Simplex™ P with Tobramycin is indicated for the fixation of prostheses to living bone for use in the second stage of a two-stage revision for total joint arthroplasty.

Device Description

Simplex™ P with Tobramycin is an acrylic bone cement intended for the fixation of prostheses to living bone for use in second stage revision for total joint arthroplasty. The cement is packaged in two sterile components; a liquid monomer component and a powder copolymer component. The liquid monomer component is comprised of methyl methacrylate, N.N-dimethyl-p-toluidine, and hydroquinone. The powder copolymer component consists of methylmethacrylate-styrene copolymer, polymethylmethacrylate, barium sulfate U.S.P., and tobramycin sulfate U.S.P. The liquid and powder components are mixed together resulting in the exothermic polymeric formation of a soft, pliable, dough-like mass. As the reaction progresses, a cement-like complex is formed.

AI/ML Overview

The provided text describes a 510(k) summary for a medical device, Simplex™ P with Tobramycin bone cement. It details the device's characteristics, intended use, and substantial equivalence to a predicate device. However, this document does not contain information on acceptance criteria or the specific study details that would prove the device meets such criteria in the way a clinical performance study for an AI medical device would.

The "Performance Data" section primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device (Surgical Simplex® P Radiopaque Bone Cement) in terms of safety and mechanical properties, not on an algorithm's performance against defined acceptance criteria.

Therefore, most of the requested information cannot be extracted from the given text. Below, I will address the points that can be gleaning from the document and explicitly state where information is missing.

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria: Not explicitly stated in the provided document. The document focuses on demonstrating "substantial equivalence" to a predicate device.
Reported Device Performance:
- "The cumulative results of extensive in vitro and in vivo test data show that a balance is achieved between antibiotic release and mechanical integrity without threats of systemic toxicity or compromised mechanical function."
- "The values predicted by the model correlate very well with clinical data from hemovac, serum, urine, and bone samples as reported by several clinicians."
- "In summary, the testing demonstrates that, in terms of safety and mechanical properties, Simplex™ P with Tobramycin bone cement is substantially equivalent to the legally marketed predicate Surgical Simplex® P Bone Cement."

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

Sample Size (Test Set): Not specified.
Data Provenance:
- "traditional literature searching"
- "unpublished details" from authors of relevant papers
- "arthroplasty registries"
- "additional in vivo studies were performed, which evaluated the antibiotic release from cement polymerized in situ in rabbits." (Animal study)
- "clinical data from hemovac, serum, urine, and bone samples as reported by several clinicians." (Implies human clinical data, but specifics are lacking).
Retrospective or Prospective: Not explicitly stated for all data. The "in vivo studies in rabbits" would be prospective. The literature review and registry data would likely be retrospective.

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 as this is not an AI/algorithm performance study that relies on expert ground truth for a "test set" in the traditional sense of AI evaluation. The "ground truth" seems to be established through physical and chemical testing, and correlation with clinical outcomes or observations.

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

Not applicable. This is not an AI/algorithm performance study involving human adjudication of results.

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 not an AI-assisted device, so an MRMC study comparing human readers with and without AI assistance was not performed.

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

Not applicable. This is a PMMA bone cement, not an algorithm, so standalone algorithm performance is not relevant.

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

The "ground truth" for this device appears to be established through:
- In vitro testing for mechanical properties and antibiotic release.
- In vivo animal studies (rabbits) for antibiotic release and systemic levels.
- Correlation with clinical data (hemovac, serum, urine, bone samples) from "several clinicians", suggesting real-world patient outcomes or measurements.
- Comparison to the performance of the predicate device.

8. The sample size for the training set

Not applicable. This is not an AI device, therefore there's no "training set" in the context of machine learning. The data gathered (literature, registries, in vitro/in vivo studies) informs the understanding of the device's properties and performance, but it's not a "training set" for an algorithm.

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

Not applicable. As there is no AI algorithm or training set, this question is not relevant to the provided document.

Summary

{0}------------------------------------------------

510(k) Summary for Simplex™ P with Tobramycin

Simplex™ P with Tobramycin Bone Cement Proprietary Name: Common Name: Antibiotic Bone Cement 21 CFR 888.3027 Classification Name and Reference: Polymethylmethacrylate (PMMA) Bone Cement ।। Proposed Regulatory Class: MAY 0 6 2003 Device Product Code: OR (87) LOD For Information contact: Jennifer A. Daudelin Regulatory Affairs Specialist Howmedica Osteonics Corp. 59 Route 17 Allendale, NJ 07401-1677 (201) 831-5379 Fax: (201) 831-6038 Email: Jdaudelin@howost.com April 28, 2003 Date Summary Prepared:

Device Description

{1}------------------------------------------------

510(k) Summary for Simplex™ P with Tobramycin

Intended Use

Simplex™ P with Tobramycin is indicated for the fixation of prostheses to living bone for use in the second stage of a two-stage revision for total joint arthroplasty.

Substantial Equivalence

Simplex™ P with Tobramycin is substantially equivalent in intended use, overall materials, mechanical propertics, and operational principles to Surgical Simplex® P Radiopaque Bone Cement (Howmedica Osteonics N-17-004).

Performance Data

Information on the safe use of Simplex™ P with Tobramycin was initially gathered through traditional literature searching. Information in published papers was supplemented by contacting authors of the relevant papers for additional unpublished details. Finally, arthroplasty registries were contacted to determine whether they had data that might be relevant to the safe use of this product.

The cumulative results of extensive in vitro and in vivo test data show that a balance is achieved between antibiotic release and mechanical integrity without threats of systemic toxicity or compromised mechanical function.

Additional in vivo studies were performed, which evaluated the antibiotic release from cement polymerized in situ in rabbits. Local concentrations were measured in the femoral bone bed surrounding the cement, following animal sacrifice and excision, as well as systemic levels drawn throughout the study. The values predicted by the model correlate very well with clinical data from hemovac, serum, urine, and bone samples as reported by several clinicians.

In summary, the testing demonstrates that, in terms of safety and mechanical properties, Simplex™ P with Tobramycin bone cement is substantially equivalent to the legally marketed predicate Surgical Simplex® P Bone Cement.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 0 6 2003

Ms. Jennifer A. Daudelin Regulatory Affairs Specialist Stryker Howmedica Osteonics 59 Route 17 South Allendale, NJ 07401

Re: K014199

Trade/Device Name: Simplex™ P with Tobramycin Regulation Number: 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: II Product Code: LOD Dated: February 3, 2003 Received: February 4, 2003

Dear Ms. Daudelin:

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.

{3}------------------------------------------------

Page 2 – Ms. Jennifer A. Daudelin

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 (301) 594-4659. 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/dsma/dsmamain.html

Sincerely yours,

Alan Witt

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

{4}------------------------------------------------

Indications for Use

510(k) Number (if known): K014199

Simplex™ P with Tobramycin Device Name:

Indications for Use:

Simplex™ P with Tobramycin is indicated for the fixation of prostheses to living bone for use in the second stage of a two-stage revision for total joint arthroplasty.

Mark n millerer
(Division Sign-Off)

Division of General, Restorative and Neurological Devices 510(k) Number _

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

C Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

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.”