Straumann® Ceramic Healing abutments are indicated to be placed in the patient's mouth at the implant placement to protect the inner configuration of the implant and maintain, stabilize and form the soft tissue during the healing process. Healing abutments should be used only with suitable implant connections. The healing components are intended to be used up to 6 months.

Device Description

Healing abutments are screwed into the implant to protect the inner configuration in cases of transmucosal healing protocols. They are placed out of occlusion and do not support a prosthetic restoration. The Ceramic Healing Abutments are two-piece devices that feature a ceramic ring in various heights to accommodate individual gingival thickness, with a preassembled TAN basal screw. The pre-assembled TAN basal screw is fixed into the ceramic ring and cannot be removed.

AI/ML Overview

The provided text is a 510(k) Summary for a medical device (Straumann® Ceramic Healing Abutments). It describes the device, its intended use, and how it was determined to be substantially equivalent to predicate devices. However, this document does not contain the specific information required to answer your questions about acceptance criteria or a study proving the device meets those criteria, especially in the context of an "AI/algorithm-only" medical device, or a multi-reader multi-case study with human readers assisted by AI.

This 510(k) deals with a physical medical device (dental abutments) and its substantial equivalence is primarily based on material composition, intended use, and physical/biocompatibility testing, not on algorithm performance data.

Therefore, I cannot extract the requested information from the provided text. The document focuses on:

Device identification: Trade/Device Name, Regulation Number, Classification, Product Code.
Submitter information: Company and contact details.
Predicate devices: List of devices used for comparison.
Device description: Physical characteristics and materials.
Intended use and Indications for Use: What the device is for.
Technological Characteristics Comparison: A table comparing features of the proposed device with predicate devices (materials, connections, dimensions).
Performance Testing (for a physical device): Biocompatibility (ISO 10993-1, 5, 12, 17, 18), Sterilization Validation (ISO 11135), and Endotoxin testing (LAL Endotoxin Analysis).

There is no mention of:

Acceptance criteria related to AI/algorithm performance (e.g., sensitivity, specificity, AUC).
A test set of data (e.g., images for an AI algorithm).
Ground truth establishment by experts.
Multi-reader multi-case studies, or AI assistance for human readers.
Standalone algorithm performance.
Training set details for an AI model.

To answer your detailed questions, you would typically need a document that describes the clinical performance study of an AI-enabled medical device, which is not what this 510(k) summary is.

Summary

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January 3, 2020

Institut Straumann AG % Jennifer Jackson Director, Regulatory Affairs Straumann USA, LLC 60 Minuteman Road Andover, Massachusetts 01801

Re: K192893

Trade/Device Name: Straumann® Ceramic Healing Abutments Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: October 10, 2019 Received: October 11, 2019

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. 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

for Srinivas Nandkumar, Ph.D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality 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: 06/30/2020 See PRA Statement below.

510(k) Number (if known)

K192893

Device Name:

Straumann® Ceramic Healing Abutments

Indications for Use (Describe)

Type of Use (Select one or both, as applicable) �Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED

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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 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:

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FORM FDA 3881 (7/17)

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K192893 – Traditional 510(k)

Straumann® Ceramic Healing Abutments

510(k) Summary

510(k) Summary 5

5.1 Submitter's Contact Information

Submitter:	Straumann USA, LLC (on behalf of Institut Straumann AG)60 Minuteman RoadAndover, MA 01810Registration No.: 1222315 Owner/Operator No.: 9005052On the behalf of:
	Institut Straumann AGPeter Merian Weg, 12CH-4002 Basel, Switzerland
Contact Person:	Jennifer M. Jackson, MSDirector Regulatory AffairsPhone Number: +1 978 747 2509Fax Number: +1 978 747 0023
Prepared By &Alternate Contact:	Laure Kuhner BorsenbergerRegulatory Affairs SpecialistInstitut Straumann AGPhone number : +41 61 965 13 89
Date Prepared:	January 2, 2020

5.2 Name of the Device

Trade Names:	Straumann® Ceramic Healing Abutments
Common Name:	Endosseous Dental Implant Abutment
Classification Name:	Endosseous Dental Implant Abutment
Regulation Number:	§872.3630
Device Classification:	II
Product Codes(s):	NHA
Classification Panel:	Dental

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K192893 - Traditional 510(k)

Straumann® Ceramic Healing Abutments

510(k) Summary

5.3 Predicate Device(s)

Primary Predicate:

. K190654 - Straumann PURE Ceramic Healing caps
Reference Devices:
K162890 Small Diameter Implant (SDI) .
. K 190662 - MRI compatibility for existing Straumann dental implant systems

5.4 Device Description

5.5 Intended Use

Healing abutments are intended for use with the Straumann® Dental Implant System (SDIS) to protect the inner configuration of the implant and maintain, stabilize and form the soft tissue during the healing process.

5.6 Indications for Use

Straumann® Ceramic Healing abutments are indicated to be placed in the patient's mouth at the end of the implant placement to protect the inner configuration of the implant and maintain, stabilize and form the soft tissue during the healing process. Healing abutments should be used only with suitable implant connections. The healing components are intended to be used up to 6 months.

Technological Characteristics 5.7

The technological characteristics of the subject devices are compared to the primary predicate and reference devices in Table 1. For clarity in comparison to the reference device K162890, only the relevant part of the indications for use is included in the

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K192893 – Traditional 510(k)

Straumann® Ceramic Healing Abutments

510(k) Summary

comparison table. The reference predicate K190662 is included for reference to MRI compatibility only and is not included in the comparison table below.

FEATURE	PROPOSEDDEVICE	PRIMARY PREDICATEDEVICE	REFERENCE DEVICE
K Number		K190654	K162890
Indicationsfor Use	Straumann® CeramicHealing abutments areindicated to be placed inthe patient's mouth at theend of the implantplacement to protect theinner configuration of theimplant and maintain,stabilize and form the softtissue during the healingprocess. Healing abutmentsshould be used only withsuitable implantconnections. The healingcomponents are intended tobe used up to 6 months.	Healing Caps are intendedfor use with the StraumannDental Implant System(SDIS) to protect the innerconfiguration of the implantand maintain, stabilize andform the soft tissue duringthe healing process.Healing Caps should beused only with suitableimplant connections. Thehealing components areintended to be used up to 6months.	Straumann® Closure Capsand Healing Abutments areindicated to be placed inthe dental implant afterplacement in the patient'sjaw to protect the innerconfiguration of the implantand to form, maintain andstabilize the soft tissueduring the healing process.Closure Caps and HealingAbutments should be usedonly with the correspondingimplant connection.
Material	Y-TZPTi-6Al-7Nb or TAN (screw)	Y-TZPTitanium Grade 4 (screw)	Titanium Grade 4Ti-6Al-7Nb or TAN (screw)
Implant toAbutmentConnection	Narrow CrossFit® (NC)Regular CrossFit® (RC)	Regular Diameter (RD)	Small CrossFit® (SC)
Diameter orMinor OvalDimension/Major OvalDimension	NC: Ø3.6 & 4.8 mmRC: Ø4.5, 5.0, 6.0, and 6.5mm	Ø5.2 mm	Closure Cap:Ø2.4 mmHealing Abutments:Ø3.3/4.3 mmØ3.55/4.86 mmØ3.6/5.0 mm
OverallLength	NC: 8 to 11 mmRC: 8 to 12 mm	6.2 to 8.7 mm	Closure Cap:5.8 mmHealing Abutment:7.0 to 11.5 mm
GingivalHeights	NC: 2.0, 3.5, and 5.0 mmRC: 2.0, 4.0, and 6.0 mm	2.0, 3.0, and 4.5 mm	Closure Cap:0.5 mmHealing Abutments:2.0, 3.5, 5.0, and 6.5 mm

Table 1 – Comparison of subject device versus primary predicate and reference devices

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K192893 – Traditional 510(k)

Straumann® Ceramic Healing Abutments

510(k) Summary

5.8 Performance Testing

The subject devices were evaluated for biocompatibility according to ISO 10993-1:2009 "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process" and the FDA Guidance document "Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process', Guidance for Industry and Food and Drug Administration Staff". Although the subject device materials are identical to the primary predicate and reference device materials, cytotoxicity and chemical characterization tests were performed due to differences in the manufacturing process. These tests were conducted according to ISO 10993-5, 10993-12, 10993-17 and 10993-18.

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.

The method used to make the determination that the device meets endotoxin limit specifications is LAL Endotoxin Analysis. The testing limit is 20 EU/device. The testing limit was chosen based on a device that is blood contacting and/or implanted, as outlined in the FDA Guidance Submission and Review of Sterility Information in Premarket Notification (510(k)) Submission for Devices Labeled as Sterile, issued on 21 January 2016. In all cases, the testing was performed on the completed package from a production lot after sterilization.

5.9 Conclusion

The documentation submitted in this premarket notification demonstrates the Straumann® Ceramic Healing Abutments are substantially equivalent to the primary predicate and reference devices.

Regulation Number and Section

§ 872.3630 Endosseous dental implant abutment.

(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). 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.)