Bone Cement - Normal Viscosity is indicated for fixation of prostheses to live bone in musculoskeletal orthopedic surgical interventions in cases of rheumatoid arthritis, osteoarthritis, traumatic arthritis, osteoporosis, avascular necrosis, collagen disease, severe secondary destruction of the joints after trauma or other conditions and in the review of previous arthroplasty procedures.

Device Description

The Bone Cement - Normal Viscosity is a self-curing, radiopaque, polymethyl methacrylatebased cements used for securing a metal or polymeric prothesis to living bone in arthroplasty procedures. The bone cement has no intrinsic adhesive properties but rely instead on close mechanical interlock between the irregular bone surface and the prosthesis.

AI/ML Overview

The provided text is a 510(k) summary for a medical device called "Bone Cement - Normal Viscosity." It describes its indications for use, device description, equivalence to a marketed predicate device, and performance data. However, the document does not describe a study involving an AI/Machine Learning device or a study involving human-in-the-loop performance, expert ground truth adjudication, or statistical performance metrics like sensitivity/specificity or ROC curves typically associated with AI device performance and acceptance criteria.

Instead, this document pertains to a traditional medical device (bone cement) and focuses on demonstrating substantial equivalence to a predicate device through physical, chemical, and mechanical properties, as well as sterilization, shelf-life, and biocompatibility testing according to established FDA guidance for PMMA bone cement.

Therefore, I cannot fulfill the request to describe acceptance criteria, a study proving AI device performance, sample sizes for test/training sets, expert ground truth establishment, or MRMC studies, as this information is not present in the provided text.

The document explicitly states: "No clinical data were included in this submission." This further confirms that the type of study outlined in the request (which heavily implies clinical or reader studies for AI performance) was not part of this 510(k) submission.

Summary of why the request cannot be fully answered based on the provided text:

Device Type: The device is bone cement, not an AI/ML diagnostic or assistive device.
Study Type: The studies performed are non-clinical, testing physical, chemical, and mechanical properties, sterilization, shelf-life, and biocompatibility. They are not AI performance studies.
Lack of AI-related metrics: There are no mentions of sensitivity, specificity, AUC, human reader improvement with AI assistance, or any other metrics relevant to AI device performance.
No Human-in-the-loop or standalone AI performance: The concepts of human readers, expert adjudication, or AI algorithms acting in standalone mode are not applicable to the studies described for bone cement.
No Training/Test Set Data for AI: There is no mention of training sets, test sets, or ground truth for an AI model because no AI model is being evaluated.

Therefore, for the sake of completeness, I can only state what is described regarding performance criteria for this specific device, which differs significantly from the AI/ML framework requested.

What is described for "Bone Cement - Normal Viscosity" performance testing (non-AI related):

The performance data to establish substantial equivalence were conducted in accordance with the "FDA Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement; Guidance for Industry and FDA" dated July 17, 2002.

Acceptance Criteria and Reported Device Performance (as gathered from the "PERFORMANCE DATA" section):

Acceptance Criteria Category	Type of Test Performed	Reported Device Performance Statement
Physical/Chemical/Mechanical Properties	- Mixing and Application characteristics- Chemical Composition- Molecular weight- Physical Properties- Stability of Components- Thermal Properties- Mechanical properties	"The performance data demonstrate that the new device Bone Cement - Normal Viscosity substantially equivalent to the predicate device application K053003." (This implies the results met the established criteria for substantial equivalence to the predicate as per the guidance document.)
Sterilization and Shelf Life	- Validation of ethylene oxide method- Validation of membrane filter sterilization	"The sterilization process, including the ethylene oxide method and the membrane filter sterilization has been validated and the sterility of the subject device has been verified according to ISO 11135 and ISO 13408-1/2."
Endotoxins	- Assessment on the presence of endotoxins	"The assessment on the presence of endotoxins was carried out in accordance with USP 43 - NF 38, 2020 <85> Bacterial Endotoxins Test." (Implies compliance with the standard.)
Biocompatibility	- Biological evaluation	"The biological evaluation of subject device was performed in accordance with ISO 10993-1 in accordance with the 'Biological evaluation of medical devices - Part 1: evaluation and testing within a risk management process', issued September 20202018.'" (Implies compliance with the standard.)

Regarding the AI/ML specific questions:

Sample size for test set and data provenance: Not applicable. This is not an AI/ML device study.
Number of experts and qualifications for ground truth: Not applicable. Ground truth for AI is not established.
Adjudication method: Not applicable.
MRMC comparative effectiveness study: Not applicable.
Standalone performance (algorithm only): Not applicable.
Type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" here is the adherence to material and manufacturing standards for bone cement, not diagnostic accuracy.
Sample size for the training set: Not applicable. No AI model is being trained.
How the ground truth for the training set was established: Not applicable.

Summary

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May 31, 2022

Biomecanica Indústria e Comérciode Produtos Ortopédicos LTDA % Graziela Brum Regulatory Affairs Specialist Passarini Regulatory Affairs/PR Servicos Regulatórios Administrativos Ltda ME Rua Alice Além Saadi, 855/2402 Ribeirão Preto, São Paulo 14096-570 Brazil

Re: K212729

Trade/Device Name: Bone Cement-Normal Viscosity Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) Bone Cement Regulatory Class: Class II Product Code: LOD Dated: April 11, 2022 Received: April 20, 2022

Dear Graziela Brum:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Laura C. Rose, Ph.D. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K212729

Device Name

Bone Cement - Normal Viscosity

Indications for Use (Describe)

Bone Cement - Normal Viscosity is indicated for. fixation of prostheses to live bone in musculoskeletal orthopedic surgical interventions in cases of rheumatoid arthritis, traumatic arthrilis, osteoporosis, avascular.necrosis, collagen disease, severe secondary destruction of the iciner conditions and in the review of previous arthroplasty procedures.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

ADMINISTRATIVE INFORMATION

Sponsor/Manufacturer Name	Biomecanica Indústria e Comérciode Produtos Ortopédicos Ltda.Rua Luiz Pengo 145Jaú, São Paulo, Brazil 17212-811Telephone: +55 (14) 2104-7900
Contact Person and Preparer	Graziela Brum and Ana Carolina CarvalhoRegulatory Affairs SpecialistPassarini Regulatory AffairsPR Serviços Regulatórios Administrativos LtdaE-Mail: graziela@passarini.com.brTelephone +55 (11) 98578-0200

30/May/2022 Date Prepared

DEVICE NAME AND CLASSIFICATION

Trade/ Proprietary Name	Bone Cement - Normal Viscosity
Common Name	Bone Cement
Classification Name	Polymethyl Methacrylate (PMMA) Bone Cement
Product Code	LOD
Classification Regulation	21 CFR 888.3027; Class II
Classification Panel	Orthopedic

PREDICATE DEVICE INFORMATION

K053003 - DePuy CMW 3 Bone Cements, DePuy Orthopedics, Predicate Device Inc.

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INDICATIONS FOR USE

DEVICE DESCRIPTION

EQUIVALENCE TO MARKETED DEVICE

The Bone Cement – Normal Viscosity shares many of the same technological characteristics compared to the predicate DePuy CMW 1, 2 and 3 Bone Cements important considerations such as most materials. The subject device has similar technological characteristics as the predicate devices. Both predicates and subject device provide two separate, premeasured sterilized components which, when mixed, form a radiopaque rapidly setting bone cement. The subject device and the predicate devices are all polymethylmethacrylate (PMMA) bone cements.

Characteristics		Subject Device	Predicate(K053003) Model: CMW3
Bone Cement Powder:	Radio pacifier	Barium Sulphate	Barium Sulphate
	Polymer	Poly (methyl acrylate/methyl methacrylate) (PMMA)	Poly (methyl acrylate/methyl methacrylate) (PMMA)
	Initiator	Benzoyl Peroxide	Benzoyl Peroxide
	Colour additives	None	None
Bone Cement Liquid:	Monomer	Methylmethacrylat e (MMA) stabilized with Hydroquinone	Methylmethacrylat e (MMA) stabilized with Hydroquinone
	Activator	N, N-dimethyl-p toluidine	N, N-dimethyl-p toluidine

Table 1: Comparison of the Technological Characteristics with the Predicate Devices

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ColourAdditives	None	None
---------------------	------	------

PERFORMANCE DATA

These 510(k) submissions provided performance data to establish the substantial equivalence of the new bone cements to the predicate bone cement. Performance testing was conducted in accordance with the "FDA Class II Special Controls Guidance Document: Polymethylacrylate (PMMA) Bone Cement; Guidance for Industry and FDA" dated July 17, 2002. Non-clinical performance testing was performed to characterize the bone cements in accordance with special controls guidance document. This testing included the following:

Mixing and Application characteristics
Chemical Composition
Molecular weight
Physical Properties
Stability of Components
Thermal Properties
Mechanical properties

The performance data demonstrate that the new device Bone Cement - Normal Viscosity substantially equivalent to the predicate device application K053003.

Sterilization and Shelf Life: The sterilization process, including the ethylene oxide method and the membrane filter sterilization has been validated and the sterility of the subject device has been verified according to ISO 11135 and ISO 13408-1/2.

Endotoxins: The assessment on the presence of endotoxins was carried out in accordance with USP 43 - NF 38, 2020 <85> Bacterial Endotoxins Test.

Biocompatibility: The biological evaluation of subject device was performed in accordance with ISO 10993-1 in accordance with the "Biological evaluation of medical devices - Part 1: evaluation and testing within a risk management process", issued September 20202018."

No clinical data were included in this submission.

CONCLUSION

The documentation submitted in this premarket notification demonstrates that the subject device has comparable features and performance and, therefore, are substantially equivalent to the identified predicate device.

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.”