Dorted Desert from Hand Osteosynthesis System consists of titanium plates with shapes and sizes designed for internal fixation of small bones including the hand and foot, and screws of varying lengths from 4 to 23 mm and 1.2 , 1.7, and 2.3 mm in diameter, supplied nonsterile 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 straight, "T" shaped and condylar configurations. Manual reusable surgical instruments are supplied to facilitate implantation

AI/ML Overview

This submission does not contain the information required to complete the request. The provided text is a 510(k) summary for a medical device (Mondeal® CONTOUR HO System), which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed acceptance criteria and a study design with performance metrics.

Here's a breakdown of why the information is missing and what would typically be expected for each point:

Acceptance Criteria and Reported Device Performance: This type of submission usually focuses on material equivalence and mechanical testing that mimics physiological loads, rather than clinical performance metrics (like sensitivity, specificity, accuracy) that would apply to diagnostic devices or devices with measurable clinical outcomes. The document states "overall performance characteristics," but does not list specific numerical acceptance criteria or performance results (e.g., in terms of strength, fatigue life, or clinical success rates).
Sample Size for Test Set and Data Provenance: Not applicable. As this is a mechanical fixation device, the "test set" would refer to the materials and constructs tested. The provided document doesn't specify the number of samples used in any mechanical tests, nor does it mention any clinical data or its provenance.
Number of Experts and Qualifications for Ground Truth: Not applicable. Ground truth, in the context of clinical studies, refers to the definitive determination of a condition or outcome. For a device like a bone fixation system, clinical trials might establish ground truth through imaging follow-ups, surgical assessment, or patient outcomes, but this is not covered in a 510(k) summary focused on substantial equivalence.
Adjudication Method: Not applicable for this type of submission. Adjudication methods (like 2+1 or 3+1) are typically used in studies where human readers are interpreting images or clinical data, which is not the focus here.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. MRMC studies are used to evaluate the performance of diagnostic imaging devices or algorithms with and without AI assistance, comparing human reader performance. This device is a surgical implant, not a diagnostic tool.
Standalone Performance Study: Not applicable. "Standalone performance" usually refers to the algorithm-only performance of an AI-powered diagnostic device. For a surgical implant, performance is assessed through mechanical testing and, in some cases, clinical follow-up. This document doesn't detail such studies.
Type of Ground Truth Used: Not applicable in the context of clinical "ground truth" for a diagnostic device. For an implant, "ground truth" might pertain to the success of the fixation in a mechanical test (e.g., did it fail at a certain load?) or clinical outcome measures in a trial. This document does not elaborate on these.
Sample Size for Training Set: Not applicable. This device is a mechanical implant, not an AI or machine learning system that requires training data.
How Ground Truth for Training Set was Established: Not applicable, as there is no training set for this type of device.

In summary, the provided 510(k) summary is designed to demonstrate substantial equivalence based on material properties, design, and intended use compared to a predicate device, rather than providing detailed clinical study results with acceptance criteria and performance metrics typically associated with diagnostic or AI-powered devices.

Summary

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K05-0657

Page 1 of 1

Attachment 1 – 510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 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:	July 1, 2005
Device Identification:Proprietary Name:	Mondeal® CONTOUR 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):	Howmedica Profyle™ Titanium Hand and Small Fragment System

Device Description:

Indications for use:

The Mondeal® Contour Hand Osteosynthesis System is intended to be used for the internal fixation of small bones including the hand and foot.

Substantial Equivalence:

KAPP Surgical Instrument Co., Inc. considers the Mondeal® CONTOUR 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.

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

AUG 8 - 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K050657 Trade/Device Name: Mondeal® CONTOUR 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.

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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 N. Millikan

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

Enclosure

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INDICATIONS FOR USE

KoS 0657 [510(k)] Number:

Device Name: Mondeal® CONTOUR HO System

Indications For Use:

The Mondeal® CONTOUR HO System is intended to be used for the internal fixation of small bones including the hand and foot.

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)

Mull H. Mkhun

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

510(k) Number K050657

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.