The modified screw designs for use with the Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery are intended for use in the treatment of fractures and reconstructive procedures of the craniomaxillofacial skeleton and non-weight bearing fixation, including cranial bone fixation, brow fixation and orbital fixation. Each device is intended for sinqle use only and only in conjunction with other titanium and titanium alloy implants.

Device Description

Modified screw designs for use with the Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery includes titanium allov screws of varving diameters and lengths and are used for fixation of unalloved, commercially pure titanium and titanium alloy plates to the craniofacial bony tissue.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device (Modified screw designs for use with the Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery). It is a declaration of substantial equivalence to predicate devices, not a study describing acceptance criteria and a device performance study as typically seen for AI/ML-driven devices.

Therefore, the document does not contain the information requested to fill out the table and answer the questions related to acceptance criteria, device performance, sample sizes, ground truth, experts, adjudication, or MRMC studies.

This type of submission (510(k) for a traditional medical device like screws and plates) primarily focuses on demonstrating that the new device has the same technological characteristics and intended use as devices already legally marketed (predicate devices). The "study" here is essentially a comparison to predicate devices to prove substantial equivalence, rather than a clinical trial or performance study against predefined acceptance criteria for a novel technology.

Here's why the requested information is not available in the provided text:

Acceptance Criteria & Reported Device Performance: These are not defined because the submission aims to demonstrate equivalence, not to meet specific performance metrics through a clinical study. The "performance" is implicitly deemed equivalent to the predicate devices.
Sample Size (Test Set & Training Set), Data Provenance, Ground Truth, Experts, Adjudication, MRMC Study, Standalone Study: These concepts are relevant to the evaluation of AI/ML or complex diagnostic devices, where performance is measured against a ground truth. For a bone screw, the "study" is likely mechanical testing and a review of materials, not a clinical study involving human readers or expert consensus on images.
How Ground Truth was Established: Not applicable in this context.

In summary, the provided document does not describe the kind of study and acceptance criteria typically associated with performance evaluation of AI/ML or diagnostic devices. It is a regulatory submission for a physical medical device (bone screws and plates) demonstrating substantial equivalence to already approved predicate devices.

Summary

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K022890

Summary of Safety and Effectiveness

Submitter's name, address, telephone number and contact person:

Bioplate, Inc. 6911 Melrose Avenue Los Angeles, CA 90038 (323) 549-9500 (323) 935-0110 (fax)

Contact Person: Carol E. Jones

Trade Name of Device

Modified screw designs for use with the Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery

Common name

Bone plates and bone screws

Classification name

Bone Plate (21 CFR 872.4760)

Predicate Devices

Walter Lorenz Surgical Instruments, Inc. (1) Lorenz Self Drilling Screw K013954
(2) Synthes (USA) Self Drilling Screw K983485
(3) KLS-Martin L.P. Centre-Drive Drill Free Screw K971297
(4) Osteomed Corp. Auto-Drive Bone Screw K974785

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(5) Bioplate. Inc.
Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery K972463

Description of the device

Intended used of the device

The modified screw designs for use with the Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery are intended for use in the treatment of fractures and reconstructive procedures of the craniomaxillofacial skeleton and non-weight bearing fixation, including cranial bone fixation and orbital fixation. Each device is intended for single use only and only in conjunction with other titanium and titanium allov implants.

Comparison of the devices' technological characteristics with those of predicate devices

The modified screw designs for use with the Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery has the same indications for use as the Bioplate. Inc., Walter Lorenz, Synthes USA. Osteomed Corp., and KLS-Martin predicate devices. All of the technical characteristics of the modified screw designs for use with the Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery are substantially equivalent to the corresponding characteristics of the predicate devices, and any minor differences raise no new issues of safety and efficacy.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a human figure with three lines extending above it, resembling a bird in flight. The image is in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 6 2002

Ms. Carol E. Jones Chief Operating Officer Bioplate, Incorporated 6911 Melrose Avenue Los Angeles, California 90038

Re: K022890 Trade/Device Name: Regulation Number: 21 CFR 872.4760 Regulation Name: Regulatory Class: II Product Code: JEY Dated: August 30, 2002 Received: August 30, 2002

Dear Ms. Jones:

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.

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Page 2 - Ms. Jones

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.

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 and additionally 21 CFR Part 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 Part 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.qov/cdrh/dsma/dsmamain.html

Sincerely yours.

foAluishm fer.

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

Enclosure

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Page 1 of 1

510(k) Number (if known):

Device Name: Modified screw designs for use with the Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery.

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	✓	Over-The-Counter Use
(Per 21 CFR 801.109)		(Optional Format 1-2-96)
Susan Runo:
(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
510(k) Number:	K022890

Regulation Number and Section

§ 872.4760 Bone plate.

(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.