The NBD 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. The NBD Cement Restrictor is NOT intended for any spinal indications.

Device Description

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

AI/ML Overview

The provided text describes a medical device, the NBD Cement Restrictor, and its 510(k) submission to the FDA. However, it does not contain the specific information requested in the prompt regarding acceptance criteria, a study proving the device meets those criteria, or details about training and test sets, expert involvement, or comparative effectiveness studies.

The document primarily focuses on:

Device Description: What the NBD Cement Restrictor is (hollow, titanium, rounded rectangular frame with fenestrated surfaces and spikes).
Intended Use: As a cement restrictor in orthopedic surgeries like hip stem and total knee replacement, specifically excluding acetabular cup surgeries.
Performance Data: States "No applicable performance standards have been promulgated," but mentions the material conforms to ISO 5832-3.
Functional & Safety Testing: A general statement that testing "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. The results were successful and did not raise any issues of safety and effectiveness of the device." This is a qualitative statement, not a detailed study with acceptance criteria.
Substantial Equivalence: To the RA-BEATM Cement Restrictor Device (K990345), and mentions other predicate devices. This is the primary basis for FDA clearance in this case.
FDA Communication: The FDA's clearance letter, including a specific warning against spinal indications.

Therefore, many of the requested sections cannot be filled based on the provided text.

Here's a breakdown of what can be inferred or directly stated, and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Material Conformance	The device material (wrought titanium 6-aluminum 4 vanadium alloy) conforms to ISO 5832-3.
Functional & Safety	Device function successful under conditions similar to normal usage; conformed to product specifications. No issues of safety and effectiveness raised.
Substantial Equivalence	Found substantially equivalent to RA-BEATM Cement Restrictor (K990345) in design, function, material, and indications for use.
Spinal Indications (Negative Criterion)	NOT ACCEPTED FOR SPINAL INDICATIONS. A warning is required: "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."
Other specific quantitative performance criteria (e.g., specific strength, integration, degradation rates)	Not provided in the document.

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

Not provided. The document states "Functional and safety testing... consisted of examination of the function of the device under conditions similar to those found in normal usage" but gives no details on the sample size, specifics of the "conditions," or provenance (e.g., in-vitro, ex-vivo, animal, human, country of origin).

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. The device is a physical implant, not an AI or diagnostic device that requires expert-established ground truth for a test set in the conventional sense. The "testing" mentioned is likely engineering/bench testing.

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

Not applicable/Not provided. This refers to consensus-building among experts, which is not described for the functional/safety testing of this physical device.

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. This is a physical medical device (cement restrictor), not an AI-powered diagnostic or assistive tool. MRMC studies are not relevant to its type of evaluation.

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

No. This is a physical medical device. The concept of "standalone algorithm performance" does not apply.

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

Not applicable in the typical sense. For a physical device like this, "ground truth" would be established by engineering specifications, material properties, and observed mechanical performance under simulated load or surgical scenarios. The document states "conformance to product specifications" and "successful" function without further detail.

8. The sample size for the training set

Not applicable/Not provided. This device is not an AI model, so there is no "training set."

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

Not applicable/Not provided. As there is no AI model, there is no training set or ground truth for it.

Summary

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OCT 0 4 2002

510(k) Summary of Safety and Effectiveness

In Accordance with SMDA of 1990

NBD Cement Restrictor

May 15, 2002

Company:

NBD, LLC 605 Industrial Court Woodstock, GA 30189

Trade Name: NBD Cement Restrictor

Common Name: Cement Restrictor

Product Code and Regulatory Classification:

JDK: 878.3300 Surgical Mesh

Product Classification:

Class II

Intended Use:

The NBD 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.

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Device Description:

Performance Data:

No applicable performance standards have been promulgated under Section 514 of the Food. Drug, and Cosmetic Act for this device. However, the material is subjected to ISO 5832-3 Implants for surgery - Wrought titanium 6-aluminum 4 vanadium alloy 1996-07-01.

Functional & Safety Testing:

Functional and saftey testing of the NBD 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. The results were successful and did not raise any issues of safety and effectiveness of the device.

Substantial Equivalence:

The NBD Cement Restrictor Device is substantially equivalent to RA-BEATM Cement Restrictor Device which was cleared for premarket notification K990345 on July 30, 1999. The NBD Cement Restrictor is equivalent in design, function, material, and indications for use.

Osteonics PTII Cement Spacer, K914406 Motech Surgical Mesh, K900138

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized representation of a caduceus, a symbol often associated with healthcare, featuring a staff with a serpent entwined around it.

OCT 0 4 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Tim B. Lusby President New Business Development, LLC -605 Industrial Court Woodstock, GA 30189

Re: K021788

Trade/Device Name: NBD Titanium Cement Restrictor Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: JDK Dated: August 13, 2002 Received: August 15, 2002

Dear Mr. Lusby:

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 - Mr. Tim B. Lusby

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,

Daniel Schacter, M.D.

Daniel Schultz, M.D. Director Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1.

510(K) Number:

K021788

Device Name:

NBD Cement Restrictor

Indications For Use:

The NBD Cement Restrictor is NOT intended for any spinal indications.

Concurrence of CDRH, Office of Device Evaluation (ODE)

for Mark N. Millhurn
(Div. Off

Restorative

510(k) Number: K021788

(Optional Format 3-10-98)

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.