NobelSpeedy® Groovy implants are endosseous implants intended to be surgically placed in the upper or lower jaw bone for anchoring or supporting tooth replacements to restore patient esthetics and chewing function.

NobelSpeedy® Groovy implants are indicated for single or multiple unit restorations in splinted applications. This can be achieved by a 2-stage or 1-stage surgical technique in combination with immediate, early or delayed loading protocols, recognizing sufficient primary stability and appropriate occlusal loading for the selected technique. Implants allow also for bi-cortical anchorage in cases of reduced bone density.

NobelSpeedy® Groovy implants 20, 22, 25 mm when placed in the maxilla are only indicated for multiple unit restorations in splinted applications that utilize at least two implants.

Device Description

NobelSpeedy® Groovy implants are threaded, root-form dental implants intended for use in the upper and/or lower jaw to support prosthetic devices, such as artificial teeth, in order to restore patient esthetics and chewing function to partially or fully edentulous patients. They are intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

The NobelSpeedy® Groovy implants (20 mm, 22 mm, and 25 mm) share the same design characteristics as the existing NobelSpeedy® implants but are longer than the existing range of NobelSpeedy® implants. All NobelSpeedy® implants are made of commercial pure titanium.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device called "NobelSpeedy® Groovy" dental implants. It describes the device, its intended use, comparison to predicate devices, and performance data from various studies.

Here's an analysis of the acceptance criteria and the study that proves the device meets the acceptance criteria, based on the information provided in the document:

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

The document does not explicitly state "acceptance criteria" in the traditional sense of numerical thresholds for performance metrics. Instead, it demonstrates substantial equivalence to predicate devices through various tests and clinical studies. The core acceptance criterion for a 510(k) submission is to demonstrate that the new device is as safe and effective as a legally marketed predicate device.

The reported device performance is compared to the predicate devices and general expectations for dental implants (e.g., successful osseointegration, stable marginal bone levels, no significant complications).

Category	Acceptance Criterion (Implicit)	Reported Device Performance
Substantial Equivalence	Device is as safe and effective as the predicate device(s).	Demonstrated through: - Similar design characteristics (single lead thread, tapered apex, external hex connection, materials, surface). - Same intended use. - Satisfactory performance in various tests and clinical studies, showing no new concerns for safety or effectiveness compared to predicate.
Sterilization	Validation of gamma irradiation process in accordance with established standards.	"Validation of the gamma irradiation process was previously conducted for the predicate device. There has been no change to the manufacturing or sterilization processes since then; therefore, additional validation is not required." (Implies the existing validation is sufficient for the subject device).
Shelf-Life	Product remains sterile throughout the duration of the labeled expiry according to ISO 11607-1 and 1SO 11607-2.	"Real-time and accelerated aging studies were conducted in accordance with ISO 11607-1 and 1SO 11607-2 and support that the product remains sterile throughout the duration of the labeled expiry."
Biocompatibility	Device material and manufacturing processes are biologically safe, similar to the predicate.	"Biocompatibility testing on the NobelSpeedy Groovy implants was previously conducted. As the material of construction and manufacturing processes are the same as the predicate device, no additional testing is required to support the biological safety of the subject devices." (Implies the previous testing is sufficient).
Magnetic Resonance (MR) Safety	Safe for patients in an MR environment, satisfying FDA guidance and relevant ASTM/IEC standards.	"MR testing sufficient to ensure the safety of the patient was conducted to satisfy the requirements described in the 'FDA Guidance: Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment' and ASTM F2052, ASTM F2119, ASTM F2182, ASTM F2213, ASTM F2503, and IEC 60601-2-33." (No specific results provided, but states requirements were satisfied).
Biomechanical Performance	Insertion, removal, yield, and maximum torque characteristics are acceptable and comparable to predicate devices (implied).	"A comparative torque study was conducted on the subject devices in accordance with ISO 13498:2011. The purpose of the study was to evaluate insertion and removal torque during implant placement and removal as well as the yield and maximum torque of the implants." (No specific results provided, but states a study was done according to standard).
Clinical Performance (Survival Rate)	High survival rate, comparable to established dental implant success rates.	- Agliardi et al. (2014): 100% survival rate over a mean follow-up of 50 months. - Malo et al. (2013): 100% survival rate over a mean follow-up of 14 months.
Clinical Performance (Bone Remodeling / Soft Tissue)	Stable marginal bone levels and favorable soft tissue results, within the usual range for dental implants.	- Agliardi et al. (2014): "stable marginal bone levels and favorable soft tissue results." - Malo et al. (2013): "bone level change was -0.85 (+ 0.45) mm at 1 year, being in the usual range."
Clinical Performance (Complications)	Low incidence of biological and mechanical complications.	- Agliardi et al. (2014): "No biological and mechanical complications occurred." - Malo et al. (2013): "One mechanical complication (i.e. abutment loosening) occurred that could be fixed."

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document references two investigator-initiated clinical studies:

Agliardi et al. (2014):
- Sample Size: 10 humans (patients).
- Data Provenance: Prospective, single arm study. Country of origin not specified, but the journal is "The Journal of Craniofacial Surgery." Based on author names and journal, likely European (e.g., Italy where Agliardi is active).
Malo et al. (2013):
- Sample Size: 16 humans (patients).
- Data Provenance: Prospective, single arm study. Country of origin not specified, but the journal is "Clinical Implant Dentistry and Related Research Journal." Similar to above, often international with European or North American contributors.

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)

The document does not provide details on the number or qualifications of experts used to establish "ground truth" in the context of these clinical studies. Clinical studies typically rely on the treating clinicians and researchers to assess outcomes (e.g., survival, bone levels, complications). There's no mention of an independent panel of experts reviewing cases for a separate "ground truth" determination.

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

The document does not describe any specific adjudication method (like 2+1 or 3+1) for the clinical studies. These were single-arm prospective studies, meaning outcomes were assessed by the study investigators.

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

No, the document describes studies about the performance of a dental implant device itself, not an AI or imaging diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers with or without AI assistance is not applicable and was not conducted.

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

No, this pertains to a physical dental implant, not an algorithm or AI system. Standalone algorithm performance is not relevant to this submission.

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

For the clinical studies referenced, the "ground truth" was based on clinical outcomes data observed and reported by the study investigators. This includes:

Implant survival (presence/absence of implant).
Radiographic assessment of marginal bone remodeling.
Clinical assessment of soft tissue health.
Occurrence of biological and mechanical complications.

8. The sample size for the training set

The document does not describe a "training set" in the context of machine learning or AI. This is a premarket notification for a physical medical device. The "training" in the context of device development would refer to engineering design, material science, and manufacturing processes, rather than a data-driven training set.

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

As there is no "training set" in the AI/machine learning sense for this device submission, this question is not applicable. The device's design and manufacturing are based on established engineering principles, materials science, and prior knowledge from predicate devices and general dental implant literature.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 2, 2016

Nobel Biocare AB % Charlemagne Chua Senior Regulatory Affairs Manager Nobel Biocare USA LLC 22715 Savi Ranch Parkway Yorba Linda, California 92887

Re: K160119

Trade/Device Name: NobelSpeedy® Groovy Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: April 26, 2016 Received: April 27, 2016

Dear Charlemagne Chua:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours, Tina Kiang S

for Erin I. Keith, M.S. 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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Indications for Use

510(k) Number (if known) K160119

Device Name NobelSpeedy Groovy

Indications for Use (Describe)

NobelSpeedy® Groovy implants 20, 22, 25 mm when placed in the maxilla are only indicated for multiple unit restorations in splinted applications that utilize at least two implants.

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

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FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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1. 510(k) Summary

I. Submitter

Submitted by: Nobel Biocare USA LLC 22715 Savi Ranch Parkway Yorba Linda, CA 92887

Contact Person: Charlemagne Chua, Senior Regulatory Affairs Manager Phone: (714) 282-4800 x7830 Fax: (714) 998-9348

Submitted for: Nobel Biocare AB Vastra Hamngatan 1 Goteborg, SE-411 17 Sweden

Date Prepared: June 1, 2016

II. Device

Name of Device: NobelSpeedy® Groovy Common or Usual Name: Endosseous Dental Implant Classification Name: Endosseous Dental Implants (21 CFR 872.3640) Regulatory Class: II Product Code: DZE

III.Predicate Device

Substantial equivalence is claimed to the following devices:

Primary Predicate

NobelSpeedy® Implants, K050406, Nobel Biocare ●
Additional Predicate
Osseotite Certain Dental Implants, K063341, Implant Innovations Inc (3i)

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The following is used as reference device within the submission:

NobelActive Wide Platform (WP), K133731, Nobel Biocare

IV. Device Description

V. Intended Use

NobelSpeedy® Groovy implants are indicated for single or multiple unit restorations in splinted or non-splinted applications.

NobelSpeedy® Groovy implants 20, 22, 25 mm when placed in the maxilla are only indicated for multiple unit restorations in splinted applications that utilize at least two implants.

VI. Indications for Use

NobelSpeedy® Groovy implants are indicated for single unit restorations in splinted or non-splinted applications. This can be achieved by a 2-stage or 1-stage surgical technique in combination with immediate, early or delayed loading protocols, recognizing sufficient primary stability and appropriate occlusal loading for the selected technique. Implants allow also for bicortical anchorage in cases of reduced bone density

NobelSpeedy® Groovy implants 20, 22, 25 mm when placed in the maxilla are only indicated for multiple unit restorations in splinted applications that utilize at least two implants.

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Discussion

The Indications for Use statement between the subject and predicate devices are not identical; however, the differences do not alter the intended therapeutic use of the device based on the provided clinical data. Both the subject and predicate devices are intended to restore patient esthetics and chewing function.

Comparison of Technological Characteristics VII.

The subject and primary predicate devices share the following characteristics:

Single lead thread design
Tapered apex with bone cutting flutes .
External hex connection
. Materials of construction and implant surface

The subject devices are technologically different from the predicate devices as follows:

. Implant lengths of 22, and 25 mm exceed the lengths of the cited predicate devices
A comparison of the subject and predicate devices is provided in the table below.

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		SUBJECT	PRIMARY PREDICATE	PREDICATE
		NobelSpeedy® Groovy	NobelSpeedy Implants(K050406)	Osseotite Certain Dental Implant(K063341)
Features	Thread Design	Single lead thread with groove	Single lead thread with groove	Single lead thread with groove
	Implant BodyDesign	Tapered apex with bone cutting flutes	Tapered apex with bone cutting flutes	Tapered and parallel wall
	Implant Length	20, 22, 25 mm	7, 8.5, 10, 11.5, 13, 15, 18 mm	7 to 20 mm
	Implant Width	4.0 mm	3.5, 4.0, 5.0, 6.0 mm	3.25, 3.75, 4.0, 5.0 , 6.0 mm
	Connection Type	External Hex	External Hex	Internal Hex
	Device Material	CP Titanium	CP Titanium	CP Titanium
	Surface	TiUnite	TiUnite	Acid-etched
Indications for UseStatement		NobelSpeedy® Groovy implants areendosseous implants intended to besurgically placed in the upper or lower jawbone for anchoring or supporting toothreplacements to restore patient esthetics andchewing function.NobelSpeedy® Groovy implants areindicated for single or multiple unitrestorations in splinted or non-splintedapplications. This can be achieved by a 2-stage or 1-stage surgical technique incombination with immediate, early ordelayed loading protocols, recognizingsufficient primary stability and appropriateocclusal loading for the selected technique.Implants allow also for bi-cortical anchorage	NobelSpeedy implants are root-formendosseous implants intended to besurgically placed in the bone of the upperor lower jaw arches to provide support forprosthetic devices, such as an artificialtooth, in order to restore patient estheticsand chewing function. Nobel Biocare'sNobelSpeedy implants are indicated forsingle or multiple unit restorations insplinted or non-splinted applications.NobelSpeedy implants may be placedimmediately and put into immediatefunction providing that initial stabilityrequirements detailed in the surgicalmanual are satisfied.NobelSpeedy implants are indicated foruse in soft bone or whenever immediate orearly loading is applied. The NobelSpeedyimplants incorporate a groove on the	3i dental implants are intended forsurgical placement in the upper or lowerjaw to provide a means for prostheticattachment in single tooth restorationsand in partially or fully edentulous spanswith multiple single teeth, or as aterminal or intermediary abutment forfixed or removable bridgework, and toretain overdentures. In addition, when aminimum of 4 implants,≥ 10 mm inlength, are placed in the mandible andsplinted in the anterior region, immediateloading is indicated.

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SUBJECT	PRIMARY PREDICATE	PREDICATE
NobelSpeedy® Groovy	NobelSpeedy Implants(K050406)	Osseotite Certain Dental Implant(K063341)
in cases of reduced bone densityNobelSpeedy® Groovy implants 20, 22, 25 mm when placed in the maxilla are only indicated for multiple unit restorations in splinted applications that utilize at least two implants.	implant thread and are preferred overmodels without the groove in these softbone indications because bone forms morerapidly in the groove than on other parts ofthe implant resulting in increased stabilitywhen compared to non-groove implants.In addition, the NobelSpeedy implants arepreferred in these soft bone indicationsbecause bone formation on the TiUnite®surface is more rapid and greater than onmachined surface implants resulting inbetter maintenance of initial implantstability, faster and strongerosseointegration, and higher success rates.NobelSpeedy implants may be tilted up to45°. When used with angulations between30° and 45° a minimum of 4 implants mustbe used and splinted.

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Discussion

As seen above, the only difference between the subject and predicate devices is the additional of extended implant lengths of 22 and 25 mm.

VIII. Performance Data

The following performance data were provided or relied upon in support of the substantial equivalence determination.

Sterilization

Validation of the gamma irradiation process was previously conducted for the predicate device. There has been no change to the manufacturing or sterilization processes since then; therefore, additional validation is not required.

Shelf-Life

Real-time and accelerated aging studies were conducted in accordance with ISO 11607-1 and 1SO 11607-2 and support that the product remains sterile throughout the duration of the labeled expiry.

Biocompatibility Testing

Biocompatibility testing on the NobelSpeedy Groovy implants was previously conducted. As the material of construction and manufacturing processes are the same as the predicate device, no additional testing is required to support the biological safety of the subject devices.

Magnetic Resonance (MR) Testing

MR testing sufficient to ensure the safety of the patient was conducted to satisfy the requirements described in the "FDA Guidance: Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment" and ASTM F2052, ASTM F2119, ASTM F2182, ASTM F2213, ASTM F2503, and IEC 60601-2-33.

Biomechanical Testing

A comparative torque study was conducted on the subject devices in accordance with ISO 13498:2011. The purpose of the study was to evaluate insertion and removal torque during implant placement and removal as well as the yield and maximum torque of the implants.

Clinical Data

Two studies with data of up to several years follow-up was referenced in the submission and support the substantial equivalence of the subject device.

The NobelSpeedy® Groovy implants with the lengths of 20 mm, 22 mm and 25 mm have been used in two investigator-initiated studies for which results have been published. The implants

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were placed mainly in the maxilla and one implant was utilized in the mandible. The implants were used in demanding situations such as soft bone and were subjected to immediate loading protocols. The follow-up ranges between 6 months for individual implants. All implants were successful and marginal bone remodeling (baseline at implant insertion) as well as soft tissue were in the usual range. These studies are further summarized below:

. Agliardi et al. (Partial Fixed Rehabilitation, The Journal of Craniofacial Surgery (2014), Volume 25, Number 3) conducted a prospective, single arm study in which 10 humans with a partially edentulous maxilla were treated. The patients received two NobelSpeedy groovy implants of lengths (one axial and one tilted) of up to 25 mm. whereof the distal implants were tilted. Surgeries included typically the sinus and implants were immediately loaded with fixed bridges. Follow up was 42-57 months (mean 50 months). The survival rate was 100% with stable marginal bone levels and favorable soft tissue results. No biological and mechanical complications occurred.
Malo et al. (Preliminary Report on the Outcome of Tilted Implant with Longer Lengths (20-25 mm) in Low Density Bone: One-Year Follow-Up of a Prospective Cohort Study, Clinical Implant Dentistry and Related Research Journal (2013), Volume 17, Supplement 1) report on a prospective single arm study. A total of 16 humans with fully edentulous arches and low bone density were included and received immediately loaded NobelSpeedy® Groovy implants according the All-on-4 treatment concept. Of the implants used, 43 implants were up to 18 mm in lengths and 16 implants were 20 mm long, 7 implants were 22 mm and 2 implants were 25 mm in length. Patients were followed for 6-26 months (mean 14 months). Survival rate was 100 % and bone level change was -0.85 (+ 0.45) mm at 1 year, being in the usual range. One mechanical complication (i.e. abutment loosening) occurred that could be fixed.

IX. Conclusion

Although differences in implant length exist between the subject and predicate devices, the testing supports that the subject device is substantially equivalent to the predicate devices.

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.

Indications for Use

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FOR FDA USE ONLY

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1. 510(k) Summary

I. Submitter

II. Device

III.Predicate Device

IV. Device Description

V. Intended Use

VI. Indications for Use

Discussion

Comparison of Technological Characteristics VII.

Discussion

VIII. Performance Data

Sterilization

Shelf-Life

Biocompatibility Testing

Magnetic Resonance (MR) Testing

Biomechanical Testing

Clinical Data

IX. Conclusion

§ 872.3640 Endosseous dental implant.

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