The RABEATM Cement Restrictor Device 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 appropriate for acetabular cup surgeries.

Device Description

The RABEATM Cement Restrictor Device is a hollow, titanium, rounded rectangular frame with fenestrated surfaces on all sides and 1 mm toothed spikes on opposite sides. The device is intended to be used in conjunction with standard PMMA cement.

AI/ML Overview

This document is a 510(k) summary for the RABEA™ Cement Restrictor Device. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting new clinical study data with specific acceptance criteria. Therefore, most of the requested information regarding acceptance criteria and detailed study parameters for device performance is not applicable in this context.

Here's a breakdown based on the provided text:

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

Not applicable. The provided document is a 510(k) summary, which demonstrates substantial equivalence to predicate devices. It does not present specific quantitative performance metrics against pre-defined acceptance criteria from a clinical trial or performance study. The "performance" described is in terms of functional and safety testing, which are qualitative in nature here.

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

Not applicable. No clinical test set or data provenance is mentioned as this is a 510(k) submission based on substantial equivalence and functional/safety testing, not a clinical trial. The testing performed was "examination of the function of the device under conditions similar to those found in normal usage." This would typically involve bench testing or engineering verification rather than a human subject test set.

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. There is no mention of a test set requiring expert ground truth establishment. The evaluation centered on functional and safety testing.

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

Not applicable. No test set requiring adjudication is described.

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 device is a cement restrictor, not an AI-powered diagnostic device. No MRMC study was performed.

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

Not applicable. This is a physical medical device, not an algorithm.

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

Not applicable. The evaluation was based on functional and safety testing of the physical device to ensure conformance to product specifications.

8. The sample size for the training set

Not applicable. This device is not an AI/ML algorithm requiring a training set.

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

Not applicable. This device is not an AI/ML algorithm requiring a training set.

Summary of Device Performance and Equivalence (as described in the document):

The document states:

Acceptance Criteria/Performance Goal: "Functional and safety testing of the RABEA™ Cement Restrictor Device consisted of examination of the function of the device under conditions similar to those found in normal usage and testing to ensure conformance to product specifications."
Reported Device Performance: "The results of the examination and testing were successful and did not raise any issues of safety and effectiveness of the device."

The primary conclusion is that the RABEA™ Cement Restrictor Device is substantially equivalent to two predicate devices:

Osteonics PTII Cement Spacer (K914406)
Motech Surgical Mesh (K900138)

This substantial equivalence is based on "the devices' similarities in functional design, materials and indications for use." The FDA's clearance letter confirms this substantial equivalence, with an added WARNING regarding its use for spinal indications, indicating that safety and effectiveness for such use have not been established.

Summary

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JUL 30 1999

¥990345

Attachment 2

510(k) Summary

510(K) SUMMARY

SUBMITTER:	SIGNUS Medizintechnik GmbHRannenbergring 54D-63755 AlzenauGermany
CONTACT PERSON:	Mr. Thomas HoghaugNewport Medical International27660 Woodside RoadShorewood, MN 55331Phone: 612-470-9545Fax: 612-470-6985
DATE PREPARED:	April 30, 1999
TRADE NAME:	RABEATM Cement Restrictor Device
CLASSIFICATION NAMEand NUMBER:PRODUCT CODE:	Surgical MeshClass II, 21 CFR 878.3300JDK
PREDICATE DEVICE(S):	The RABEA™ Cement Restrictor Device is substantiallyequivalent to the Osteonics PTII Cement Spacer which wascleared via premarket notification K914406 on December 20,1991, and the Motech Surgical Mesh which was cleared for useas a cement restrictor via premarket notification K900138 onMarch 20, 1990.
DEVICE DESCRIPTION:	The RABEATM Cement Restrictor Device is a hollow, titanium,rounded rectangular frame with fenestrated surfaces on all sidesand 1 mm toothed spikes on opposite sides. The device isintended to be used in conjunction with standard PMMA cement.
INTENDED USE:	The RABEATM Cement Restrictor Device is intended for use as acement restrictor in orthopedic surgeries such as those involvingthe femoral canal and tibial plateau in hip stem and total kneereplacement. This device is not appropriate for acetabular cupsurgeries.
FUNCTIONAL &SAFETY TESTING:	Functional and safety testing of the RABEA™ CementRestrictor Device consisted of examination of the function of thedevice under conditions similar to those found in normal usageand testing to ensure conformance to product specifications. The

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results of the examination and testing were successful and did not raise any issues of safety and effectiveness of the device.

CONCLUSION:

The RABEA™ Cement Restrictor Device is substantially equivalent to the Osteonics PTII Cement Spacer which was cleared via premarket notification K914406 on December 20, 1991, and the Motech Surgical Mesh which was cleared for use as a cement restrictor via premarket notification K900138 on March 20, 1990, based upon the devices' similarities in functional design, materials and indications for use.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 3 1 2001

Mr. Thomas Hoghaug Newport Medical International 27660 Woodside Road Shorewood, Minnesota 55331

Re: K990345

Tradc Namc: RABEATM Cement Restrictor Regulation Number: 878.3350 Regulatory Class: II Product Code: JDK Dated: April 30, 1999 Received: May 3, 1999

Dear Mr. Hoghaug:

This letter corrects our substantially equivalent letter of July 30, 1999.

We have reviewed your Section 510(k) 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). 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 p. visions of equirements 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.

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Page 2 - Mr. Thomas Hoghaug

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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 information about the application of other labeling requirements to your device (21 CFR Part 801 and additionally 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"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrl/dsma/dsmamain.html".

Sincerely vours

H. Ehlers

E. Statland, M.D., Ph.D. Bernard Director Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Page

K990345. 510(k) Number (if known):

Device Name:

RABEA™ Cement Restrictor Device

ALUUESI INC

Indications for Use:

Indications for Use.
The RABEAT* Cement Restrictor Device is intended for use as a cement restrictor in orthopedic The RABEATK Cement Restricter Device is intended for use as a cement results are and total provention
surgeries such as those involving the femoral canal and tibial placeries Inc. 11:22:00
surgeries such as those involving the femoral canal and tions. Included in the surgeries.
replacement. This device is not appropriate for acctabular cup surger

Concurrence of CDRH, Office of Device Evaluation (ODE)

Signature

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number	K990345

Prescription Use
(Per 21 CFR 801.109)

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.