Straumann® temporary prosthetic components are indicated to be used prior to the insertion of the final components to maintain, stabilize and shape the soft tissue during the healing phase. They must not be placed in occlusion. Straumann® temporary abutments are indicated to be placed into Straumann® dental implants to provide a support structure for the functional and esthetic oral rehabilitation of partially edentulous patients with temporary crowns and bridges.

Device Description

Straumann® BLX Temporary Abutments PMMA are temporary abutments intended for placement on Straumann BLX Dental Implants with RB/WB and WB connection platforms. The temporary abutments are made of polymethyl methacrylate (PMMA), with a Titanium Alloy (TAN) inlay.

AI/ML Overview

The provided text is a 510(k) Summary for a medical device (Straumann® BLX Temporary Abutment, VITA CAD-Temp, PMMA). It outlines the device description, indications for use, technological characteristics, and a comparison to predicate devices, but it does not contain information about the acceptance criteria and the study that proves the device meets those criteria in the context of an AI/ML-enabled medical device performance study.

Specifically, the document focuses on the physical and material properties, and mechanical performance testing (dynamic fatigue and static strength) of a dental implant abutment, rather than the performance of a software or AI/ML algorithm.

Therefore, I cannot extract the requested information (acceptance criteria table, sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, ground truth types and establishment for training/test sets, training set sample size) from this document as it pertains to an AI/ML device study.

The "Performance Testing" section (5.7) mentions:

"Dynamic fatigue and static strength tests were conducted according to the FDA guidance document 'Guidance for Industry and FDA Staff – Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments' and demonstrated the BLX Temporary Abutments PMMA performed as well as the reference devices."
This refers to physical testing of the device's durability and strength, not AI/ML performance.

The "Conclusion" (5.8) states that the device is "substantially equivalent to the legally marketed primary predicate and reference devices" based on nonclinical tests (which would include the mechanical and material tests mentioned).

In summary, the provided text does not contain the information needed to answer your request about acceptance criteria and study details for an AI/ML-enabled medical device.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Institut Straumann AG % Jennifer Jackson Director, Regulatory Affairs Straumann USA, LLC 60 Minuteman Road Andover, Massachusetts 01810

Re: K220751

Trade/Device Name: Straumann® BLX Temporary Abutment, VITA CAD-Temp, PMMA Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: March 11, 2022 Received: March 15, 2022

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.

Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT 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

510(k) Number (if known)

K220751

Device Name:

Straumann® BLX Temporary Abutment, VITA CAD-Temp, PMMA

Indications for Use (Describe)

Straumann® temporary prosthetic components are indicated to be used prior to the final components to maintain, stabilize, and shape the soft tissue during the healing phase. They must not be placed in occlusion. Strauman® temporary abutments are indicated to be placed into Straumann® dental implants to provide a support structure for the functional and esthetic oral rehabilitation of partially edentulous patients with temporary crowns and bridges.

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

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

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Straumann® BLX Temporary Abutment, VITA CAD-Temp, PMMA

510(k) Summary

ട് 510(k) Summary

Submitter's Contact Information 5.1

Submitter:	Straumann USA, LLC60 Minuteman RoadAndover, MA 01810Registration No.: 1222315 Owner/Operator No.: 9005052On the behalf of:Institut Straumann AGPeter Merian-Weg 124052 Basel, Switzerland.
Contact Person:	Jennifer M. Jackson, MSDirector of Regulatory Affairs and QualityPhone Number: +1-978-747-2509Fax Number: +1-978-747-0023
Prepared By & Alternate Contact:	Viviana HorhoiuRegulatory Affairs and Compliance managerInstitut Straumann AGPhone number: +41 61 965 1512
Date of Submission:	May 30, 2022

5.2 Name of the Device

Trade Names:	Straumann® BLX Temporary Abutment, VITA CAD-Temp,PMMA
Common Name:	Endosseous dental implant abutment
Classification Name:	Endosseous dental implant abutment
Regulation Number:	§872.3630
Device Classification:	Class II
Product Code(s):	NHA
Classification Panel:	Dental

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Straumann® BLX Temporary Abutment, VITA CAD-Temp, PMMA

510(k) Summary

5.3 Predicate Device(s)

Primary Predicate:

K173961 Straumann® BLX Implant System Institut Straumann AG .
Reference Device:
. K122192 – Straumann Temporary Abutments, PMMA – Institut Straumann AG

Device Description 5.4 -

The subject temporary abutments will be marketed as Straumann® BLX Temporary Abutment, VITA CAD-Temp, PMMA, however, throughout this 510(k) Summary the subject devices will be referred to as BLX Temporary Abutment, PMMA.

5.5 Indications for Use

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Straumann® BLX Temporary Abutment, VITA CAD-Temp, PMMA

510(k) Summary

5.6 Technological Characteristics

FEATURE	SUBJECT DEVICE	PRIMARY PREDICATE DEVICE	REFERENCE DEVICE	EQUIVALENCE DISCUSSION
K Number		K173961	K122192
Indicationsfor Use	Straumann® temporaryprosthetic components areindicated to be used prior to theinsertion of the final componentsto maintain, stabilize and shapethe soft tissue during the healingphase. They must not be placedin occlusion. Straumann®temporary abutments areindicated to be placed intoStraumann® dental implants toprovide a support structure forthe functional and esthetic oralrehabilitation of partiallyedentulous patients withtemporary crowns and bridges.	Straumann® BLX Basal Screwsand Temporary AbutmentsProsthetic components directly orindirectly connected to theendosseous dental implant areintended for use as an aid inprosthetic rehabilitations.Temporary components can beused prior to the insertion of thefinal components to maintain,stabilize, and shape the softtissue during the healing phase;they may not be placed intoocclusion. Final abutments maybe placed into occlusion when theimplant is fully osseointegrated.BLX Temporary Abutments havea maximum duration of usage of180 days.	Straumann® temporaryabutments are indicated to beplaced into Straumann® dentalimplants to provide a supportstructure for the functional andesthetic oral rehabilitation ofpartially edentulous patientswith temporary crowns andbridges.	EquivalentThe subject and primary predicatedevice indications for usestatements are equivalent. Thesubject device does not containlanguage regarding final abutmentsand the subject device is fortemporary use only.The type of prosthetic restorationsis implied for the primary predicatedevice, but included specifically inthe subject and reference deviceindications for use statements.The statement regarding themaximum duration of usage hasbeen moved to the Instructions forUse for the subject devices.
Material	Titanium alloy/TAN(Ti-6Al-7Nb),PMMA	Titanium alloy/TAN(Ti-6Al-7Nb)	Titanium alloy/TAN(Ti-6Al-7Nb),PMMA	IdenticalThe materials are identical to thereference device.
Implant toAbutmentConnection	TorcFit®	TorcFit®	CrossFit®synOcta	IdenticalThe connection is identical to theprimary predicate device.
FEATURE	SUBJECT DEVICE	PRIMARY PREDICATE DEVICE	REFERENCE DEVICE	EQUIVALENCE DISCUSSION
K Number		K173961	K122192
Compatibility	RB/WB and WB	RB/WB and WB	Narrow CrossFit® (NC)Regular CrossFit® (RC)Narrow Neck CrossFit® (NNC)Regular Neck (RN)Wide Neck (WN)	IdenticalThe compatibility is identical to theprimary predicate device.
Diameter orMinor OvalDimension/Major OvalDimension	Major oval diameter: 10 mmMinor oval dimensions: 5 mm	RB/WB:$Ø$ 3.8, $Ø$ 4.5, $Ø$ 6.0WB:$Ø$ 5.5	Major oval diameter: 10.1 mmMinor oval dimensions: 5 mm	EquivalentThe diameters are nearly identicalto the reference devices.
Overallabutmentlength	15.1 and 16.1 mm	13.5, 14.1, 15.1, 16.1, 17.1 mm	16.3 mm	IdenticalThe overall abutment lengths areidentical to two of the abutmentlengths of the primary predicatedevice.
Gingivalheights	1.5 mm	0.75, 1.5, 2.5 and 3.5 mm	1.0 mm	IdenticalThe gingival height is identical toone of the gingival heights of theprimary predicate device.
ProsthesisFixation	Screw-retained	Screw-retained	Screw-retained	IdenticalThe prosthetic fixation is identicalto the primary predicate andreference devices.
SterilizationMethod	Non-sterile	Non-sterile	Non-sterile	IdenticalThe subject devices are providednon-sterile and require the samecleaning, disinfection andsterilization procedure as theprimary predicate and referencedevices.
FEATURE	SUBJECT DEVICE	PRIMARY PREDICATE DEVICE	REFERENCE DEVICE	EQUIVALENCE DISCUSSION
K Number		K173961	K122192
Duration ofUse	6 months	6 months	6 months	IdenticalThe duration of use is identical forthe subject, primary predicate, andreference devices.

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Straumann® BLX Temporary Abutment, VITA CAD-Temp, PMMA

510(k) Summary

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Straumann® BLX Temporary Abutment, VITA CAD-Temp, PMMA

510(k) Summary

Table 1 – Comparison of the subject devices with the primary predicate and reference devices

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Straumann® BLX Temporary Abutment, VITA CAD-Temp, PMMA

510(k) Summary

Performance Testing 5.7 -

Dynamic fatigue and static strength tests were conducted according to the FDA guidance document "Guidance for Industry and FDA Staff – Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments" and demonstrated the BLX Temporary Abutments PMMA performed as well as the reference devices.

The subject device materials, PMMA and TAN (titanium alloy), are identical to the reference device materials. The manufacturing processes, packaging, body/fluid contact are identical to the reference devices; therefore, no new issues regarding biocompatibility were raised.

The sterilization validation for the BLX Temporary Abutments PMMA, according to applicable recommendations in the FDA guidance document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, issued on March 17, 2015", was leveraged from K162890.

Conclusion 5.8

The conclusion drawn from the nonclinical tests demonstrates that the subject devices, the BLX Temporary Abutments PMMA, are substantially equivalent to the legally marketed 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.)