The Mondeal® Hand Contour 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 document is a 510(k) summary for the Mondeal® Hand Contour System. It does not describe a study involving device performance metrics related to acceptance criteria in the typical sense of a diagnostic or AI-driven device. Instead, it demonstrates substantial equivalence to a predicate device based on material, design, and intended use.

Therefore, the following information is not directly extractable from the provided text in the context of a "study that proves the device meets the acceptance criteria" in terms of clinical performance or accuracy:

A table of acceptance criteria and the reported device performance
Sample sizes used for the test set and the data provenance
Number of experts used to establish the ground truth for the test set and their qualifications
Adjudication method
If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, and its effect size
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
The type of ground truth used
The sample size for the training set
How the ground truth for the training set was established

However, I can extract information related to the acceptance criteria and the "study" (in this case, a comparative analysis) that led to the device's market clearance based on substantial equivalence.

Here's the information that can be extracted or inferred from the provided text regarding the "acceptance criteria" for 510(k) clearance:

Acceptance Criteria and Reported Device Performance (for 510(k) Substantial Equivalence)

Characteristic	Acceptance Criterion (Similarity to Predicate)	Mondeal® Hand Contour System (Subject Device Performance/Characteristics)
Indications for Use	Same or similar to predicate device to establish substantial equivalence	"intended to be used for the internal fixation of small bones of the hand and foot."
Technology	Identical to predicate device	Titanium plates and screws
Application	Identical to predicate device	Internal Fixation of small bones of hand and foot
Design / Components	Similar materials to predicate device	CP Titanium Grade 2 plates and Ti-6Al-4V ELI screws
Corrosion resistance	Identical to predicate device	Identical to predicate
Mechanical properties	Similar hardness, yield/tensile strength, elongation, reduction in area, chemical content to predicate device	Similar hardness, yield and tensile strength, elongation, reduction in area, chemical content to predicate
Sterilization Method	Identical to predicate device	Steam Autoclave
Packaging	Similar packaging practices to predicate device	Tempered plastic and/or stainless steel trays for steam sterilization; plates/screws also packaged individually; all non-sterile, intended for sterilization by purchaser. (Similar to predicate)

Study Information (for 510(k) Pre-market Notification):

This submission is a 510(k) premarket notification to demonstrate substantial equivalence to a legally marketed predicate device, not a diagnostic accuracy study or a clinical trial.

Sample size used for the test set and the data provenance: Not applicable. The "test" here involves comparing characteristics of the subject device to a predicate device. This is a comparison of manufacturing specifications and intended use, not a performance study on a particular data set.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" is established by the specifications and regulatory status of the predicate device. The FDA reviews the submitted comparison.
Adjudication method: Not applicable.
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 (surgical implant) for internal fixation, not an AI-driven diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm.
The type of ground truth used:
- Basis for "Ground Truth": The "ground truth" in this context is the established safety and effectiveness of the predicate device (Howmedica Profyle® Hand and Small Fragment System, K961497) as determined by its prior market clearance.
- The "study" here involves a comparison table highlighting that the subject device (Mondeal® Hand Contour System) has identical or similar characteristics (materials, design, performance specifications like corrosion resistance and mechanical properties, sterilization method, packaging) and substantially similar indications for use to the predicate device.
The sample size for the training set: Not applicable. This is not a machine learning or AI device.
How the ground truth for the training set was established: Not applicable.

In summary, the "study" described in this document is a comparative analysis demonstrating that the Mondeal® Hand Contour System is substantially equivalent to a previously cleared predicate device, the Howmedica Profyle® Hand and Small Fragment System, based on:

Identical or similar fundamental technology (titanium plates and screws).
Similar materials (CP Titanium Grade 2 plates and Ti-6Al-4V ELI screws).
Comparable performance specifications (corrosion resistance, mechanical properties like hardness, yield/tensile strength, elongation).
Identical sterilization methods and similar packaging.
Substantially similar Indications for Use (internal fixation of small bones of the hand and foot).

The acceptance criteria are met by demonstrating this substantial equivalence across these characteristics.

Summary

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Mondeal® Hand Contour System 510(k) Summary of Safety and Effectiveness

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.

The assigned 510(k) number is K071797 . . This Summary was prepared on August 27, 2007

GENERAL INFORMATION

Manufacturer and Applicant Information:

Mondeal Medical Systems GmbH Moltkestr. 39 Tuttlingen, GERMANY 78532 Contact: Jay Evans Telephone: 858-901-4123 858-225-0311 Fax:

Trade Name:

Mondeal® Hand Contour System Device Name: Common Name: Screw, Fixation, Bone and Plate, Fixation, Bone Plate, Fixation, Bone, Class II Classification Name: and Regulation: 21 CFR 888.3030, 87HRS

Substantial Equivalence:

Mondeal Medical Systems GmbH, claims substantial equivalence to the Howmedica Profyle ® Hand and Small Fragment System, K961497.

Indications for Use:

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

Description of the Device

SEP 1 7 2007

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ATTACHMENT III - 510(k) SUMMARY, REVISED

Characteristic	Mondeal® Hand Contour System (subject of this 510(k))	Howmedica Profyle Hand and Small Fragment System
Names	Mondeal® Hand Contour System	Howmedica Profyle Hand and Small Fragment System
510(k) number	K071797	K961497
Indications for use	The Mondeal® Hand Contour System is intended to be used for the internal fixation of small bones of the hand and foot.	Howmedica Profyle Hand and Small Fragment System is intended for use in internal fixation of small bones including the hand, foot, and cranialmaxillofacial skeleton.
Design and Device Characteristics
Technology	Titanium plates and screws	Titanium plates and screws
Application	Internal Fixation of small bones of hand and foot	Internal Fixation of small bones of hand and foot
Design / Components	CP Titanium Grade 2 plates and Ti-6Al-4V ELI screws	CP Titanium Grade 2 plates and Ti-6Al-4V ELI screws
Performance Specifications
Corrosion resistance	Identical	Identical
Mechanical properties	Similar hardness, yield and tensile strength, elongation, reduction in area, chemical content	Similar hardness, yield and tensile strength, elongation, reduction in area, chemical content
Sterilization Method	Steam Autoclave	Steam Autoclave
Packaging	Tempered plastic and or stainless steel trays suitable for steam sterilization including plate, screw, and hand tools (Class I) assortment, plates and screws also packaged individually, all non-sterils, intended for sterilization by purchaser	Tempered plastic and or stainless steel trays suitable for steam sterilization including plate, screw, and hand tools (Class I) assortment, plates and screws also packaged individually, all non-sterils, intended for sterilization by purchaser

Conclusions

Mondeal Medical Systems GmbH considers the Mondeal® HAND CONTOUR 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 above comparison summary.

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

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 17 2007

Mondeal Medical Systems, GmbH % Mr. Jay Evans Mondeal North America, Inc. 13566 Freeport Road San Diego, California 92133

Re: K071797

Trade/Device Name: Mondeal® Hand Contour System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS Dated: August 28, 2007 Received: September 4, 2007

Dear Mr. Evans:

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

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Page 2 - Mr. Jay Evans

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. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Barbara Buellm

Mark N. Melkerso 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

510(k) Number: _______________________________________________________________________________________________________________________________________________________________

Device Name: Mondeal® Hand Contour System

Indications For Use:

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

M
Pivision Sign.000

Division of General, Restorative, and Neurological Devices

510(k) Number K071797

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Mondeal® Hand Contour™ Implant System Mondeal Medical Systems GmbH Traditional 510(k) Application Page 37 of 62

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.