SmartSet HV Bone Cement is indicated for the fixation of prostheses to living bone in orthopaedic musculoskeletal surgical procedures for rheumatoid arthritis, osteoarthritis, traumatic arthritis, osteoporosis, avascular necrosis, collagen disease, severe joint destruction secondary to trauma or other conditions, and revision of previous arthroplasty.

Device Description

SmartSet HV Bone Cement is a high viscosity bone cement which is equally suited for both digital and syringe use. It has a short dough time (approximately 1 minute), a setting time of 9 -11 mins and consequently a long working time. These handling characteristics make SmartSet HV Bone Cement ideally suited for use with modern cementing techniques and clinical applications. The subject device is for single use only and is available in either 20g or 40g single unit packs and 10 ×1 unit dispenser cartons. Each single unit (device) pack consists of a polymeric powder component and a monomeric liquid component.

AI/ML Overview

This 510(k) premarket notification for the SmartSet HV Bone Cement does not include a study demonstrating the device meets acceptance criteria. Instead, the submission focuses on establishing substantial equivalence to predicate devices already on the market.

Therefore, many of the requested details about acceptance criteria, study design, and ground truth establishment are not present in this document. The manufacturer's basis for substantial equivalence is primarily through similarities in design, materials, and intended use, rather than a performance study against predefined acceptance criteria for the new device.

Here's a breakdown of the information that can and cannot be extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Not provided in the document. The submission does not detail specific acceptance criteria for performance metrics (e.g., mechanical strength, setting time within a specified range) that the SmartSet HV Bone Cement was tested against. It primarily discusses its handling characteristics (short dough time, setting time of 9-11 mins, long working time) as descriptive features, not as metrics with pre-defined acceptance limits.

2. Sample Size Used for the Test Set and Data Provenance:

Not applicable / Not provided. Since a formal study demonstrating the device meets acceptance criteria against a defined test set is not presented, there is no information on sample size or data provenance for such a test set.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

Not applicable / Not provided. Ground truth establishment is relevant for studies where AI algorithms or diagnostic tools are being evaluated against expert opinion or known states. This document describes a medical device (bone cement), not such a tool.

4. Adjudication Method for the Test Set:

Not applicable / Not provided.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No. This type of study is typically for evaluating diagnostic tools or AI assistance for human readers. This document is for a medical device (bone cement).

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance):

Not applicable / No. This phrase is typically used for AI/algorithm performance. While the bone cement itself is a "standalone" device, the concept of "standalone performance" in this context refers to an algorithm's performance without human interaction for diagnostic or interpretive tasks. The document does not describe such an evaluation for the bone cement.

7. Type of Ground Truth Used:

Not applicable / Not explicitly defined in this context. For a bone cement, "ground truth" would generally refer to established scientific and engineering principles for material properties, biocompatibility, and clinical performance. The document implies compliance with these principles through similarity to predicate devices, but doesn't detail a specific "ground truth" used in a study to validate acceptance criteria.

8. Sample Size for the Training Set:

Not applicable / Not provided. Training sets are relevant for machine learning models. This document is for a medical device.

9. How the Ground Truth for the Training Set Was Established:

Not applicable / Not provided.

Summary of what the document does provide regarding the device and its justification:

The document establishes substantial equivalence by:

Device Name: SmartSet HV Bone Cement
Intended Use: Fixation of prostheses to living bone in orthopaedic musculoskeletal surgical procedures for various conditions (rheumatoid arthritis, osteoarthritis, traumatic arthritis, osteoporosis, avascular necrosis, collagen disease, severe joint destruction, revision of previous arthroplasty).
Design and Materials: High viscosity PMMA Bone Cement, equally suited for digital and syringe use. Consists of a polymeric powder component and a monomeric liquid component.
Handling Characteristics: Short dough time (approx. 1 minute), setting time of 9-11 minutes, long working time.
Predicate Devices:
- DePuy 1 Bone Cement (P960001/Supplement 3)
- Palacos R40 Bone Cement (P810020/Supplement 3)
Basis for Equivalence: Similarities in design, materials, and intended use to the predicate devices. The document implies that because these characteristics are similar to already cleared devices, direct performance studies against new acceptance criteria for the SmartSet HV Bone Cement are not required for 510(k) clearance, as long as it meets general safety and efficacy standards based on the predicate.

Summary

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FEB 1 3 2003

K023012

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

SPONSOR OF THIS 510(K):	DePuy Orthopaedics, Inc.700 Orthopaedic DriveP.O. Box 988Warsaw, Indiana 46581-0988
MANUFACTURER:	DePuy International LtdTrading as DePuy CMWCornford RoadBlackpool, LancashireFY 4 4QQ, England
510(K) CONTACT:	Janet Johnson, RACDePuy Orthopaedics, Inc.Group Leader, Regulatory Submissions(574) 371-4907; FAX (574) 371-4987E-mail: jjohnso7@dpyus.jnj.com
TRADE NAME:	SmartSet HV Bone Cement
COMMON NAME:	PMMA Bone Cement
CLASSIFICATION:	PMMA Bone Cement: Class II per 21 CFR 888.302
DEVICE CODE:	LOD
EQUIVALENT DEVICES:	DePuy 1 Bone Cement - P960001/Supplement 3Palacos R40 Bone Cement - P810020/Supplement 3

DEVICE DESCRIPTION AND INTENDED USE:

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K 023012

BASIS OF SUBSTANTIAL EQUIVALENCE:

SmartSet HV Bone Cement has similar indications for use as other bone cements currently marketed in the United States. These predicate devices include:

1. DePuy 1 Bone Cement
1. Palacos R40 Bone Cement

All three bone cements are intended to be used for the fixation of artificial joints and prosthesis to host bone.

Based on similarities of design, materials, intended use, and testing performed, DePuy believes that the subject SmartSet HV Bone Cement is substantially equivalent to the above described FDA cleared devices currently on the market.

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Image /page/2/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 three human profiles facing right, stacked on top of each other. The profiles are enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper half of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FFB 1 3 2003

Ms. Janet G. Johnson, RAC DePuy Orthopaedics, Inc. 700 Orthopaedic Drive P.O. Box 988 Warsaw, Indiana 46581-0988

Re: K023012

Trade Name: SmartSet HV Bone Cement Regulation Number: 21 CRF 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) Bone Cement Regulatory Class: Class II Product Code: LOD Dated: January 3, 2003 Received: January 6, 2003

Dear Ms. Johnson:

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 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.

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.

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Page 2 -- Ms. Janet G. Johnson

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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,

Mark N Mulkeren

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)

Device Name: SmartSet HV Bone Cement

Indications for Use:

SmartSet HV Bone Cement is indicated for the fixation of prostheses to living bone in orthopaedic musculoskeletal surgical procedures for rheumatoid arthritis, osteoarthitis, traumatic arthritis, osteoporosis, avascular necrosis, collagen disease, severe joint destruction secondary to trauma or other conditions, and revision of previous arthroplasty.

Concurrence of CDRH, Office of Device Evaluation

for Mark n Mckeen
Division Sign-

Divisio: and Neurological Dev

KO 23012 710(k) Number ________________________________________________________________________________________________________________________________________________________________

Prescription Use_ (Per 21 CFR 801.109) OR

Over-The-Counter Use

Regulation Number and Section

§ 888.3027 Polymethylmethacrylate (PMMA) bone cement.

(a)
Identification. Polymethylmethacrylate (PMMA) bone cement is a device intended to be implanted that is made from methylmethacrylate, polymethylmethacrylate, esters of methacrylic acid, or copolymers containing polymethylmethacrylate and polystyrene. The device is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement.”