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 commercially pure titanium.

AI/ML Overview

This is a 510(k) premarket notification for a medical device (Modified plate designs for use with the Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery) and as such, it focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel safety and effectiveness through clinical trials with defined acceptance criteria and statistical performance metrics. Therefore, explicit "acceptance criteria" for device performance in the context of an AI study, and a "study that proves the device meets the acceptance criteria" as typically described for AI/algorithm performance, are not present in the provided text.

The document primarily relies on comparison with predicate devices to establish substantial equivalence regarding technological characteristics and intended use.

However, I can extract information related to the device and its intended purpose, which could hypothetically form the basis of acceptance criteria if this were an AI device.

Here's a breakdown of the requested information based on the provided document, noting that many items are not applicable (N/A) because this is not an AI device or an AI study:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Hypothetical for a similar AI device)	Reported Device Performance (N/A - This submission is for a physical medical device)
Mechanical Strength/Stiffness:	The document states "All of the technical characteristics of the modified plate designs...are substantially equivalent to the corresponding characteristics of the predicate devices..."
* Tensile strength <X MPa*	(Implicitly, the device meets the mechanical performance of predicate devices, which would have undergone their own testing for strength, fatigue, etc. These specific values are not provided in this 510(k) summary.)
* Fatigue life >Y cycles under Z load*
Biocompatibility:	The bone plates will be manufactured of commercially pure titanium, which is a well-established biocompatible material in predicate devices.
* No cytotoxicity (ISO 10993-5)*	(Presumed to be met by using commercially pure titanium.)
* No irritation (ISO 10993-10)*
Dimensional Accuracy:	The device is a "modified plate design," implying specific dimensions and configurations.
* Plate thickness within +/- 0.XX mm*	(Implicitly, the dimensions are consistent with predicate devices for the intended applications. Specific tolerances are not detailed.)
* Screw hole diameter within +/- 0.XX mm*
Fixation Security:	N/A - This would be a clinical outcome for a physical device, not an AI performance metric.
* Successful fracture stabilization in 95% of cases*
* No plate failure during expected use*

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

N/A. This is a 510(k) submission for a physical medical device, not an AI device or an AI study. There is no "test set" in the context of an algorithm's performance. The submission relies on a comparison of technical characteristics to predicate devices.

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)

N/A. Since this is not an AI device or an AI study, there is no ground truth, test set, or experts establishing ground truth in this context. The FDA's review process itself involves experts within the agency, but this is for regulatory clearance based on substantial equivalence, not for evaluating an algorithm's performance against a ground truth.

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

N/A. As there is no test set for an algorithm, there is no adjudication method described.

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

N/A. No MRMC study was done, as this is not an AI device.

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

N/A. This is a physical medical device, not an algorithm.

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

N/A. There is no ground truth described as this is not an AI study. The "truth" in this submission relies on the established safety and effectiveness of the predicate devices and the physical properties of the materials and design.

8. The sample size for the training set

N/A. This is a physical medical device, not an AI algorithm, so there is no training set.

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

N/A. As there is no training set, there is no ground truth for it.

In summary, the provided document is a 510(k) summary for a physical medical device (bone plates and screws). The regulatory pathway for such devices primarily involves demonstrating substantial equivalence to pre-existing, legally marketed predicate devices, rather than conducting new clinical trials or performance studies with specific statistical acceptance criteria as would be the case for a novel AI/software as a medical device (SaMD).

Summary

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KO23645

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)

Carol E. Jones Contact Person:

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

(1) Bioplate, Inc. Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery K943071
Bioplate, Inc. (2) Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery K992330
TiMesh Inc. (3) Softplates and screws K923419, K923802, K973145

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(4) Techmedica, Inc. Anspach Fixation System K921801
Walter Lorenz Surgical Instruments, Inc. (5) Ultra-micro Titanium Cranial Osteosynthesis System K910038
(6) KLS-Martin L.P. 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 Osteosynthesis System (2.0mm) K943347
Sofamor Danek (9) Timesh System K974017
(10) Howmedica, Inc. Luhr Titanium Pan Fixation System K945139

Description of the device

The bone plates will be manufactured of commercially pure titanium.

Intended used of the device

The modified plate designs for use with the Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery are intended for use in

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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.

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 Bioplate, 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/3/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is an emblem that features a stylized human figure in profile, with three faces overlapping each other. The emblem is meant to represent the department's mission of protecting the health of all Americans and providing essential human services.

Food and Drug Administration 9200 Corporate Boulevard

NOV 2.2 2002

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

Re: K023665

Trade/Device Name: Modified Plate Design for use with the Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY Dated: October 31, 2002 Received: October 31, 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 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.

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Page 2 – Mr. Jones

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,

Patricia Quearity for

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:

Kein Mulins for Susan Runner

esthesiology. General Hospital. 510(k) Number.

(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)

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.