Bioplate® Resorbable Bone Screws are intended for use in conjunction with Codman Craniosorb™ plates and meshes in the treatment of fractures and reconstructive oranioon's of the craniomaxillofacial skeleton in which resorbable fixation is desired. The plates and screws are used to align and stabilize fractures of bony tissue while normal tissue healing occurs.

The Bioplate® Resorbable Bone Screws are intended for minimally load bearing fixation for the following indications:

Reconstructive procedures of the craniomaxillofacial skeleton ●
. Repair of Craniofacial fractures
Cranial bone fixation .
Brow lift procedures

Device Description

The Bioplate® Resorbable Bone Screws are resorbable implants made from a Poly(L-The Dioplates I Rosofbable Bons are provided pre-sterilized by gamma radiation and are not intended to be resterilized by the user.

AI/ML Overview

The provided text is a 510(k) summary for the Bioplate® Resorbable Bone Screw, and it primarily focuses on establishing substantial equivalence to predicate devices rather than presenting a study demonstrating the device meets specific acceptance criteria based on performance metrics like accuracy, sensitivity, or specificity.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth types cannot be extracted from the provided text because such information is not present. This type of document is a regulatory submission for a medical device that often relies on existing data or similarities to previously approved devices, rather than a de novo performance study like those conducted for AI-driven diagnostic tools.

Here's a breakdown of why each point cannot be addressed:

A table of acceptance criteria and the reported device performance: Not present. The document focuses on "substantial equivalence" of design, material, intended use, and principles of operation to predicate devices, not on quantifiable performance metrics.
Sample sized used for the test set and the data provenance: Not present. There is no mention of a "test set" in the context of performance evaluation.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present. Ground truth is not discussed in the context of device performance evaluation.
Adjudication method for the test set: Not present.
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 relevant. This device is a bone screw, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not relevant. This device is a bone screw, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not present.
The sample size for the training set: Not relevant. There is no "training set" as this is not an AI/ML device.
How the ground truth for the training set was established: Not relevant. There is no "training set" as this is not an AI/ML device.

In summary, the provided 510(k) submission is for a physical medical device (bone screw) and does not contain the kind of performance study data and acceptance criteria information that would be expected for a diagnostic device or an AI/ML product.

Summary

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NOV 2 8 2001

510(k) Summary The Bioplate® Resorbable Bone Screw PAGE 1 OF 2

August 28, 2001

Bioplate, Inc. 6911 Melrose Avenue Los Angeles, CA 90038 Tel: (323) 549-9500, Fax: (323) 935-0110

Contact: Eric V. Hohenstein

PROPRIETARY NAME

Bioplate® Resorbable Bone Screw

COMMON NAME

Absorbable Bone Screw

CLASSIFICATION NAME

Screw, fixation, bone

CLASSIFICATION NO

87HWC

DEVICE CLASSIFICATION

Class II, 21 CFR 888.3040

STATEMENT OF SUBSTANTIAL EQUIVALENCE

The Bioplate® Resorbable Bone Screws are substantially equivalent to the screws of The Bloplate® Hesofbable Done Craniomaxillofacial Surgey, Biolactat™ Indiana the Blophatos Berior Plaing Of the predicate devices in intended use, design, material, and principles of operation.

DESCRIPTION OF DEVICE

6911 Melrose Avenue, Los Angeles, California 90038 TEL . (888) BIOPLATE . (323) 549 9500 . FAX . (323) 935 0110 E-MAIL . info@bioplate.com INTERNET . http://www.bioplate.com

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510(k) Summary The Bioplate Biosorb™ Resorbable Bone Screw PAGE 2 OF 2

INDICATIONS FOR USE:

The Bioplate® Resorbable Bone Screws are intended for minimally load bearing fixation for the following indications:

Reconstructive procedures of the craniomaxillofacial skeleton ●
. Repair of Craniofacial fractures
Cranial bone fixation .
Brow lift procedures

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized symbol that resembles an eagle or a bird in flight, with three curved lines representing the wings and body.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 8 2001

Mr. Eric Hohenstein Bioplate, Incorporated 6911 Melrose Avenue Los Angeles, California 90038

Re: K012908

Trade/Device Name: Bioplate Resorbable Bone Screw Regulation Number: 872.4880 and 872.4760 Regulation Name: Resorbable Bone Screw Regulatory Class: II Product Code: DZL and JEY Dated: August 28, 2001 Received: August 30, 2001

Dear Mr. Hohenstein:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your becases one 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 Interstate commerce prior to that have been reclassified in accordance with the provisions of Amendinents, or to do rioto that in to a ct (Act) that do not require approval of a premarket the Federal Food, Drug, and Cosments , too gray, therefore, subject to the general approval application (1 Milly) - - The general controls provisions of the Act include confors provisions of the Fren - 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 II your device is classified (boo as 10) was a morely. Existing major regulations affecting (PMA), it may of subject to such additions, Title 21, Parts 800 to 898. In your device can be found in the be as nouncements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not Flease be advisod that I DTF 8 ibsudi.co on that your device complies with other requirements mean that I DA mas made a astes and regulations administered by other Federal agencies. of the Act of ally i ederal statutes and reguirements, including, but not limited to: registration

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Page 2 - Mr. Hohenstein

and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and listing (21 CFR Part 607), laceling (21 CFR Part 820), and if
requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if requirements as set form in als quality ion 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 This letter will anow you to begin maintening of substantial equivalence of your device to 310(K) premarket notification. I secults 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 IT you desire specific as now 809.10 for in vitro diagnostic devices), please contact the and additionally 21 CFR Part 609-4613. Additionally, for questions on the promotion and Office of Confightance at (301) as contact the Office of Compliance at (301) 594-4639. ad verailing on your the regulation entitled, "Misbranding by reference to premarket Also, proase note the togal 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and the Act may be obtained in its be number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours

A. Ulatowski Timot 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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K012908

STATEMENT OF INDICATIONS FOR USE

DEVICE NAME:

The Bioplate Resorbable Bone Screw

INDICATIONS FOR USE:

Bioplate Resorbable Bone Screws are intended for use in conjunction with Codman CRANIOSORB™ plates and meshes in the treatment of fractures and reconstructive procedures of the craniomaxillofacial skeleton in which resorbable fixation is desired. The plates and screws are used to align and stabilize fractures of bony tissue while normal tissue healing occurs.

The Bioplate Resorbable Bone Screws are intended for minimally load bearing fixation for the following indications:

Reconstructive procedures of the craniomaxillofacial skeleton .
Repair of Craniofacial fractures
. Cranial bone fixation
. Brow lift procedures

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

CONCURRANCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)

Prescription Use J (Per 21 CFR 801.109

Over-The-Counter Use_ (Optimal Format 1-2-96)

Susan Turner

Division Sign-Off

510(k) Number K 01 290 8

Regulation Number and Section

§ 872.4880 Intraosseous fixation screw or wire.

(a)
Identification. An intraosseous fixation screw or wire is a metal device intended to be inserted into fractured jaw bone segments to prevent their movement.(b)
Classification. Class II.