The NEOTIS plate is designed for medial approach High Tibial Osteotomy stabilization. Anatomically shaped, thin and short, the NEOTIS plate enables minimally invasive surgery. The changes brought by the NEOTIS plate are as follows (vs. OTIS-C Plus plate):

The proximal temporary screw is replaced with a pin that offers a simpler and faster placement of the plate. The area of the cortical bone drilled through the process is also reduced.
The distal temporary screw is replaced with an AO screw in order to maintain compression. The compression will be maintained by the 4 permanent 6.5 mm screws (OTIS screws).

AI/ML Overview

The provided documentation describes a traditional 510(k) submission for the NEOTIS Plate and Screws, a medical device for bone fixation. Here's a breakdown of the acceptance criteria and the study information as extracted from the text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Type	Acceptance Criteria	Reported Device Performance
Mechanical Properties	Not explicitly stated as acceptance criteria, but implied to be equivalent to the predicate device.	"The mechanical properties are the same as for the previous OTIS-C Plus"
Placement Process (Temporary Screw/Pin)	Improved ease and speed of placement, reduced drilled cortical bone area.	"The proximal temporary screw is replaced with a pin that offers a simpler and faster placement of the plate. The area of the cortical bone drilled through the process is also reduced."
Compression Maintenance (Distal Screw)	Compression to be maintained.	"The distal temporary screw is replaced with an AO screw in order to maintain compression. The compression will be maintained by the 4 permanent 6.5 mm screws (OTIS screws)."
Substantial Equivalence	Demonstrate that the modified NEOTIS plate is as safe, as effective, and performs as safely and effectively as its predicate device.	"Verification and validation tests demonstrate that modified the NEOTIS plate is as safe, as effective, and performs as safely and effectively as its predicate device."
Confirmation of Compression (Cadaver Study)	Not explicitly stated as an acceptance criterion, but the cadaver study's purpose was to confirm this.	"Non-clinical performance testing includes a cadaver study that confirms the level of compression induced during the placement of the plate."

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

Sample Size for Test Set: Not explicitly stated. The document mentions a "cadaver study" but does not provide details on the number of cadavers or specimens used.
Data Provenance: The cadaver study is implied to be laboratory-based (non-clinical performance testing). The document does not specify the country of origin for the cadaver data, nor does it explicitly state if it was retrospective or prospective, though "non-clinical performance testing" typically implies prospective experimental testing.

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

The documentation does not provide information about experts establishing ground truth for the cadaver study. The study appears to be a mechanical performance test rather than one requiring clinical interpretation by experts to establish ground truth.

4. Adjudication Method for the Test Set

Not applicable/Not mentioned. The study described is a non-clinical performance test, not a study involving human interpretation with adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The device is hardware (plate and screws), not an AI algorithm or diagnostic tool that would typically undergo an MRMC study.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No, this is not applicable. The device is a physical medical implant, not an algorithm.

7. The Type of Ground Truth Used

For the cadaver study, the "ground truth" was the level of compression induced by the device during placement. This is a direct physical measurement/observation in a controlled experimental setting, not expert consensus, pathology, or outcomes data in the clinical sense.

8. The Sample Size for the Training Set

Not applicable. The device is not an AI/ML algorithm that requires a training set.

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

Not applicable. The device is not an AI/ML algorithm.

Summary

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Traditional 510(k) NEOTIS System

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K140226 page 1 of 2

JUN 0 3 2014

510(k) SUMMARY

As required by section 807.92

1. GENERAL INFORMATION

· .

Type of 510(k)	TRADITIONAL
Trade Name	NEOTIS Plate and Screws
CFR section	21CFR 888.3030
Classification Name	Single/multiple component metallic bone fixation appliancesand accessories
Device panel	ORTHOPEDIC
Product Code	HRS: PLATE, FIXATION, BONEHWC : SCREW, FIXATION, BONE
Class	II
Legally marketedpredicate devices	K100604 and K120818 OTIS-C Plus® Plate Fixation Systemmanufactured by SBM Sciences for Bio Materials.
Submitter	SCIENCE FOR BIOMATERIALSSciences et Bio MatériauxZI du MongeF 65100 LOURDES - FRANCERegistration Number : 3004549189
Contact	Denis CLEMENT, CEOTel : +33 (0)5 62 42 21 01Fax : +33 (0)5 62 42 21 00e-mail : denis.clement@sbm-fr.comRegulatory contact : Anne COSPIN-LATAPIEanne.cospin@sbm-fr.com

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Traditional 510(k) NEOTIS System

K140226 page 2 of 2

2. DEVICE DESCRIPTION

The proximal temporary screw is replaced with a pin that offers a simpler and faster placement of the plate. The area of the cortical bone drilled through the process is also reduced.
The distal temporary screw is replaced with an AO screw in order to maintain compression. The compression will be maintained by the 4 permanent 6.5 mm screws (OTIS screws).

3. INDICATIONS FOR USE

NEOTIS plate is intended to be used in conjunction with OTIS screws to provide fixation following Proximal Tibial opening wedge osteotomies.

4. PERFORMANCE DATA ·

The mechanical properties are the same as for the previous OTIS-C Plus, the only changes occur during the placement of the plate. No clinical data has been presented. Non-clinical performance testing includes a cadaver study that confirms the level of compression induced during the placement of the plate.

5. SUBSTANTIAL EQUIVALENCE

The NEOTIS plate is substantially equivalent to its predicate device OTIS-C Plus plate (K100604 and K120818). Verification and validation tests demonstrate that modified the NEOTIS plate is as safe, as effective, and performs as safely and effectively as its predicate device.

Summary preparation date: June 2, 2014

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 3, 2014

Science for Biomaterials (Sciences et Bio Matériaux) Mr. Denis Clement General Manager ZI du Monge F 65100 Lourdes - FRANCE

Re: K140226

Trade/Device Name: NEOTIS Plate and Screws Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: April 11, 2014 Received: April 14, 2014

Dear Mr. Clement:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Mr. Denis Clement

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default,htm.

Sincerely yours,

Ronald P. Jean -S for

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Traditional 510(k) NEOTIS Plate

SBM

INDICATIONS FOR USE

510(k) Number (if known): K140226 Device Name: NEOTIS Plate and Screws Indications for Use:

NEOTIS Plate is intended to be used in conjunction with bone screws to provide fixation following Proximal Tibial Opening wedge osteotomies.

AND/OR

Prescription Use く (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Elizabet标验厂rank -S

Division of Orthopedic Devices

Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.