BonOs® Inject bone cement is indicated for the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesions using a vertebroplasty or balloon kyphoplasty procedure.

Device Description

BonOs® Inject is a radiopaque, injectable bone cement for use in spine surgery like percutaneous vertebral augmentation during vertebroplasty or kyphoplasty. It is a two-component system consisting of a powder and a liquid. Methylmethacrylate polymer is the primary constituent of the powder component. Zirconium dioxide is added as radiopacifier. Methylmethacrylate monomer is the primary constituent of the liquid component. Mixing the two separate sterile components, initially an injectable paste is produced which can be transferred into a syringe and which then can be injected under slight pressure into the vertebral body. After curing of the bone cement by exothermic polymerization it stabilizes the vertebral lesions and vertebral compression fractures.

AI/ML Overview

This submission is for a 510(k) premarket notification, which demonstrates substantial equivalence to a predicate device rather than explicitly defining and meeting acceptance criteria through a standalone study with specific performance metrics. Therefore, the information typically requested for acceptance criteria and a study proving device performance (like sensitivity, specificity, or reader improvement with AI) is not directly available in this document.

Instead, the submission focuses on demonstrating that the new device, BonOs® Inject, is as safe and effective as the predicate device, OSTEOPAL® V, through comparative physical, chemical, and mechanical tests.

Here’s a breakdown based on the provided text, addressing your points where possible, and noting where the information is not applicable to this type of submission:

1. A table of acceptance criteria and the reported device performance

Since this is a 510(k) submission proving substantial equivalence, explicit "acceptance criteria" in terms of clinical performance metrics (like sensitivity, specificity, etc.) are not provided. Instead, the "performance" revolved around demonstrating equivalence to the predicate device in key physical, chemical, and mechanical properties.

Characteristic/Test	Acceptance Criteria (Implicit: Equivalent to Predicate)	Reported Device Performance (BonOs® Inject)
Chemical Composition	Same as OSTEOPAL® V	Same chemical components
Physical Properties	Comparable to OSTEOPAL® V	Demonstrated through comparative tests
Mechanical Properties	Comparable to OSTEOPAL® V	Demonstrated through comparative tests
Intended Use	Same as OSTEOPAL® V	Treatment of pathological vertebral fractures via vertebroplasty or kyphoplasty
Safety & Effectiveness	Equivalent to OSTEOPAL® V	Demonstrated through comparative tests

Note: The document states, "The effectiveness and substantial equivalence of BonOs® Inject was determined by physical, chemical and mechanical comparative tests to OSTEOPAL®V and by comparing the results of the relevant data." The specific values or direct comparisons for each property are not detailed in this summary.

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

This submission does not detail a clinical "test set" in the way a diagnostic AI device would. The "tests" likely refer to bench-top laboratory tests for physical, chemical, and mechanical properties.

Sample Size for Test Set: Not specified. The submission refers to "comparative tests" and "relevant data" but does not provide numbers for specimens or batches used in these tests.
Data Provenance: Not specified, but the applicant is from Germany, so it's likely the tests were conducted in Germany or a related clinical setting. The device is also "successfully marketed in Europe."
Retrospective or Prospective: Not applicable as these are not human subject studies in the traditional sense for evaluating device performance. These would be laboratory studies.

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. This device is a bone cement, not a diagnostic imaging device requiring expert interpretation for ground truth establishment. The "ground truth" here would be established by validated laboratory testing methods and standards for material properties.

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

Not applicable. This is not a study involving human readers or subjective assessments.

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 a medical device involving AI or human readers for diagnostic interpretation.

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

Not applicable. This device is a medical implant (bone cement), not an algorithm.

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

The "ground truth" in this context would be the established material properties and performance characteristics of the predicate device (OSTEOPAL® V), determined through standard laboratory testing methods and industry specifications for bone cements. The new device was then tested against these established benchmarks to demonstrate equivalence.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device.

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

Not applicable. This is not an AI/machine learning device.

Summary

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K090460

5. 510(k) summary

Preparation date:	February 13, 2009
Submitter:	aap Biomaterials GmbHLagerstraße 11-1564807 DieburgGermanyPhone: +49 6071 / 929-0Fax: +49 6071 / 929-100	APR 1 4 2009
Contact person:	Volker Stirnal
Trade name:	BonOs® Inject
Common name:	PMMA Bone Cement (For Vertebroplasty)
Classification:	Polymethylmethacrylate (PMMA) Bone Cement21 CFR 888.3027, Class II
Product Code:	LOD, NDN
Panel:	Orthopedics

Predicate device to which substantial equivalence is claimed:

Manufacturer	Device Name	510(k) #
Heraeus Kulzer GmbH	OSTEOPAL® V	(K050085)

Device description:

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Scientific concepts, significant physical and performance characteristics:

Bone cements in general are self-polymerizing two-component systems comprising a powder and a liguid which polymerize at room temperature immediately after they are mixed together.

The bone cement powder mainly consists of polymethylmethacrylate (PMMA), benzoyl peroxide (BPO) as initiator and zirconium dioxide as radiopacifier. The liquid component comprises monomer methylmethacrylate (MMA) and N,Ndimethyl-p-toluidine (DmpT) as activator. Additionally MMA is stabilized with hydroquinone (HQ).

When the two components are mixed together, the activator DmpT contained in the liquid activates the initiator BPO. This reaction starts polymerization of the monomer MMA, which cross-links with the polymer powder during the ongoing polymerization. As a result, a viscous injectable mass is obtained which can be introduced into the vertebral fracture using a suitable application system. Heat is generated during setting as a result of the progressive polymerization and exothermic reaction respectively. The setting or curing time is greatly influenced by the temperature of the components and environment.

Statement of the intended use:

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

BonOs® Inject comprises the same chemical components as the legally marketed device OSTEOPAL®V. BonOs® Inject has been and is down to the present day successfully marketed in Europe.

The effectiveness and substantial equivalence of BonOs® Inject was determined by physical, chemical and mechanical comparative tests to OSTEOPAL®V and by comparing the results of the relevant data.

In summary, BonOs® Inject is safe and effective for the declared indications and substantially equivalent to OSTEOPAL®V.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

aap Biomaterials GmbH % Mr. Volker Stirnal Director QA/RA Lagerstrasse 11-15 D 64807 Dieburg Germany

APR 1 4 2009

Re: K090460 Trade/Device Name: BonOs® Inject Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: II Product Code: NDN Dated: February 13, 2009 Received: February 23, 2009

Dear Mr. Stirnal:

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.

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 - Mr. Volker Stirnal

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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,

Arbarmeinn

Mark N. Melkers Director Division of General, Restorative, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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4. Indications for Use

510(k) Number:

Device Name:

BonOs® Inject

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

510(k) Number

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

Soulaue Buetip

Concurrence of CDRH, Office of Device

Divi General, Restorative. sion of and Neurological Devices

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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.”