The modified plate 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-load 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 alloy implants.

Device Description

Modified plate designs for use with the Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery includes a variety of plate configurations for different anatomical applications. 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 a titanium 6AI-4V alloy that meets The American Society for Testing and Materials (A.S.T.M.) F136 and/or F1472 Standards. 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.

AI/ML Overview

This document is a 510(k) summary for a medical device called "Modified plate designs for use with the Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery." It is a premarket notification to the FDA, asserting substantial equivalence to previously marketed devices.

Based on the provided text, there is no acceptance criteria or study that proves the device meets specific acceptance criteria in the way you've outlined for an AI/algorithm-based device. This document describes a traditional medical device (bone plates and screws), not an AI or software device that would typically have performance metrics like sensitivity, specificity, or an MRMC study.

Therefore, many of the requested fields cannot be filled as they are not applicable to this type of device submission.

Here's a breakdown of what can be extracted and why other fields are not applicable:

A table of acceptance criteria and the reported device performance
- Not Applicable. This is a hardware device (bone plates and screws). Acceptance criteria for such devices typically relate to material properties (e.g., ASTM standards for titanium alloy), mechanical strength, biocompatibility, and manufacturing quality. The submission asserts that the device meets existing standards for these properties by stating the materials meet ASTM F136 and F1472. There are no performance metrics like sensitivity or specificity.
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. This is a hardware device. There is no "test set" of data in the context of an algorithm's performance. The "testing" mentioned would typically refer to mechanical and material property testing, not clinical data evaluation for performance.
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. There is no "test set" requiring ground truth establishment by experts for performance evaluation in this context.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No test set of data for performance evaluation.
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 hardware device, not an AI system. MRMC studies are not relevant.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. This is a hardware device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. No ground truth in the context of an algorithm's performance. For a hardware device, "ground truth" would relate to whether the manufacturing met specifications, the material properties were as stated, and mechanical tests confirmed expected behavior. These are typically verified by engineering and quality control procedures.
The sample size for the training set
- Not Applicable. This is a hardware device, not an AI system. There is no training set.
How the ground truth for the training set was established
- Not Applicable. No training set.

Summary regarding the device in the provided text:

The document is a 510(k) submission for "Modified plate designs for use with the Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery." The basis for its acceptance (substantial equivalence to predicate devices) is primarily rooted in:

Material Equivalence: The plates are made of titanium 6Al-4V alloy meeting ASTM F136 and/or F1472 Standards, and screws from titanium 6Al-4V ELI alloy meeting ASTM F136 Standard. These standards specify material composition, mechanical properties, and other characteristics considered safe and effective in predicate devices.
Intended Use Equivalence: The device has the same indications for use as listed predicate devices.
Technological Characteristics Equivalence: The submitter states that "All of the technical characteristics of the modified plate designs... are substantially equivalent to the corresponding characteristics of the predicate devices, and any minor differences raise no new issues of safety and efficacy." This implies that design, dimensions, and mechanical performance are comparable to the predicate devices, which are already deemed safe and effective.

The FDA's letter (K021684) grants clearance based on this "substantial equivalence" finding, meaning the new device is considered as safe and effective as the legally marketed predicate devices. It does not involve performance metrics or studies relevant to an AI/algorithm-based device as requested in your prompt.

Summary

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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 plate 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) Wurzburg Titanium Mini Bone Plates and Bone Screws K854886
(2) Synthes (USA) Maxillofacial Titanium Micro Set K912932
(3) TiMesh Inc. Softplates and screws K923419, K923802, K973145
(4) Techmedica, Inc. Anspach Fixation System K921801
(5) Walter Lorenz Surgical Instruments, Inc. Ultra-micro Titanium Cranial Osteosynthesis System K910038
(6) KLS-Martin L.P. KLS-Martin Micro Osteosynthesis System (1.0mm) L944561

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(7) KLS-Martin L.P. KLS-Martin Micro Osteosynthesis System (1.5mm) K944545
KLS-Martin L.P. (8) KLS-Martin Osteosynthesis System (2.0mm) K943347
(છ) Sofamor Danek Timesh System K974017
(10) Howmedica, Inc. Luhr Titanium Pan Fixation System K945139

Description of the device

Intended used of the device

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

The modified plate designs for use with the Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery has the same indications for use as the Wurzburg, Synthes, TiMesh, and KLS-Martin predicate devices. All of the technical characteristis of the modified plate 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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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an emblem featuring a stylized eagle with three human profiles incorporated into its body. The eagle's head faces left, and its wings are represented by three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 6 2002

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

Re: K021684

Trade/Device Name: Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery Regulation Number: 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Codes: JEY and HRS Dated: May 22, 2002 Received: May 22, 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.

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

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KO21684 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:

The modified plate 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 nonload 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 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

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.