CRANIOFACIAL ANCHORS by BIOMET, INC.

The Craniofacial Anchors are indicated for use with resorbable suture in open and endoscopic brow lift procedures. The device is placed into a preditiled, tapped bone hole and assists the suture in anchoring soft tissue. These devices are not designed for use in the mandible and/or full load bearing procedures.

Device Description

AI/ML Overview

This document is a 510(k) summary for the Craniofacial Anchors, focusing on establishing substantial equivalence to previously marketed devices. It does not contain information about specific acceptance criteria or a dedicated study proving device performance against those criteria in the way a clinical trial for a new drug or a novel AI diagnostic device would.

Here's an analysis based on the provided text, addressing your questions where possible:

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

This information is not present in the provided document. The 510(k) summary focuses on demonstrating substantial equivalence, primarily through the material composition (LactoSorb®) and its historical use, rather than presenting a performance study with specific acceptance criteria.

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

This information is not present in the provided document. As this is a 510(k) for a medical device (craniofacial anchors) made from a well-established resorbable material (LactoSorb®), the "test set" and "data provenance" as you might expect for an AI or diagnostic device study are not directly applicable or reported here. The safety and effectiveness are primarily supported by the long history of the material.

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 present in the provided document. Ground truth as typically defined for diagnostic device studies is not relevant to this 510(k) submission.

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

This information is not present in the provided document. Adjudication methods are typically used in clinical trials or diagnostic accuracy studies, which are not detailed 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

A multi-reader multi-case (MRMC) comparative effectiveness study is not applicable and not mentioned in this document. This type of study is relevant for AI-powered diagnostic devices, not for a resorbable craniofacial anchor.

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

A "standalone algorithm performance" study is not applicable and not mentioned in this document. This is a medical device, not an algorithm.

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

"Ground truth" as a concept is not directly applicable to this 510(k) submission in the way it is for diagnostic devices. The safety and effectiveness are established based on:

Material properties: LactoSorb® material's history of biocompatibility and resorption.
Prior clinical use of material: "[T]he exact same LactoSorb® material has been implanted in humans for over 10 years in the form of a ligating clip and safety and effectiveness has been studied in two different clinical trials." This implies clinical outcomes data from previous uses of the material serve as the "ground truth" for the material's safety and bioresorption characteristics.
Animal studies: "based on animal studies, completely resborbs by 12 months In Vivo."

8. The sample size for the training set

This information is not present in the provided document. "Training set" is a concept for machine learning, which is not relevant here.

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

This information is not present in the provided document. "Ground truth for a training set" is a concept for machine learning, which is not relevant here.

Summary of Device Acceptance (as per 510(k) process):

The acceptance of this device by the FDA for market clearance (as granted in the letter) is based on the determination of substantial equivalence to existing legally marketed predicate devices, not on meeting specific, de novo acceptance criteria from a new clinical study.

The primary evidence presented to support substantial equivalence revolves around:

Material Safety and Effectiveness: The Craniofacial Anchors are made from LactoSorb® material. The document highlights:
- It's a bioresorbable and biocompatible polymer (PLA/PGA).
- Its safety is "well documented since the early 1970's" with FDA-approved resorbable sutures.
- The "exact same LactoSorb® material has been implanted in humans for over 10 years in the form of a ligating clip" and its "safety and effectiveness has been studied in two different clinical trials."
- It maintains strength for soft tissue reattachment and fracture healing.
- Animal studies show complete resorption by 12 months in vivo.
Indications for Use: The anchors are intended for use with resorbable suture in open and endoscopic brow lift procedures, where they assist in anchoring soft tissue. The document explicitly states they are not for use in the mandible or full load-bearing procedures.

The "study" referenced in the 510(k) is the long history and established safety and effectiveness of the LactoSorb® material itself, as demonstrated in prior animal studies and human clinical trials (for a ligating clip use). The FDA's letter confirms that based on this information, the device is considered substantially equivalent to pre-amendments devices and can be marketed.

Summary

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K974136

510(k) Summary of Safety and Effectiveness

SUBMITTER: Biomet, Inc. Airport Indutrial Park P. O. Box 587 Warsaw, IN 46581-0587

CONTACT PERSON: Mary L. Verstynen (219) 267-6639 ext. 1343

PRODUCT CODE: 79 GAN Device Name: Craniofacial Anchors

SUMMARY

The devices are made of LactoSorb® material, which based on animal studies, completely resorbs by 12 months In Vivo. The devices are made of bioresorbable and biocompatible polymers that have been used in surgical procedures for years. LactoSorb® resorbable copolymer is a synthetic polyester derived from lactic and glycolic acids. Polylactic/polyglycolic (PLA/PGA) acid copolymer degrades and resorbs In Vivo by hydrolysis to lactic and glycolic acids which are then metabolized by the body. The safety of PLAPGA material has been well documented since the early 1970's when FDA first approved the use of resorbable PLA/PGA sutures. The exact same LactoSorb® material has been implanted in humans for over 10 years in the form of a ligating clip and safety and effectiveness has been studied in two different clinical trials. The LactoSorb® material has been found to be biocompatible in both soft and hard bone tissue and maintains its strength for soft tissue reattachment and fracture healing.

As demonstrated in this submission, the Craniofacial Anchors are safe and effective for use in brow lift procedures.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure with three wavy lines extending from the head, resembling hair or a flowing garment. The figure is positioned to the right of a circular emblem containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

3 0 1998 : 1

Ms. Mary Verstynen ·Clinical Research Manager Biomet, Inc. Airport Industrial Park P.O. Box 587 Warsaw, Indiana 46581-0587

Re: K974136 Craniofacial Anchor Trade Name: Regulatory Class: II Product Codes: MBI, HWC, and GAN Dated: October 31, 1997 Received: November 3, 1997

Dear Ms. Verstynen:

We have reviewed your Section 510 (k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A . . . . substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Mary Verstynen

This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.qov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D.

Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510 (k) NUMBER (IF KNOWN) : K974136 DEVICE NAME: Craniofacial Anchors

INDICATIONS FOR USE:

5 -

The Craniofacial Anchors are indicated for use to assist resorbable suture in open and endoscopic brow lift procedures.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number	1979136

Prescription Use
(Per 21 CFR 801.109) X OR Over-The-Counter-Use
(Optional Format 1-2-96)

Regulation Number and Section

N/A