CRANIOFACIAL CALCIUM PHOSPHATE CERAMIC BONE FILLER by BIOMET, INC.

The Craniofacial Calcium Phosphate Ceramic Bone Filler is a self-setting calcium phosphate cement indicated for use in the repair of neurosurgical burr holes, craniotomy cuts and other cranial defects as well as in the augmentation and restoration of bony contour in the craniofacial skeleton.

Device Description

The Craniofacial Calcium Phosphate Ceramic Bone Filler is comprised of a calcium phosphate powder and a liquid component. The two components are mixed to produce a homogenous paste, which can then be applied to burr holes, bone gaps, and other defect sites.

AI/ML Overview

This document is a 510(k) submission summary for a medical device called "Craniofacial Calcium Phosphate Ceramic Bone Filler." It describes the device, its intended use, and states that it has been found substantially equivalent to a predicate device based on biocompatibility and mechanical testing.

However, the provided text does not contain detailed information about specific acceptance criteria or a study designed to prove the device meets those criteria in the way you've outlined for an AI/algorithm-based device. This document is for a physical medical implant, not a software algorithm.

Therefore, many of the requested fields cannot be answered from the given text.

Here's an attempt to answer what can be extracted or reasonably inferred, and note where information is missing for your specific request format:

Acceptance Criteria and Device Performance Study Details

Criteria Aspect	Acceptance Criteria (Not Explicitly Stated for this Device Type)	Reported Device Performance (as stated in the summary)
Biocompatibility	Expected: Non-toxic, non-mutagenic, non-hemolytic, non-pyrogenic.	"The Craniofacial Calcium Phosphate Ceramic Bone Filler is a biocompatible material... found to be non-toxic, non-mutagenic, non-hemolytic, and non-pyrogenic."
Mechanical Strength	Expected: Adequate strength for intended non-load bearing use.	"Mechanical testing determined the material has adequate strength for the intended use."
Substantial Equivalence (Overall Safety & Effectiveness)	Expected: Performance similar to a legally marketed predicate device for the same indications.	Device found to be "substantially equivalent" to predicate device.

Detailed Study Information (Based on the provided text for a physical device)

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable / Not Provided. This summary refers to "biocompatibility testing" and "animal studies" for safety, and "mechanical testing" for strength. It does not describe a "test set" in the context of an algorithm's performance evaluation or patient data.
- For biocompatibility: In vitro assays and in vivo animal studies (provenance and specific sample sizes not detailed).
- For mechanical strength: In vitro testing (provenance and specific sample sizes not detailed).
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 / Not Provided. This is not relevant for the type of device (bone filler) and studies mentioned (biocompatibility, mechanical strength, animal studies). Ground truth in the context of expert consensus isn't applicable here.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable / Not Provided.
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 a physical bone filler, not an AI or imaging device involving human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device's safety and effectiveness determination is based on:
  - Biocompatibility standards and test results: Proving non-toxicity, non-mutagenicity, non-hemolysis, non-pyrogenicity.
  - Mechanical properties: Measured strength against established requirements for the intended application (non-load bearing).
  - Similarity to predicate device: The predicate device has an established safety and effectiveness record.
The sample size for the training set
- Not Applicable. This is not an algorithm with a training set.
How the ground truth for the training set was established
- Not Applicable. This is not an algorithm with a training set.

Summary based on the document:

The device, Craniofacial Calcium Phosphate Ceramic Bone Filler, was deemed safe and effective through:

Biocompatibility testing and animal studies: Demonstrating the material is non-toxic, non-mutagenic, non-hemolytic, and non-pyrogenic.
Mechanical testing: Confirming adequate strength for its non-load bearing applications.
Substantial Equivalence: Comparison to a legally marketed predicate device with a history of safe and effective use for the same indications.

The document does not detail specific acceptance criteria in a quantifiable manner (e.g., "strength must be > X MPa") or specific study protocols, sample sizes, or data provenance beyond stating that tests were performed and results were positive. This type of information would typically be found in more detailed sections of a 510(k) submission, not necessarily in the summary provided.

Summary

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SUMMARY OF SAFETY AND EFFECTIVENESS

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

Contact Person: Michelle L. McKinley

Product Code: 84GXP, 84JBA

Device Name: Craniofacial Calcium Phosphate Ceramic Bone Filler

Craniofacial Calcium Phosphate Ceramic Bone Filler is comprised of a calcium phosphate powder and a liquid component. The two components are mixed to produce a homogenous paste, which can then be applied to burr holes, bone gaps, and other defect sites.

The Craniofacial Calcium Phosphate Ceramic Bone Filler is a biocompatible material, and is similar to the predicate device used in the same non-load bearing indications. Biocompatibility testing and animal studies demonstrate the safety of the material. The material is found to be non-toxic, non-mutagenic, non-hemolytic, and non-pyrogenic. Mechanical testing determined the material has adequate strength for the intended use.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol that resembles three parallel lines curving upwards, often interpreted as representing human aspiration and well-being.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Nov 1 8 1999

Ms. Michelle L. McKinley Requlatory Specialist Biomet, Inc. P.O. Box 587 46581-0587 Warsaw, Indiana

K990290 Re: Craniofacial Calcium Phosphate Ceramic Bone Filler Requlatory Class: II Product Code: GXP Dated: August 26, 1999 Received: August 27, 1999

Dear Ms. McKinley:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), 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 895. ਦੇ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Michelle L. McKinley

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 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 requlation (21 CFR Part 801 and additionally 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510 (k) NUMBER (IF KNOWN): K990690

DEVICE NAME: Craniofacial Calcium Phosphate Ceramic Bone Filler

INDICATIONS FOR USE:

The Craniofacial Calcium Phosphate Ceramic Bone Filler is a self-setting calcium phosphate cement intended for the use in the repair of neurosurgical burr holes, craniotomy cuts and other cranial defects as well as in the augmentation or restoration of bony contour in the craniofacial skeleton.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use Use (Per 21 CFR 801.109) :

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Over-The-Counter-

(Optional Format 1-2-96)

Division Sign. Org.

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number. K990292

000003

Regulation Number and Section

§ 882.5300 Methyl methacrylate for cranioplasty.

(a)
Identification. Methyl methacrylate for cranioplasty (skull repair) is a self-curing acrylic that a surgeon uses to repair a skull defect in a patient. At the time of surgery, the surgeon initiates polymerization of the material and forms it into a plate or other appropriate shape to repair the defect.(b)
Classification. Class II (performance standards).