(279 days)
The subject devices are intended to be place in the mouth for use as an anchor in orthodontic procedures.
The anchor plates for attachment to the orthodontic device offer four types (T-Type, Y-Type and W-Type). This plate has three portions; head, arm and body, and there are two types of head portion. Anchor plate is developed to provide intraoral absolute anchorage for the intrusion or molars. Anchor Plate does not disturb any kind of tooth movement because they are placed outside the dentition. The anchor plate consists of pure titanium alloy, which is suitable for osseointegration and also tissue integration.
The provided document is a 510(k) premarket notification for a medical device called "Anchor plate." This type of document is generally used by manufacturers to demonstrate that their device is substantially equivalent to a predicate device already legally marketed in the U.S. It primarily focuses on comparing the new device against existing predicates based on technological characteristics, intended use, and performance data to establish safety and effectiveness.
This document does not describe the acceptance criteria and study that proves the device meets the acceptance criteria in the format requested in the prompt.
Specifically, it lacks:
- A table of acceptance criteria with reported device performance against those criteria.
- Details on sample size used for a "test set" (as this is not a diagnostic device, there isn't a traditional test set of clinical cases).
- Information on data provenance for a clinical test set.
- Number and qualifications of experts for ground truth establishment.
- Adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness study.
- Standalone (algorithm only) performance study.
- Type of ground truth used (pathology, outcomes data, etc.) for clinical evaluation.
- Training set size or how ground truth for a training set was established (again, not a diagnostic AI device).
Instead, the document focuses on non-clinical performance data and a comparison to predicate devices, which is typical for a 510(k) submission for a mechanical implantable device.
Here's an extraction of the relevant performance data and comparisons that are available in the document:
1. A table of acceptance criteria and the reported device performance:
The document mentions comparative performance testing but does not present a formal table of acceptance criteria. Instead, it compares the proposed device's mechanical properties to those of the primary predicate device. The "acceptance criteria" are implicitly that the proposed device performs comparably or better than the predicate device.
| Performance Metric | Acceptance Criteria (Implied "Similar to Predicate") | Reported Device Performance (Anchor Plate) | Reported Predicate Performance (K091051) |
|---|---|---|---|
| Bending strength (Avg.) | Comparable to K091051 (97.125 N·mm) | 102.428 N·mm | 97.125 N·mm |
| Tensile force (Avg.) | Comparable to K091051 (176.782 N) | 301.814 N | 176.782 N |
| Biocompatibility | Compliance with ISO 10993-1 | Compliant per ISO 10993-1 | Compliant per ISO 10993-1 |
| Sterilization Efficacy | Needs autoclave prior to use (specific temp/time) | Autoclave at 121°C for 30 min exposure, 15 min dry | Gamma Radiation (ISO 11137-1) |
Note: The document states "the results showed that the properties considered were similar when used for intended use" despite the numerical differences in bending strength and tensile force, suggesting that the observed differences were deemed clinically acceptable.
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated for performance testing. Mechanical tests typically involve a certain number of units, but the specific quantity is not reported. This is a non-clinical device; there isn't a "test set" of clinical data.
- Data Provenance: The tests were conducted by the manufacturer, BioMaterials Korea, Inc., (South Korea). It is preclinical (bench and biocompatibility) data, not clinical patient data. The tests are non-clinical (bench testing and biocompatibility).
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):
- Not applicable. This is a pre-clinical (bench) study for a mechanical device, not a diagnostic or clinical study requiring expert ground truth for imaging or clinical outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This is a pre-clinical (bench) study.
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. This is not an AI-enabled device requiring MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For mechanical properties: The "ground truth" is measured physical properties against established standards (e.g., ISO 9585 for bending strength) or internal validated test methods.
- For biocompatibility: The "ground truth" is established by adherence to recognized standards like ISO 10993.
8. The sample size for the training set:
- Not applicable. This is a mechanical device, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established:
- Not applicable.
{0}------------------------------------------------
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 seal on the left and the FDA acronym with the full name of the agency on the right. The seal features an abstract design, while the FDA part includes the acronym in a blue square and the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
BioMaterials Korea, Inc Jiyea Kim Staff #413, #329, #331 150, Jojeong-daero, Hanam-si Gyeonggi-do, KR 12930
Re: K173623
Trade/Device Name: Anchor plate Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: OAT Dated: November 9, 2017 Received: November 24, 2017
Dear Jiyea Kim:
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. 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 located 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.
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
August 30, 2018
{1}------------------------------------------------
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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Mary S. Runner -S
For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K173623
Device Name Anchor plate
Indications for Use (Describe)
The subject devices are intended to be place in the mouth for use as an anchor in orthodontic procedures.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW *
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
Date: August 30, 2018
1. Submitter:
| Manufacturer Name: | BioMaterials Korea, Inc#413, #329, #331 150, Jojeong-daero, Hanam-si,Gyeonggi-do, Rep of KoreaPhone: +82-31-790-4511Fax: +82-31-790-4519Contact name: Jiyea KimEmail: jiyea210@biomk.comWeb page: www.BioMK.com |
|---|---|
| Correspondent Name: | Regulatory Insight, Inc33 Golden Eagle Lane, Littleton, CO, 80127Phone: 720-9625412Fax: 720-9625413Contact name: Kevin WallsEmail: Kevin@Reginsight.com |
2. Device Name and Classification
| Trade/Proprietary Name: | Anchor Plate |
|---|---|
| Common Name: | Endosseous Dental Implant |
| Regulatory Class: | Class II, 872.3640 |
| Product Code: | OAT |
3. Predicated Device
- . Primary Predicate Device BOLLARD MINIPLATE SKELETAL ANCHORAGE SYSTEM, TITA-LINK, K091051
- . Reference Predicate Devices KLS MARTIN ORTHO ANCHORAGE SYSTEM, KLS-MARTIN L.P., K040891 SYNTHES ORTHODONTIC BONE ANCHOR SYSTEM, SYNTHES(USA), K063473
4. Device Description
The anchor plates for attachment to the orthodontic device offer four types (T-Type, Y-Type and W-Type). This plate has three portions; head, arm and body, and there are two types of head portion.
Anchor plate is developed to provide intraoral absolute anchorage for the intrusion or molars. Anchor Plate does not disturb any kind of tooth movement because they are placed outside the dentition. The anchor plate consists of pure titanium alloy, which is suitable for osseointegration and also tissue integration.
{4}------------------------------------------------
| Anchor plate | Screw | |||
|---|---|---|---|---|
| Design | Type | Design | Trade names | Model name |
| Image: T-Type Anchor Plate | T-Type | Image: Bone Screw | Bone Screw | OSS-T2004SOSS-T2005SOSS-T2006S |
| Image: I-Type Anchor Plate | I-Type | Image: Bone Screw | Bone Screw | OSS-T2004SOSS-T2005SOSS-T2006S |
| Image: I-Type Anchor Plate | ||||
| Image: Y-Type Anchor Plate | Y-Type | Image: Bone Screw | Bone Screw | OSS-T2004SOSS-T2005SOSS-T2006S |
| Image: W-Type Anchor Plate | W-Type | Image: CT Type Screw | CT Type | OAS-T1506T |
| Image: C-Type Screw | C-Type | OAS-T1507 |
Compatibility information is summarized in the table below.
{5}------------------------------------------------
| Image: W-Type | CT Type | OAS-T1506T |
|---|---|---|
| C-Type | OAS-T1507 |
5. Intended Use
The subject devices are intended to be place in the mouth for use as an anchor in orthodontic procedures.
{6}------------------------------------------------
| - | Proposed Device | Primary Predicate Device(K091051) | ReferenceDevice I(K040891) | PredicateReferenceDevice II(K063473) | Predicate Discuss/Justifydifferences |
|---|---|---|---|---|---|
| Trade name | Anchor Plate | BOLLARD MINIPLATESKELETALANCHORAGE SYSTEM | KLS MARTIN ORTHOANCHORAGE SYSTEM | SYNTHESORTHODONTIC BONEANCHOR SYSTEM | |
| Common name | Endosseous dentalimplant | Endosseous dentalimplant | Bone plate | Endosseous dentalimplant | Same |
| Classification name | Endosseous implant | Endosseous implant | Endosseous implant | Endosseous implant | Same |
| Class | II | II | III | II | Same |
| Product Code | OAT | DZE | DZE | OAT | There are different productcodes, DZE and OATbetween proposed deviceand predicate devices.However, all devices consistof orthodontic anchoragesystem under same intendeduse.For product code as DZE,Bollard Miniplate SkeletalAnchorage System(K091051) and OrthoAnchorage System(K040891) are used as ananchor for orthodonticprocedures by providingskeletal fixation which aresame with T-Type, I-Typeand Y-Type of proposeddevice.For product code as OAT, |
| TheOrthodonticBoneAnchor System (K063473)are used as an anchor fororthodontic procedure byproviding bone fixationwhich is same with W-Typeof proposed device. | |||||
| Device description | The anchor plates for theattachment to theorthodontic device offerfour types (T-Type, I-Type, Y-Type and W-Type). This plate has threeportions; head, arm andbody, and there are twotypes of head portion.Anchor plate is developedto provide intraoralabsolute anchorage for theintrusion or distalizationof molars. Anchor Platedoes not disturb any kindof tooth movementbecause they are placedoutside the dentition. Theanchor plate consists ofpure titanium and titaniumalloy, which is suitable forosseointegration and alsotissue integration. | The Bollard MiniplateSkeletal AnchorageSystem was invented byDr. Hugo DeClerck.The Bollard MiniplateSkeletal AnchorageSystem provides a fixedanchorage point for theattachment of orthodonticappliances to facilitateorthodontic movement ofteeth. Small stationarypoints connected to boneinside the Mouth allowconnection of wire,elastic, or other hardware.The Bollard MiniplateSkeletal AnchorageSystem includesCommercially PureTitanium miniplates fixedby miniscrews to thecortical bone. Afterinsertion by the surgeonthe miniplates arecompletely covered bysoft tissue. The miniplatesand miniscrews are soldsterile and are sterilizedusing Gamma Radiationper ISO 111137-1. | The KLS-Martin OrthoAnchorage Systemincludes several differentdesigns of titanium plates. | The Synthes (USA) SameOrthodontic Bone AnchorSystem is a plate andscrew system designed tobe implanted intraorallyand used as an anchor fororthodontic procedures.The plate anchor portionof the system consists ofT-shaped plate anchorswhich are attached to thebone via 1.55 mm cortexscrews and 1.85 mmemergency screws. Theplate anchors are offeredin various designs forattachment to theorthodontic device. Thescrew anchor portion ofthe system consists of1.55 mm self-drilling andself-tapping screwanchors which incorporatea non-threaded gingivalcollar beneath the screwhead which protects thesoft tissue. | |
| The bone anchor consistsof a miniplate (M) with 2or 3 holes, a roundconnecting bar (C), and afixation unit (F) with ablocking screw (5). Theminiplate is fixed to thebone by self-tapping orselfdrilling screws. Thefixation unit contains 2slots with a diameter of0.045" (1.1mm). Asquare connecting wirewith a maximum size of0.032x0.032" can beinserted and tightly fixedby the blockingscrew.The Bollard miniplatesare also offered with ahook. The Bollard withhook is smaller than theoriginal model andcontains a tube withsection 0.020"x0.020".The hook can affixdirectly to elastics or coilspringsThe subject devices areused with standardinstrumentation fororthodontic surgeryincluding pliers,punches, screwdrivers,burrs, and grasping orholding instruments. | |||||
| Indications for use | The subject devices areintended to be place in the | The subject devices areintended to be placed in | Orthodontic tooth-moving procedures where | The Orthodontic BoneAnchor (OBA) System is | Same |
| mouth for use as ananchor in orthodonticprocedures. | the mouth for use as ananchor in orthodonticprocedures. | maximum stability isrequired• Patients in theirpermanent dentition• Patients where dentalfixation is not possible(tooth or alveolar loss,trauma) | indicated for intrusion andextrusion of teeth, distaland mesial movement ofteeth, treatment ofanterior cross bite andopen bite, space closure,3-D control of teeth. | ||
| Raw material | ASTM F67ASTM F136-02a | Pure titanium | F67 grade 2 titanium | ASTM-F67 grade 4ASTM-R136-02a | Same |
| Design | T-TypeImage: T-Type | The BollardImage: The Bollard | C-tube platesImage: C-tube plates | Mesh plate anchorImage: Mesh plate anchor | Different.In clinical applicationliterature, different shapesof the plates are described inthe literature as following; |
| Image: I-Type | The Bollard with hookImage: The Bollard with hook | Image: Hook plates | Image: Mesh plate anchor | L-shaped, T-shaped, Y-shaped, I-shaped rectangularor triangular comprising 2,or 5 holes for screwfixation.(Reference 1-5)Also, some articles studiedthe influence of the shape ofthe bone plate, but it didn'tseem to be a significantfactor forsuccess.(Reference 1) | |
| Image: I-Type | Finally, the variations inshape mean that the surgeoncan select the mostappropriate anchor plateaccording to the bonecontour of the implantationsite. Therefore, its minor |
6. Comparison of technological characteristics with the predicate device
{7}------------------------------------------------
{8}------------------------------------------------
{9}------------------------------------------------
{10}------------------------------------------------
Image /page/10/Picture/0 description: This image shows different types of surgical plates. The plates are labeled as Y-Type, W-Type, BH-UR-19 Y, C-palatal Plate, Bondable surface plates, Bracket Plate anchor, and Domed plate anchor. The bracket plate anchor has 4-hole and 5-hole variations.
{11}------------------------------------------------
| Intended Use | The subject devices areintended to be place in themouth for use as ananchor in orthodonticprocedures. | In cases of dentalregulations a C-tube(Chung'smicroplate with tube) canbe fixed in the lateral partof the maxilla ormandible. The eyelet willremainin the buccal sulcus andserves to hold the dentalarch wire.The KLS-Martin OrthoAnchorage System isintended to be surgicallyplaced in the mouth foruse as an anchor fororthodontic procedures. | The Orthodontic BoneAnchor(OBA) System isintended to be implantedintraorally and used as ananchor for orthodonticprocedures. | Similar | |
|---|---|---|---|---|---|
| Dimensions(unit:mm) | Thickness : 0.8/ 1Length : 13.35 - 40.35 | Not Listed | Thickness : 0.6/1.0/1.5 | Not Listed | Similar.As literature (Reference 6)C-tube plate, 0.66 ofdimension and 14.0 oflength, were used. andSynthes OBA domed design |
| 4 holes, 0.76 of thicknessand 13.5 of length, wereused. | |||||
| Generally, Anchor plate wasselected according to thedistance between theimplantation site and thedentition by professional. | |||||
| Surface Treatment | Machined | Machined | Machined | Not Listed | Same |
| Sterilization | Provided as non-sterile,needs autoclave prior touse.· Temperature : 121 °C· Exposure time : 30 min· Dry time : 15 min | Gamma RadiationISO 11137-1 | Not Listed | Provided as non-sterile,needs autoclave prior touse.Thermal disinfect at 93°Cfor minimum of 2 minutesand 30 seconds. | Same |
| Usage | Single use Only | Single use Only | Not Listed | Single use Only | Same |
| Biocompatibility | Device is biocompatiblewhen used as directed bydental professionals perISO 10993-1. | Device is biocompatiblewhen used as directed bydental professionals perISO 10993-1. | Device is biocompatiblewhen used as directed bydental professionals perISO 10993-1. | Device is biocompatiblewhen used as directed bydental professionals perISO 10993-1. | Same |
| mechanical properties | Bending strength (Avg.,N·mm): 102.428Tensile force (Avg., N):301.814 | Bending strength (Avg.,N·mm): 97.125Tensile force (Avg., N):176.782 | Not Listed | Not Listed | Different.Mechanical and physicalproperties of subject deviceare compared with primarypredicate device wheredetails method, apparatusand results can be found in |
{12}------------------------------------------------
{13}------------------------------------------------
| the test report (Bench testreport (subject device VS | |
|---|---|
| predicate device). Since | |
| there is no unknown | |
| standard for performance, | |
| the results showed that the | |
| properties considered were | |
| similar when used for | |
| intended use. |
The subject device is similar to predicate device in terms of indication for use, design, raw material etc.
The subject device consists of orthodontic anchorage system, as is the mechanical properties and performance of subject device are not significantly from the predicate device, as indicated by non-clinical performance testing.
The shape, dimension and mechanical properties are different between the primary predicate device. But the variations in shape or dimension mean that the surgeon can select the most according to the bone contour or distance of the implantation site by professional. Also, in terms of mechanical properties, these differences are not significantly difference on its intended use or performance. Therefore, its minor deviation is acceptable for clinical application.
{14}------------------------------------------------
7. Performance Data(Non-Clinical)
The test such as appearance, dimension and bending strength is to verify the performance of the device as it designed. Bending strength was performed according to ISO 9585. All of test results obtained from these tests indicated that Anchor Plate is substantially equivalent to the predicate device in terms of mechanical properties and performance.
The biocompatibility evaluation for the Anchor Plate was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO 10993, 'Biological Evaluation of Medical Devices Part 1:Evaluation and Testing" May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1 : Evaluation and Testing Within a Risk Management Process" as recognized by FDA. The device of testing included the following tests:
- . Genotoxicity, ISO 10993-3(2014)
- Cytotoxicity, ISO 10993-5(2009)
- Implantation, ISO 10993-6(2007)
- Sensitization(GPMT), ISO 10993-10(2010)
- Oral mucous irritation / Intracutaneous reactivity, ISO 10993-10(2010)
- . Systemic toxicity(Acute), ISO 10993-11(2006)
Anchor Plate and the primary predicate device were tested for the non-clinical performance including Pullout force with 3-point bending test according to JS T 0312:2008, Testing methods for bending properties of metallic osteosynthesis devices and tensile force test. For tensile force test, there is no international standard or required guidance, therefore it is performed according to own test method. The results showed that the subject and predicate devices are fundamency. Based on the comparative data, subject devices are essentially the same as currently marketed devices for the same indication, with similar physical properties or design, which supports our claim for substantial equivalence. Anchor plate shows no differences in technological characteristics compared to the predicate devices.
8. Substantial Equivalence Discussion
The subject device is similar to predicate device in terms of indication for use, design, raw material etc.
The subject device consists of orthodontic anchorage system, as is the predicate device. The mechanical properties and performance of subject device are not significantly different from the predicate device, as indicated by non-clinical performance testing.
The length and thickness are different between subject device and predicate device.
9. Conclusions
The indications and technological characteristics of anchor plate are very similar to predicate device. Therefore, anchor plate is substantially equivalent to the identified predicate device.
§ 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.