SIMPLEX P SPEEDSET BONE CEMENT by HOWMEDICA OSTEONICS CORP

Simplex™ P SpeedSet bone cement is indicated for fixation of prostheses to living bone during orthopaedic musculoskeletal procedures for rheumatoid ecthritis, osteoarthritis, traumatic arthritis, osteoporosis, avascular necrosis, collagen discase, severe joint destruction secondary to trauma or other conditions, or revision of a previous arthroplasty. Simplex™ P SpeedSet bone cement is also indicated for the fixation of pathological fractures where loss of bone substance or recalcitrance of the fracture renders more conventional procedures ineffective.

Device Description

Simplex™ P SpeedSet Bone Cement is a radiopaque bone cement capable of being applied digitally and with a syringe. The cement will be available in 10-pack of 10-pack of 1-pack dispensers, with each individual pack containing one 40.0g unit of sterile polymeric powder and one 20.0ml ampoule of sterile monomer, for single-use. The working time of the Simplex™ P SpeedSet Bone Cement is approximately 4.8 minutes, with a dough time of 2.53 minutes and a setting time of 8.2 minutes.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device (Simplex™ P SpeedSet Bone Cement) and an FDA clearance letter. It does not contain information about acceptance criteria or a study proving the device meets said criteria in the way a modern AI/ML device submission would.

This document is for a traditional medical device (bone cement), and its clearance is based on substantial equivalence to previously marketed devices, not on performance metrics derived from a study with acceptance criteria.

Therefore, many of the requested sections (e.g., sample size for test/training sets, number of experts, adjudication methods, MRMC studies, standalone performance) are not applicable to this submission type and are not present in the provided text.

Here's a breakdown of what can be extracted and what cannot:

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

Acceptance Criteria	Reported Device Performance
Not applicable	Not applicable

Explanation: The device (Simplex™ P SpeedSet Bone Cement) gained clearance based on substantial equivalence to predicate devices (Simplex™ P and Palacos R bone cements), not through meeting predefined performance acceptance criteria from a clinical study. The submission focuses on demonstrating similarities in indications for use, monomer/powder components, and physical properties like dough time, setting time, and working time.

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. There is no "test set" in the context of an AI/ML study described for this device. The evaluation was
based on comparing the new device's characteristics to predicates.

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 "ground truth" established by experts in this context. The assessment is a comparison of product specifications and indications of use.

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

Not applicable. No adjudication method for a test set is mentioned.

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 submission is not for an AI/ML device, so 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 not an AI/ML algorithm.

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

Not applicable. No ground truth in the context of AI/ML validation is used. The "truth" for this submission is based on the established safety and effectiveness of the legally marketed predicate devices.

8. The sample size for the training set

Not applicable. There is no "training set" as this is not an AI/ML algorithm.

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

Not applicable. There is no "training set" or corresponding ground truth.

Summary of Device Evaluation in the Provided Text:

The evaluation for the Simplex™ P SpeedSet Bone Cement was based on demonstrating Substantial Equivalence to legally marketed predicate devices: Simplex™ P bone cement (PMA N17004) and Palacos R bone cement (K030902).

The key similarities highlighted for substantial equivalence (as per the "Substantial Equivalence" section) are:

Same indications for use.
Same liquid monomer.
Similar powder component.
Similar dough time, setting time, and working time.

The FDA's letter confirms that they "determined the device is substantially equivalent... to legally marketed predicate devices." This means the device met the regulatory standard of substantial equivalence, which is the "acceptance criteria" for a 510(k) submission of this nature. The "study" (or rather, the comparative analysis presented in the 510(k) submission) showed that the new device shared fundamental characteristics and performance profiles with already cleared devices, making it equally safe and effective for its intended use.

Summary

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JAN 2 6 2006

Image /page/0/Picture/1 description: The image contains the word "Stryker" in a bold, sans-serif font, followed by the letter "K" and the number "053198" in a handwritten style. Below "Stryker", the word "Howmedica" is written in a bold, sans-serif font. Underneath "Howmedica", the word "OSTEONICS" is written in a regular, sans-serif font.

510(k) Summary of Safety and Effectiveness Simplex™ P SpeedSet Bone Cement

325 Corporate Drive Mahwah, NJ USA 07430

Proprietary Name:	Simplex TM P SpeedSet Bone Cement
Common Name:	PMMA Bone Cement
Classification Name and Reference	Polymethylmethacrylate (PMMA) bone cement21 CFR §888.3027
Regulatory Class:	Class II
Device Product Code:	87 LOD - Polymethylmethacrylate (PMMA) bone cement.
Device Manufacturer:	Howmedica International S. de R.L.Raheen Business Park, Limerick, Ireland
For Information contact:	Tiffani RogersRegulatory Affairs SpecialistStryker Orthopaedics325 Corporate DriveMahwah, New Jersey 07432Phone: (201) 831-5412Fax: (201) 831-6038E-Mail: Tiffani.Rogers@stryker.com
Date Summary Prepared:	November 14, 2005

Device Description

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Indications For Usc:

Simplex™ P SpeedSet bone cement is indicated for fixation of prostheses to living osteoorthritis treasedie musculoskeletal procedures for rheumatoid arthritis, osteoarthritis, traumatic arthritis, osteoporosis, avascular necrosis, collagen disease, severe joint destruction secondary to transmal or other conditions, or revision of a previous arthroplastical posted bone coment is also indivors, or revision of a fixation of pathological fractures where loss of bone substance or recalcitrance of the fracture renders more conventional procedures ineffective.

Substantial Equivalence:

The Simplex™ P SpeedSet bone cement has the same indications, same liquid monomer and similar powder component as Simplex™ P bone cement. Additionally, the Simplex™ P SpeedSet bone cement is similar in dough time, setting time, setting time and working time as Palacos R bone cement. Howmedica Osteonics Corp. believes the SimplexTM P SpeedSet bone cement to be substantially equivalent to Simple® I bone cement approved in PMA N17004 and Palacos R bone cement to Smpless P bone
cement approved in PMA N17004 and Palacos R bone cement cleared in K030902.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features an abstract design of an eagle with three stylized lines representing its wings. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" are arranged in a circular pattern around the eagle. The seal is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 6 2006

Ms. Tiffani Rogers Regulatory Affairs Specialist Stryker Orthopaedics 325 Corporate Drive Mahwah, New Jersey 07430

Re: K053198/S1

Trade/Device Name: Simplex PTM SpeedSet Bone Cement Regulation Number: 21 CFR 888.3027 Regulation Name: PMMA Bone Cement Regulatory Class: II Product Code: LOD Dated: January 18, 2006 Received: January 19, 2006

Dear Ms. Rogers:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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 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 - Tiffani Rogers

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), please contact the Office of Compliance at (240) 276-0120 . Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.

Sincerely yours,

Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): _K1253199

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications

Prescription Use X (Per 21 CFR 801.109)

OR Over-the-Counter Use

(Please Do Not Write Below This Line – Continue on Another Page if Needed)

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

510(k) Number_KoS31 99

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.”