The OrthoPediatrics Fracture and Osteotomy Bone Plate System is intended for temporary internal fixation and stabilization of long bone fractures and osteotomies, mal-unions and non-unions, in pediatric and small stature adults. Specific indications include: intertrochanteric derotation and varus osteotomies, femoral neck and pertrochanteric fractures, intertrochanteric valgus osteotomies.

Device Description

The OrthoPediatrics Fracture and Osteotomy Bone Plate System will combine implants and instruments in one convenient system. This system will offer the advantages of the osteotomy blade plates and cannulated instrumentation. Osteotomy plates provide ease of reduction and good rotational stability while maintaining bone stock. Cannulated instruments work over a guide wire for precise placement and safety.

AI/ML Overview

The provided document describes the 510(k) premarket notification for the OrthoPediatrics Fracture and Osteotomy Bone Plate System. This type of submission relies on demonstrating substantial equivalence to predicate devices rather than proving safety and effectiveness through clinical trials with specific acceptance criteria in the same way a novel device might.

Therefore, the document does not contain information on acceptance criteria in terms of performance metrics (like sensitivity, specificity, accuracy) for a diagnostic or AI-driven device, nor does it detail a study proving the device meets such criteria. Instead, the "performance analysis" section focuses on demonstrating mechanical equivalence and similarity to already-approved predicate devices.

Here's a breakdown of the information that is present, organized to address your request as much as possible, along with what is explicitly not applicable (N/A) for this type of submission:

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

Acceptance Criteria (based on substantial equivalence to predicates)	Reported Device Performance
Technological Characteristics:
Plate thickness(s) and width(s) substantially equivalent to predicates	Similar configuration, sizes, and design as predicate device(s).
Identical materials to cited predicates	All implant components manufactured from medical grade metals (316L stainless steel, BIODUR stainless steel) meeting ASTM standards.
Range of plate angles substantially equivalent to predicates	Similar configuration, sizes, and design as predicate device(s).
Range of screw sizes and threads substantially equivalent to predicates	Similar configuration, sizes, and design as predicate device(s).
Indications for Use substantially equivalent to predicates	The OrthoPediatrics Fracture and Osteotomy Bone Plate System's Indications for Use are substantially equivalent to predicates. This is the core of the 510(k) submission.
Mechanical Performance:
Equivalent or better strength and resistance to bending moments compared to predicates	Engineering calculations with worst-case loading confirmed equivalent or better strength and resistance to bending moments.
Safety and Effectiveness:
Support safety and effectiveness based on predicate device history	A review of the MAUDE complaint database of similar predicate devices supports the safety and effectiveness.
Expected safety and efficacy given material, intended use, and technological features are similar to predicates	Safety and efficacy expected to be equivalent due to similar materials, intended use, and technological features.

2. Sample size used for the test set and the data provenance:

N/A. This device is a bone plate system, not a diagnostic or AI device that would typically use a "test set" in the context of performance metrics like sensitivity/specificity. The "performance analysis" is based on engineering calculations and comparison to predicate devices, not analysis of a data set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

N/A. This information is not relevant to a 510(k) submission for a bone plate system showing substantial equivalence.

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

N/A. Not applicable, as there is no "test set" in the sense of a clinical or image analysis study.

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:

N/A. This is a medical device (bone plate system), not an AI-assisted diagnostic tool. Therefore, MRMC studies and AI improvement metrics are irrelevant.

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

N/A. Not applicable. This is a physical medical implant, not an algorithm.

7. The type of ground truth used:

The "ground truth" in this context is established by the performance and safety history of the predicate devices (K062872, K072095, K083286, K082949, K100240, K070906, K003496) and the established engineering principles for biomechanical testing and material standards.
Engineering calculations (for strength and bending moments).
MAUDE complaint database review for similar predicate devices.

8. The sample size for the training set:

N/A. This is not an AI device or a diagnostic device that requires a "training set."

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

N/A. Not applicable.

In summary, the provided document details a 510(k) submission for a Class II medical device (bone plate system). The "acceptance criteria" and "study" are not based on clinical performance metrics or AI algorithm validation. Instead, they are centered on demonstrating substantial equivalence to legally marketed predicate devices through comparison of technological characteristics, materials, intended use, and biomechanical engineering analysis. Therefore, many of the requested points related to AI/diagnostic study design are not present.

Summary

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510(K) Summary - K111086

JUN 1 7 2011

SUMMARY OF SAFETY AND EFFECTIVENESS

April 15, 2011 - Revised June 7, 2011

NAME OF FIRM:	OrthoPediatrics, Corp.2850 Frontier DriveWarsaw, Indiana 46582Establishment Registration No.:3006460162
510(K) CONTACT:	Mark FoxVice President of Regulatory AffairsTel: (574) 268-6379Fax: (574) 269-3692
TRADE NAME:	OrthoPediatrics Fracture and OsteotomyBone Plate System

COMMON NAME: Bone Plates and Bone Screws

RECOMMENDED CLASSIFICATION:

21 CFR 888.3030: Single/Multiple components metallic bone fixation appliances and accessories: Class II per 21 CFR §888.3030

21 CFR 888.3040: Smooth or threaded metallic bone fixation fastener: Class II per 21 CFR §888.3040

Recommended Class: II

DEVICE PRODUCT CODE(S):	HRS, (Plate. Fixation, Bone)
	HWC, (Screw, Fixation, Bone)

DEVICE DESCRIPTION:

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INDICATIONS FOR USE:

PREDICATE DEVICES:

K062872, Pediatric LCP Hip Plate System, Synthes (USA)

K072095, Pediatric LCP Hip Plate System Modifications, Synthes (USA)

K083286, PediLoc Locking Plate System, Orthopediatrics

K082949, OrthoPediatrics Bone Screws, OrthoPediatrics

K100240, PediLoc Tibial Plate System, OrthoPediatrics K070906, Periarticular Locking Plate System, Zimmer K003496, Cannulated Screw System, Pioneer

MATERIALS:

All implant components are manufactured from medical grade metals including 316L stainless steel which meets the ASTM-F138 standard. In addition, the cannulated screws are manufactured from medical grade BIODUR stainless steel which meets ASTM 2229-07 standard.

TECHNOLOGIC CHARACTERISTICS:

The fundamental scientific principles and technological characteristics, including the intended use, material, sizes, and general design are the same as, or similar to, the predicate devices.

Summary of technological characteristics:

Plate thickness(s) and width(s) are substantially equivalent to predicates.

1. Identical materials to cited predicates.
1. Range of plate angles are substantially equivalent to predicates.
1. Range of screw sizes and threads are substantially equivalent to predicates.

Indications for Use is substantially equivalent to predicates.

The technological characteristics of the subject device and the predicates are substantially equivalent to the predicates.

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PERFORMANCE ANALYSIS:

Subject device has similar configuration, sizes and design as the predicate device(s). Engineering calculations with worst case loading calculations of subject device and corresponding predicate device, confirmed that subject device has equivalent or better strength and resistance to bending moments. A review of the MAUDE complaint data base of similar predicate devices support the safety and effectiveness of the device.

FUNCTION:

The system functions to provide immediate stability and temporary fixation during the natural healing process.

EQUIVALENCY:

Therefore, since materials, intended use, and technological features used in the OrthoPediatrics Fracture and Osteotomy Bone Plate System are similar to the predicate devices, safety and efficacy is expected to be equivalent.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

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

OrthoPediatrics, Corporation % Mr. Mark Fox Vice President of Regulatory Affairs 2850 Frontier Drive Warsaw, Indiana 46582

2017 1 1 אטע

Re: K111086

Trade/Device Name: OrthoPediatrics Fracture and Osteotomy Bone Plate System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliance and accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: April 15, 2011 Received: April 19, 2011

Dear Mr. Fox:

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.

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. Mark Fox

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.gov/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/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 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/Resourcesfor You/Industry/default.htm.

Sincerely vours.

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

Enclosure

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KIII086 (11/1)

Indications for Use Statement

510(k) Number: K111086

Device Name: OrthoPediatrics Fracture and Osteotomy Bone Plate System

The OrthoPediatrics Fracture and Osteotomy Bone Plate System is intended for temporary internal fixation and stabilization of long bone fractures and osteotomies, mal-unions, in pediatric and small stature adults. Specific indications include: intertrochanteric derotation and varus osteotomies, femoral neck and pertrochanteric fractures, intertrochanteric valgus osteotomies.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Po. Am. Nor.

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K111086

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.