The OTIS-C Plus plate is designed for the stabilization of High Tibial Osteotomy with a medial approach. Anatomically shaped, thin and short, the OTTS-C Plus plate enables mini-invasive surgery. Its locking system provides immediate compression of the graft as well as stable fixation, thus allowing early weight-bearing. The selftapping OTIS-C Plus screws allows easy and reliable one step locking, without counternut, in a simple and concise approach. With its range of twelve screws lengths, fixation can be either mono or bi-cortical, upon the choice of the surgeon.

AI/ML Overview

The provided document is a 510(k) summary for a medical device (OTIS-C Plus) and does not contain information about a study with acceptance criteria often seen for AI/ML-driven devices. Instead, it describes non-clinical performance testing for a traditional metallic bone fixation appliance.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, training set information, ground truth types) are not applicable to the information provided in this document excerpt.

However, I can extract the relevant information regarding the performance claims and the type of testing performed.

1. Table of acceptance criteria and the reported device performance

Performance Metric	Acceptance Criteria (Implied by equivalence)	Reported Device Performance
Biocompatibility	Not explicitly stated as acceptance criteria, but implied by regulatory requirements for medical devices.	The device is made of stainless steel, a common material for bone fixation devices. While not explicitly stated as "performance," it's mentioned to be similar to predicates.
Mechanical Performance (General)	Perform at least as safely and effectively as predicate devices (K041709 NUMELOCK II SYSTEM and K973812 ARTHREX PUDDU OSTEOTOMY SYSTEM).	Non-clinical performance testing demonstrated that OTIS-C Plus system is "as safe, as effective, and performs at least as safely and effectively as its predicate devices." This is a general statement of equivalence as assessed by the specific tests below.
Fretting Corrosion	Performance comparable to or better than predicate devices.	Testing was done, and the results supported the claim of substantial equivalence. No specific numerical values or direct comparison points are given in this summary.
Torsional Yield Strength	Performance comparable to or better than predicate devices.	Testing was done, and the results supported the claim of substantial equivalence. No specific numerical values or direct comparison points are given in this summary.
Ultimate Torsional Strength	Performance comparable to or better than predicate devices.	Testing was done, and the results supported the claim of substantial equivalence. No specific numerical values or direct comparison points are given in this summary.
Insertion Torque	Performance comparable to or better than predicate devices.	Testing was done, and the results supported the claim of substantial equivalence. No specific numerical values or direct comparison points are given in this summary.
Removal Torque	Performance comparable to or better than predicate devices.	Testing was done, and the results supported the claim of substantial equivalence. No specific numerical values or direct comparison points are given in this summary.
Pull-out Strength	Performance comparable to or better than predicate devices.	Testing was done, and the results supported the claim of substantial equivalence. No specific numerical values or direct comparison points are given in this summary.

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

This information is not provided in the document for the non-clinical performance testing. The "test set" in this context refers to the samples of the device components (plates and screws) used for mechanical and corrosion testing, not a clinical data set.

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)

This is not applicable. The ground truth for mechanical testing is derived from engineering standards and physical measurements, not expert consensus.

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

This is not applicable. Adjudication methods are typically used for clinical study data, not for non-clinical mechanical testing.

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

This is not applicable. This document describes a traditional medical device (bone plate and screws), not an AI/ML-driven diagnostic or assistive technology.

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

This is not applicable. This describes a physical medical device.

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

For the non-clinical performance testing, the "ground truth" (or reference standard) would be established by engineering standards, material properties, and validated testing methodologies (e.g., ISO, ASTM standards for material testing) to measure the mechanical properties of the device components.

8. The sample size for the training set

This is not applicable. This document describes a traditional medical device, not an AI/ML system requiring a training set.

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

This is not applicable. This document describes a traditional medical device, not an AI/ML system.

Summary

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K100604#1/6

510(k) OTIS-C Plus

SB

510(k) Summary

As required by section 807.92

JUN 1 4 2010

1. GENERAL INFORMATION

Type of 510(k)	TRADITIONAL
Trade Name	OTIS-C Plus
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	K041709 NUMELOCK II SYSTEM manufactured byHOWMEDICA OSTEONICS CORP (now STRYKERORTHOPAEDICS) and K973812 ARTHREX PUDDUOSTEOTOMY SYSTEM manufactured by ARTHREX, INC.
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: Idée Consulting (FRANCE)Isabelle DRUBAIX e-mail : idrubaix@nordnet.fr

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510(k) OTIS-C Plus

2. DEVICE DESCRIPTION

3. INDICATIONS FOR USE

OTIS-C Plus is intended to be used in conjunction with bone screws to provide fixation following Proximal Tibial opening wedge osteotomies.

4. SUBSTANTIAL EQUIVALENCE

Both OTIS-C Plus system and its predicates are plate and screw systems made of stainless steel. Plates included in all these systems present 4 holes. Both OTIS-C Plus system and its predicate NUMELOCK II SYSTEM include screw 6.5 mm in diameter and plate 3 mm thick. Both plates and screws are supplied in a similar range of length.

Non clinical performance testing including fretting corrosion, and determination of torsional yield strength, ultimate, insertion and removal torque and Pull-out strength demonstrate that OTIS-C Plus system is as safe, as effective, and performs at least as safely and effectively as its predicate devices.

Summary preparation date: revised May 31, 2010

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Public Health Service

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

Science Et Bio Materiaux (SMB) % Mr. Denis Clement Zi du Monge Lourdes France 65100

JUN 1 4 2010

Re: K100604 Trade/Device Name: OTIS-C Plus Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS, HWC Dated: June 01, 2010 Received: June 03, 2010

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

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Page 2 - Mr. Denis Clement

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 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 go to http://www.fda.goy/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mark N Milliken

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

Enclosure

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510(k) OTIS-C Plus

INDICATIONS FOR USE

510(k) Number (if known): K100604 Device Name: OTIS-C Plus Indications for Use:

OTIS-C Plus is intended to be used in conjunction with bone screws to provide fixation following Proximal Tibial Opening wedge osteotomies.

Prescription Use |▲ (Part 21 CFR 801 Subpart D)

AND/OR

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)

Smith for nxa

and Restorative Devic

510(k) Number K100604

Page 6 / 25

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.