The Medicon Epiplating System is indicated for the attachment of an external restoration prosthesis for restoration of a physical defect when other means of attachment are inadequate. The Epiplating system provides the bone anchorage for the prosthetic attachment. These devices are indicated for use in the maxillo-craniofacial region (including ear, nose and eye).

Device Description

The Medicon Epiplating System is an implant system consisting of various plates used as the foundation for anchoring prostheses or epitheses in the craniofacial region. The system offers various implant sizes to fit the anatomical needs of a wide variety of patients. Components are manufactured from pure titanium (ASTM F67) or Ti6Al4V alloy (ASTM F136).

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "Medicon Epiplating System" and primarily focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study of its performance against specific acceptance criteria for an AI/ML-based device.

Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, and ground truth establishment cannot be found in the provided document.

The document is a regulatory submission for a physical medical device (an implant system), not an AI/ML software device. The "Performance Data" section discusses mechanical testing, sterilization validation, cleaning validation, and biocompatibility, which are standard for such devices, but not the type of performance metrics (e.g., sensitivity, specificity, AUC) typically associated with AI/ML solutions and their acceptance criteria.

Summary of what can be extracted based on the provided text:

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

Not applicable/Not found. The document does not specify quantitative "acceptance criteria" in terms of clinical performance metrics that would be relevant for an AI/ML device (e.g., sensitivity, specificity). Instead, it refers to mechanical testing standards (ASTM F382) and biocompatibility standards (ISO 10993-1). The results are qualitative ("demonstrate substantial equivalence") rather than quantitative against specific clinical performance thresholds.

2. Sample sized used for the test set and the data provenance:

Not applicable/Not found. This section is irrelevant for the type of device described. No "test set" of clinical data (images, patient records) is mentioned. "Performance data" refers to bench testing on the device itself.

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

Not applicable/Not found. This information pertains to studies with human expert interpretation, typically in the context of AI/ML evaluation. This document describes a physical implant system.

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

Not applicable/Not found. This is for clinical data interpretation, not for evaluating a physical implant.

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/Not found. This is specific to AI/ML devices that assist human readers.

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

Not applicable/Not found. This is specific to AI/ML algorithm performance.

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

Not applicable/Not found. For this physical device, "ground truth" would be related to material properties meeting standards, mechanical performance under specified loads, and biocompatibility, which are evaluated against established engineering and biological standards, not clinical ground truth derived from expert consensus or pathology.

8. The sample size for the training set:

Not applicable/Not found. There is no AI/ML training set.

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

Not applicable/Not found. There is no AI/ML training set.

Information that is mentioned in the document (but not directly addressing the AI/ML specific questions):

Device Type: Medicon Epiplating System, an implant system.
Purpose: Attachment of an external restoration prosthesis for physical defects in the maxillo-craniofacial region (ear, nose, eye).
Regulatory Mechanism: 510(k) premarket notification.
Substantial Equivalence: Demonstrated through comparison of technological characteristics (design, intended use, material composition, function) to predicate devices.
Performance Data (for this device type):
- Mechanical Testing: Performed in accordance with ASTM F382 (proof of load, bending strength, bending stiffness, structural bending stiffness).
- Sterilization Validation: Pre-vacuum (steam) sterilization in accordance with ANSI/AAMI/ISO 17665-1:2006/(R)2013.
- Cleaning Validation: Manual and machine cleaning validation in accordance with AAMI TIR30:2011.
- Biocompatibility: Based on previously cleared devices with identical material and manufacturing methods, tested according to ISO 10993-1.

The document entirely pertains to a physical medical device and does not involve AI/ML technology, which is why the specific questions about AI/ML acceptance criteria and study design cannot be answered from the provided text.

Summary

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December 12, 2024

CMF Medicon Surgical Inc. Matthias Alber Executive Vice President 11200 St. Johns Industrial Pkwy N. Ste. 1 Jacksonville, Florida 32246

Re: K241253

Trade/Device Name: Medicon Epiplating System Regulation Number: 21 CFR 878.3680 Regulation Name: Nose Prosthesis Regulatory Class: Class II Product Code: FZE Dated: May 3, 2024 Received: September 13, 2024

Dear Matthias Alber:

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 (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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

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Sincerely,

Alicia Hemphill -S

Digitally signed by Alicia Hemphill -S Date: 2024.12.12 17:53:26 -06'00'

Alicia L. Hemphill Assistant Director DHT4B: Division of Plastic and Reconstructive Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Submission Number (if known)

| K241253

Device Name

Medicon Epiplating System

Indications for Use (Describe)
--------------------------------	--

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

| Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary

Submitter's Name and Address:	CMF MEDICON SURGICAL INC11200 St. Johns Industrial Pkwy N. Suite 1Jacksonville, FL 32246USA
Official Contact:	Matthias AlberExecutive Vice President
Contact Person and Telephone:	Matthias Alber904-642-7500
Date Summary Prepared:	11/19/2024
Device Name:	Proprietary Name - Medicon Epiplating System
Device Class:	Class II
Classification:	21 CFR § 878.3680
Product Code:	FZE

Predicate Device:

Primary Predicate Device

Manufacturer	Device Name	K Number	Classification
Southern Implants(Pty) Ltd.	Osseointegrated Fixtures	K161548	Prosthesis, Nose,Internal

Reference Devices

Manufacturer	Device Name	K Number	Regulationnumber andproduct code	Classification
MEDICON,E.G.	TITANIUM MINIPLATESYSTEM	K951690	872.4760JEY	Plate, Bone
MEDICON,E.G.	CMS CRANIO MAXILLOFACIAL TITANIUM IMPLANTSYSTEM	K951691	872.4760JEY	Plate, Bone
HOWMEDICALEIBINGER,INC.	Epitec™ Titanium ImplantSystem	K961719	888.3030HRS	Plate, Fixation,Bone

Device Description:

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Indication for Use:

Technological Characteristics:

The subject Medicon Epiplating System and the predicate devices are all used in the same way: they are fixated in bone where they are intended to osseointegrate to provide an attachment for a prosthesis. The material for all implants and the operating principle, which is permanent fixation by osseointeqration, are the same.

	Subject Device K241253	Predicate Device K161548	Reference Device K961719
Trade name:	Medicon Epiplating System	Osseointegrated Fixtures	EPITEC TITANIUM IMPLANT SYSTEM
Indicationsfor use:	The Medicon EpiplatingSystem is indicated for theattachment of an externalrestoration prosthesis forrestoration of a physicaldefect when other means ofattachment are inadequate.The Epiplating systemprovides the boneanchorage for theprosthetic attachment.These devices areindicated for use in themaxillo-craniofacial region(including ear, nose andeye).	Southern ImplantsOsseointegrated Fixtures isindicated for the attachment ofan external aesthetic restorationprosthesis for the restoration of aphysical defect when othermeans of attachment areinadequate. The endosseousimplant provides the boneanchorage for the prostheticattachment. These devices areindicated for use in the maxillo-craniofacial region (includingear, nose and eye).	The Epitec system can be used for thefixation of diverse kinds of craniofacialprostheses, including the followingexamples:Ear prosthesesOrbital prosthesesNose prosthesesCheek prosthesesHair piecesAlthough the Epitec system will primarilybe used for the alloplastic reconstructionof craniofacial defects caused by geneticanomalies, tumor resections, or trauma, itcan also be used in other craniofacialcases best treated with surgicalanchoring.
UserInterface	Manual insertion of theimplants with specificallydeveloped tools provided tothe end-user. In addition,instructions for use areavailable.	Same	Same
OperatingPrinciple	Permanent fixation byosseointegration	Same	Same
Physical(Design)	Plates and screws in manydifferent shapes	Single implants with differentlengths and diameters	Plates and screws in many different shapes
Bonefixationpoints perimplant	Multiple	Single	Multiple
Materials	Titanium	Same	Same
Sterility	Unsterile delivery	Sterile delivery	Unsterile Delivery
Biocompati	ASTM F136-13	Same	Same
	Subject Device K241253	Predicate Device K161548	Reference Device K961719
bility	ASTM F67-13ISO 5832-2ISO 5832-3
CleaningandSterilization	Pre-vacuum (steam)sterilization in accordancewith ANSI/AAMI/ISO17665-1:2006/(R)2013Manual cleaning andmachine cleaning inaccordance with AAMITIR30:2011	Not applicable, items aredelivered in sterile condition	Unknown

The subject and predicate devices are based on the following same technological elements:

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As was established in this submission, the subject Medicon Epiplating System is substantially equivalent to the other predicate devices cleared by the FDA for commercial distribution in the United States. The subject device was shown to be substantially equivalent based on technological characteristics to its predicate devices through comparison in areas including design, intended use, material composition, and function.

Performance Data:

The following performance data were provided in support of the substantial equivalence determination:

Mechanical testing

Bench testing of the Medicon Epiplating System was performed in accordance with ASTM F382. The following tests were performed with the worst-case implant:

proof of load. O
bending strength, O
O bending stiffness (=slope)
structural bending stiffness of the worst-case implant O

A side-by-side comparison and detailed worst-case analysis of each of the subject devices to the reference device K961719 has been performed. K961719 has the same indications for use and a very similar design as this subject device. The results of this side-by-side comparison demonstrate substantial equivalence to the legally marketed predicate devices.

Sterilization validation

Pre-vacuum (steam) sterilization in accordance with ANSI/AAMI/ISO 17665-1:2006/(R)2013.

Cleaning

Manual cleaning and machine cleaning validation in accordance with AAMI TIR30:2011.

Biocompatibility

Previously cleared devices with identical material and manufacturing methods have been tested according to ISO 10993-1.

Conclusion:

Based on the indication for use, technological characteristics, mechanical testing, and comparison to predicate devices, the subject Medicon Epiplating System demonstrates substantial equivalence to the legally marketed predicate devices.

Regulation Number and Section

§ 878.3680 Nose prosthesis.

(a)
Identification. A nose prosthesis is a silicone rubber solid device intended to be implanted to augment or reconstruct the nasal dorsum.(b)
Classification. Class II.