The Mondeal® RADIUS HO System is intended to be used for the fixation of fractures and osteotomies involving the distal radius applied to the volar and dorsal aspect.

Device Description

The Mondeal® Radius Hand Osteosynthesis System consists of titanium volar and dorsal plates with shapes and sizes designed for internal fixation of distal radius fractures and osteotomies, and screws of varying lengths from 8 to 38 mm and 2.7 or 3.0 mm in diameter, supplied non-sterile packaged together in either tempered plastic or stainless steel trays suitable for recommended steam sterilisation, and also individually for single implantable use. The plates include dorsal and volar "T" shaped right and left hand configurations.. Manual reusable surgical instruments are supplied to facilitate implantation

AI/ML Overview

This document describes a 510(k) submission for the Mondeal® RADIUS HO System, a bone fixation system. The information provided is primarily focused on establishing substantial equivalence to predicate devices rather than providing detailed acceptance criteria and study results in the context of device performance metrics often seen in AI/software device submissions.

Therefore, many of the requested fields cannot be directly answered from the provided text. The submission focuses on comparing physical attributes and intended use.

Here's an analysis of the provided text in relation to your request:

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

The provided text does not present explicit acceptance criteria in terms of numerical performance metrics (e.g., accuracy, sensitivity, specificity) for a study. Instead, it demonstrates substantial equivalence to predicate devices based on a comparison of design, materials, intended use, and other physical characteristics.

Attribute	Acceptance Criteria (Implied by Substantial Equivalence)	Reported Device Performance (from comparison table)
Product Name	Be a bone fixation system for distal radius fractures.	Mondeal® RADIUS HO System (is a bone fixation system)
Use	Single Use, Permanent implant.	Single Use, Permanent
Plate and Screw Material	Bio-compatible material suitable for bone fixation, ideally Ti-6Al-4V ELI or similar titanium alloy.	Ti-6Al-4V ELI plates and screws
Sizes	Offer a range of screw diameters and lengths suitable for distal radius fixation.	2.7 mm x 8 - 32 mm, 3.0 mm x 8 - 32 mm
Available configurations	Offer right and left volar and dorsal configurations.	Right and left volar and dorsal
Indications for use	Intended for the fixation of fractures and osteotomies involving the distal radius, applied to volar and dorsal aspects.	Intended for the fixation of fractures and osteotomies involving the distal radius applied to the volar and dorsal aspect.
Recommended sterilisation method	Compatible with standard sterilization methods, such as steam.	Steam
Packaging	Packaged non-sterile, intended for sterilization by purchaser, potentially in tempered plastic or stainless steel trays.	Tempered plastic and stainless steel trays, non-sterile, intended for sterilization by purchaser.

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

This information is not provided in the document. This type of detail is typical for software or AI device studies involving patient data, not for traditional mechanical devices like bone plates, where performance is often evaluated through bench testing and material characterization against established standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable and not provided. Ground truth in the context of this device would involve engineering specifications, material properties, and mechanical testing, not expert interpretation of diagnostic data like images.

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

This information is not applicable and not provided. Adjudication methods are typically used in studies where human readers are making subjective interpretations of data, such as images, and their agreement needs to be reconciled.

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

This information is not applicable and not provided. MRMC studies are specific to evaluating the impact of AI or other tools on human reader performance, which doesn't apply to a bone fixation system.

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

This information is not applicable and not provided. This device is a physical implant, not an algorithm.

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

The ground truth for this type of device would be derived from:

Material specifications and standards: Verification that the Ti-6Al-4V ELI material meets industry standards.
Design specifications: Verification that the dimensions and geometry match the intended design.
Mechanical testing data: (Implied, but not detailed in this summary) This would involve tests for strength, fatigue, bending, and torsion to ensure the plate and screws can withstand physiological loads, often compared against established ASTM or ISO standards for bone fixation devices.

The document does not elaborate on specific test results or ground truth methodology, focusing instead on descriptive comparison to predicates.

8. The sample size for the training set

This information is not applicable and not provided. There is no "training set" for a physical medical device.

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

This information is not applicable and not provided.

In summary:

The provided document is a 510(k) summary for a traditional medical device (bone fixation system). The "study" proving the device meets acceptance criteria is fundamentally a comparison to predicate devices to demonstrate substantial equivalence in terms of design, materials, intended use, and general performance characteristics. It is not an AI/software performance study, and therefore, many of the requested details about statistical significance, reader studies, and AI-specific metrics are not present or applicable. The "acceptance criteria" are implicitly defined by the attributes and performance of the chosen predicate devices, which the Mondeal® RADIUS HO System is shown to match or be comparable to.

Summary

{0}------------------------------------------------

Kapp Surgical Instrument, Inc.

510(k) Notification: Mondeal® Radius HO

Attachment 1 – 510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance This Summary of 510(R) Surety and 21 CFR 807.92, upon which the substantial equivalence determination is based.

Summary Information:

Applicant:	Kapp Surgical Instrument Co., Inc.4919 Warrensville Center RoadWarrensville Heights, Ohio 44128Tel: (216) 587-4400Fax: (216) 587-0411
Contact :	Albert Santilli, President
Prepared:	March 10, 2005
Device Identification:
Proprietary Name:	Mondeal® RADIUS HO System
Common Name:	Screw, Fixation, Bone and Plate, Fixation, Bone
Classification Nameand Regulation:	Plate, Fixation, Bone, Class II21 CFR 888.3030, 87HRS
Predicate Device(s):	Synthes (USA) Distal Radius Plate System (DRPS) andHand Innovations, Inc. Distal Radius Fracture Repair System

Device Description:

Indications for use:

The Mondeal® Radius Hand Osteosynthesis System is intended to be used for the fixation of fractures and osteotomies involving the distal radius applied to the volar and dorsal aspect.

Substantial Equivalence:

KAPP Surgical Instrument Co., Inc. considers the Mondeal® RADIUS HO System to be substantially equivalent to the aforementioned predicate devices with regard to intended use, materials, biocompatibility, and overall performance characteristics in accordance with the following comparison summary.

{1}------------------------------------------------

Attribute	Candidate Device	Predicate Devices
Product Name	Mondeal® RADIUSHO System	Hand Innovation DistalRadius Fracture Repair	SYNTHES (USA)Radius Plate System
Use	Single Use, Permanent	Single Use, Permanent	Single Use, Permanent
Plate and Screw Material	Ti-6Al-4V ELI platesand screws	Ti-6Al-4V ELI platespegs, and screws	Titanium alloy andtitanium plates andscrews
Sizes	2.7 mm x 8 - 32 mm3.0 mm x 8 - 32 mm	2.5mm x 10 - 28 mm	1.8mm x 10 - 26 mm2.4mm x 10 - 26 mm
Available configurations	Right and left volar anddorsal	Right and left volar anddorsal	Right and left volar anddorsal
Indications for use:	Intended for the fixationof fractures andosteotomies involvingthe distal radius appliedto the volar and dorsalaspects	Intended for the fixationof fractures andosteotomies involvingthe distal radius	Intended for the fixationof fractures andosteotomies involvingthe distal radius appliedto the volar and dorsalaspects
Recommendedsterilisation method	Steam	Steam	Steam
Packaging	Tempered plastic andstainless steel traysintended for steamsterilisation includingplate, screw, and handtool (Class I)assortment, plates andscrews also packagedindividually, all non-sterile, intended forsterilisation bypurchaser.	Tempered plastic andstainless steel traysintended for steamsterilisation includingplate, screw, and handtool (Class I)assortment, plates andscrews also packagedindividually, all non-sterile, intended forsterilisation bypurchaser.	Stainless steel traysintended for steamsterilisation includingplate, screw, and handtool (Class I)assortment, all non-sterile, intended forsterilisation bypurchaser.

Comparison to the Predicate Devices:

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines representing its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 8 - 2005

Albert Santilli, Ph.D. Kapp Surgical Instrument Co., Inc. 4919 Warrensville Center Road Warrensville Heights, Ohio 44128

Re: K050655

Trade/Device Name: Mondeal® RADIUS HO System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS Dated: July 1, 2005 Received: July 5, 2005

Dear Dr. Santilli:

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 such 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); 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.

{3}------------------------------------------------

Page 2 - Albert Santilli, Ph.D.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark H. Miken

Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

INDICATIONS FOR USE

KOSD655 |510(k)] Number:

Device Name: Mondeal® RADIUS HO System

Indications For Use:

The Mondeal® RADIUS HO System is intended to be used for the fixation of fractures and osteotomies involving the distal radius applied to the volar and dorsal aspect.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-the-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A. Milliken

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number_

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.