The intended use of the Ortho Solutions Trauma Plates for Osteosynthesis of fixation device(s) is to draw two or more aligned bone fragments together to facilitate healing.

Ortho Solutions Bone Plates, Bone Screws, and Washers System is indicated for use in fixation of various fractured bones. Mini plates and screws 3.5mm or smaller are intended for use in small bones in the hand or foot and include the metacarpal, metatarsal, and phalange bones. Small and large plates and screws 4.0mm and larger are intended for use in large and long bones which can include the clavicle, scapula, pelvis, calcaneus, talus and long bones (humerus, ulna, radius, femur, tibia, and fibula) in the skeletal anatomy.

Ortho Solutions Compression Hip Screw CHS/SCS System is indicated for fracture fixation in the proximal and distal regions of the human anatomy skeletal femur. Specific indications include: intracapsular fractures of the femoral neck; trochaneric and subtrochanteric neck fractures; osteotomies for patients with diseases or deformities of the hip; hip arthrodesis; supracondylar fractures and distal femoral fractures.

The Ortho Solutions Trauma Plates for Osteosynthesis is not intended for spinal use.

Device Description

The Ortho Solutions Trauma Plates for Osteosynthesis consists of general predicate type trauma implant components commonly found with large companies with orthopedic markets in the United States. These 'general trauma implant devices' consist of the following categories:

Bone Plates, Bone Screws and Washers System
Adult Compression Hip Screw (CHS/SCS) System
Bone Plates, Bone Screws and Washers System: This implant system consists of a Mini Fragment System (MFS), a Small Fragment System (SFS), and a Large Fragment System (LFS).

The Mini Fragment System is composed of 2.7mm A.C.P Plates in various hole lengths. These mini plates are secured to bone using 1.5mm, 2.0mm, and 2.7mm Cortical Screws. All Mini Fragment System plates and screws are intended for use in small bone extremity skeletal anatomy. The Small Fragment System is composed of 1/3 Tubular, 3.5mm A.C.P., 3.5mm Reconstruction, 3.5mm Cloverleaf, and 3.5mm 'T' - Plates in various hole lengths, Left, Right, and Oblique configurations. These small fragment plates are secured to bone using 3.5mm and 4.0mm cortical and cancellous screws, selftapping, partial, and fully threaded. A 7 x 3.6mm Washer is also offered. All Bone Screws with or without the washer can be used separate from the plates. All Small Fragment plates and screws are intended for use in small bone skeletal anatomy. The Large Fragment System is composed of 4.5mm Narrow A.C.P, 4.5mm Broad A.C.P., 'T', 'T-Buttress', and 'L-Buttress' Left & Right Angled Plates in various hole length configurations. These large plates are secured to bone using 4.5mm, 4.0mm Malleolar, and 6.5mm cortical and cancellous screws, self-tapping, partial, and fully threaded. A washer is also offered. All bone screws with or without the washer can be used separate from the plates. All large fragment plates and screws are intended for use in large and long bone skeletal anatomy. All bone plates, bone screws, and washers are made of surgical grade 316LVM Stainless Steel to ASTM F138. All plates, screws, and washers are offered 'sterile' to the customer.

Adult Compression Hip Screw (CHS/SCS) System: This implant system consists of various angled (950 for SCS, 130°, 135°, and 150° for CHS) high strength forged plates in multiple hole lengths, various Lag Screw lengths with various length Compression Screws, and various length 4.5mm Cortical Screws for securing the plate to femoral bone. Associated guide pin, drills, and ancillary instrumentation is available. The system is intended for use in repair of fractures of the femoral hip neck/head and supra-condylar area of the skeletal femur. All components are manufactured of surgical grade 316LVM Stainless Steel to ASTM F138. All plates and screws are offered 'sterile' to the customer.

AI/ML Overview

This 510(k) summary for the Ortho Solutions Trauma Plates for Osteosynthesis does not contain the kind of detailed study information (acceptance criteria, sample sizes, ground truth establishment, expert qualifications, etc.) that would typically be described for a device employing AI or requiring such rigorous validation.

Instead, this document focuses on demonstrating substantial equivalence to existing predicate devices based on material, geometry, design/markings, and indications for use. It's a regulatory submission for a traditional, hardware-based medical device (bone plates, screws, and washers), not a software or AI-driven diagnostic or treatment device.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets those criteria, as typically understood for AI/software-based devices, is not present in this document.

However, I can extract the information that is implicitly part of a substantial equivalence claim for a traditional medical device:

Implicit Acceptance Criteria and "Study" for Substantial Equivalence

For a traditional device like the Ortho Solutions Trauma Plates, the "acceptance criteria" and "study" are interpreted through the lens of regulatory substantial equivalence. The "study" isn't a clinical trial or algorithm performance test, but rather a comparison to legally marketed predicate devices. The "acceptance criteria" are the demonstration that the new device is as safe and effective as the predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implicit for Substantial Equivalence)	Reported Device Performance (as stated in 510(k) Summary)
Material Equivalence: Device materials meet established standards and are equivalent to predicates.	"All bone plates, bone screws, and washers are made of surgical grade 316LVM Stainless Steel to ASTM F138." (Page 2) "All components are manufactured of surgical grade 316LVM Stainless Steel to ASTM F138." (Page 2) "The Ortho Solutions Trauma Plates for Osteosynthesis is Similar in Material, Geometry Design/Markings, and Indications to many predicate systems currently sold in the U.S. market." (Page 3)
Geometric/Design Equivalence: Device geometry and design are equivalent to predicates and suitable for intended use.	"The Ortho Solutions Trauma Plates for Osteosynthesis consists of general predicate type trauma implant components commonly found with large companies with orthopedic markets in the United States." (Page 2) Detailed descriptions of various plates, screws, and washers, their sizes, configurations (e.g., 2.7mm ACP plates, 3.5mm Reconstruction plates, 4.5mm Narrow ACP, various angled hip plates), and intended bone locations. (Page 2) "The Ortho Solutions Trauma Plates for Osteosynthesis is Similar in Material, Geometry Design/Markings, and Indications to many predicate systems currently sold in the U.S. market." (Page 3)
Indications for Use Equivalence: Device is indicated for the same or very similar uses as predicates, without raising new questions of safety or effectiveness.	"The intended use of the Ortho Solutions Trauma Plates for Osteosynthesis of fixation device(s) is to draw two or more aligned bone fragments together to facilitate healing." (Page 3) Specific indications are listed for bone plates/screws (small bones in hand/foot, large and long bones) and for the Compression Hip Screw System (fracture fixation in proximal/distal femur, including various types of hip/femoral neck fractures, osteotomies, hip arthrodesis, supracondylar/distal femoral fractures). (Page 3 & 5) "The Ortho Solutions Trauma Plates for Osteosynthesis is Similar in Material, Geometry Design/Markings, and Indications to many predicate systems currently sold in the U.S. market." (Page 3) "The Ortho Solutions Trauma Plates for Osteosynthesis is substantially equivalent to predicate systems from many orthopedic companies (as listed)." (Page 3)
Safety and Effectiveness: Implied by equivalence to predicates that are already deemed safe and effective. New device is safe and effective in its 'sterile' and 'single-use' condition.	"The Ortho Solutions Trauma Plates for Osteosynthesis is shown to be safe and effective for use as 'sterile' and for single-use in a surgical setting." (Page 3) The FDA's substantial equivalence determination implies that the device is considered as safe and effective as the predicate devices for its stated indications.
Sterility & Biocompatibility: Device components can be supplied sterile and are biocompatible for implantation. (Implicit, as 316LVM Stainless Steel is a well-established implant material)	"All plates, screws, and washers are offered 'sterile' to the customer." (Page 2) "All plates and screws are offered 'sterile' to the customer." (Page 2) Implicitly, surgical grade 316LVM Stainless Steel is known to be biocompatible for its stated use.
Manufacturing Quality: Device is manufactured under appropriate quality systems. (Implicit, as a requirement for all medical devices cleared by FDA)	The FDA letter mentions: "good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820)." (Page 4) This is a general regulatory requirement for the firm, not a specific performance metric, but central to device safety and effectiveness.

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

Sample Size: Not applicable in the context of an "algorithm only" or "human-in-the-loop" study. The "test set" here refers to the comparison of the device's specifications against predicate devices. The "sample" is the detailed technical specifications and intended use of the Ortho Solutions device components compared to the listed predicate devices.
Data Provenance: Not applicable. This is a comparison of technical specifications and regulatory clearances, not clinical data or images.

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

Number of Experts: Not applicable. Establishing "ground truth" with experts, typical for diagnostic software, is not relevant here. The ground truth for substantial equivalence is the established safety and effectiveness of the predicate devices as determined by regulatory bodies and clinical consensus over time.
Qualifications of Experts: N/A.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. There is no human adjudication of algorithm output in this context. The "adjudication" is the FDA's regulatory review process, determining if the comparison to predicate devices is sufficient for substantial equivalence.

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

MRMC Study: No, this type of study is entirely irrelevant for a bone fixation hardware device. There are no "human readers" or "AI assistance" involved in the device's function.

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

Standalone Study: No, this device does not involve any algorithms. It is a physical implant.

7. The type of ground truth used

Ground Truth: The "ground truth" implicitly used for this type of submission is the established safety and effectiveness profile of the legally marketed predicate devices against which the Ortho Solutions device is compared. This is based on years of clinical use, regulatory review, and scientific understanding of biomechanics and biomaterials.

8. The sample size for the training set

Sample Size: Not applicable. There is no "training set" as this device does not use machine learning or AI.

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

Ground Truth Establishment: Not applicable. Refer to point 8.

In summary, the provided document is a 510(k) summary for a traditional medical device (bone plates and screws), demonstrating substantial equivalence to existing products. The framework for "acceptance criteria" and "study" in your request is designed for AI/software devices and therefore does not directly apply to this submission. The "study" here is the comparative analysis presented in the 510(k) demonstrating that the new device is "similar in material, geometry design/markings, and indications" to cleared predicate devices.

Summary

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Page 1/3

SAFE MEDICAL DEVICES ACT OF 1990 510(k) Summary

NAME OF FIRM:

Ortho Solutions Limited West Station Business Park Spital Road Maldon ESSEX. CM9 6FF United Kingdom

510(k) FIRM CONTACT:

Al Lippincott Engineering Consulting Services, Inc. 3150 E. 200th St. Prior Lake, MN 55372 e-mail: allippincott@msn.com

DATE:

January 30, 2012

TRADE NAME:

COMMON NAME:

CLASSIFICATION:

Compression Hip Screw System (CHS/SCS) Smooth or threaded metallic bone fixation fastener

Ortho Solutions Trauma Plates for Osteosynthesis

(per 21CFR888.3040) - Screw, Fixation, Bone.

Bone Plates, Bone Screws & Washers System;

Single/multiple component metallic bone fixation appliances and accessories (per 21CFR888.3030) - Plate, Fixation, Bone; Washer, Bolt Nut; Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component.

DEVICE PRODUCT CODE:

HRS

SUBSEQUENT PRODUCT CODE:

HWC, HTN, KTT

SUBSTANTIALLY EQUIVALENT DEVICES

'Bone Plates, Screws & Washers' aap Implantate AG (K072411) 'Fixation Plate and Screw System' Mahe Medical GmbH (K102845) 'CHS/SCS System' Smith & Nephew (K993289, K921786, K895241) 'CHS/SCS System' DePuy (K946156) 'CHS/SCS System' Howmedica (K781762) 'CHS/SCS System' aap Implantate AG (K071852)

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<120360 Pege

Ortho Solutions Limited - 510(k) Summary - K120360:

DEVICE DESCRIPTION:

1. Bone Plates, Bone Screws and Washers System

2. Adult Compression Hip Screw (CHS/SCS) System

A brief and concise description of each system is as follows:

Bone Plates, Bone Screws and Washers System: This implant system consists of a Mini Fragment System (MFS), a Small Fragment System (SFS), and a Large Fragment System (LFS).

Adult Compression Hip Screw (CHS/SCS) System: This implant system consists of various angled (950 for SCS, 130°, 135°, and 150° for CHS) high strength forged plates in multiple hole lengths, various Lag Screw lengths with various length Compression Screws, and various length 4.5mm Cortical Screws for securing the plate to femoral bone. Associated guide pin, drills, and ancillary instrumentation is available. The system is intended for use in repair of fractures of the femoral hip neck/head and supra-condylar area of the skeletal femur. All components are manufactured of surgical grade 316LVM Stainless Steel to ASTM F138. All plates and screws are offered 'sterile' to the customer.

Section XII

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Ortho Solutions Limited - 510(k) Summary – K120360:

INTENDED USE:

The intended use of the Ortho Solutions Trauma Plates for Osteosynthesis of fixation device(s) is to draw two or more aligned bone fragments together to facilitate healing.

Ortho Solutions Bone Plates, Bone Screws and Washers System is indicated for use in fixation of various fractured bones. Mini plates and screws 3.5mm or smaller are intended for use in small bones in the hand or foot and include the metacarpal, metatarsal, and phalange bones. Small and large plates and screws 4.0mm and larger are intended for use in large and long bones which can include the clavicle, scapula, pelvis, calcaneus, talus and long bones (humerus, ulna, radius, femur, tibia, and fibula) in the skeletal anatomy.

The Ortho Solutions Trauma Plates for Osteosynthesis is not intended for spinal use.

EQUIVALENCE:

The Ortho Solutions Trauma Plates for Osteosynthesis is substantially equivalent to predicate systems from many orthopedic companies (as listed).

SUMMARY OF TECH-NOLOGICAL CHAR-ACTERISTICS

The Ortho Solutions Trauma Plates for Osteosynthesis is Similar in Material. Geometry Design/Markings, and Indications to many predicate systems currently sold in the U.S. market.

SUMMARY OF SAFETY AND EFFECTIVENESS:

The Ortho Solutions Trauma Plates for Osteosynthesis is shown to be safe and effective for use as 'sterile' and for single-use in a surgical setting.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

Public Health Service

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

Ortho Solutions Limited % Mr. Al Lippincott Engineering Consulting Services, Inc. 3150 E. 200th St. Prior Lake, MN 55372

MAY 2 9 2012

Re: K120360

Trade/Device Name: Ortho Solutions Trauma Plates for Osteosynthesis Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Product Code: HRS, HWC, HTN, KTT Dated: April 26, 2012 Received: April 30, 2012

Dear Mr. Lippincott:

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

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Page 2 - Mr. Al Lippincott

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 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 yours,

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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Image /page/5/Picture/0 description: The image shows the logo for "ORTHO SOLUTIONS". The word "ORTHO" is in all caps and is to the left of a large, bold "S" that is enclosed in a circle. The word "SOLUTIONS" is in all caps and is to the right of the "S".

West Station Business Park, Spital Road, Maldon, Essex CM9 6FF Tel: 0870 7777515 Fax: 0870 7777525 Email: sales@orthosol.com www.orthosolutions.com

Indications for Use

510(k) NUMBER: K120360 DEVICE NAME: Ortho Solutions Trauma Plates for Osteosynthesis INDICATIONS FOR USE:

The intended use of the Ortho Solutions Trauma Plates for Osteosynthesis of fixation device(s) is to draw two or more aligned bone fragments together to facilitate healing.

The Ortho Solutions Trauma Plates for Osteosynthesis is not intended for
spinal use.(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K120360

Prescription Use X Over-The-Counter-Use_

(Per 21 CFR 801 Subpart D)

(21 CFR 801 Subpart C)

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

· AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

Registered Office: West Station Business Park, Spital Road, Maldon, Essex CM9 6FF Registered in England No: 4311933

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.