The OrthoPediatrics Blade Plate System is intended for fixation of long bone fractures and osteotomies in all pediatric subgroups (except neonates) and in small stature adults. Specific indications include: intertrochanteric derotation and varus osteotomies, femoral neck and pertrochanteric fractures, intertrochanteric valgus osteotomies, proximal and distal tibial osteotomies and humeral fractures and osteotomies.

Device Description

The OrthoPediatrics Blade 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

This 510(k) premarket notification describes the OrthoPediatrics Blade Plate System. The document focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than proving performance against specific acceptance criteria through a clinical study.

Here's an analysis based on the provided text, addressing your points:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion (Implicit)	Reported Device Performance
Material Equivalence: Manufactured from a recognized standard biomaterial.	Met: The devices are manufactured from 316L stainless steel which meets the ASTM-F138 standard. (This is identical to cited predicates.)
Technological Characteristics Equivalence: Similar plate thickness, width, angle range, screw sizes, threads, and general design to predicates.	Met: - Plate thickness(s) and width(s) are substantially equivalent to predicates.- Range of plate angles are substantially equivalent to predicates.- Range of screw sizes and threads are substantially equivalent to predicates.- 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. The technological characteristics of the subject device and the predicates are substantially equivalent to the predicates.
Indications for Use Equivalence: Same or similar intended use as predicates.	Met: Indications for Use is substantially equivalent to predicates. The OrthoPediatrics Blade Plate System is intended for fixation of long bone fractures and osteotomies in all pediatric subgroups (except neonates) and in small stature adults. Specific indications include: intertrochanteric derotation and varus osteotomies, femoral neck and pertrochanteric fractures, intertrochanteric valgus osteotomies, proximal and distal tibial osteotomies and humeral fractures and osteotomies. Consistent with the predicate devices.
Mechanical Strength & Resistance to Bending Moments: Equivalent or better mechanical properties compared to predicates.	Met: 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. (This is a claim based on calculations, not a direct performance measurement against a benchmark from a study.)
Safety and Effectiveness: No new questions of safety or effectiveness are raised.	Met (by inference): A review of the MAUDE complaint database of similar predicate devices supports the safety and effectiveness of the device. The FDA's substantial equivalence determination implies they found no new questions of safety or effectiveness. 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, leading to the conclusion that "safety and efficacy is expected to be equivalent."

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

Sample Size for Test Set: Not applicable. This submission relies on bench testing (engineering calculations) and comparison to predicates, not a clinical test set with human subjects or medical image data.
Data Provenance: The "data" primarily comes from:
- Specifications and material properties of the subject device.
- Specifications and material properties of predicate devices.
- Engineering calculations for mechanical properties.
- MAUDE (Manufacturer and User Facility Device Experience) database – this is a post-market surveillance database for adverse events for marketed devices (predicates in this case), not a data set for a prospective study. Its provenance is from various healthcare facilities in the US reporting issues.

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

Not applicable. There was no "test set" requiring ground truth established by experts in the context of clinical or diagnostic performance. This is a submission for a mechanical device, primarily demonstrating equivalence in design and materials.

4. Adjudication Method for the Test Set

Not applicable. No test set requiring expert adjudication was used.

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 a medical device (bone plate system), not an AI/software as a medical device (SaMD) that would involve human readers or AI assistance.

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

Not applicable. This is a physical medical device, not an algorithm.

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

Not applicable in the conventional sense of clinical ground truth. The "ground truth" for this submission is implicitly based on:
- Engineering Principles: Equations and models used for the strength calculations.
- Material Standards: ASTM-F138 for 316L stainless steel.
- FDA's Premarket Notification (510(k)) Process: The determination of "substantial equivalence" to legally marketed predicate devices, meaning the previous predicate devices serve as an established baseline for safety and effectiveness.

8. The sample size for the training set

Not applicable. There is no machine learning or AI component requiring a training set.

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

Not applicable. No training set.

Summary of the Study (Performance Analysis):

The "Performance Analysis" section clearly states: "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."

Essentially, the "study" demonstrating the device meets (implicit) acceptance criteria for safety and effectiveness is a bench-top engineering analysis (computational modeling/calculations) and a comparison to the established safety record (MAUDE data) of substantially equivalent predicate devices, rather than a clinical trial or diagnostic performance study. The core method is demonstrating substantial equivalence to legally marketed devices.

Summary

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510(K) Summary - K110959

SUMMARY OF SAFETY AND EFFECTIVENESS

March 31, 2011 - Revised July 1, 2011

NAME OF FIRM:	OrthoPediatrics, Corp.2850 Frontier DriveWarsaw, Indiana 46582Establishment Registration No.: 9102640
510(K) CONTACT:	Mark FoxVice President of Regulatory AffairsTel: (574) 268-6379Fax: (574) 269-3692

OrthoPediatrics Blade Plate System TRADE NAME:

Bone Plates and Bone Screws COMMON NAME:

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: Il

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

SUBSTANTIALLY EQUIVALENT DEVICES:

K083286, PediLoc Locking Plate System, OrthoPediatrics

K100240, PediLoc Tibial Plate System, OrthoPediatrics

K082949, OrthoPediatrics Bone Screws, OrthoPediatrics

K993289,Bone Plate System (TC-100 Plating System ) Blade Plates, Smith & Nephew
Pre Ammendment - Osteotomy / Blade Plates, Smith & Nephew

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DEVICE DESCRIPTION:

INDICATIONS:

MATERIALS:

The devices are manufactured from 316L stainless steel which meets the ASTM-F138 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:

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

Identical materials to cited predicates.
Range of plate angles are substantially equivalent to predicates.
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.

KI10959693

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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 Blade 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 or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.

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

OrthoPediatrics, Corp. c/o Mr. Mark Fox Vice President of Regulatory Affairs 2850 Frontier Drive Warsaw. Indiana 46582

AUG - 5 2011

Re: K110959

Trade/Device Name: OrthoPediatrics Blade 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: August 3, 2011 Received: August 3, 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. 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.

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Page 2 - Mr. Mark Fox

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 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.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.

Sincerely yours,

Mark A. Millken

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: K110959

Device Name: OrthoPediatrics Blade Plate System

INDICATIONS:

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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

for M. Mellar

(Division Sign Oft) (Division Surgical, Orthopedic, and Restorative Devices

510(k) Number K110959

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.

510(K) Summary - K110959

SUMMARY OF SAFETY AND EFFECTIVENESS

OrthoPediatrics Blade Plate System TRADE NAME:

RECOMMENDED

CLASSIFICATION:

Recommended Class: Il

SUBSTANTIALLY EQUIVALENT DEVICES:

DEVICE DESCRIPTION:

INDICATIONS:

MATERIALS:

TECHNOLOGIC CHARACTERISTICS:

PERFORMANCE ANALYSIS:

FUNCTION:

EQUIVALENCY:

Indications for Use Statement

INDICATIONS:

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