The Bioplate® Bioclip® Craniotomy Fixation System is intended to re-attach a cranial bone flap to the surrounding cranium after a craniotomy procedure. Each device is intended for single use only and only in conjunction with other titanium and titanium alloy implants.

The Bioplate® Bioclip® Craniotomy Fixation System is contraindicated in the following conditions: The gap in the cranial bone is greater than 2.5mm for standard sizes. The gap in the cranial bone is greater than 4mm for XT sizes. The skull thickness is less than 4.5mm

Device Description

The Bioplate® Bioclip® Craniotomy Fixation System consists of a bone plate manufactured of 6Al 4V titanium alloy that utilizes a combination of fastening tabs and spring action to re-attach a cranial bone flap following a craniotomy procedure. Each device is provided non-sterile and must be sterilized prior to use. The device is intended for single use only and may be combined only with other titanium and titanium alloy implants.

AI/ML Overview

This document describes a medical device, the Bioplate® Bioclip® Craniotomy Fixation System, for which the manufacturer is seeking 510(k) clearance. This is a premarket notification process for devices that can be demonstrated to be "substantially equivalent" to a legally marketed predicate device. This process does not typically involve clinical efficacy studies or statistical performance criteria as would be expected for a novel AI/software medical device.

Therefore, a detailed response regarding acceptance criteria, study design for proving performance, sample sizes, expert involvement, and ground truth establishment, which are typical for AI/software medical devices, cannot be provided from the given text. The provided text focuses on demonstrating substantial equivalence to predicate devices, which is a different regulatory pathway.

However, I can extract the relevant information regarding the device's intended use and contraindications, which act as de facto "performance" boundaries for its application.

1. Table of Acceptance Criteria and Reported Device Performance

As this is a mechanical fixation system seeking 510(k) clearance by demonstrating substantial equivalence, there are no specific quantitative "acceptance criteria" and "device performance" metrics in the way one would evaluate an AI algorithm's sensitivity and specificity. Instead, the "performance" is implicitly tied to its ability to reattach a cranial bone flap under certain conditions, and the "acceptance criteria" are defined by its contraindications.

Acceptance Criteria (Contraindication Limits)	Reported Device Performance (Operational Limits)
Gap in cranial bone is not greater than 2.5mm (for standard sizes)	Intended to reattach cranial bone flap where gap is ≤ 2.5mm (standard)
Gap in cranial bone is not greater than 4mm (for XT sizes)	Intended to reattach cranial bone flap where gap is ≤ 4mm (XT)
Skull thickness is not less than 4.5mm	Intended to reattach cranial bone flap where skull thickness is ≥ 4.5mm
Device used for single use only	Designed for single use only
Combined only with other titanium and titanium alloy implants	Designed to be combined only with other titanium and titanium alloy implants

2. Sample size used for the test set and the data provenance:

Not applicable (N/A). This 510(k) submission does not describe a clinical performance study with a test set of data points in the context of AI/software. It is a mechanical device. The "test" for substantial equivalence would involve comparing the technical characteristics and intended use of the new device to existing predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

N/A. Ground truth establishment by experts is not described or required for this type of 510(k) submission for a mechanical device.

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

N/A. Adjudication methods are not described for this type of device submission.

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. This is a mechanical bone fixation device, not an AI/software medical device that would involve human readers or comparative effectiveness studies with AI assistance.

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

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

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

N/A. The "ground truth" for this device's performance would be engineering specifications, material properties, and in-vitro or in-vivo biomechanical testing (which are not detailed in this summary). The basis for its substantial equivalence is comparison to previously cleared devices, suggesting that the underlying safety and effectiveness of its design principles have been established through those earlier devices.

8. The sample size for the training set:

N/A. There is no training set in the context of an AI/software device. For a mechanical device, the "training" aspect would relate to design iterations and engineering testing, not data-driven learning.

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

N/A. No training set or associated ground truth establishment is applicable to this mechanical device submission.

Summary

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K0/3055

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

The Bioplate® Bioclip® Craniotomy Fixation System

Common name

Bone Plate

Classification name

Bone Plate

Device Classification

76 JEY (21CFR - 872.4760)

Predicate Devices

The Bioplate® Bioclip® Craniotomy Fixation System -(K001530) (K002879) (K011380)

Description of the device

Intended used of the device

The Bioplate® Bioclip® Craniotomy Fixation System is intended to reattach a cranial bone flap to the surrounding cranium after a craniotomy procedure. Each device is intended for single use only and only in conjunction with other titanium and titanium alloy implants.

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The Bioplate® Bioclip® Craniotomy Fixation System is contraindicated in the following conditions:

The gap in the cranial bone is greater than 2.5mm for standard sizes. The gap in the cranial bone is greater than 4mm for XT sizes. The skull thickness is less than 4.5mm

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

The Bioplate® Bioclip® Craniotomy Fixation System has the same indications for use as the predicate devices marketed by Bioplate, Inc. All of the technical characteristics of The Bioplate® Bioclip® Craniotomy 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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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The symbol is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement. The logo is black and white.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 0 7 2001

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

Re: K013055

Trade/Device Name: The Bioplate Bioclip Craniotomy Fixation System Regulation Number: 872.4760 Regulation Name: Bone Plates and Bone Screws Regulatory Class: II Product Code: JEY Dated: September 11, 2001 Received: September 11, 2001

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 1 ou listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and listing (21 et rear of 7) equality 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 s 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

Enclosure

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Page 1 of 1

Bioplate Inc. APPLICANT:

510(k) NUMBER: (if known):____________________________________________________________________________________________________________________________________________________

DEVICE NAME: Bioplate® Bioclip® Craniotomy Fixation System

INDICATIONS FOR USE:

The Bioplate® Bioclip® Craniotomy Fixation System is intended to re-attach a The Bloplate® Blocilip® Craniotomy procedure. The clipplate is used to align and cranial bone nap following a craniconiy procuse. Each device is intended for single stablize bony tissue while normal healing occarer Lich world and the results and

The Bioplate® Bioclip® Craniotomy Fixation System is contraindicated in the following conditions:

The gap in the cranial bone is greater than 2.5mm for standard sizes. The gap in the cranial bone is greater than 4mm for XT sizes. The skull thickness is less than 4.5mm

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED.)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use______________________________________________________________________________________________________________________________________________________________ Use (Per 21 CFR 801.109) Over-The-Counter-

(Optional Format 1-2-96)

Susan Pierce

(Division Sign-Off) Olvision of Dental, Infection Control, ematon of Deneral Hospital Devicess
బంగార General Hospital Devicess
No.Gli - Number 110();; 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.