The sterile plate and screw kit configurations for use with the Bioplate® Titanium Fixation System are intended for use in non-load bearing fixation, including, but not limited to cranial bone fixation and brow fixation, and the treatment of fractures and reconstructive procedures of the craniomaxillofacial skeleton. Each device is intended for single use only and only in conjunction with other titanium and titanium alloy implants.

Device Description

The sterile plate and screw kit configurations for use with the Bioplate® Titanium Fixation System includes a variety of plate confiqurations for different anatomical applications. Titanium alloy screws of varying lengths are included for fixation of the plates to the craniomaxillofacial bony tissue. Titanium alloy screws of varying lengths are included for fixation of the plates to the craniomaxillofacial bony tissue.

The bone plates will be manufactured of unalloved, commercially pure titanium and titanium 6AI-4V ELI allov. The materials adhere to the American Society of Testing and Materials (A.S.T.M) F67 Standards and The American Society for Testing and materials (A.S.T.M.) F136 Standard. The screws will be manufactured of a titanium 6Al-4V ELI alloy that meets The American Society for Testing and materials (A.S.T.M.) F136 Standard.

The plate and screw kit confiqurations are sterilized using gamma radiation sterilization methods. Successful completion of sterilization validation and packaging validation studies provides a high level of assurance that sterility of the devices has been achieved and can be maintained.

AI/ML Overview

This submission K022033 does not contain a study that describes acceptance criteria for device performance in the manner typically seen for software or AI/ML devices. This is a 510(k) premarket notification for a Class II medical device, specifically Sterile Plate & Screw Kit Configurations for use with the Bioplate® Titanium Fixation System.

For devices like bone plates and screws, the "acceptance criteria" and "study" proving they meet those criteria are typically focused on substantial equivalence to predicate devices and adherence to established material and sterilization standards, rather than performance metrics like sensitivity, specificity, or accuracy.

Here's a breakdown based on the provided document, addressing the requested points where applicable, and noting where the information is not present or not relevant to this type of device:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred)	Reported Device Performance (Inferred)
Material Composition Standards:	- Plates: Unalloyed, commercially pure titanium and titanium 6Al-4V ELI alloy, adhering to ASTM F67 and ASTM F136 Standards.- Screws: Titanium 6Al-4V ELI alloy, meeting ASTM F136 Standard.
Sterilization Efficacy:	- Successfully completed sterilization validation studies proving sterility has been achieved.- Successfully completed packaging validation studies proving sterility can be maintained.
Intended Use Equivalence:	- Intended for use in non-load bearing fixation, cranial bone fixation, brow fixation, and treatment of fractures and reconstructive procedures of the craniomaxillofacial skeleton.- Matches the indications for use of predicate devices: Bioplate, Inc., Wurzburg, Synthes, TiMesh, and KLS-Martin.- Intended for single use only.
Technological Characteristics Equivalence:	- Same indications for use as predicate devices.- All technical characteristics are "substantially equivalent" to predicate devices.- "Minor differences raise no new issues of safety and efficacy."
Manufacturing Quality System:	- Implicitly meets Good Manufacturing Practice (GMP) requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820), as mandated by FDA for all medical devices. (Mentioned in FDA letter as a general requirement, not a specific claim from the submitter).
Safety and Efficacy (Overall Substantial Equivalence):	- Found substantially equivalent by FDA to legally marketed predicate devices, allowing it to proceed to market. The FDA letter states: "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."

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

This information is not applicable and not provided in the document. This type of device (bone plates and screws) does not typically involve a "test set" in the context of diagnostic or AI/ML performance evaluation studies. The "testing" refers to material and sterilization validation, which are engineering and manufacturing tests, not clinical performance tests with patient data.

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)

This information is not applicable and not provided. "Ground truth" for this device is established by adherence to engineering standards (ASTM), manufacturing specifications, and successful physical/chemical testing for material properties and sterility. It doesn't involve expert medical interpretation in the way an AI diagnostic device would.

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

This information is not applicable and not provided. Adjudication methods are relevant for disputes in expert-labeled datasets, which is not the case here.

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

This information is not applicable and not provided. MRMC studies are used for evaluating diagnostic performance, often involving human readers and AI/ML systems. This is not a diagnostic device; it's a surgical implant.

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

This information is not applicable and not provided. This device does not involve an algorithm.

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

The "ground truth" for this device is effectively established by:

Adherence to Material Standards: ASTM F67 and ASTM F136 specifications define the "truth" for material composition and properties.
Validation of Manufacturing Processes: Successful completion of sterilization validation and packaging validation studies (likely per ISO standards or similar) serves as "ground truth" for sterility.
Substantial Equivalence: The ultimate "ground truth" for marketing approval is that the device is substantially equivalent to predicate devices already on the market, meaning it performs as intended and introduces no new safety or efficacy concerns.

8. The sample size for the training set

This information is not applicable and not provided. There is no "training set" in the context of an AI/ML algorithm for this device.

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

This information is not applicable and not provided. There is no "training set" or "ground truth" establishment in the AI/ML sense for this device.

Summary

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K022033

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

Sterile plate and screw kit configurations for use with the Bioplate® Titanium Fixation System

Common name

Bone plates and bone screws

Classification name

Bone Plate (21 CFR 872.4760)

Predicate Devices

Walter Lorenz Surgical Instruments, Inc. (1) Lorenz 1.5mm Neuro Pack/Lorenz 2.0FT Plates (Sterile Version) . K972322
(2) Synthes (USA) Maxillofacial Titanium Micro Set K912932
(3) TiMesh Inc. Softplates and screws K923419, K923802, K973145
(4) Techmedica, Inc. Anspach Fixation System K921801

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Walter Lorenz Surgical Instruments, Inc. (5) Ultra-micro Titanium Cranial Osteosynthesis System K910038
KLS-Martin L.P. (6) KLS-Martin Micro Osteosynthesis System (1.0mm) L944561
KLS-Martin L.P. (7) KLS-Martin Micro Osteosynthesis System (1.5mm) K944545
KLS-Martin L.P. (8) KLS-Martin Oseosynthesis System (2.0mm) K943347
Sofamor Danek (છ) Timesh System K974017
(10) Howmedica, Inc. Luhr Titanium Pan Fixation System K945139

Description of the device

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assurance that sterility of the devices has been achieved and can be maintained.

Intended used of the device

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

The sterile plate and screw kit configurations for use with the Bioplate® Titanium Fixation System have the same indications for use as the Bioplate, Inc., Wurzburg, Synthes, TiMesh, and KLS-Martin predicate devices. All of the technical characteristics of the sterile plate and screw kit configurations for use with the Bioplate® Titanium Fixation System 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/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes extending from its head, representing the department's mission to protect the health of all Americans. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 9 2002

Bioplate. Incorporated C/O Mr. Bruce F. Mackler Heller. Ehrman, White & Mcauliffe 815 Connecticut Avenue NW Washington, D. C. 20006-4004

Re: K022033

Trade/Device Name: Sterile Plate & Screw Kit Configurations for use with the Bioplate® Titanium Fixation System Regulation Number: 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY Dated: June 10, 2002 Received: June 21, 2002

Dear Mr. Mackler:

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 vour 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 - Mr. Mackler -

You must comply with all the Act's requirements, including, but not limited to: registration ないではないとなるとなるならなくなる 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.gov/cdrh/dsma/dsmamain.html

Sincerely yours!

Timothy A. Ulatowski

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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10 ===========================================================================================================================================================================

Device Name: Sterile plate and screw kit configurations for use with the Bioplate® Titanium Fixation System

Indications for Use:

The sterile plate and screw kit configurations for use with the Bioplate® Titanium Fixation System are intended for use in non-load bearing fixation, including cranial bone fixation and brow fixation, and the treatment of fractures and reconstructive procedures of the craniomaxillofacial skeleton and. Each device is intended for single use only, and only in conjunction with other titanium and titanium alloy implants.

(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)

(Division Sign-Off)

Division of Dental, Infection Control,

and General Hospital Devices

510(k) Number
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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.