporated 12012 Technology Blvd. Suite 100 Austin, Texas 78727

K023647 Trade Name: Cadence™ PEEK Cement Restrictor Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: JDK Dated: October 28, 2002 Received: October 30, 2002

Dear Dr. Hooper:

Re:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we 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 (PMA) application. You may, therefore, market the device, subject to the general controls provisions of the Act and the limitations described below. 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.

The Office of Device Evaluation has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following limitation must appear in the Warnings section of the device's package insert and also as a Warning on the product label:

WARNING: THIS DEVICE IS NOT INTENDED FOR ANY SPINAL INDICATIONS.

THE SAFETY AND EFFECTIVENESS OF THIS DEVICE WHEN IMPLANTED IN THE SPINE HAVE NOT BEEN ESTABLISHED.

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

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Page 2 - Dr. David Hooper

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.

The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market. This letter will allow you to begin marketing your device as described in your 510(k) premarket notification if the limitation statement above is added to your labeling, as described.

Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.

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 yours,

Alan Webb for Dan Schultz
David C. Schultz, MD

Daniel G. Schultz, MD Director Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE STATEME

Page 1 of 1

510(k) Number (if known):

Device Name: Spinal Concepts, Inc. Cadence™ PEEK Cement Restrictor

Indications for Use:

This device is not intended for any spinal indications. The safety and effectiveness of this device when implanted in the spine have not been established.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use: (Per 21 CFR 801.109) Over-The-Counter: (Optional Format 1-2-96)

(Optional Format 1-2-96)

Mark J. Miller

(Division Sign-Off) Dirision of General, Restorative ano Neurological Devices

Regulation Number and Section

§ 878.3300 Surgical mesh.

(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.