The Orthodontic Screw is indicated for use as a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. Screws are intended for single use only. The orthodontic screw is intended in patients aged 12 years and older.

Device Description

The Mini Screws system has been designed to provide a firm anchorage point in the oral cavity for orthodontic treatment. Mini screws are manufactured with CP Ti Gr 4 and are SLA treated. The Mini Screw system is designed to be applied with different orthodontic solutions and is versatile enough to satisfy different clinical cases. Titanium orthodontic mini screws are intended to provide fixed anchorage for orthodontic treatment used by implanting in the maxillary and mandibular bone. These mini screws used for anchoring purposes can be divided into 3 parts as head, neck and body.

AI/ML Overview

The provided text is an FDA 510(k) clearance letter and summary for a medical device called "Proimtech Mini Screw". This document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets strict performance acceptance criteria through the kind of study typically associated with AI/ML software.

Therefore, the information required to answer the prompt regarding acceptance criteria and a study proving a device meets these criteria (especially sections related to AI/ML software performance like sample size, experts, MRMC, standalone performance, and ground truth establishment) is not present in the provided document.

The document discusses the physical characteristics, materials, and intended use of a dental mini-screw, and compares it to similar existing devices to show it is substantially equivalent, thus not requiring a new PMA (Premarket Approval Application). It does not involve an AI/ML component or a study with performance metrics in the way the prompt implies.

Here's how to interpret the available information in the context of the prompt:

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

Acceptance Criteria (Implicit for Substantial Equivalence): The implicit acceptance criterion for a 510(k) clearance is that the new device is substantially equivalent to a legally marketed predicate device. This means it has the same intended use, and the same technological characteristics, or if it has different technological characteristics, these differences do not raise new questions of safety and effectiveness.
Reported Device Performance: The document states: "However, testing data such as mechanical testing provided in the submission show that these differences do not raise issues in performance." This very generally indicates that the device met certain mechanical performance benchmarks, but no specific quantitative acceptance criteria or results are provided in the public summary.
- The document also mentions: "The biocompatibility of our finished products has been carried out in accordance with EN 10993-1 Standard." and "Tests for the mechanical strength of our products have been carried out in accordance with TS EN ISO 19023 and ASTM F543 Standard." This indicates the types of tests performed for this physical device, but not the specific criteria or results.

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

Not applicable (N/A) / Not provided. The summary mentions "testing data" but does not detail sample sizes, data provenance (e.g., country of origin, retrospective/prospective), as it's a physical device, not an AI/ML software tested on a dataset of images/cases.

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

N/A / Not provided. This is relevant for AI/ML software that requires expert annotation for ground truth. For a physical medical device like a mini-screw, ground truth is established through material standards, mechanical testing protocols, and biocompatibility assessments, not human expert interpretation of data.

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

N/A / Not provided. This concept applies to human reader studies or data annotation for AI/ML, not a physical device's mechanical or material testing.

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:

N/A / Not provided. This is specific to AI/ML software. The device is a surgical implant.

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

N/A / Not provided. This is specific to AI/ML software.

7. The type of ground truth used:

For a physical device, "ground truth" would be established through engineering standards, material specifications (e.g., ISO 5832-2, ASTM F67-13 for material composition), mechanical testing protocols (e.g., TS EN ISO 19023, ASTM F543 for mechanical strength), and biocompatibility assessments (e.g., EN 10993-1). The document indicates these standards were followed.

8. The sample size for the training set:

N/A / Not provided. There is no "training set" in the context of a physical device. This refers to AI/ML model development.

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

N/A / Not provided. As above, no training set for a physical device.

In summary, the provided document details the regulatory clearance of a physical medical device (dental mini-screw) based on substantial equivalence, and therefore does not contain the information typically associated with acceptance criteria and studies for AI/ML software performance.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue rectangle with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

September 04, 2024

Proimtech Saglik Urunleri Anonim Sirketi Hakan Cevik General Manager Imes Sitesi, No:3 Dudullu Osb Mahallesi Imes 305.Sokak Istanbul. Istanbul 34773 TURKEY

Re: K231502

Trade/Device Name: Proimtech Mini Screw Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: OAT Dated: May 12, 2024 Received: August 8, 2024

Dear Hakan Cevik:

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 (the 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,

Sherrill Lathrop Blitzer

for Andrew Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K231502

Device Name Mini Screws

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 510k number: K231502 Mini Screws Proimtech Saglik Urunleri Anonim Sirketi

Company Name	:	Proimtech Saglik Urunleri A.S.
Authorised Person / Title	:	Hakan Çevik / General Manager
Address-1	:	Dudullu OSB Mahallesi Imes 305 Sokak C Blok No:3 PK:34775Umraniye / İstanbul
Address-2	:	Dudullu OSB Mahallesi Imes 501 Sokak E Blok No:25 PK:3477.Umraniye / İstanbul
Phone	:	+90 (216) 999 5041-44
Web/Mail	:	www.bilimplant.com / info@bilimplant.com

Official Contact	: Hakan Cevik, General Manager of Proimtech Saglik Urunleri Anonim Sirket
Phone Number	: +90 535 355 51 00
E-Mail	: hakancevik@bilimplant.com

DEVICE INFORMATION

Preparation Date	: September 04, 2024
Device Trade Name	: Mini Screws
Common Name	: Mini Screw
Classification Name	: screw, fixation, bone (21 CFR 872.3640)
Device Class	: II
Product Code	: OAT
Regulation Number	: 872.3640
Review Panel	: Dental

INDICATION FOR USE

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DEVICE DESCRIPTION

These mini screws used for anchoring purposes can be divided into 3 parts as head, neck and body.

► Head Part:

Head part, it is the part where both the rotational force necessary for the screw to move in the bone is applied and where it is used as a fulcrum for the force to occur. The heads of the mini screws are designed in the shape of a hexagon in which the screwdriver bit is fully inserted. The hole in the head is designed for the attachment of chains, elastic wires or springs to initiate the necessary tooth movements.

► Neck Part:

Neck part It is the part between the gingiva and the cortical bone, has no grooves and a shiny surface. The maximum compression of the screw occurs in this area and during insertion into the cortical bone.

► Body Part:

Body part is the threaded part of the screw that remains in the bone. The inner part of the body (core) provides the resistance of the screw against fracture and the groove depth provides the resistance of the screw against pulling.

The head part of the screws is cross-shaped or button-shaped and this part is the part where the necessary rotational force is applied to ensure that the screw advances in the bone. It is also the part where mechanics such as wire, spring or rubber are connected to the teeth to be moved. The neck part is designed to be smooth to make the use more comfortable, especially in patients with thin gingival biotype. The body part is designed as cylindrical and grooved in order to keep the screw fixed in the bone. The tip is angled conical for ease of application.

> Length of Screws:

Screw lengths vary between 5 mm and 16 mm. The length of the screw is determined by some factors such as the angle of application, thickness of the mucosa, bone quality and proximity of neighboring structures.

> Screw Diameters:

Screw diameters vary between 1.4 and 2 mm. The stability of the screws is affected by the screw surface area in contact with the cortical bone. As the diameter increases, the contact surface area will increase and the stability will also increase.

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> Surface Characteristics of Screws:

The tips of the mini screws with 0 1.4 mm, Ø 1.65 mm and Ø 2 mm diameters used for orthodontic anchorage have a sandblasted and acid etched (SLA) surface structure and have a surface roughness of 1.5-2 Ra. Since similar screws on the market are not expected to be osseointegrated, the surfaces of most of them are not treated. However, in order to apply high anchorage force and increase screw stability, the ends of these products are treated with "Sandblasted, large-grid, acid etched" (SLA) process, which is sandblasting followed etching.

> Groove Structure of Screws:

Screws can be classified as self-tapping (ST) and self-drilling (SD) according to their thread design. Our mini screws, which are used for tooth mobilization are placed directly as SD without predrilling. However, in areas with dense cortical bone, the need for pilot slot preparation with drills may rarely be encountered. Our mini screws are placed with a hand tool or a low-torque rotary instrument (contraangle handpiece) at the recipient site.

> Connection Type of Products:

The connection of the mini screws features a hexagon socket.

Image /page/6/Picture/6 description: The image contains three different views of a medical device. The first view shows a screw with a hexagonal head and a threaded shaft. The second view shows a spherical component with a hexagonal indentation. The third view shows a tool with a blade and a mechanism for gripping the screw.

Hexagon Connection Structure

Image /page/6/Picture/8 description: The image shows three different views of a screw. The first view is a side view of the screw, showing the threads and the head. The second view is a top-down view of the screw head, showing a cross-shaped indentation. The third view shows the screw being inserted into a piece of material using a screwdriver.

Length of SLA Surface Treatment Area:

All our mini screws have 1/2 apical part with SLA surface.

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MATERIALS:

Only materials approved for medical purposes are used in the manufacture of products: Pure Titanium Grade 4 according to standard ISO 5832-2 and ASTM F67-13.

PERFORMANCE AND SAFETY SPECIFICATION

Surface Characterization:

SLA is used to roughen the surface by applying a strong acid to the surface sandblasted with coarse grainy particles. The SLA technique has been used as an alternative to TPS coatings to achieve better surface chemistry and topography. This process is applied in combination after osseointegration to achieve macroroughness and micropits, as well as grit-sandblasting and acid etching to increase surface roughness.

MRI Compatibility:

The Mini Screw has not been evaluated for safety in the MR environment. It has not been tested for heating or unwanted movement in the MR environment. The safety of Mini Screws in the MR environment is unknown. Performing an MR exam on a person who has this medical device may result in injury or device malfunction.

The product design has been made to include all kinds of safety and performance requirements considering the intended use and location of the product. In this direction, especially;

√ The product is manufactured from pure titanium (Grade 4) raw material in accordance with EN 1642, TS EN ISO 19023, ISO 5832-2 and ASTM F67-13 Standard.
Our products are packaged in a Class 100,000 Clean Room according to ISO 11607 standard to ensure microbiological safety. They are then sterilized with Gamma radiation in accordance with the parameters specified in our user manual.
The gamma sterilization method declared by us has been validated in accordance with EN 11137-1/2 Standard.
The biocompatibility of our finished products has been carried out in accordance with EN 10993-1 Standard.
Tests for the mechanical strength of our products have been carried out in accordance with TS EN ISO 19023 and ASTM F543 Standard.

Primary Predicate Device and Reference Device

For primary device Mini Screws: K161197; Orthodontic screw, OSSTEM Implant Co., Ltd.

For reference device Mini Screws: K152297; OBS Anchorage Screw, BOMEI

For reference device Mini Screws: K191041; Orthodontic Fixation Screw (Smart Anchor Miniscrew), GNI Co., LTD

For reference device Mini Screw: K122069; Storm Mini Screw, Lancer Orthodontics

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For reference device Mini Screw: K161335; Dual Top Screw System, Jeil Medical Corporation

SUMMARIES OF TECHNOLOGICAL CHARACTERISTICS & SUBSTANTIAL EQUIVALENCE DISCUSSION

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TechnologicalCharacteristics	Subject Device	Primary Predicate Device	Reference Device	Reference Device	Reference Device	Reference Device							removed afterorthodontictreatment hasbeencompleted. TheStorm MiniScrew isprovided sterileand is intendedfor single useonly.
	Mini Screws	Orthodontic screw	OBS Anchorage Screw	Orthodontic FixationScrew (Smart AnchorMiniscrew)	Storm MiniScrew	Dual TopScrewSystem	Design	Image: screw	Image: screw	Image: screw	Image: screw	Image: screw	Image: screw	Image: screw
510(k)Number	K231502	K161197	K152297	K191041	K122069	K161335	Material	Titanium (Ti Grade 4, ASTM F67)		Ti-6Al-4V ELI, ASTM F 136	Stainless Steel (ISO 5832-1:2007/ ASTM F138-13)Titanium Alloy (ISO 5832-3:1996/ ASTM F136-13)	Ti-6Al-4V ELI, ASTM F 136	Ti-6Al-4V ELI,ASTM F 136	TitaniumAlloy (ASTMF136)
Manufacturer	Proimtech Saglik Urunleri A.S	OSSTEM Implant Co., Ltd.	BOMEI	GNI Co., LTD	LancerOrthodontics	Jeil MedicalCorporation	BodyDiameter	Ø1.4 mmØ1.65 mmØ2 mm	Ø1.2 mmØ1.4 mmØ1.6 mmØ1.8 mm		Ø1.5Ø2	Ø1.2 mmØ1.4 mmØ1.6 mmØ1.8 mmØ2 mm	Ø1.5 mmØ2 mm	Ø1.3 – Ø2.5
Product Code	OAT	OAT	OAT	OAT	OAT	OAT
Indications forUse	The Orthodontic Screw is indicatedfor use as a fixed anchorage point forattachment of orthodonticappliances to facilitate theorthodontic movement of teeth. It isused temporarily and is removedafter orthodontic treatment has beencompleted. Screws are intended forsingle use only. The orthodonticscrew is intended in patients aged 12years and older.	The Orthodontic Screw isindicated for use as a fixedanchorage point forattachment of orthodonticappliances to facilitate theorthodontic movement ofteeth. It is used temporarilyand is removed afterorthodontic treatment hasbeen completed. Screws areintended for single use only	Temporary anchoragescrews are intended toprovide a fixed anchoragepoint for attachment oforthodontic appliances tofacilitate the orthodonticmovement of the teeth. Itis used temporarily and isremoved after orthodontictreatment has beencomplete.	The Orthodontic FixationScrew[Smart AnchorMiniscrew] is intendedfor use as a temporaryanchor for orthodontictreatment for use inpatients aged 12 andolder.	The Storm MiniScrew is athreadedtitanium dentalimplant screwintended toprovide a fixedanchoragepoint for !heattachment .oforthodonticappliances andfacilltate theorthodonticmovement of,teeth. it is usedtemporarilyand must be	The DualTop ScrewSystem isintendedfor use as atemporaryanchor fororthodontictreatmentfor use inpatientsaged 12and older.

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Length	Ø1.4 x 6 mmØ1.4 x 7 mmØ1.4 x 8 mmØ1.4 x 9 mmØ1.4 x 10 mmØ1.65 x 6 mmØ1.65 x 7 mmØ1.65 x 8 mmØ1.65 x 9 mmØ1.65 x 10 mmØ1.65 x 11 mmØ1.65 x 12 mmØ2 x 6 mmØ2 x 7 mmØ2 x 8 mmØ2 x 9 mmØ2 x 10 mmØ2 x 11 mmØ2 x 12 mmØ2 x 14 mm	6 mm8 mm10 mm	Ø1.5 x 8 mmØ1.5 x 10 mmØ1.5 x 12 mmØ2 x 8 mmØ2 x 10 mmØ2 x 12 mmØ2 x 14 mm	6 mm8 mm10 mm	8 mm10 mm	5 mm – 16mm
SingleUse	Yes	Yes	Yes	Yes	Yes	Yes
Surface	Sandblasted Large grit Acid etched (SLA)	Acid etching	---	Machined (not acidetched)	---	No surfacetreatment
Sterilization	Radiation Sterile	Radiation Sterile	Non-Sterile (Steamsterilized by user)	Non-Sterile (Steamsterilized by user)	Sterile via betairradiation	Non-Sterile(Steamsterilized byuser) orGamma-Sterilized
Shelflife	5 years	8 years	5 years	5 years	5 years	-
Targetpopulation	Professional use only – qualifieddentists, orthodontist or oralsurgeon. Strictly reserved tospecialized and trained users.	Professional use only –qualified dentists. Strictlyreserved to specialized andtrained users.	Professional use only -qualified dentists. Strictlyreserved to specialized andtrained users.	Professional use only –qualified dentists. Strictlyreserved to specializedand trained users.	People havingorthodontiawork	Professional use only –qualifieddentists.Strictlyreserved tospecializedand trainedusers.
Principle ofOperation	Anchorage mini screws are used tomove the teeth.	Orthodontic screw is insertedinto either jaw to help theorthodontist move the correctteeth and stop the wrongteeth from moving in thewrong direction.	Anchorage mini screws areused to move the teeth.	Anchorage mini screwsare used to move theteeth.	Dental andorthodonticspecialistsoffices	Anchoragemini screwsare used tomove theteeth.
Substantial Equivalence Discussion

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Similarities

The device has similar characteristics compared to the following respects. Indication for use, product code, design, diameter, disposable, intended population and operating principle.

Difference

The differences between the subject device is the surface treatment. However, testing data such as mechanical testing provided in the submission show that these differences do not raise issues in performance. Additionally, the subject device are available in slightly different however the such dimensional changes do not raise any performance concerns.

Conclusion

On the basis of the above discussion, it is concluded that the device in question is substantially equivale device.

Regulation Number and Section

§ 872.3640 Endosseous dental implant.

(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.