SIMPLEX P BONE CEMENT by STRYKER ORTHOPAEDICS

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

Device Description

Simplex™ P Bone Cement is a radiopaque bone cement capable of being applied digitally and with a syringe. The cement will be available in 10-pack or 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.

AI/ML Overview

This document is a 510(k) summary for Simplex™ P Bone Cement, a PMMA bone cement. It focuses on demonstrating substantial equivalence to a previously approved device rather than providing a study on acceptance criteria with detailed performance metrics characteristic of AI/ML device submissions.

Therefore, most of the requested information regarding acceptance criteria, device performance, study design, and ground truth establishment, which are typical for AI/ML device evaluations, are not applicable to this document.

Here's an analysis based on the provided text:

1. Table of acceptance criteria and the reported device performance:

This document does not contain a table of acceptance criteria or reported device performance in the way an AI/ML device submission would. The core of this 510(k) summary is to demonstrate substantial equivalence to a predicate device.

Acceptance Criteria (Not Explicitly Stated for this type of device)	Reported Device Performance (Not Explicitly Stated for this type of device)
Adherence to the existing predicate device's formula and manufacturing processes.	The Simplex™ P powder and liquid monomer formula have not been modified and will be the same as what was approved in PMA N17004.
Meeting established standards for PMMA bone cement (implied by regulatory class and product code, but not detailed here).	Implicitly, the device is expected to perform comparably to its predicate regarding its physical and chemical properties and clinical efficacy.

2. Sample size used for the test set and the data provenance:

Not Applicable. This submission is for a traditional medical device (bone cement) and relies on demonstrating substantial equivalence to a predicate device. There is no "test set" in the context of an AI/ML model's performance evaluation. The data provenance would relate to the manufacturing and testing of the cement itself, not a dataset for algorithm evaluation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable. As there is no test set for an AI/ML model, there are no experts establishing ground truth in this context. The "truth" in this submission relates to the chemical composition and manufacturing of the bone cement matching the predicate.

4. Adjudication method for the test set:

Not Applicable. No test set or adjudication method is described for this traditional medical device submission.

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 is not an AI/ML device. Therefore, no MRMC study, human readers, or AI assistance is relevant.

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

Not Applicable. This is not an AI/ML device.

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

Not Applicable / Implied by Substantial Equivalence. The "ground truth" here is that the physical and chemical properties, as well as the manufacturing process, of the Simplex™ P Bone Cement are identical to those of the previously approved device (PMA N17004). This is a factual comparison of product specifications rather than interpreted data.

8. The sample size for the training set:

Not Applicable. There is no training set for an AI/ML model in this submission.

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

Not Applicable. There is no training set for an AI/ML model in this submission.

Summary regarding the device meeting acceptance criteria:

The document states that the "Simplex™ P powder and liquid monomer formula have not been modified and will be the same as what was approved in PMA N17004." This statement serves as the core "proof" that the device meets the implicit "acceptance criteria" for a 510(k) submission seeking substantial equivalence for a non-modified predicate. By being identical to a device already approved via a PMA (Premarket Approval, a more rigorous review pathway), the manufacturer asserts that all performance, safety, and effectiveness criteria previously met by the PMA device are inherently met by this identical 510(k) device. The study is fundamentally a comparison of the current device's formula and manufacturing to the approved predicate, rather than a clinical trial or algorithmic performance study.

Summary

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K062553

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

JAN - 8 2007

Proprietary Name:	Simplex™ P Bone Cement
Common Name:	PMMA Bone Cement
Classification Name and Reference	Polymethylmethacrylate (PMMA) bonecement21 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) 831-5612Fax: (201) 831-6038E-Mail: Tiffani.Rogers@stryker.com)
Date Summary Prepared:	August 28, 2006

Device Description

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Indications For Use:

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

Substantial Equivalence:

The Simplex™ P powder and liquid monomer formula have not been modified and will be the same as what was approved in PMA N17004.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/12 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

JAN - 8 2007

Re: K062553

Trade/Device Name: Simplex™ P Bone Cement Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: II Product Code: LOD Dated: November 13, 2006 Received: November 22, 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 - Ms. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours

for
Mark N. Malkerson

Mark N Aelkerson 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): ____________________________________________________________________________________________________________________________________________________

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)

Polo Rz

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

510(k) Number V062553

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.”