Palacos® G with gentamicin is indicated for use as bone cement in arthroplasty procedures of the hip, knee and other joints to fix plastic and metal prosthetic parts to living bone when reconstruction is necessary because of revision of previous arthroplasty procedures due to joint infection. The cement is intended for use to affix a new prosthesis in the second phase of a two-stage revision after the initial infection has been cleared.

Device Description

Palacos® G (with gentamicin) is a fast setting polymer (polymethylmethacrylate) bone cement. Mixing the two sterile components, consisting of a powder and a liquid, initially produces a paste, which is used to anchor the prosthesis or to fill an anatomical cavity. The hardened bone cement allows stable fixation of the prosthesis and transfers stresses produced on movement to the bone via the large interface. Insoluble zirconium (IV) oxide is included in the cement powder as an x-ray contrast medium. The chlorophyll additive serves as optical marking of the bone cement at the site of the operation. The gentamicin component is a broad-spectrum antibiotic.

AI/ML Overview

The provided text is a 510(k) Summary of Safety and Effectiveness for the Palacos® G Bone Cement with Gentamicin. It describes a medical device, and 510(k) submissions typically focus on demonstrating substantial equivalence to a predicate device rather than presenting detailed acceptance criteria and studies in the way one might for a novel AI/software device.

Based on the information provided, it's clear that this is not a study of a software or AI device, but rather a submission for a medical device (bone cement) under the 510(k) pathway, which emphasizes substantial equivalence. Therefore, many of the requested categories (like sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance) are not applicable in the context of this specific document.

However, I can extract the relevant information and indicate where categories are not applicable.

Acceptance Criteria and Study for Palacos® G Bone Cement with Gentamicin

The core "acceptance criteria" for Palacos® G Bone Cement with Gentamicin, as per this 510(k) submission, is its substantial equivalence to a previously approved predicate device, Palacos® R (PMA No. P810020). The "study" proving this equivalence is a comparison of material composition and performance characteristics against the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria/Benchmark	Reported Device Performance (Palacos® G)
Substantial Equivalence to Predicate Device	Identical material components and manufacturing process to predicate Palacos® R, with the addition of Gentamicin.	"The components of Palacos® G (with gentamicin) are identical to the device Palacos® R and are identically processed and sterilized." The only difference is the addition of gentamicin.
Mechanical Characteristics	Must fulfill intended use, comparable to predicate Palacos® R.	"The results showed that Palacos® G (with gentamicin) possesses mechanical and chemical characteristics to fulfill its intended use." (Implies comparability to Palacos® R, though no specific metrics are given in this summary).
Chemical Characteristics	Must fulfill intended use, comparable to predicate Palacos® R.	"The results showed that Palacos® G (with gentamicin) possesses mechanical and chemical characteristics to fulfill its intended use." (Implies comparability to Palacos® R, though no specific metrics are given).
Set Time	Hard within 15 minutes.	"The bone cement hard within 15 minutes." (This is a general characteristic of the PMMA bone cement, not specific to Palacos G vs. R in this context, but describes its functional performance.)
Biocompatibility	Compatible with the body, long clinical history.	"These materials [of Palacos® R] have shown to be compatible and have a long clinical history of use." "Palacos® G (with gentamicin) is the same cement as Palacos® R... no toxicological studies have been conducted [for Palacos G specifically] because of the long clinical history of its components."
Intended Use	For arthroplasty procedures of hip, knee, and other joints to fix prosthetic parts to bone, specifically for revision of previous arthroplasty due to joint infection (second phase of two-stage revision after infection cleared).	Palacos® G is "indicated for use as bone cement in arthroplasty procedures of the hip, knee and other joints to fix plastic and metal prosthetic parts to living bone when reconstruction is necessary because of revision of previous arthroplasty procedures due to joint infection. The cement is intended for use to affix a new prosthesis in the second phase of a two-stage revision after the initial infection has been cleared."

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 (N/A) in the context of an AI/software device test set.
The comparison is based on the known characteristics and regulatory approval of the predicate device (Palacos® R) and the material specifications of Palacos® G. It's a device submission, not a study involving patient data in the sense implied by this question.
The document mentions "comparative testing to Palacos® R" but does not detail the nature or sample size of this testing.
It notes that Gentamicin has been "used in Europe for approximately 20 years," indicating a historical clinical use provenance for one of the active ingredients.

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)

N/A. This information is for AI/software device validation, not for a bone cement 510(k) submission.

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

N/A. This information is for AI/software device validation, not for a bone cement 510(k) 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

N/A. This is a medical device (bone cement) submission, not an AI/software device. No MRMC study was performed or is relevant here.

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

N/A. This is a medical device (bone cement) submission, not an AI/software device.

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

The "ground truth" for this 510(k) submission is the established safety and effectiveness profile of the predicate device (Palacos® R), as well as the chemical and mechanical specifications for bone cements of this type, and the long clinical history of gentamicin-containing bone cements in Europe.
The effectiveness and safety conclusions are drawn by comparing Palacos® G's characteristics and intended use to these established standards and the predicate device.

8. The sample size for the training set

N/A. This information is for AI/software device validation, not for a bone cement 510(k) submission.

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

N/A. This information is for AI/software device validation, not for a bone cement 510(k) submission.

Summary

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

K030086 page 17

DEC 17 2003

510(k) Summary of Safety and Effectiveness Palacos® G Bone Cement with Gentamicin

Submitter's Name and Address: Biomet Inc., P.O. Box 587 S6 East Bell Drive Warsaw, IN 46581

Contact Person: Lonnie Witham Biomet Inc. P.O. Box 587 Warsaw, IN 46581

Name of the Device: Palacos® G Bone Cement (with Gentamicin)

Legally marketed device to which the submitter claims substantial equivalence: Legally marketod de needs to m. FDA PMA No. P810020 (1984) - Subsequently reclassified into class II.

Description Of Palacos® G (with Gentamicin)

Description O1 1 anacos® O (With Gentamicin)
Palacos® G (with gentamicin) is a fast setting polymer (polymethylmethacy from don Fillacosw O (with gentamism) is a the two sterile components, consisting of a powder and a liquid, initially produces a paste, which is used to anchor the prosthesis or to fill an and a inquiry intrially produced bone cement allows stable fixation of the prosthesis and transfers stresses produced on movement to the bone via the large interface. Insoluble translers succioi in included in the cement powder as an x-ray contrast medium. The chlorophyll additive serves as optical marking of the bone cement at the site of the omorophyn Batalavamicin component is a broad-spectrum antibiotic.

Material used:

40.8 grams powder

Gentamicin sulfate (equivalent to 0.5 grams Gentamicin)	0.835 grams
Methyl acrylate-methyl methacrylate copolymer (6:94)	27.77 grams
Methyl acrylate-methyl methacrylate copolymer (42:58)	5.68 grams
Zirconium (IV) oxide (mono-clinic)	6.13 grams
Benzoyl peroxide	0.315 grams
Chlorophyll	0.008 grams (200 ppm)

Methylmethacrylate copolymer is the primary constituent of the powder component. Mediaci yiate coporymer is alle pacifier. Chlorophyll is added as a colorant to distinguish polymer from bone at the site of operation. Benzoylperoxide is a starter. All ulstinginsit poryiner from arment. Gentamicin® sulfate is an antibiotic that has been used in bone cement in Europe for approximately 20 years.

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

K030086 page 72

20 ml liguid Methyl methacrylate N, N-Dimethyl-p-toluidine Chlorophyll

18.4 grams 0.38 grams 0.005 grams (200 ppm)

Methymethacrylate monomer is the primary constituent of the liquid component. In much Methyliedlaci yiate monomer 16 the primary over the stablidine, and the stabilizer, smaller qualifics are the accelerative in the stituents of PMMA bone cement.

Scientific concepts, significant physical and performance characteristics:

Scientific concepts, significant puyscal and pixed, the accelerator speeds the generation When the powder and liquid components and many of the early free radicals,
of free radicals and the stabilizer in the liquid reacts with many of the early free radicals, of tree radicals and the Stabilized in the rigard reason formation of polymer chains.
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 Polymerizanon proceeds stowly over the fire rowly formed polymer chans, while
of the powder beads mingle with monomer and newly researce rises as set time of of the powder beads millgre with modiomer and now for rises as set time of the smaller beads may dissolve completely. The concern valiped and the bone cement hard within 15 minutes.

Palacos® G with gentamicin is made of the same materials as the approved bone cements Palacos® G with gemaintient is made of the same to be compatible and have a long
Palacos® R (P 810020). These materials have shown to be compatible and have a for Palacos® K (F 810020). These materials no retamicin has been used in Europe for approximately 20 years. Since Palacos® G (with gentamicin) is the same cement as approximately 20 years. Shice Falacose & (vines girstituents added nor removed),
Palacos® R approved in P810020 (1984) (no chemical vecco in Europe, no Palacos® R approved in P810020 (1964) (1964) (1984) (1984) 1984 119 11999) 1999 1999, 10 toxicological studies have been conducted.

Statement of intended use of the device:

Palacos® G with gentamicin is indicated for use as bone cement in arthroplasty Palacosw of the hip, knee and other joints to fix plastic and metal prosthetic parts to procedures of the hip, Kice and outler joints to inx previous of previous arthroplasty living bone when reconstruction. The coment is intended for the new prositesis
procedures due to joint infection. The coment is intense has been cleared procedures and to John firection. The center is the initial infection has been cleared

Summary of the technological characteristics of the new device in comparison to those of the predicate device:

those of the predicate device.
The components of Palacos® G (with gentamicin) are identical to the difference is the I he components of Falacos® O (with genearsed and sterilized. The only difference is the device Palacos® K and are identically proveder component. Palacos® R impregnated with gentamicin has a long clinical history of use in Europe.

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

K030086 page 373

The effectiveness and substantial equivalence of Palacos® G (with gentamicin) was The Creenveness and substantial equivparative testing to Palacos® R and by comparing the relevant data. The results showed that Palacos® G (with gentamicin) possesses mechanical and chemical characteristics to fulfill its intended use.

In summary, Palacos® G with gentamicin is safe and effective for use in the abovementioned indications. Palacos® G is substantially equivalent to Palacos® R for its primary intended use of fixation of prosthetic components.

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

Image /page/3/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 bars representing health, human services, and the USA. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 7 2003

Mr. Lonnie Witham Biomet, Inc. P.O. Box 587 Warsaw, Indiana 46581-0587

Re: K030086

Trade/Device Name: Palacos® G Bone Cement with Gentamicin Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: II Product Code: LOD and MBB Dated: September 19, 2003 Received: September 22, 2003

Dear Mr. Witham:

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 complics 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.

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

Page 2 - Mr. Lonnic Witham

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), plcase 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) you may obtain. 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 vours,

Mark A. Melkersen

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

{5}------------------------------------------------

STATEMENT OF INDICATIONS FOR USE

510(k) Number

Device Name: Palacos® G Bone Cement with Gentamicin

Indications for Use:

(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-Use No
(Optional Format 1-2-96)

Mark A. Mellers

morel, Restorative

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.”