The MODUS® Titanium Osteosynthesis System is intended for use in oral, maxillofacial surgery such as: trauma; surgical correction of dentofacial deformities; reconstructive surgery; orthognathic and craniofacial surgery. The MODUS® Sagittal Split Plate with slider is used for stabilization of mandibular bone segments after a sagittal split osteotomy.

Device Description

The MODUS® System sagittal split plate with slider has a U-shaped design. It is available in two configurations, with six or eight screw holes. The plate is composed of CP Grade 1 titanium. The plate has a thickness of 0.7 mm and is available in a range of lengths of 31.65mm to 52.65 mm. The slider is 10 mm in diameter and is composed of Grade 4 CP titanium meeting ASTM F67.

AI/ML Overview

The provided text is a 510(k) summary for the MODUS® Titanium Osteosynthesis System, specifically the Sagittal Split Plate and Slider. This document primarily focuses on establishing substantial equivalence to previously cleared devices rather than presenting a performance study with detailed acceptance criteria and supporting data as one would find for a novel device or AI/software-as-a-medical-device (SaMD).

Therefore, based on the provided text, a table of acceptance criteria and reported device performance, information about sample sizes, ground truth establishment, expert qualifications, adjudication methods, multi-reader multi-case studies, or standalone algorithm performance cannot be extracted because this information is not present in the document.

The document details a predicate device comparison study, which is a different type of submission for medical devices focused on demonstrating equivalence to already cleared devices.

Here's a breakdown of what can be extracted and why other information isn't available:

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

Not Applicable / Not Provided: The 510(k) summary for this device (K993862) establishes substantial equivalence based on intended use, design, and material comparison to predicate devices, not on a new performance study with specific acceptance criteria and reported numerical performance metrics.

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: This 510(k) is for a physical orthopedic implant. Clinical studies with test sets in the typical sense (like for diagnostic algorithms) are not described. The basis for equivalence is primarily engineering specifications and material properties compared to predicate devices.

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: There is no mention of a test set requiring expert-established ground truth in this submission. This is not a diagnostic device or an AI/SaMD product.

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

Not Applicable / Not Provided: No test set or adjudication method is described.

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 / Not Provided: This is not an AI/SaMD device. No MRMC study was conducted.

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

Not Applicable / Not Provided: This is not an AI/SaMD device.

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

Not Applicable / Not Provided: No ground truth in this context is relevant or described for this physical device submission.

8. The sample size for the training set

Not Applicable / Not Provided: There is no training set mentioned, as this is not a machine learning device.

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

Not Applicable / Not Provided: No training set or ground truth for it is mentioned.

Summary of what the document DOES demonstrate:

The document demonstrates that the MODUS® Sagittal Split Plate with Slider is substantially equivalent to legally marketed predicate devices, specifically:

MODUS® System Plates and Mesh (K946165)
Synthes 2.0 mm Sagittal Split Plates (K981890)
Synthes (MMFS) - Adjustable Sagittal Split Plate (K964328)

This equivalence is based on:

Intended Use: Used for stabilization of mandibular bone segments after a sagittal split osteotomy in oral, maxillofacial surgery.
Design: U-shaped design, available in two configurations (six or eight screw holes), 0.7 mm plate thickness, 10 mm diameter slider.
Material: Plate composed of CP Grade 1 titanium; slider composed of Grade 4 CP titanium meeting ASTM F67.

The "study" in this context is the 510(k) submission process itself, which involves comparing the new device to predicate devices to establish substantial equivalence. It's a regulatory "study" rather than a clinical performance study with statistical endpoints. The acceptance criteria for this type of submission are met if the FDA agrees that the new device does not raise new questions of safety and effectiveness compared to the predicate device.

Summary

{0}------------------------------------------------

K993862

DEC 2 9 1999

ATTACHMENT 8 - 510(k) Summary

1. Applicant's Name and Address

Straumann USA (on behalf of Medartis GmbH) Reservoir Place 1601 Trapelo Road Waltham, MA 02451 Telephone Number: 781-890-0001 781-890-6464 Fax Number: Contact Person: Linda Jalbert, Director of Regulatory Affairs

2. Name of the Device

Trade Name:	MODUS® Titanium Osteosynthesis SystemSagittal Split Plate and Slider
Common Name:	Craniomaxillofacial Fixation Plates
Classification Name:	Bone plate, 21 CFR 872.4760, Class II

Legally Marketed Devices to which Equivalence is Claimed (Predicate 3. Devices)

MODUS® System Plates and Mesh (K946165) Synthes 2.0 mm Sagittal Split Plates (K981890) Synthes (MMFS) - Adjustable Sagittal Split Plate (K964328)

4. Description of the Device

న. Intended Use of the Device

ર. Basis for Substantial Equivalence

The MODUS® Sagittal Split Plate with Slider and Screws are substantially equivalent to previously cleared MODUS® craniofacial plates and mesh, and to Synthes sagittal split-fix plates in terms of intended use, design, and material.

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines representing its wings and head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle image.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 9 1999

Ms. Linda Jalbert Director, Requlatory Affairs The Straumann Company Reservoir Place 1601 Trapelo Road Waltham, MA 02451

Re: K993862

Trade Name: MODUS® Titanium Osteosynthesis System Regulatory Class: II Product Code: JEY Dated: November 12, 1999 Received: November 15, 1999

Dear Ms. Jalbert:

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) regulation (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

{2}------------------------------------------------

Page 2 - Ms. Jalbert

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.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic 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" (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,

Gerald W Shipp

Timothy A. Ulatowski (gon Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health

Enclosure

{3}------------------------------------------------

Indications for Use Statement

Device Name:

MODUS® Titanium Osteosynthesis System - Sagittal Split Plate and Slider

Indications for Use:

The MODUS® Titanium Osteosynthesis System is intended for use in oral maxillofacial surgery such as: trauma; surgical correction of dentofacial deformities; reconstructive surgery; orthognathic and craniofacial surgery. The Sagittal Split Plate with slider is used for stabilization of mandibular bone segments after a sagittal split osteotomy.

Prescription Use
(Per 21 CFR 801.109)

Angela Blackwell for MSK

Division of Dental, Infection Control, and General Hospital 510(k) Number .

MODUS Sagittal Split Plate 510(k)

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.