LACTOSORB BONE PIN by BIOMET, INC.

The LactoSorb® Bone Pin is made of bioresorbable and biocompatible polymers that have been used in surgical procedures for numerous years. LactoSorb® resorbable copolymer is a synthetic polyester derived from lactic and glycolic acids. Polylactic/polyglycolic acid (PLLA/PGA) copolymer degrades and resors IN VIVO by hydrolysis to lactic and glycolic acids, which are then metabolized by the body.

AI/ML Overview

Here's an analysis of the provided text regarding the LactoSorb® Bone Pin, focusing on acceptance criteria and the supporting study, organized according to your requested points:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Initial Strength	Demonstrated "adequate initial strength" compared to currently marketed resorbable pins.
Strength Retention	Retained "at least 80% of that strength at 8 weeks."
Comparison to Marketed Resorbable Pins	In the same test environment at eight weeks, comparative pins exhibited "little or no strength," implying LactoSorb® Bone Pin performed better.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document does not specify the exact sample size for the comparative in vitro mechanical testing. It refers to "the LactoSorb® pins" and "comparative pins" in the plural, without providing numerical details.
Data Provenance: The study was conducted as "In VITRO mechanical comparative testing." This indicates the data was generated in a lab setting, not from human or animal subjects. The provenance of the comparative pins (e.g., specific manufacturers or models) is not provided.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable. This was an in vitro mechanical testing study, not a study requiring expert clinical review to establish ground truth. The "ground truth" here is the mechanical properties measured by the test equipment.

4. Adjudication Method for the Test Set

Not applicable. As this was an in vitro mechanical test, there was no need for adjudication of results by experts.

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

Not applicable. This device is not an AI-assisted diagnostic or imaging device, and the study described is in vitro mechanical testing. Therefore, an MRMC comparative effectiveness study involving human readers and AI is not relevant.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is a medical device (bone pin), not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for this study was the measured mechanical properties (initial strength and strength retention over time) obtained through standardized in vitro testing. This is a direct measurement of physical attributes rather than an expert consensus, pathology, or outcomes data in a clinical sense.

8. The Sample Size for the Training Set

Not applicable. This information is irrelevant for an in vitro mechanical comparative testing study of a physical device. There is no machine learning model being trained here.

9. How the Ground Truth for the Training Set Was Established

Not applicable. There is no training set as this is not a machine learning study.

Summary

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3/23/99

K996291

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510 (K) Summary of Safety and Effectiveness

Submitter:	Biomet, Inc.P.O. Box 587Airport Industrial ParkWarsaw, Indiana 46581-0587
Contact Person:	Michelle L. McKinley
Product Code:	87HTY
Device Name:	LactoSorb® Bone Pin

The LactoSorb® Bone Pin is 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

The LactoSorb® Bone Pin is made of bioresorbable and biocompatible polymers that have been used in surgical procedures for numerous years. LactoSorb® resorbable copolymer is a synthetic polyester derived from lactic and glycolic acids. Polylactic/polyglycolic acid (PLLA/PGA) copolymer degrades and resorbs IN VIVO by hydrolysis to lactic and glycolic acids, which are then metabolized by the body.

The effectiveness of the LactoSorb® Bone Pin was determined by In VITRO mechanical comparative testing to currently marketed resorbable pins. The tests showed that the LactoSorb® pins demonstrated adequate initial strength and retained at least 80% of that strength at 8 weeks. In the same test environment at eight weeks, the comparative pins exhibited little or no strength.

In summary, the LactoSorb® Bone Pin is safe and effective for metacarpel and phalangeal repair. Mechanical testing demonstrated the Lactosorb® Bone Pin to be as effective or better than comparative resorbable bone pins.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 3 1994

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

Re: K990291 LactoSorb® Bone Pin Trade Name: Requlatory Class: II Product Codes: HTY and MAI Dated: January 22, 1999 Received: January 29, 1999

Dear Ms. McKinley:

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 The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, qood 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ಗಿ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (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 requlation 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. Michelle L. McKinley

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.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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510 (k) NUMBER (IF KNOWN): K99029 /

DEVICE NAME: LactoSorb® Bone Pin

INDICATIONS FOR USE:

The LactoSorb® Bone Pin is indicated for use in the presence of appropriate immobilization in the following procedures:

1. correction of hallux valgus (bunion)
1. repair of metacar pal 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 _ メ Use (Per 21 CFR 801.109)

Over-The-Counter-

(Optional Format 1-2-96)

Tocòell

(Divisio eneral Restorative Devi 510(k) Numb

00003

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.