The OrthoPediatrics PediLoc™ Tibial Plates are machined metallic plates that offer screw to plate locking designed for various fracture modes of the distal end of the tibia and other small bones.

AI/ML Overview

The provided submission describes a medical device, the OrthoPediatrics PediLoc™ Tibial Plate System, and its substantial equivalence to previously cleared predicate devices. It does not contain information about a study proving the device meets specific acceptance criteria in the context of AI/ML performance, nor does it include details on clinical studies with defined endpoints, statistical analysis, or ground truth establishment relevant to AI/ML device evaluations.

Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth for an AI/ML device is not applicable or cannot be extracted from this document.

However, based on the document's content, here's what can be inferred about the "acceptance criteria" and "study" in the context of this 510(k) submission:

Acceptance Criteria and Device Performance (in the context of 510(k) for a traditional medical device)

Acceptance Criteria (Inferred from 510(k) process)	Reported Device Performance
Technological Characteristics Substantial Equivalence: Device shares indications for use, similar materials, and similar technological characteristics with predicate devices.	"Components comprising OrthoPediatrics PediLoc™ Tibial Plate (and screws) System are similar to the predicate devices listed above in that they share indications for use, are made from similar materials, and incorporate similar technological characteristics."
Performance Characteristics (Strength): Device's mechanical strength is comparable to predicate devices.	"Engineering (strength) calculations were included demonstrating these devices are as strong as the devices cleared through K080522." (K080522 is Synthes LCP Distal Tibia T-Plates, a predicate device).
Materials: Device is manufactured from materials meeting established standards.	"The devices are manufactured from 316L stainless steel which meets the ASTM-F138 standard."
Intended Use: The intended use aligns with the predicate devices and is appropriate for the device design.	"OrthoPediatrics PediLoc™ Tibial Plates are indicated for fractures, osteotomies, and non-unions of the pediatric and small stature adult tibia." This is compared to and found similar to predicate devices.

Study Information (in the context of 510(k) for a traditional medical device)

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

Sample Size: Not applicable. This 510(k) relies on engineering calculations and comparison to predicate devices, not a test set of data in the AI/ML sense. Mechanical testing (implied by "engineering (strength) calculations") would involve a sample of manufactured devices, but the specific number is not provided, and it's not a "test set" of patient data.
Data Provenance: Not applicable in the context of patient data. The "data" here refers to engineering and material specifications.

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

Not Applicable. Ground truth, in the AI/ML sense, is not established for patient data in this submission. The "ground truth" for a mechanical device would be the physical properties and performance measured against engineering standards. The FDA reviewers and the manufacturer's engineers are the "experts" involved in assessing this.

4. Adjudication method for the test set

Not Applicable. There is no "test set" of patient data requiring adjudication.

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. This is not an AI/ML device.

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

Not Applicable. This is not an AI/ML device.

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

Engineering Specifications and Material Standards: The "ground truth" for this device's performance is its adherence to mechanical engineering principles, material science standards (e.g., ASTM-F138 for 316L stainless steel), and comparison of its design and intended use to legally marketed predicate devices.

8. The sample size for the training set

Not Applicable. This is not an AI/ML device, so there is no training set.

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

Not Applicable. This is not an AI/ML device, so there is no training set or associated ground truth establishment.

In summary: This document is a 510(k) premarket notification for a traditional surgical implant. The "study" predominantly refers to engineering calculations and a comparison to known predicate devices to establish substantial equivalence, rather than a clinical trial or AI/ML performance evaluation study against specific acceptance criteria.

Summary

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MAY 1 7 2010

SUMMARY OF SAFETY AND EFFECTIVENESS

NAME OF FIRM:	OrthoPediatrics, Corp.210 N. Buffalo StreetWarsaw, Indiana 46580Establishment Registration No.: 9102640
510(K) CONTACT:	Gary BarnettVP-Regulatory & Medical AffairsTel: (574) 268-6379Fax: (574) 269-3692
TRADE NAME:	OrthoPediatrics PediLoc™ Tibial PlateSystem
COMMON NAME:	Bone Plates and Bone Screws
CLASSIFICATION:	21 CFR 888.3030: Single/Multiple componentsmetallic bone fixation appliances and accessoriesClass II per 21 CFR §888.3030
PRODUCT CODE:	HRS HWC

SUBSTANTIALLY EQUIVALENT DEVICES:

K080522, LCP Distal Tibia T-Plates, Synthes K083286, PediLoc Locking Plate System, OrthoPediatrics K090666, PediPlate System, OrthoPediatrics

DEVICE DESCRIPTION:

The OrthoPediatrics PediLoc™ Tibial Plates are machined metallic plates that offer screw to plate locking designed for various fracture modes of the distal end of the tibia and other small bones.

Intended use: OrthoPediatrics PediLoc™ Tibial Plates are indicated for . fractures, osteotomies, and non-unions of the pediatric and small stature adult tibia.
Materials: The devices are manufactured from 316L stainless steel which . meets the ASTM-F138 standard.
Function: The system functions to provide immediate stability and . temporary fixation during the natural healing process.

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Technological Characteristics: Components comprising OrthoPediatrics . PediLocTM Tibial Plate (and screws) System are similar to the predicate devices listed above in that they share indications for use, are made from similar materials, and incorporate similar technological characteristics.
Performance Characteristics: Engineering (strength) calculations were . included demonstrating these devices are as strong as the devices cleared through K080522.

BASIS FOR SUBSTANTIAL EQUIVALENCE:

OrthoPediatrics believes that this system is substantially equivalent to the legally marketed predicate devices based on similarities in design, materials, and indications.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines representing its body and wings. The eagle is facing to the right. 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

MAY 1 7 2010

OrthoPediatrics Corp. % Gary D. Barnett 210 N. Buffalo Street Warsaw, Indiana 46580

Re: K100240

Trade/Device Name: OrthoPediatrics PediLoc Tibia Plate System Regulation Number: 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: May 4, 2010 Received: May 11, 2010

Dear Mr. Barnett:

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

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Page 2 - Mr. Gary D. Barnett

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

Sincerelv vours.

Sarbanu Prehm

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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Indications for Use Statement

510(k) Number (if known): K \cO2YO (pg // >

Device Name: OrthoPediatrics PediLoc™ Tibial Plate System

OrthoPediatrics PediLoc™ Tibia Plates are indicated for fractures, osteotornies, and non-unions of the pediatric and small stature adult tibia.

AND/OR Over-The-Counter Use __
(21 CFR 801 Subpart C) Prescription Use X (Part 21 CFR 801 Subpart D)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Souther for mxn
(Division Sign-Off)

Division of Surgical, OHhopedic, and Restorative Devices

510(k) Number K100240

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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.