(360 days)
The Implant-One™ System is indicated for surgical placement in partially or completely edentulous upper or lower jaws to provide a means for prosthetic attachment to restore a patient's chewing function. The Implant-One™ system is indicated for immediate loading only when primary stability is achieved and with the appropriate occlusal loading.
Endosseous implants are self-tapping and threaded, and offered having root-form or wide thread forms. Root-form implant diameters range from 3.25mm to 5.5mm having lengths from 8mm to 14mm. Wide thread implant diameters are available in 4.1 and 4.5mm (8mm to 14mm lengths), 5.5mm (8mm to 12mm lengths) and 6.5mm (8mm to 10mm lengths). Cover screws and healing caps provide protection to the threads of the abutment connection during endosseous and gingival healing. Cover screws are pre- packaged with each implant. Healing caps are provided as an alternative to the cover screw and are packaged separately. The Implant-One™ dental implants and cover screws are provided sterile. Not all abutments can be used for single-unit restorations. The conical, angled conical, ball, locator and glueless abutments are intended only for multi-unit loaded restorations. The ball, locator and glueless abutments are to be used in fully removable dentures. The conical and angled conical abutments are to be used in screw retained dentures and with the titanium sleeve for screw retention. The final design parameters for the custom blank abutment are as follows: maximum total height, 12.5mm; minimum/maximum gingival height, 0.5mm/6mm; minimum post height, 4mm; maximum angulation, 30°; minimum wall thickness, 0.78 (at 1.5mm above the proximal end); minimum diameter, 3.75 mm for the 300 Series, 4.25 mm for the 300 Series and 4.75 mm for the 500 Series.
The provided text is a 510(k) summary for the Implant-One™ System, a dental implant device. It demonstrates the device's substantial equivalence to existing legally marketed predicate devices through non-clinical performance data.
However, the document does not describe a study involving an algorithm, AI assistance, human readers, or any form of "acceptance criteria" related to diagnostic performance or accuracy as one would expect for an AI/ML medical device.
Instead, the "acceptance criteria" and "study" described in this document pertain to engineering and biocompatibility performance of a physical medical device (dental implants and abutments), not a software or AI-driven system.
Therefore, for each of the requested points, the answer is that the information is not applicable (N/A) in the context of this document, as it describes a physical dental implant system and not an AI/ML device that would have such performance criteria.
Here's how to address each point based on the provided text:
Acceptance Criteria and Device Performance (Based on Device Type - Dental Implants)
Since this is for a physical dental implant system, the "acceptance criteria" are related to mechanical integrity, biocompatibility, sterilization, and packaging/shelf-life, rather than diagnostic accuracy. The "device performance" indicates that the device met these criteria by demonstrating substantial equivalence to predicates.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Demonstrated Equivalence To) | Reported Device Performance |
|---|---|---|
| Mechanical Performance | ISO 14801 (for worst-case construct performance) | "Non-clinical mechanical testing of the worst case Implant-One™ System construct was performed according to ISO 14801 and demonstrated that the Implant-One™ system performs as well as or better than the predicate devices." |
| Biocompatibility | ISO 10993-5 | "Biocompatibility testing was performed according to ISO 10993-5 and demonstrated substantial equivalence." |
| Sterilization | ISO 11137 and ISO 17665 | "Sterilization validations were performed according to ISO 11137 and 17665 and demonstrated substantial equivalence." |
| Packaging & Shelf-life | ASTM D4169 (including ASTM F1886, ASTM F88, and ASTM F1929) | "Packaging and shelf-life validations were performed according to ASTM D4169 including ASTM F1886, ASTM F88 and ASTM F1929 and demonstrated substantial equivalence." |
| Endotoxin Limit | <20 EU/Device (per AAMI ST72) | "The Limulus amebocyte lysate (LAL) test was performed on sterile devices per AAMI ST72 and met the <20EU/Device endotoxin limit." |
| Material/Surface Analysis | Identification of blast media/particles, removal treatments/agents, chemical analysis, SEM photomicrographs (per FDA Guidance) | "For the modified implant surfaces, the following information was submitted per FDA Guidance...: identification of the blast media, composition of the particles, identification of the treatments and agents used to remove the particles, a chemical analysis of the surface and SEM photomicrographs of the surface." |
Regarding AI/ML Device Specifics (Not Applicable to this Document):
The following points are typically relevant for AI/ML device submissions, and the provided document for a physical dental implant system explicitly states "No clinical data was used in support of this submission." Therefore, these points are not applicable.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- N/A. The submission is for a physical medical device (dental implant). No test set of clinical data was used. The document explicitly states: "No clinical data was used in support of this submission."
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)
- N/A. No clinical test set or ground truth established by experts was used.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A. No clinical test set requiring adjudication was used.
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. This is a physical device, not an AI/ML system, so an MRMC study is not relevant and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A. This is a physical device, not an AI/ML system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- N/A. No clinical ground truth was established or used, as no clinical data was involved in this submission.
8. The sample size for the training set
- N/A. This is a physical device, not an AI/ML system requiring a training set.
9. How the ground truth for the training set was established
- N/A. This is a physical device, not an AI/ML system.
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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 and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 29, 2018
Implant Logistics, Inc. % Karen E. Warden, PhD President BackRoads Consulting, Inc. PO Box 566 Chesterland, Ohio 44026
Re: K173701
Trade/Device Name: Implant-One™ System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: October 29, 2018 Received: October 30, 2018
Dear Karen E. Warden, PhD:
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.
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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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 mediation-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,
Andrew I. Steen -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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
510(k) Number (if known)
Device Name Implant-One™ System
Indications for Use (Describe)
The Implant-One™ System is indicated for surgical placement in partially or completely edentulous upper or lower jaws to provide a means for prosthetic attachment to restore a patient's chewing function. The Implant-One™ system is indicated for immediate loading only when primary stability is achieved and with the appropriate occlusal loading.
Type of Use (Select one or both, as applicable)
区 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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510(k) Summary for K173701
| Date: | 28 November 2018 |
|---|---|
| Sponsor: | Implant Logistics, Inc.305 3rd Street SouthLacrosse, WI 54601Phone 608-498-4855 |
| Sponsor Contact: | Thomas Arendt |
| Trade Name: | Implant-One™ System |
| Common Name: | Dental implant and abutment system |
| Regulatory Class: | Class II |
| Primary ClassificationName, Regulation,Product Code: | Endosseous dental implant, 21 CFR 872.3640, DZE |
| Secondary ProductCode: | NHA |
| Submission purpose: | To add new components to the system. |
| Device Description: | Endosseous implants are self-tapping and threaded, and offered having root-form or wide thread forms. Root-form implant diameters range from 3.25mm to5.5mm having lengths from 8mm to 14mm. Wide thread implant diameters areavailable in 4.1 and 4.5mm (8mm to 14mm lengths), 5.5mm (8mm to 12mmlengths) and 6.5mm (8mm to 10mm lengths). Cover screws and healing capsprovide protection to the threads of the abutment connection during endosseousand gingival healing. Cover screws are pre- packaged with each implant.Healing caps are provided as an alternative to the cover screw and arepackaged separately. The Implant-One™ dental implants and cover screws areprovided sterile.Not all abutments can be used for single-unit restorations. The conical, angledconical, ball, locator and glueless abutments are intended only for multi-unitloaded restorations. The ball, locator and glueless abutments are to be used infully removable dentures. The conical and angled conical abutments are to beused in screw retained dentures and with the titanium sleeve for screw retention.The final design parameters for the custom blank abutment are as follows:maximum total height, 12.5mm; minimum/maximum gingival height,0.5mm/6mm; minimum post height, 4mm; maximum angulation, 30°; minimumwall thickness, 0.78 (at 1.5mm above the proximal end); minimum diameter,3.75 mm for the 300 Series, 4.25 mm for the 300 Series and 4.75 mm for the500 Series. |
| Indications for Use: | The Implant-One™ System is indicated for surgical placement in partially orcompletely edentulous upper or lower jaws to provide a means for prostheticattachment to restore a patient's chewing function. The Implant-One™ system isindicated for immediate loading only when primary stability is achieved and withthe appropriate occlusal loading. |
| Materials: | All components (implants, abutments, cover screws, healing caps and abutmentscrews) are manufactured from titanium alloy (Ti-6Al-4V ELI) as described byASTM F136 or wrought titanium alloy (Ti-6Al-4V) as described by ASTM F1472. |
| Primary Predicate: | Implant-One™ System (Implant Logistics, Inc. – K102822) |
| Reference Devices: | Ankylos C/X Dental Implant System (Dentsply International – K083805),SynCone Abutment 5° (Dentsply International – K131644), Nobel Active® Multi-unit Abutment (Nobel BioCare® – K072570), Temporary Snap Abutment (NobelBioCare® - K161435), ArgenIS Titanium Abutment Blanks (The ArgenCorporation - K143051), LOCATOR® R-Tx Attachment System (K150295 -Zest Anchors LLC), O-Ring Abutment (K990277 - Biohorizons ImplantSystems), MiNi Internal Implant System (K150537 - Megagen Implant Co, Ltd) |
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| Performance Data: | Non-clinical mechanical testing of the worst case Implant-One™ System construct was performed according to ISO 14801 and demonstrated that the Implant-One™ system performs as well as or better than the predicate devices. Biocompatibility testing was performed according to ISO 10993-5 and demonstrated substantial equivalence. | ||
|---|---|---|---|
| For the modified implant surfaces, the following information was submitted per FDA Guidance, "Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments: identification of the blast media, composition of the particles, identification of the treatments and agents used to remove the particles, a chemical analysis of the surface and SEM photomicrographs of the surface. | |||
| Sterilization validations were performed according to ISO 11137 and 17665 and demonstrated substantial equivalence. Packaging and shelf-life validations were performed according to ASTM D4169 including ASTM F1886, ASTM F88 and ASTM F1929 and demonstrated substantial equivalence. The Limulus amebocyte lysate (LAL) test was performed on sterile devices per AAMI ST72 and met the <20EU/Device endotoxin limit. | |||
| No clinical data was used in support of this submission. | |||
| TechnologicalCharacteristics: | The fundamental scientific technology of the Implant-One™ System is the same as previously cleared devices as shown below. Minor differences between the subject and predicate devices did not raise new questions of safety or effectiveness. | ||
| Specifically, the minor differences in dimension, surface or connection features between the subject implants, primary predicate and reference device do not introduce new issues of safety or efficacy as demonstrated by the non-clinical mechanical and biocompatibility testing. | |||
| Reference devices have been identified to accommodate the dimensional features for the ball, straight, post, wide post, glueless, anatomical angled, solid, custom blank, conical, angled conical, temporary and locator abutments therefore these subject abutments do not introduce new issues of safety or efficacy. |
| System: | Implant-One™ 300,400, 500 series(K173701) | Implant-One™ 100,200 series (K102822) | Ankylos C/X DentalImplant (K083805) |
|---|---|---|---|
| Material ofmanufacture: | Titanium and/or titaniumalloy | Titanium and/or titaniumalloy | Commercially puretitanium |
| Design: | |||
| Endosseous implant | Root-form | Root-form | Root-form |
| Method ofstabilization | Threaded fixation | Threaded fixation | Threaded fixation |
| Range ofDiameters (mm) | 3.5 – 6.5 | 3.25 – 5.5 | 3.5 – 5.57.0 |
| Range ofLengths (mm) | 8 - 14 | 8 – 14 | 8 - 178 - 14 |
| Modified surface | Yes, resorbable mediablasted | Yes, AIO2 blasted | Yes, grit blasted andetched |
| Connection toabutment | Hex alignment, 12°included taper, screwattachment or integralscrew attachment | Hex alignment, 6°included taper, screwattachment | Keyed alignment,friction-lock taper,thread attachment |
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| Abutments | Implant-One™ 300,400, 500 series(K173701) | Implant-One™ 100,200 series(K102822) | Biohorizons O-Ring Abutment(K990277) | |
|---|---|---|---|---|
| Ball | SurfaceTreatment | Color anodization,full | None | Color anodization,partial |
| Diameter(mm) | 4.0, 5.0, 5.5 | 3.8 | 3.0, 3.5, 4.5, 5.7 | |
| CollarHeight (mm) | 2, 3, 4, 5 | 2, 3, 4, 5 | 1, 3, 5 | |
| Material | ASTM F136 orF1472 | ASTM F1472 | Titanium alloy |
| Abutments | Implant-One™ 300,400, 500 series(K173701) | Implant-One™ 100,200 series (K102822) | MiNi Implant System"milling"(K150537) | |
|---|---|---|---|---|
| Straight | SurfaceTreatment | Color anodization | None | Color anodization |
| Diameter(mm) | 3.1, 4.1, 4.5mm | 4.0mm | 3.0, 3.5mm | |
| CollarHeight (mm) | 1mm | 0.5, 1, 2, 3, 4, 5mm | 1.0, 1.5, 2.5, 3.5,4.5mm | |
| Material | ASTM F136 or F1472 | ASTM F1472 | ASTM F136 | |
| Abutments | Implant-One™ 300, 400, 500 series (K173701) | Implant-One™ 100, 200 series (K102822) | ||
| Post | Surface Treatment | Color anodization | None | |
| Diameter (mm) | 4.0, 5.0, 5.5 | 4.0 | ||
| Collar Height (mm) | 0.5, 1, 2, 3, 4, 5 | 0.5, 1, 2, 3, 4, 5 | ||
| Material | ASTM F136 or F1472 | ASTM F1472 | ||
| Wide Post | Surface Treatment | Color anodization | None | |
| Diameter (mm) | 4.0, 5.0, 5.5 | 4.0 | ||
| Collar Height (mm) | 0.5, 1, 2, 3, 4, 5 | 0.5, 1, 2, 3, 4, 5 | ||
| Material | ASTM F136 or F1472 | ASTM F1472 |
| Abutments | Implant-One™ 300, 400,500 series | Dentsply International | |
|---|---|---|---|
| Glueless | 510(k) # | K173701 | SynCone 5° (K131644) |
| Surface Treatment | Color anodization | None | |
| Diameter (mm) | 4 | 4 | |
| Collar Height (mm) | 0.5 | 1.5, 3.0, 4.5 | |
| Angulation | 0° and 15° | 0°, 7.5°, 15°, 22.5°, 30° | |
| Material | ASTM F136 or F1472 | Ti6Al4V ELI |
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| Abutments | Implant-One™ 300, 400,500 series | Dentsply International | |
|---|---|---|---|
| Anatomicalangled | 510(k) # | K173701 | Ankylos C/X (K083805) |
| Surface Treatment | Color anodization | None | |
| Diameter (mm) | 4.0, 5.0, 5.5 | 5.7 | |
| Collar Height (mm) | 0.5, 1, 2, 3, 4, 5 | 0.75, 1.5, 3.0, 4.5 | |
| Angulation | 15° and 30° | 7.5°, 15°, 22.5°, 30°, 37.5° | |
| Material | ASTM F136 or F1472 | Titanium | |
| Solid | 510(k) # | K173701 | Ankylos C/X (K083805) |
| Surface Treatment | Color anodization | None | |
| Diameter (mm) | 4.0, 5.0, 5.5 | 3.3, 4.5 | |
| Collar Height (mm) | 0.5, 1, 2, 3, 4, 5 | 1.5, 3.0, 4.5, 6 | |
| Material | ASTM F136 or F1472 | Titanium | |
| Abutments | Implant-One TM, 300,400, 500 series | Nobel BioCare | |
| Conical | 510(k) # | K173701 | Nobel Active Multi-unitAbutment (K072570) |
| Surface Treatment | Color anodization | None | |
| Diameter (mm) | 4.8 | 4.8 | |
| Collar Height (mm) | 0.5, 1, 2, 3, 4, 5 | 1.5, 2.5, 3.5, 4.5 | |
| Material | ASTM F136 or F1472 | Titanium vanadium alloy | |
| Angled conical | 510(k) # | K173701 | Nobel Active Multi-unitAbutment (K072570) |
| Surface Treatment | Color anodization | None | |
| Diameter (mm) | 4.8 | 4.8 | |
| Collar Height (mm) | 1 | 1.5, 2.5, 3.5, 4.5 | |
| Angulation | 15° | 17° and 30° | |
| Material | ASTM F136 or F1472 | Titanium vanadium alloy | |
| Temporary | 510(k) # | K173701 | Temporary SnapAbutment (K161435) |
| Surface Treatment | Color anodization | None | |
| Diameter (mm) | 4.0, 5.0, 5.5 | 4.0, 4.5, 6.0 | |
| Collar Height (mm) | 0.5, 1, 2, 3, 4, 5 | 1.5, 3.0 | |
| Material | ASTM F136 or F1472 | ASTM F136 or F1472 | |
| Abutments | Implant-One™ 300, 400,500 series (K173701) | LOCATOR® R-Tx(K150295) | |
| Locator® | Surface Treatment | Color anodization | Titanium nitride (TiN) orCarboNitride (TiCN) |
| Diameter (mm) | 3.9 | 3.9 | |
| Collar Height (mm) | 0.5, 1, 2, 3, 4, 5 | 1, 2, 3, 4, 5, 6 | |
| Material | ASTM F136 or F1472 | Titanium alloy |
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| Abutments | Implant-One TM, 300, 400,500 series (K173701) | ArgenIS Titanium AbutmentBlanks (K143051) | |
|---|---|---|---|
| Custom blank | Surface Treatment | None | None |
| Total height (mm) | 12.5 (max) | 12.5 (max) | |
| Gingival height(mm) | 0.5 (min) 6 (max) | 0 (min) 6 (max) | |
| Post height (mm) | 4 (min) | 4 (min) | |
| Angulation | 30° (max) | 30° (max) | |
| Wall thickness(mm) | 0.78 (1.5mm above theproximal end) | 0.65 (at abut/implant interface) | |
| Diameter (mm) | 3.75 (min) | 3.5 (min) | |
| Material | ASTM F136 or F1472 | ASTM F136 | |
| Mode of retention | Hex alignment, screw | Screw |
Conclusion:
The Implant-One™ System is substantially equivalent to the predicate devices referenced above.
§ 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.