2.5 MM LACTOSORB SCREWS by BIOMET, INC.

The 2.5 mm LactoSorb® Screws are composed 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/pclyglycolic acid copolymer degrades and rescrbs IN vIVO by hydrolysis to lactic and glycolic acids which are then metabolized by the body. In animal studies LactoSorb® has been found to be biocompatible in both soft tissue and bone tissue. Lact:oSorb® devices have been marketed for over two years for use in trauma and reconstructive procedures in the craniomaxillofacial skeleton and have been found to be both safe and effective.

AI/ML Overview

The provided text describes the 510(k) summary for the 2.5 mm LactoSorb® Screws. It outlines the device's indications for use, material composition, and how its efficacy was demonstrated. However, it does not contain the detailed information required to fully answer all aspects of your request, especially regarding specific acceptance criteria, study design details, and statistical analysis.

Based on the provided text, here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Explicitly Stated/Implied)	Reported Device Performance
Maintain strength for a specified period	Maintains strength for at least 6-8 weeks
Complete resorption within a specified period	Completely resorbs in approximately one year
Biocompatibility	Found to be biocompatible in both soft tissue and bone tissue (in animal studies)
Safety and Effectiveness	Found to be both safe and effective (based on previous marketing of LactoSorb® devices for over two years)

Missing Information:

Specific quantitative acceptance criteria (e.g., minimum tensile strength, degradation rates) are not provided.
Details of the "biomechanical testing" are not given, so specific performance metrics from these tests are unavailable.
The "clinical use" is mentioned, but no specific performance data from clinical studies are reported in this summary.

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

The document mentions "animal studies" for biocompatibility and "clinical use" (referring to previous marketing of LactoSorb® devices).

Sample Size for Test Set: Not specified for animal studies or clinical use. The summary does not describe a distinct "test set" in the context of the requested AI/ML study design.
Data Provenance:
- Animal studies mentioned.
- Clinical use mentioned, referring to devices marketed for over two years. No country of origin is specified, and it's unclear if the data were retrospective or prospective.

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

Not applicable. The document describes a medical device for surgical fixation, not an AI/ML diagnostic or prognostic tool that would typically involve establishing ground truth from expert interpretations of medical images or data.

4. Adjudication Method for the Test Set:

Not applicable. This is relevant for studies involving human interpretation or consensus, which is not the primary focus of this device's demonstration of efficacy based on the provided text.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No. The document describes biomechanical testing and general clinical use, not a comparative effectiveness study involving human readers with and without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Not applicable. This device is a physical surgical screw, not an algorithm. Therefore, "standalone algorithm performance" is not relevant here.

7. Type of Ground Truth Used:

For Biocompatibility: Histological assessment, gross observation, and potentially other biological markers from "animal studies."
For Strength/Resorption: Mechanical property testing (biomechanical testing) and potentially in-vivo imaging or explant analysis to confirm resorption rates. The "clinical use" implies real-world observation of device performance and patient outcomes.

8. Sample Size for the Training Set:

Not applicable. This device is a physical product, not an AI/ML model that requires a "training set."

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

Not applicable. (See #8)

Summary of Device Efficacy Demonstration from the Text:

The document states: "The efficacy of the 2.5 mm LactoSorb® Screws have been demonstrated by biomechanical testing and clinical use. The screws maintain their strength for at least 6-8 weeks and completely resorb in approximately one year." It also highlights that LactoSorb® polymer has been found biocompatible in animal studies and that LactoSorb® devices have been "marketed for over two years for use in trauma and reconstructive procedures in the craniomaxillofacial skeleton and have been found to be both safe and effective." This suggests that the predicate device's established safety and effectiveness, combined with biomechanical testing confirming similar properties for the new screw dimensions, were the basis for demonstrating efficacy.

Summary

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3 1998 NOV

510 (k) Summary of Safety and Effectiveness

K981666

Biomet, Inc. Submitter: P.(). Box 587 Ai::port Industrial Park Warsaw, IN 46581-0587

Contact Person: Mary L. Verstynen

Product Code: JEY

2.5 mm LactoSorb® Screws Device Name:

The 2.5 mm LactoSorb® Screws are indicated for use as fixation in mandibular osteotomy procedures, including but not limited to:

ﺮ ﺍﻟ

sagittal split osteotomy 1.
1. vertical ramus osteotomy
inferior border osteotomy 3 .
subapical osteotomy বাংলাদেশে
genioplasty 5.

The 2.5 mm LactoSorb® Screws are composed 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/pclyglycolic acid copolymer degrades and resorbs IN vIVO by hydrolysis to lactic and glycolic acids which are then metabolized by the body. In animal studies LactoSorb® has been found to be biocompatible in both soft tissue and bone tissue. Lact:oSorb® devices have been marketed for over two years for use in trauma and reconstructive procedures in the craniomaxillofacial skeleton and have been found to be both safe and effective.

The efficacy of the 2.5 mm LactoSorb® Screws have been demonstrated by biomechanical testing and clinical use. The screws maintain their strength for at least 6-8 weeks and completely resorb in approximately one year.

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three human figures. The figures are connected and appear to be moving forward.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 3 1998

Ms. Mary L. vertstynen Biomet, Incorporated Airport Industrial Park Warsaw, Indiana 46581-0587

Re: K981666 Trade Name: 2.5 mm LactoSorb® Screws Requlatory Class: II Product Code: DZL Dated: August 5, 1998 Received: August 6, 1998

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 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). You may, therefore, market the device, subject to the qeneral 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 requlations 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 requirements, 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 regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

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Page 2 - Ms. Verstynen

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at (301) 594-4692. 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" (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/dsma/dsmamajn.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

રું .

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510 (k) NUMBER (IF KNOWN) : __________________________________________________________________________________________________________________________________________________

2.5mm LactoSorb Screw__ DEVICE NAME:

INDICATIONS FOR USE:

The 2.5mm IactoSorb Screws are indicated for use as fixation
The 2.5mm Iactores are associence, including but not limited The 2.5mm Iacto5orb Screws are Indicated 10. about 10.000
in mandibular osteotomy procedures, including but not limited to:

1. sagittal split osteotomy
1. vert:cal ramus osteotomy
1. infecior border osteotomy
1. subapical osteotomy
1. genioplasty

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescript:.on Use
(Per 21 CFR 801.109)

. ...

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

ﺮ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤ

(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number. K981666

00003

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.