GENERATION 4 Bone Cement is indicated for the fixation of prostheses to living bone in orthopedic musculoskeletal surgical procedures for osteoarthritis, rheumatoid arthritis, traumatic arthritis, osteoporosis, avascular necrosis, collagen disease, severe joint destruction secondary to trauma or other conditions and revision of previous arthroplasty procedures.

Device Description

GENERATION 4 Bone Cement System is a self-curing agent comprised of two sterile components (liquid and powder) mixed in the Vacuum Pac delivery system forming polymethyl methacrylate (PMMA) bone cement. The liquid component (monomer) is comprised of Methyl methacrylate monomer (98%), N,N-dimethyl-p-toluidine (2%), and Hydroquinone (60ppm). The powder component is comprised of Methyl methacrylate - stryrene copolymer (90%) and Barium sulfate, U.S.P. (10%).

AI/ML Overview

The provided text is a 510(k) premarket notification for a medical device, GENERATION 4 Bone Cement. It focuses on establishing substantial equivalence to a predicate device rather than presenting a study demonstrating the device's performance against specific acceptance criteria in a clinical setting with AI.

Therefore, many of the requested details about acceptance criteria, study design, expert involvement, and AI performance cannot be extracted from this document.

Here's what can be inferred related to your request, with an explanation of why other parts are not applicable:

Table of acceptance criteria and reported device performance:
- Acceptance Criteria for Substantial Equivalence: The primary "acceptance criteria" discussed here are related to demonstrating substantial equivalence to a legally marketed predicate device (Surgical Simplex P Radiopaque Bone Cement). This means the GENERATION 4 Bone Cement must be similar in terms of:
  - Indications for use
  - Intended use
  - Technological characteristics
  - Material
- Reported Device Performance: The document describes the chemical composition and polymerization process of the GENERATION 4 Bone Cement but does not provide quantitative performance metrics (e.g., strength, set time, biocompatibility test results) that would typically be associated with clinical acceptance criteria. Instead, it asserts that these characteristics are "typical constituents of PMMA bone cement," implying their equivalence to established standards and the predicate.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not Applicable: This document does not describe a clinical study with a test set of data. The submission is based on the chemical formulation and existing knowledge of PMMA bone cements, and comparison to a predicate device, not on evaluating performance on a patient dataset.
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: No clinical test set requiring ground truth established by experts is mentioned in this document.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable: No clinical test set or adjudication method is described.
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 document is about a bone cement, not an AI device or a diagnostic tool involving human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable: This device is not an algorithm or AI system.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not Applicable: As no clinical study or test set is presented, no ground truth data is discussed. The "ground truth" for this submission is essentially the established performance and safety profile of the predicate device and the known properties of PMMA bone cement.
The sample size for the training set:
- Not Applicable: This device does not involve a training set as it is not an AI/machine learning model.
How the ground truth for the training set was established:
- Not Applicable: No training set is involved.

Summary based on the provided document:

The regulatory submission for GENERATION 4 Bone Cement does not include a study with acceptance criteria and device performance in the way you've outlined for AI or diagnostic devices. Instead, it focuses on demonstrating substantial equivalence to an existing, legally marketed predicate device (Surgical Simplex P Radiopaque Bone Cement).

The "acceptance criteria" for this type of submission are that the new device shares the same:

Indications for Use
Intended Use
Technological Characteristics (composition and polymerization process are similar to typical PMMA cements)
Materials (components are common in PMMA cements)

The document reports the chemical composition of the cement and broadly describes its polymerization process, asserting that these are typical for PMMA bone cements and therefore equivalent to the predicate. No clinical performance data against specific quantitative metrics or a study involving human readers/AI is presented.

Summary

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DEC 1 9 2001

K 993836
page 1 of 2

SUMMARY OF SAFETY AND EFFECTIVENESS

Submitter: Biomet, Inc. Airport Industrial Park P.O. Box 587 Warsaw, IN 46581-0587

Contact Person: Mary L. Verstynen

Product Code: LOD

Device Name: GENERATION 4 Bone Cement

Indications for Use:

Device Description:

The liquid component (monomer) is comprised of the following:

Methyl methacrylate monomer	98%
N,N-dimethyl-p-toluidine	2%
Hydroquinone	60ppm

Methyl methacrylate monomer is the primary constituent of the liquid component. In much smaller quantities are the accelerator, N,N-dimethyl-p-toluidine, and the stabilzer, hydroquinone, both of which are typical constituents in PMMA bone cement.

Formula:

CH3

CH2=C-COOCH3 Methyl methacrylate monomer

The powder component is comprised of the following: Methyl methacrylate - stryrene copolymer 90 % 10% Barium sulfate, U.S.P.

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page 2 of 2

Methyl methacrylate -- styrene copolymer is the primary constituent of the powder component. Barium sulfate is added as a radiopacifier. Both are typical constituents of PMMA bone cement.

Formula:

`CH3

CH2=C-CH2-CH-C-
|
COOCH3 C6C5 COOCH3 n`

Methyl methacrylate - styrene copolymer

When the powder and liquid components are mixed, the accelerator speeds the generation of free radicals and the stabilizer in the liquid reacts with many of the early free radicals, but is soon consumed. Free radicals can then initiate formation of polymer chains.

Polymerization proceeds slowly over the first few minutes. Polymer chains at the surface of the powder beads mingle with monomer and newly formed polymer chains, while smaller beads may dissolve completely. The cement temperature rises as set-time of the cement approaches. Polymerization is essentially complete and the bone cement hard within 10 minutes.

Potential Risks:
Cardiac arrest	Transitory fall in blood pressure
Myocardial infarction	Thromobophlebitis
Pulmonary embolism	Hemorrhage and hematoma
Cerebrovascular accident	Loosening or displacement of prosthesis
Sudden death	Superficial or wound infection
Trochanteric bursitis	Short-term cardiac conduction irregularities
Heterotopic new bone formation	Trochanteric separation
Pyrexia (due to allergy)	Hematuria
Dysuria	Bladder fistula
Local neuropathy	Local vascular erosion and occlusion
Intestinal obstruction due to extrusion of the bone cement beyond the region of its

Substantial Equivalence: The GENERATION 4 Bone Cement was found to be substantially equivalent to the following predicate bone cement in terms of indications for use, intended use, technological characteristics and material.

intended use

Predicate device: Surgical Simplex P Radiopaque Bone Cement Howmedica Corporation PMA Number: N17004

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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 stylized eagle with three stripes forming its body and wings. The eagle is enclosed within a circle that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 9 2001

Ms. Mary L. Verstynen Manager of Clinical Affairs Biomet, Inc. P.O. Box 587 Warsaw, Indiana 46581

Re: K993836

Trade Name: Generation 4® Bone Cement Regulation Number: 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) Bone Cement Regulatory Class: II Product Code: LOD Dated: October 2, 2001 Received: October 3, 2001

Dear Ms. Verstynen:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your wed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for are basical to May 28, 1976, the enactment date of the Medical Device Amendments, or to conniner of Prial 2011-12-11 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 r ou may, alereleve, mains of the Act include requirements for annual registration, listing of general controls proficituring 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 rr your device to such additional controls. Existing major regulations affecting your device can may or babyer to data arrant 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 r 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 or any I 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. Mary L. Verstynen

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. 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,

S. Gail M. Witte, Ph.D., M.D.

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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Page _ of _

510(k) NUMBER (iF KNOWN): _ K 9 9 3 8 3 6

DEVICE NAME: GENERATION 4 Bone Cement

INDICATIONS FOR USE:

GENERATION 4 Bone Cement is intended for the fixation of prostheses to living bone in orthopedic musculoskeletal surgical procedures for osteoarthritis, rheumatoid arthritis, traumatic arthritis, osteoporosis, avascular necrosis, collagen disease, severe joint destruction secondary to trauma or other conditions and revision of previous arthroplasty.

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

510(k) Number ≤ 9938 3 C

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

(Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use __ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ (Per 21 CFR 801.109)

Over- The- Counter- No (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.”