The Locking Pediatric Osteotomy Plate (LolliPOP) system is a modular hip blade-plate system intended for stable fixation of valgus, varus, derotation, flexion and extension of proximal femoral osteotomies (PFO) and fractures in the pediatric (ages 2 to 21 years old) population. Indications for use include the following:

*Inter and subtrochanteric valgus osteotomies

*Inter and subtrochanteric varus osteotomies

*Inter and subtrochanteric derotation osteotomies

*Inter and subtrochanteric flexion and extension osteotomies,

*Inter and subtrochanteric fractures.

Device Description

The Locking Pediatric Osteotomy Plate (LolliPOP) system is a modular hip blade-plate system intended for stable fixation of valgus, varus, derotation, flexion and extension, of proximal femoral osteotomies (PFO) and fractures in the pediatic population. PFOs are widely performed reconstructive surgeries in children with hip deformities, such as Coxa Valga, Coxa Vara and other congenital deformities. The implants are made of medical grade 316L Stainless Steel (ASTM F138) and are offered in four sizes: infant, child, adolescent and adolescent HD. The system is comprised of a set of plates, connectors, locking cortical screws, polyaxial compressions screws, and all the instrumentation required for implantation and retrieval of the device.

AI/ML Overview

The provided document is a 510(k) summary for the "The Locking Pediatric Osteotomy Plate (LolliPOP) System" and does not describe a study involving an AI/CADe device or an imaging device. Instead, it describes a mechanical bone fixation appliance. Therefore, many of the requested fields (such as "effect size of how much human readers improve with AI vs without AI assistance", "standalone performance", "training set", "ground truth for the training set", etc.) are not applicable.

Here's an analysis based on the information provided in the document for the medical device in question, which is a physical orthopedic implant system:

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

Acceptance Criteria (Implied)	Reported Device Performance
Equivalent design, intended use, and function to predicate devices	Stated to be substantially equivalent in design, intended use, and function to the predicate devices.
Equivalent technological characteristics	Technological characteristics are the same or similar to predicate devices. Uses screws as the primary fixation method, similar to predicate systems. Modularity is equivalent to the Modular Blade Plate system (K080109).
Resistance/Mechanical Properties (bench testing)	Verification calculations completed. Mechanical properties of all blade, plate, and screw components analyzed in comparison to predicate systems. Bench testing in static and fatigue confirmed validity of calculations.
Single cycle and fatigue compression bend testing on the construct	Completed, but specific numerical results for acceptance are not provided. The conclusion states that results demonstrate equivalent performance to predicate devices.
Screw performance (torsional strength, axial pullout, driving torque)	Completed, but specific numerical results for acceptance are not provided. The conclusion states that results demonstrate equivalent performance to predicate devices.
Bending strength of the plate	Completed, but specific numerical results for acceptance are not provided. The conclusion states that results demonstrate equivalent performance to predicate devices.
Safety and effectiveness for intended use	A systematic search of scientific literature (Clinical Evidence Review report) was carried out to identify and analyze published peer-reviewed scientific literature regarding intended uses and predicate systems, to establish safety and effectiveness, addressing clinical hazards from device Risk Analysis.

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

This device is an orthopedic implant system, not a data-driven AI/CADe device. Therefore, the concept of a "test set" in the context of data points is not directly applicable.

Mechanical Testing: Bench testing was performed on the device and a predicate device (Synthes CAPOS System). The exact sample size (number of devices or constructs tested) for these mechanical tests is not specified in the summary document. The "data provenance" would be laboratory testing.
Clinical Evidence Review: A systematic search of scientific literature was conducted. This would involve reviewing existing published studies; no new clinical data was generated for this submission. The provenance would be the published scientific literature.

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

Not applicable for a mechanical device. "Ground truth" in this context would be established by engineering standards and mechanical test results, and by established clinical knowledge from the scientific literature review.

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

Not applicable for a mechanical device.

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 mechanical orthopedic implant, not an AI/CADe device.

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

Not applicable. This is a mechanical orthopedic implant, not an AI/CADe device.

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

For the mechanical testing, the "ground truth" would be the engineering specifications, performance standards, and the measured mechanical properties of the predicate device. For the clinical evidence review, the "ground truth" was derived from published peer-reviewed scientific literature related to the intended uses and the predicate devices.

8. The sample size for the training set

Not applicable. This is a mechanical orthopedic implant, not an AI/CADe device that uses a training set.

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

Not applicable.

Summary

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

September 8, 2017

Pega Medical Inc. Mr. Ariel Dujovne President 1111 Highwav Chomedev Laval. Quebec. H7W 5J8 Canada

Re: K170704

Trade/Device Name: The Locking Pediatric Osteotomy Plate (LolliPOP) System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: KTT Dated: July 24, 2017 Received: July 26, 2017

Dear Mr. Dujovne:

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

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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 devicerelated 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 contact the Division of Industry and Consumer Education (DICE) 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. 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 (DICE) 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,

Mark N. Melkerson -S

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

Enclosure

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Indications for Use

510(k) Number (if known) K170704

Device Name

The Locking Pediatric Osteotomy Plate (LolliPOP) System

Indications for Use (Describe)

*Inter and subtrochanteric valgus osteotomies

*Inter and subtrochanteric varus osteotomies

*Inter and subtrochanteric derotation osteotomies

*Inter and subtrochanteric flexion and extension osteotomies,

*Inter and subtrochanteric fractures.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

Applicant:	Pega Medical Inc.1111 Highway ChomedeyLaval, Quebec, Canada, H7W 5J8Phone: 1-877-739-5175
Contact Person:	Ariel R. Dujovne
Proprietary Name:	The Locking Pediatric Osteotomy Plate (LolliPOP)System
Common Name:	Blade plate system
Regulation Number:	21 CFR 888.3030Single/multiple component metallic bone fixationappliances and accessories.
Device Classification:	Class II
Device Classification Name:	Appliance, Fixation, Nail/Blade/plate Combination,Multiple Components
Device Product Code:	KTT
Establishment Registration Number:	9048931

Intended Use:

The Locking Pediatric Osteotomy Plate (LolliPOP) system is a modular hip blade-plate system intended for stable fixation of valgus, varus, derotation, flexion and extension of proximal femoral osteotomies (PFO) and fractures in the pediatic (ages 2 to 21 years old) population. Indications for use include the following:

. Inter and subtrochanteric valgus osteotomies
0 Inter and subtrochanteric varus osteotomies
Inter and subtrochanteric derotation osteotomies
Inter and subtrochanteric flexion and extension osteotomies ●
Inter and subtrochanteric fractures

Description:

Basis for substantial equivalence:

The Locking Pediatric Osteotomy Plate (LolliPOP) System is claimed to be substantially equivalent in design, indicated use and function to the following predicate devices:

Labeling Name	marketed by	510(k) number
Cannulated Pediatric Osteotomy (CAPOS) system(Primary predicate)	Synthes USA LLC	Angled Blade PlateK914546
TC-100 plating and screw system	Smith & Nephew, Inc. Orthopaedic Division	Locking Bone Plate SystemK033669(previously K993106)
Locking Cannulated Blade (LCB) plate system	OrthoPediatrics, Corp.	Blade Plate SystemK110959
Modular Blade Plate System	Synthes USA LLC	Modular Blade Plate SystemK080109

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Summary of Technologies:

The technological characteristics of the Locking Pediatric Osteotomy Plate (LolliPOP) System are the same or similar to the ones of the predicate devices for the described intended uses. Furthermore, the Locking Pediatric Osteotomy Plate (LolliPOP) System and all predicate systems use screws as the primary fixation method. Finally, modularity of the LolliPOP System is equivalent to that of the Modular Blade Plate system.

Non-clinical Performance Data:

Verification calculations were completed to evaluate resistance of the Locking Pediatric Osteotomy Plate System in comparison to the predicate systems. The mechanical properties of all the blade, plate and screw components of the system were analysed in comparison to the predicate systems. Furthermore, the bench testing of the Locking Pediatric Osteotomy Plate in static and fatigue confirmed the validity of these calculations.

The following non-clinical Performance testing were completed:

Single cycle and fatigue compression bend testing on the construct
Screw performance (torsional strength, axial pullout, driving torque)
Bending strength of the plate

Results of the bench testing on the Locking Pediatric Osteotomy Plate System and predicate Synthes CAPOS System demonstrate that the systems perform equivalently.

Finally, a systematic search of the scientific literature was carried out and a Clinical Evidence Review report was issued. This report intended to identify and analyze the published peer-reviewed scientific literature regarding the intended uses, and more specifically of the two predicate systems, in order to establish the safety and effectiveness of the subject system by addressing the clinical hazards identified in the device Risk Analysis.

As per the findings of the bench testing and the scientific literature review, the data supports the use of this product as safe and effective for its intended use; the anticipated benefits of such a system clearly outweigh the possible residual risks.

Clinical Performance Data:

No clinical testing is provided as a basis for substantial equivalence.

Conclusion:

Based on the similarities in the intended use, design, materials, manufacturing methods, and packaging, the Locking Pediatric Osteotomy Plate (LolliPOP) System has been established as substantially equivalent to the previously cleared predicate devices. Furthermore, mechanical evaluation results demonstrate that the proposed system is substantially equivalent to the predicate 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.