The modified plates 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 single use only and only in conjunction with other titanium and titanium alloy implants.

Device Description

The modified plate designs for use in conjunction with the Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery includes a variety of plate configurations for different anatomical applications. Commercially pure titanium plates, and titanium alloy screws of varying lengths are included for fixation of the plates to the craniomaxilloffacial bony tissue. The bone plates will be manufactured of commercially pure titanium (Grade 4). The materials adhere to the American Society of Testing and Materials (A.S.T.M) F67 Standards.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the "Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery." This submission focuses on modifications to existing predicate devices.

Crucially, this document does not contain acceptance criteria or a study that proves the device meets specific performance criteria in the way one might expect for a new AI/software device or a device requiring clinical performance validation.

Instead, this 510(k) summary is centered on demonstrating substantial equivalence to previously cleared predicate devices. The "study" here is essentially a comparison to existing devices, asserting that the modified plate designs are functionally the same and raise no new safety or efficacy concerns.

Therefore, many of the requested categories (like sample size for test set, number of experts, adjudication method, MRMC studies, standalone performance, training set details) are not applicable to this type of submission.

Here's a breakdown based on the provided text, indicating where information is present and where it is absent/not applicable:

Acceptance Criteria and Device Performance Study for Bioplate® Rigid Fixation Bone Plating System

As this is a 510(k) premarket notification affirming substantial equivalence for device design modifications, the "acceptance criteria" and "study" are framed around similarity to predicate devices rather than novel performance benchmarks.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied by Substantial Equivalence)	Reported Device Performance (as stated in the submission)
Material Composition: Adhere to accepted standards.	The bone plates will be manufactured of commercially pure titanium (Grade 4). The materials adhere to the American Society of Testing and Materials (A.S.T.M) F67 Standards.
Intended Use: Match predicate devices.	The modified plate design for use with the Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial surgery has the same indications for use as the predicate devices (K021684, K980983, K972463, K953273, and K943071), specifically for "treatment of craniofacial fractures, reconstructive procedures, and non-load bearing fixation including, maxillofacial fixation, cranial bone fixation and orbital fixation." Intended for single use only and in conjunction with other titanium and titanium alloy implants.
Technological Characteristics: Substantial equivalence to predicate devices, with no new safety/efficacy issues.	"All of the technical characteristics are substantially equivalent to the corresponding characteristics of the predicate devices, and any minor differences raise no new issues of safety and efficacy." Specific details on the "modified plate designs" are not provided beyond them being "a variety of plate configurations for different anatomical applications."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not applicable. This submission doesn't describe a clinical or performance "test set" in the traditional sense for evaluating a new device's performance against specific metrics. It's a comparison to existing predicate devices.
Data Provenance: Not applicable. No new efficacy data from human subjects or retrospective/prospective studies are presented for the modified designs. The data "provenance" here relates to the established safety and efficacy of the predicate devices.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Number of Experts & Qualifications: Not applicable. No "ground truth" for a test set was established by experts for this submission. The determination of "substantial equivalence" is made by the FDA based on the comparison provided by the manufacturer.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. No test set requiring expert adjudication was conducted or described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study: No. This type of study is not mentioned as it is irrelevant for a submission focused on demonstrating substantial equivalence of minor design modifications to existing hardware. There is no AI component or human-in-the-loop performance being evaluated.
Effect Size of Human Readers with/without AI: Not applicable. No AI component is described.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Standalone Study: Not applicable. This device is a physical bone plating system, not an algorithm or software.

7. The Type of Ground Truth Used

Type of Ground Truth: The "ground truth" in this context is the established safety and efficacy profile of the legally marketed predicate devices. The submission argues that the modified device is equally safe and effective due to its substantial equivalence. There is no new "ground truth" derived from pathology, outcomes data, or expert consensus specifically for these modified plates beyond the assertion that they are functionally similar to the predicates.

8. The Sample Size for the Training Set

Sample Size for Training Set: Not applicable. This is a hardware device, not an AI/ML algorithm requiring a training set.

9. How the Ground Truth for the Training Set Was Established

Ground Truth for Training Set: Not applicable. No training set for an algorithm was used.

Summary

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K0238/0

Summary of Safety and Effectiveness DEC 0 4 2002

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: Judy Sokua

Trade Name of Device

Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery

Common name

Bone Plates

Classification name

Bone Plate (21 CFR 872.4760)

Predicate Devices

(1) Bioplate, Inc. Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery K021684
(2) Bioplate, Inc. Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery K980983
(3) Bioplate, Inc. Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery K972463

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Bioplate. Inc. (4) Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery K953273
(5) Bioplate. Inc. Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery K943071

Description of the device

The bone plates will be manufactured of commercially pure titanium (Grade 4). The materials adhere to the American Society of Testing and Materials (A.S.T.M) F67 Standards

Intended used of the device

The Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery is intended for use in the treatment of craniofacial fractures, reconstructive procedures, and non-load bearing fixation including, maxillofacial fixation, 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 plate design for use with the Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial surgery has the same indications for use as the Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surqery (K021684, K980983, K972463, K953273, and K943071) predicate devices. All of the technical characteristics 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 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" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three wing-like extensions, suggesting movement or flight.

Public Health Service

ood and Drug Administration 00 Corporate Boulevard Rockville MD 20850

DEC 04 2002

Ms. Judy Sokua Regulatory Affairs Associate Bioplate, Incorporated 6911 Melrose Avenue Los Angeles, California 90038-3305

Re: K023810

Trade/Device Name: Modified Plate designed for use with the Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery Regulation Number: 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY Dated: November 14, 2002 Received: November 15, 2002

Dear Ms. Sokua:

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.

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Page 2 - Ms. Sokua

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); 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), 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.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Timothy A. Ulatowski

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

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510(k) Number (if known):

Device Name: Modified plate 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
(Per 21 CFR 801.109)

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

Suxin Rair

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

KCd 3810 510(k) Number _

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.