3i® 's Calcium Sulfate Bone Cement is used over a filled defect providing a stable barrier to graft material migration and is also indicated for use as a binder of bone graft particles. For use in dental applications only.

Device Description

318 Calcium Sulfate Cement is packaged in two syringes. One svringe contains the powder component while the other syringe contains the liguid component. The powder component is calcium sulfate dihydrate (CaSO4 · 2H2O). The liquid component is a solution comprised of potassium citrate monohydrate (KaC6HsOr " H2O), sodium phosphate dibasic (NazHPO4 7H2O), and distilled water (H2O). The svringe with the liguid component comes with a female-female Luer coupler for connecting the two syringes together for mixing. When mixed, the powder and liquid combine to form a homogenous paste. The paste hardens approximately 5-10 minutes after the start of mixing.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called "3i® Calcium Sulfate Bone Cement." This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving the device meets specific acceptance criteria through a clinical study with detailed performance metrics like an AI/ML device would require.

Therefore, many of the requested sections regarding acceptance criteria, study design, and performance metrics for an AI/ML device are not applicable to this document.

Here's an analysis based on the provided text, highlighting what information is available and what is not:

1. Table of acceptance criteria and the reported device performance

Not Applicable. This document does not describe acceptance criteria in the sense of performance metrics for an AI/ML model (e.g., sensitivity, specificity, AUC). Instead, it focuses on demonstrating "substantial equivalence" of the new device to a predicate device based on technological characteristics and intended use. The "performance" discussed is related to biodegradability, resorption time, and biocompatibility in animal studies, not statistical measures of diagnostic accuracy.

2. Sample size used for the test set and the data provenance

Not Applicable. No human clinical test set was used. "Animal studies" are mentioned for biodegradability and biocompatibility, but specific sample sizes or species are not detailed. The document states "Clinical Testing: Not performed on this device."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable. No clinical test set or human ground truth establishment process is described.

4. Adjudication method for the test set

Not Applicable. No clinical test set or adjudication process is described.

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 an AI/ML device, and no MRMC study was performed.

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

Not Applicable. This is not an AI/ML device.

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

Not Applicable. For the non-clinical testing performed:
- Biodegradability and resorption: Likely assessed through animal dissection, imaging, and histological analysis over time.
- Biocompatibility: Assessed through "biocompatibility testing and animal studies," which typically involves in vitro cell assays (cytotoxicity, genotoxicity, sensitization) and in vivo implantation studies with histological examination, blood chemistry, etc. The "ground truth" here would be the results of these biological and analytical tests.

8. The sample size for the training set

Not Applicable. This is not an AI/ML device and therefore no training set was used.

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

Not Applicable. This is not an AI/ML device and therefore no training set or its ground truth establishment is relevant.

Summary of Relevant Information from the Document:

Summary of Non-Clinical Testing:
- The device is biodegradable and in animal studies was found to resorb in approximately four to eight weeks, depending on defect size.
- Biocompatibility testing and animal studies demonstrate the safety of the material; it was found to be non-toxic, non-mutagenic, non-hemolytic, and nonpyrogenic.
Clinical Testing: Not performed on this device.
Substantial Equivalence: The device is deemed substantially equivalent to the predicate device CAPSET® Calcium Sulfate Bone Graft Plaster based on having the "same technological characteristics."
Intended Use: Used over a filled defect providing a stable barrier to graft material migration and also indicated for use as a binder of bone graft particles. For use in dental applications only.

Summary

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SEP 1 9 2001

KOIZ

Summary of Safety and Effectiveness

Applicant/Sponsor: Biomet, Inc. 56 E. Bell Drive Warsaw, Indiana 46582

Contact Person: Mary L. Verstynen Telephone: (219) 267-6639 Fax: (219) 372-1683
Proprietary Name: 3i® Calcium Sulfate Bone Cement

Common Name: calcium sulfate dihydrate

Classification Name: Implant, endosseous for bone filling and/or reconstruction (872.3640)

Legally Marketed Device To Which Substantial Equivalence Is Claimed: CAPSET® Calcium Sulfate Bone Graft Plaster

Device Description: 318 Calcium Sulfate Cement is packaged in two syringes. One svringe contains the powder component while the other syringe contains the liguid component. The powder component is calcium sulfate dihydrate (CaSO4 · 2H2O). The liquid component is a solution comprised of potassium citrate monohydrate (KaC6HsOr " H2O), sodium phosphate dibasic (NazHPO4 7H2O), and distilled water (H2O). The svringe with the liguid component comes with a female-female Luer coupler for connecting the two syringes together for mixing. When mixed, the powder and liquid combine to form a homogenous paste. The paste hardens approximately 5-10 minutes after the start of mixing.

Intended Use: 3i® Calcium Sulfate Bone Cement is used over a filled defect providing a stable barrier to graft material migration and is also indicated for use as a binder of bone graft particles.

Summary of Technologies: The cement has the same technological characteristics as the predicate device

Non-Clinical Testing: 38 Calcium Sulfate Cement is biodegradable and in animal studies, depending on the defect size, was found to resorb in approximately four to eight weeks. Biocompatibilty testing and animal studies demonstrate the safety of the material, which was found to be non-toxic, non-mutagenic, non-hemolytic, and nonpyrogenic.

Clinical Testing: Not performed on this device,

00259

3i is a registered trademark of Implants Innovations, Inc. Capset is a registered trademark of Lifecore Biomedical, Inc.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of a human figure in profile, with three overlapping silhouettes suggesting a sense of community or interconnectedness.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 9 2001

Implant Innovations, Incorporated C/O Ms. Mary L. Verstynen Biomet. Incorporated 56 East Bell Drive Warsaw, India 46582

Re: K012047

Trade/Device Name: 31 Calcium Sulfate Bone Cement Regulation Number: None Regulation Name: Calcium Ulfate Dihydrate Regulatory Class: Unclassified Product Code: LYC Dated: June 22, 2001 Received: June 29, 2001

Dear Ms. Verstynen:

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

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Page 2 - Ms. Verstynen

and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and insting (21 er read on the quality systems (QS) regulation (21 CFR Part 820); and if roquirelier as as betronic product radiation control provisions (section 531-542 of the Act; 21); CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a premilated 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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 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 vours,

L. Alatorre

Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K012047

Page of

510(k) NUMBER (IF KNOWN): ___K012047

DEVICE NAME: 3i® Calcium Sulfate Bone Cement

INDICATIONS FOR USE:

3i® 's Calcium Sulfate Bone Cement is used over a filled defect providing a stable barrier to graft material migration and is also indicated for use as a binder of bone graft particles.

For use in dental applications only.

(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) OR

Over-The-Counter-Use (Optional Format 1-2-96)

Susan Pharr

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number _ COLORY

Regulation Number and Section

§ 872.3930 Bone grafting material.

(a)
Identification. Bone grafting material is a material such as hydroxyapatite, tricalcium phosphate, polylactic and polyglycolic acids, or collagen, that is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.(b)
Classification. (1) Class II (special controls) for bone grafting materials that do not contain a drug that is a therapeutic biologic. The special control is FDA's “Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices.” (See § 872.1(e) for the availability of this guidance document.)(2) Class III (premarket approval) for bone grafting materials that contain a drug that is a therapeutic biologic. Bone grafting materials that contain a drug that is a therapeutic biologic, such as biological response modifiers, require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.