Straumann PURE Ceramic Implants by Straumann USA, LLC (on behalf of Institut Straumann AG)

The Straumann® PURE Ceramic Implant (Monotype) is indicated for restoration in single tooth gaps and in an edentulous or partially edentulous jaw. The prosthetic restorations used are single crowns, fixed partial or full dentures, which are connected to the implants through the corresponding components.

The ø3.3 mm reduced diameter implants are recommended for central and lateral incisors only.

Device Description

The Straumann® PURE Ceramic Implants are made of 100% yttrium-stabilized zirconia. The endosteal region presents macro- and micro-roughness, a ZLA surface. The implant has a 1.8 mm high machined neck. The implant features a monotype design where the ceramic abutment for final restoration is already built in. Straumann® PURE Ceramic Implant prosthetic components are identified with RD (Regular Diameter) corresponding to the neck diameter of 4.8 mm, and ND (Narrow Diameter) corresponding to the neck diameter of 3.5 mm.

AI/ML Overview

In this submission, the device is the Straumann® PURE Ceramic Implants. This documentation discusses a 510(k) premarket notification for a change in the sterilization method of an existing device, rather than the initial introduction of a novel AI/software device. As such, the presented information does not align with the typical structure of an AI/software device study and acceptance criteria as outlined in your request. The core of this submission revolves around demonstrating that a change in sterilization from H₂O₂ plasma to Ethylene Oxide (EO) for a dental implant does not negatively impact its safety and effectiveness.

Therefore, many of the requested categories, such as "Multi-reader multi-case (MRMC) comparative effectiveness study," "Effect size of human readers improvement with AI vs without AI," "Stand-alone algorithm performance," "Training set sample size," and "Ground truth for the training set," are not applicable to this type of medical device submission.

However, I can extract the relevant information regarding acceptance criteria and the studies performed to address the change in sterilization method.

1. Table of Acceptance Criteria and Reported Device Performance:

The "acceptance criteria" here are implicitly linked to maintaining the same performance and safety profile as the predicate device despite the change in sterilization method. The "reported device performance" refers to the results of the tests conducted to confirm this.

Acceptance Criteria (Implied)	Reported Device Performance
Sterility Assurance Level (SAL): Achieve a minimum SAL of 10-6.	A sterilization validation was performed per ISO 11135 (Half Cycle Overkill Approach). The validation demonstrated that the EO sterilization process is capable of reliably and consistently sterilizing the subject device to a minimum SAL of 10-6.
Packaging Integrity post-Transportation: Maintain sterile barrier system integrity after transportation.	A transportation study (per ISTA 2A) demonstrated the integrity of the sterile barrier system, with subject devices continuing to meet product release requirements after being subjected to worst-case environmental and handling changes.
Packaging Stability and Sterile Barrier Integrity: Maintain sterile barrier system integrity throughout shelf-life after sterilization, handling, distribution, and storage.	A packaging stability study demonstrated the integrity of the packaging system and the sterile barrier system after EO sterilization, handling, distribution, transport, and storage up to the defined product shelf life. The subject devices continued to meet product release requirements after being subjected to worst-case environmental and handling changes. Shelf-life studies were conducted per ASTM F1980.
Biocompatibility: Maintain biological safety profile; no cytotoxicity, acceptable EO/ECH residues.	Biocompatibility testing was re-evaluated per ISO 10993-1, 2009 and FDA standards (FDA, 2016). EO and ECH residues were not detected in chemical analysis, and no cytotoxicity was observed. The test results confirm the change in sterilization method did not affect the biological safety profile.
Mechanical Performance (Static and Dynamic Fatigue): No adverse effect of new sterilization on product strength as per ISO 14801 and FDA Guidance.	Mechanical testing (static and dynamic fatigue strength) was performed per ISO 14801:2007 and FDA-Guidance to "Root-form endosseous dental implants and endosseous dental implant abutments." All mechanical testing demonstrated that the new sterilization method does not affect product performance after being subjected to hydrothermal aging.
Surface Chemistry: No significant difference in surface chemistry compared to predicate sterilization method.	Cleanliness analysis demonstrated no significant difference in surface chemistry between H₂O₂ plasma (predicate sterilization method) and EO sterilization. This indicates the integrity of the ZLA surface treatment is maintained.

2. Sample Size Used for the Test Set and the Data Provenance:

The document does not specify exact sample sizes for each test (e.g., how many implants were tested for mechanical strength, how many packages for transportation studies, etc.). It refers to "subject devices" and "worst-case environmental and handling changes."
Data Provenance: The studies were conducted by the manufacturer (Straumann USA, LLC on behalf of Institut Straumann AG), and the data are part of a regulatory submission to the FDA for a device to be marketed in the US. The provenance is therefore related to the manufacturer's internal testing. It is retrospective in the sense that the studies were performed prior to the submission; they are not drawn from real-world patient data (prospective or retrospective) in the context of device performance in humans.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:

This concept is not directly applicable here. The "ground truth" for these tests is defined by established international standards (ISO 11135, ISTA 2A, ASTM F1980, ISO 10993-1, ISO 14801) and FDA guidance documents. The "experts" are the engineers, scientists, and technicians who designed and executed these tests and interpreted the results according to these predefined standards. Their qualifications would align with expertise in sterilization validation, biocompatibility, mechanical engineering, and quality assurance for medical devices. Specific numbers and qualifications of individual experts are not provided in this type of summary.

4. Adjudication Method for the Test Set:

Not applicable in the context of expert review of images or data. Adjudication in this context relates to how the test results are evaluated against the relevant standards and how compliance is determined. This is typically done through interpretation by the conducting laboratory/personnel and reviewed by regulatory affairs, quality assurance, and potentially notified bodies or the FDA, based on the pass/fail criteria outlined in the standards.

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 submission is not about an AI/software device or its impact on human reader performance.

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

Not applicable. This device is a physical dental implant, not an algorithm.

7. The Type of Ground Truth Used:

The "ground truth" is based on established international standards and regulatory guidance documents for medical device performance and safety. For example:
- Sterility: ISO 11135 (Sterility Assurance Level of 10⁻⁶)
- Biocompatibility: ISO 10993-1 (Pass/fail criteria for cytotoxicity, residue levels)
- Mechanical Strength: ISO 14801 (defined load limits and fatigue cycles)
- Packaging: ISTA 2A, ASTM F1980 (criteria for package integrity and shelf life)
The ground truth is not derived from expert consensus on clinical cases, pathology, or outcomes data in the usual sense of an AI study. Instead, it's about meeting pre-defined scientific and engineering benchmarks.

8. The Sample Size for the Training Set:

Not applicable. There is no "training set" as this is not a machine learning or AI device.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. No training set exists for this type of device submission.

Summary

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Straumann USA, LLC (on behalf of Institut Straumann AG) % Jennifer Jackson Director, Regulatory Affairs & Quality Straumann USA, LLC 60 Minuteman Road Andover, Massachusetts 01810

Re: K171769

Trade/Device Name: Straumann® PURE Ceramic Implants Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE Dated: August 15, 2017 Received: August 16, 2017

Dear Jennifer Jackson:

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.

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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

November 14, 2017

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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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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,

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

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Indications for Use

510(k) Number (if known) K171769

Device Name Straumann® PURE Ceramic Implants

Indications for Use (Describe)

The g3.3 mm reduced diameter implants are recommended for central and lateral incisors only.

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

5.1 Submitter

Straumann USA, LLC (on behalf of Institut Straumann AG) 60 Minuteman Road Andover, MA 01810 Phone Number: 1-978-747-2509 Fax Number: 1-978-747-0023 E-mail: jennifer.jackson@straumann.com Contact Person: Jennifer M. Jackson, MS Prepared By: Chanrasmey White Date of Submission: November 14, 2017 5.2 Device Trade Name: Straumann® PURE Ceramic Implants Common Name: Endosseous Dental Implant Classification Name: Implant, Endosseous, Root-Form Regulatory Number: 8872.3640 Classification: Class II Product Code: DZE Subsequent Product Code: NHA 5.3 Predicate Device

Primary Predicate: K151328, Straumann® PURE Ceramic Implants

5.4 Device Description

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510(k) Summary

corresponding to the neck diameter of 4.8 mm, and ND (Narrow Diameter) corresponding to the neck diameter of 3.5 mm.

5.5 Indications for Use

The ø3.3 mm reduced diameter implants are recommended for central and lateral incisors only.

Technological Characteristics 5.6

The proposed Straumann® Pure Ceramic Implants intended use, material, fundamental operating principles and overall design are identical to the primary predicate device, K151328. The subject device is identical to the primary predicate, K151328 with the exception that the subject device will be delivered to the user sterile via Ethylene Oxide as opposed to sterile via H₂O₂plasma.

The additional components mentioned in the predicate device indications for use statement are not subject to this submission as the change only impacts the sterilization of the endosseous dental implants. The technological characteristics of the subject devices are compared to the predicate device in the following table.

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510(k) Summary

FEATURE	SUBJECT DEVICE	PRIMARY PREDICATE DEVICE
K Number	K171769	K151328
Indications for Use	The Straumann® PURECeramic Implant (Monotype)is indicated for restoration insingle tooth gaps and in anedentulous or partiallyedentulous jaw. The prostheticrestorations used are singlecrowns, fixed partial or fulldentures, which are connectedto the implants through thecorresponding components.The ø3.3 mm reduceddiameter implants arerecommended for centraland lateral incisors only.	The Straumann® PURE Ceramiclmplant (Monotype) is indicated forrestoration in single tooth gaps andin an edentulous or partiallyedentulous jaw. The prostheticrestorations used are single crowns,fixed partial or full dentures, whichare connected to the implantsthrough the correspondingcomponents.The ø3.3 mm reduced diameterimplants are recommended forcentral and lateral incisors only.The Straumann® PURE CeramicImplant Protective Cap is intendedto protect the Straumann® PURECeramic Implant (Monotype)during the healing phase afterimplant placement for up to 6months.Temporary copings are intended toserve as a base for temporarycrown or bridge restoration for theStraumann® PURE CeramicImplant (Monotype) for up to 30days.
Material	Y-TZP	Y-TZP
SurfaceTreatment	Sand-blasted, large-grit, acid etched	Sand-blasted, large-grit, acidetched (ZLA®)
Apical Diameter	Ø3.3 and Ø4.1 mm	Ø3.3 and Ø4.1 mm
CoronalDiameter	Ø3.5 and Ø4.8 mm	Ø3.5 and Ø4.8 mm
Length	8, 10, 12, and 14 mm	8, 10, 12, and 14 mm
ImplantDesign	Cylindrical Monotype	Cylindrical Monotype
Implant Neck	1.8 mm, machined	1.8 mm, machined
Thread Pitch	0.8 mm	0.8 mm
Implant/AbutmentConnection	None (Monotype)	None (Monotype)
Sterilization	End user receives productsterilized per Ethylene OxideValidated per ISO 11135 toa SAL of 10-6	End user receives productsterilized per H2O2 - plasma inaccordance with DIN EN 556-1:2002 (equivalent to ANSI AAMIST67:2011) to a SAL of 10-6

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510(k) Summary

5.7 Performance Data

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

Sterilization and Shelf-Life

A sterilization validation was performed per ISO 11135, Sterilization of healthcare products – Ethylene Oxide – Requirements for development, validation and routine control of a sterilization process for medical devices, using the Half Cycle Overkill Approach. The validation demonstrates that the sterilization process and equipment is capable of reliably and consistently sterilizing the subject device to a minimum Sterility Assurance Level (SAL) of 10-6.

A transportation study has been performed per ISTA 2A to demonstrate the integrity of the sterile barrier system considering the new sterilization process. The subject devices continue to meet product release requirements after being subjected to worst-case environmental and handling changes.

A packaging stability study was performed to demonstrate the integrity of the packaging system and the sterile barrier system after sterilization process via Ethylene Oxide,

handling, distribution, transport and storage up to the defined product shelf life. The subject devices continue to meet product release requirements after being subjected to worst-case environmental and handling changes.

Shelf-Life studies have been conducted in accordance with ASTM F1980.

Biocompatibility Testing

The biological safety of the Straumann® PURE Ceramic Implants sterilized via Ethylene Oxide was re-evaluated and further biocompatibility testing was required according to ISO and FDA standard (FDA, 2016; ISO 10993-1, 2009). EO and ECH residues were not detected in the chemical analysis and no cytotoxicity was observed. Based on the test results the change in sterilization method did not affect the biological safety profile of the devices.

Bench Testing

Mechanical testing (static, dynamic fatigue and torque) and surface chemistry analysis was performed to demonstrate the new sterilization method does not affect product performance. Static and dynamic fatigue strength testing was performed per ISO 14801:2007 and the FDA-Guidance to "Root-form endosseous dental implants Straumann USA, LLC November 14, 2017

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510(k) Summary

and endosseous dental implant abutments." All mechanical testing performed demonstrated the new sterilization method does not affect the product performance after being subjected to hydrothermal aging. Cleanliness analysis demonstrated no significant difference in surface chemistry between H2O2 plasma (sterility method per predicate device) and EO sterilization.

5.8 Conclusion

The documentation submitted in this premarket notification demonstrates that the Straumann® PURE Ceramic Implants are substantially equivalent to the predicate device and do not pose new issues of safety and effectiveness.

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.