LACTOSORB SHEETS

• K Number: K992158
• Device Name: LACTOSORB SHEETS
• Manufacturer: BIOMET, INC.
• Date Cleared: 1999-08-20 ( 56 days)
• Product Code: JEY
• Regulation Number: 872.4760
• Type: Traditional
• Panel: Dental
• Reference & Predicate Devices: N/A
• Predicate For: K011569 , K011590 , K021522 , K032641 , K073115 , K092590

Intended Use

The LactoSorb® Sheets are used as fixation devices in the following procedures:

A. General Indication: Trauma procedures of the midface or craniofacial skeleton. Specific Indications:

1. Comminuted fractures of the naso-ethmoidal infraorbital areas
2. Comminuted fractures of the frontal sinus wall
3. Pediatric midface or craniofacial trauma
4. Orbital floor fractures
5. Trauma of the craniofacial skeleton including: frontal, parietal, temporal, sphenoid, and occipital bones
   B. General Indication: Reconstructive procedures of the midface or craniofacial skeleton.

Specific Indications:

1. Infant craniofacial surgery (i.e. craniosynostosis, congenital malformation, trauma, etc.)
2. Tumor reconstruction in midface or craniofacial procedures
3. Bone graft procedures in the midface or craniofacial skeleton
4. Pediatric reconstructive procedures
5. Reconstructive procedures of the craniofacial skeleton including: frontal, parietal, temporal, sphenoid, and occipital bones
6. Craniotomy flap fixation
   C. Mandible Indication: Used to maintain the position of bony fragments in mandibular bone graft procedures and are used in conjunction with rigid internal fixation.

Device Description

The LactoSorb® 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 acid polymer degrades and resors 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 tissue and bone tissue. The material retains its strength for at least 8 weeks and completely resors by 9-15 months.

AI/ML Overview

The provided text is a 510(k) summary for the LactoSorb® Sheets, a medical device. This document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device.

Crucially, this type of submission (510(k)) generally does NOT involve "acceptance criteria" or a "study that proves the device meets the acceptance criteria" in the way one would describe for an AI/algorithm-based diagnostic device.

Instead, the 510(k) process focuses on demonstrating substantial equivalence to an existing, legally marketed device (the predicate device). This often involves comparing technological characteristics, intended use, and performance data (which may include bench testing, biocompatibility testing, or, less commonly, limited clinical data if necessary to demonstrate equivalence). It does not typically involve a formal study with a 'test set', 'ground truth', or 'experts' as you'd find for evaluating AI performance.

Therefore, I cannot extract the information requested in your bullet points because the provided document and the nature of a 510(k) submission for this type of device do not contain that kind of data.

To directly address your request, based only on the provided text:

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

   • Acceptance Criteria: Not explicitly stated as pass/fail criteria from a specific study within the document. The implicit "acceptance criteria" for a 510(k) is demonstrating substantial equivalence to a predicate device in terms of safety and effectiveness.
   • Reported Device Performance:
     • "The LactoSorb® material has been found to be biocompatible in both soft tissue and bone tissue."
     • "The material retains its strength for at least 8 weeks and completely resorbs by 9-15 months."
     • Context: These are descriptions of material properties and biological behavior, not performance metrics from a comparative clinical study.

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

   • Not applicable/Not provided. The document does not describe a "test set" in the context of an algorithmic performance study.

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):

   • Not applicable/Not provided.

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

   • Not applicable/Not provided.

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:

   • No MRMC study was done. This device is a physical implant, not an AI diagnostic tool for human readers.

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

   • Not applicable. This is not an algorithm.

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

   • Not applicable.

8. The sample size for the training set:

   • Not applicable/Not provided.

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

   • Not applicable/Not provided.

In summary: The provided document describes a 510(k) premarket notification for a physical medical implant (bioresorbable sheets). The regulatory pathway for such devices, especially from 1999, does not require the types of "acceptance criteria" and "studies" that are relevant to AI/machine learning diagnostic tools. The information you're asking for is specific to AI performance evaluation and is not contained within this document.

Summary

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AUG 20 1999

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:	87 HRS (plate)
Device Name:	LactoSorb® Sheets

The LactoSorb® Sheets are used as fixation devices in the following procedures:

• A. General Indication: Trauma procedures of the midface or craniofacial skeleton Specific Indications:
  • 1. Comminuted fractures of the naso-ethmoidal infraobital areas
  • 2. Comminuted fractures of the frontal sinus wall
  • 3. Pediatric midface or craniofacial trauma
  • 4. Orbital floor fractures
  • Trauma of the craniofacial skeleton including: frontal, parietal, ternoral, રે sphenoid, and occipital bones
• B. General Indication: Reconstructive procedures of the moface or craniofacial skeleton Specific Indications:
  • 1. Infant craniofacial surgery (i.e. craniosynostosis, congenital malformation, trauma, etc.)
  • 2. Tumor reconstruction in midface or craniofacial procedures
  • 3. Bone graft procedures in the midface or craniofacial skeleton
  • 4. Pediatric reconstructive procedures
  • 5. Reconstructive procedures of the craniofacial skeleton including: frontal, parietal, temporal sphenoid, and occipital bones
  • 6. Craniotomy flap fixation
• C. Mandible Indication: Used to maintain the postion of bony fragments in mandibular bone graft procedures and are used in conjunction with rigid internal fixation

At the time of surgery, drill holes can be places as needed to accept LactoSorb® screws and rivets.

The LactoSorb® devices are made of bioresorbable and biocompatible polymers that have been used in surgical procedures for years. LactoSorb® resorbable copolymer is a

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synthetic polyester derived from lactic and glycolic acids. Polylactic/polyglycolic acid polymer 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 tissue and bone tissue. The material retains its strength for at least 8 weeks and completely resorbs by 9-15 months.

.

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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" around the perimeter. In the center of the seal is a stylized image of an eagle.

Public Health Service

AUG 20 1999

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Michelle L. McKinley Requlatory Specialist Biomet Incorporated Airport Industrial Park P.O. Box 587 Warsaw, Indiana 46581-0587

K992158 Re : Lactosorb Sheets Trade Name: Requlatory Class: II Product Code: JEY June 21, 1999 Dated: Received: June 25, 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 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 Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP 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. this response to your premarket notification Please note: 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. 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 Additionally, for questions on the promotion and [phone]. advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 Other general information on your responsibilities CFR 807.97). under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Time 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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of Page -

510(k) NUMBER (IF KNOWN): K992 158

DEVICE NAME: LactoSorb® Sheets

INDICATIONS FOR USE:

The LactoSorb® Sheets are used as fixation devices in the following procedures:

A. General Indication: Trauma procedures of the midface or craniofacial'skeleton. Specific Indications:

• 1. Comminuted fractures of the naso-ethmoidal infraorbital areas
• 2. Comminuted fractures of the frontal sinus wall
• 3. Pediatric midface or craniofacial trauma *
• 4. Orbital floor fractures
• 5. Trauma of the craniofacial skeleton including: frontal, parietal, temporal, sphenoid, and occipital bones
• B. General Indication: Reconstructive procedures of the midface or craniofacial skeleton.

Specific Indications:

• 1. Infant craniofacial surgery (i.e. craniosynostosis, congenital malformation, trauma, etc.)
• 2. Tumor reconstruction in midface or craniofacial procedures
• 3. Bone graft procedures in the midface or craniofacial skeleton
• 4. Pediatric reconstructive procedures
• 5. Reconstructive procedures of the craniofacial skeleton including: frontal, parietal, temporal, sphenoid, and occipital bones
• 6. Craniotomy flap fixation
• C. Mandible Indication: Used to maintain the position of bony fragments in mandibular bone graft procedures and are used in conjunction with rigid internal fixation.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

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

Susor Rinoer

(Division Sign-Om
000004 Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number

Regulation Number and Section

§ 872.4760 Bone plate.

(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.