REUNITE SCREWS by BIOMET MANUFACTURING, INC.

The ReUnite™ Screws are made of bioresorbable and biocompatible polymer that have been used in surgical procedures for a number of years. LactoSorb® resorbable copolymer is synthetic polyester derived from lactic and glycolic acids. Polylactic/polyglycolic (PLLA/PGA) acid copolymer degrades and resorbs IN VIVO by hydrolysis to lactic and glycolic acids, which are then metabolized by the body. The LactoSorb® material has been found to be biocompatible in both soft and hard bone tissues.

AI/ML Overview

The provided text describes a medical device, the ReUnite™ Screws, and its substantial equivalence determination from the FDA. However, it does not contain information about acceptance criteria, device performance metrics, or a study design in the way you've outlined. The text focuses on the device's material, indications for use, and a statement about its mechanical strength relative to a predicate device.

Therefore, most of the requested information cannot be extracted from the provided document.

Here's what can be extracted:

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

Acceptance Criteria	Reported Device Performance
Mechanical Strength:	The ReUnite™ Screws are "as strong or stronger than the LactoSorb® Bone Pin."
Resorption Time:	The device "completely resorbs in approximately 12 months IN VIVO."

(Note: These are indirect acceptance criteria based on the statements in the document, not formally presented as such.)

2. Sample sized used for the test set and the data provenance
This information is not provided in the document. The document refers to "mechanical testing" but does not detail the sample size or provenance of the data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document.

4. Adjudication method for the test set
This information is not provided in the document.

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
This information is not provided in the document. The device is a bone screw, not an AI-assisted diagnostic tool, so an MRMC study related to AI would not be applicable here.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not provided in the document. This is not an algorithmic device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Based on the description of "mechanical testing" and "resorption in vivo," the ground truth likely involved:

Mechanical Strength: Physical measurement against established mechanical standards or comparison to the predicate device's measured strength.
Resorption: In vivo studies (animal or human, though not specified here) to observe the degradation and resorption over time, possibly with histological examination or imaging.

8. The sample size for the training set
This information is not provided in the document. As this is not an AI/algorithmic device, the concept of a training set is not directly applicable in the typical sense.

9. How the ground truth for the training set was established
This information is not provided in the document. Again, the concept of a training set and its ground truth is not applicable to this type of device in the context of the provided text.

Summary

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Summary of Safety and Effectiveness

Submitter:	Biomet, Inc.P.O. Box 587Airport Industrial ParkWarsaw, Indiana 46581-0587
Contact Person:	Michelle L. McKinley
Product Code:	87 HWC
Device Name:	ReUnite™ Screws

The ReUnite™ Bone Screws are indicated for use in the presence of appropriate immobilization in the following procedures:

1. correction of hallux valgus (bunion)
1. repair of metacarpal and phalangeal fusion and fracture

The effectiveness of the resorbable screws was determined by mechanical testing. These screws are as strong or stronger than the LactoSorb® Bone Pin. The device completely resorbs in approximately 12 months IN VIVO eliminating the need for long-term removal.

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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 eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 1 1999

Ms. Michelle L. McKinley Regulatory Specialist Biomet Incorporated P.O. Box 587 Warsaw, Indiana 46581-0587

Re: K992301

Trade Name: ReUniteTM Screw Regulatory Class: II Product Code: HWC and MAI Dated: July 6, 1999 Received: July 8,1999

Dear Ms. McKinley:

ﺎﺳﺘ

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 Regulations, 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 Regulation (OS) 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.

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.

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Page 2 – Ms. Michelle L. McKinley

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 at (301) 443-6597, or at its Internet address "http://www.fda.gov/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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210(K) NUMBER (IF KNOWN): KJA 230 /

DEVICE NAME: ReUnite™ Screw

INDICATIONS FOR USE:

The ReUnite™ Screws are indicated for use in the presence of appropriate immobilization in the following procedures:

1. correction of hallux valgus (bunion)
1. repair of metacarpal and phalangeal fusion and fractures

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X (Per 21 CFR 801.109)

ﺳ

Over-the-Counter Use (Optional Format 1-2-96)

hoadey

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K99230

Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.