The Tru Abutment DS is a patient-specific CAD/CAM abutment, directly connected to endosseous dental implants and is intended for use as an aid in prosthetic rehabilitation.

It is compatible with the following systems:

· Astra Tech OsseoSpeed™ EV 3.0. 3.6, 4.2, 4.8, 5.4 mm
· Nobel Active™ Internal Connection Implant 3.5, 4.3, 5.0, 5.5 mm
· Straumann® Bone Level Implants 3.3, 4.1, 4.8 mm

All digitally designed abutments and/or coping for use with the TruAbutments are intended to be sent to a TruAbutment-validated milling center for manufacture.

Device Description

The TruAbutment DS system includes patient-specific abutments which are placed into the dental implant to provide support for a prosthetic restoration. The subject abutments are indicated for cemented or "Screw- and Cement-Retained Prosthesis" (SCRP) restorations. The patient-specific abutment and abutment screw are made of Titanium grade Ti-6A1-4V ELI (meets ASTM Standard F-I 36). Each patient-specific abutment is supplied with two identical screws which are used for:

(1) For fixing into the endosseous implant
(2) For dental laboratory use during construction of related restoration.

The abutment is placed over the implant shoulder and mounted into the implant with the provided screw. All manufacturing processes of TruAbutment DS are conducted at the TruAbutment milling center and provided to the authorized end-user as a final patient-specific abutment.

Mechanical resistance of the implant-abutment connection is essential to ensure correct long-term functional performance of the complete dental restoration. Dimensional compatibility and mechanical performance of bases and screws together with the underlying implant are of primary importance. These concepts are the basis upon which the system design characteristics and functional performance are established.

The proposed patient-specific abutments are available in internal connections and are compatible with:

Astra Tech OsseoSpeed™ EV (K120414, K130999)
Nobel Active™ Internal Connection Implant (K071370) ●
Straumann® Bone Level Implants (K062129, K140878, K153758, K150938)

AI/ML Overview

The provided text describes the regulatory submission for the TruAbutment DS, a patient-specific CAD/CAM abutment for dental implants. The core of the submission is to demonstrate "substantial equivalence" to existing predicate devices, rather than proving effectiveness through a traditional clinical study with defined acceptance criteria and effect sizes.

Therefore, the information you're asking for regarding acceptance criteria, sample sizes for test/training sets, expert adjudication, MRMC studies, standalone performance, and ground truth establishment is not directly applicable or available in this document in the way it would be for a machine learning or AI-driven device performance study.

This document focuses on non-clinical testing to demonstrate the physical performance and compatibility of the device.

Here's how to address your request based on the provided document:

Acceptance Criteria and Device Performance

The "acceptance criteria" here are defined by the relevant ISO standards and FDA guidance for dental implant abutments, specifically related to mechanical integrity and biocompatibility, as well as dimensional compatibility with specified implant systems. The "device performance" is reported as having met these criteria.

Table of Acceptance Criteria and Reported Device Performance (Based on Non-Clinical Testing):

Acceptance Criteria Category	Specific Criteria (Standard/Guidance)	Reported Device Performance
Mechanical Performance	Fatigue Test according to ISO 14801:2007 (for worst-case scenario: smallest diameter with maximum angulation)	Results met the criteria of the standard; demonstrated substantial equivalence.
Material Biocompatibility	Biocompatibility tests according to ISO 10993-1:2009, ISO 10993-5:2009, and ISO 10993-10:2010	Results met the criteria of the standard; demonstrated substantial equivalence.
Sterilization	End User Steam Sterilization Test according to ISO 17665-1:2006, 17665-2:2009 and ANSI/AAMI ST79:2010	Results met the criteria of the standard; demonstrated substantial equivalence.
Dimensional Compatibility	Dimensional analysis and reverse engineering (OEM implant bodies, abutments, fixation screws)	Demonstrated implant to abutment compatibility and established substantial equivalency.
Regulatory Compliance	FDA Guidance "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments"	Testing was conducted in accordance with this guidance.

Study Details (as inferable from the document):

Since this is a submission for a physical medical device (dental abutment) and a demonstration of substantial equivalence rather than a novel AI/ML algorithm, most of your specific questions about data sets, experts, and MRMC studies do not apply.

Sample size used for the test set and the data provenance:
- Sample Size (Test Set): Not explicitly stated as a "test set" in the context of an algorithm. The "test set" here refers to the physical samples of the TruAbutment DS device and compatible implant systems that underwent non-clinical laboratory testing (fatigue, biocompatibility, sterilization, dimensional analysis). The document mentions "worst-case scenario" testing (smallest diameter with maximum angulation), implying a targeted selection of test articles rather than a large, randomized "test set" as understood in a data science context. The exact number of samples for each test (e.g., number of abutments for fatigue testing) is not provided.
- Data Provenance: The document does not specify the country of origin of the data beyond the standards being international (ISO, ANSI/AAMI). The testing was "non-clinical testing," performed in a laboratory setting. It is retrospective in the sense that the results are being leveraged for a new device submission (K172304), and some tests were performed for a prior predicate device (K152559) and leveraged.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. "Ground truth" in this context refers to the validated performance of a physical device against established engineering and biological standards. This is determined by laboratory measurements and adherence to specified test protocols, not by expert consensus on data annotations for an AI model.
- The "experts" would be the engineers and scientists conducting and validating the lab tests according to the standards. Their qualifications are not specified but would be implicit in their ability to conduct such highly technical and regulated testing.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. This concept is relevant for reconciling discrepancies in human annotations or interpretations for ground truth establishment in AI/ML. For physical device testing, the "ground truth" is defined by the technical specifications and the results of validated laboratory tests.
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, not done. This type of study (MRMC) is for evaluating diagnostic performance of AI-assisted human readers. The TruAbutment DS is a physical medical device (dental abutment), not an AI/ML diagnostic tool. The document explicitly states: "Clinical testing was not necessary to establish substantial equivalency of the device."
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. As above, this is not an AI/ML algorithm. Its "standalone" performance means its physical properties and mechanical integrity, which were evaluated through non-clinical laboratory tests.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's performance is established by engineering standards (ISO 14801), biocompatibility standards (ISO 10993 series), sterilization standards (ISO 17665, ANSI/AAMI ST79), and dimensional analysis via reverse engineering. These are objective, empirically measured outcomes from laboratory testing, not human-derived consensus or clinical outcomes data.
The sample size for the training set:
- Not Applicable. There is no "training set" in the context of an AI/ML algorithm for this device. The design and manufacturing process for the TruAbutment DS would have been developed iteratively (similar to an engineering "training phase"), but not with a structured data "training set" in the AI sense.
How the ground truth for the training set was established:
- Not Applicable. See point 7. The "ground truth" during the development of such a device would be based on design specifications, material properties, and iterative engineering testing to ensure the device meets its intended functional requirements and complies with relevant standards.

Summary

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TruAbutment Inc. % April Lee Consultant Withus Group Inc 2531 Pepperdale Drive Rowland Heights, California 91748

Re: K172304

Trade/Device Name: TruAbutment DS Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: December 21, 2017 Received: December 28, 2017

Dear April Lee:

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.

January 23, 2018

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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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); 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) K172304

Device Name TruAbutment DS

Indications for Use (Describe)

The Tru Abutment DS is a patient-specific CAD/CAM abutment, directly connected to endosseous dental implants and is intended for use as an aid in prosthetic rehabilitation.

It is compatible with the following systems:

· Astra Tech OsseoSpeed™ EV 3.0. 3.6, 4.2, 4.8, 5.4 mm
· Nobel Active™ Internal Connection Implant 3.5, 4.3, 5.0, 5.5 mm
· Straumann® Bone Level Implants 3.3, 4.1, 4.8 mm

All digitally designed abutments and/or coping for use with the TruAbutments are intended to be sent to a TruAbutment-validated milling center for manufacture.

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

Submitter

TruAbutment Inc. Brandon Kim 17742 Cowan, Irvine, CA 92614 USA Email: Brandon.kim@truabutment.com Phone: 1-714-956-1488

Official Correspondent

Withus Group, Inc April Lee 106 Superior. Irvine, CA 92620 USA Email: withus6664@gmail.com Phone: 1-909-274-9971 Fax: 1-909-460-8122

Device Information

Trade Name: TruAbutment DS
Common Name: Endosseous dental implant abutment ●
Classification Name: Abutment, Implant, Dental, Endosseous ●
Product Code: NHA
Panel: Dental
Regulation Number: 21 CFR 872.3630
Device Class: Class II ●
Date prepared: 1/18/2018 ●

Predicate Devices

The subject device is substantially equivalent to the following predicate device:

Primary Predicate
- TruAbutment DS (K170259) o
Reference Predicate
- Astra Tech OsseoSpeed™ EV (K121810) o
- NobelProcera Ti Abutment (K091756) o
- Straumann® CARES® Titanium Abutment (K052272, K072151, K081005, O K082764)

Device Description

(1) For fixing into the endosseous implant
(2) For dental laboratory use during construction of related restoration.

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The proposed patient-specific abutments are available in internal connections and are compatible with:

Astra Tech OsseoSpeed™ EV (K120414, K130999)
Nobel Active™ Internal Connection Implant (K071370) ●
Straumann® Bone Level Implants (K062129, K140878, K153758, K150938)

The available range of diameters is summarized below:

Implant System	Implant Ø(mm)	InterfaceConnectionType/Size (mm)	Implant-Abutment Connection andAnti-Rotational Feature
Astra TechOsseoSpeed™ EV	3.0	3.0	Internal Spline “Index System”Image: [Internal Spline Index System]
	3.6	3.6
	4.2	4.2
	4.8	4.8
	5.4	5.4
Nobel Active™Internal ConnectionImplant	3.5	NP	Internal HexImage: [Internal Hex]
	4.3	RP
	5.0
	5.5	WP

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Straumann® BoneLevel Implants	3.3	NC	Internal Cross Fit®
	4.1	RC
	4.8	RC

Indication for Use

The TruAbutment DS is a patient-specific CAD/CAM abutment, directly connected to endosseous dental implants and is intended for use as an aid in prosthetic rehabilitation.

It is compatible with the following systems:

· Astra Tech OsseoSpeed™ EV 3.0, 3.6, 4.2, 4.8, 5.4 mm
· Nobel Active™ Internal Connection Implant 3.5, 4.3, 5.0, 5.5 mm
Straumann® Bone Level Implants 3.3, 4.1, 4.8 mm

All digitally designed abutments and/or coping for use with the TruAbutment DS abutments are intended to be sent to a TruAbutment-validated milling center for manufacture.

Summary of Technological Characteristics

The subject device is substantially equivalent to the currently cleared devices. They are substantially equivalent in intended use, material and connection interfaces to the implants are identical for each individual diameter and connection type. Comparison demonstrating Substantial Equivalence follows at the end of this section.

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Attributes	Subject Device	Primary Predicate Device
Trade Name	TruAbutment DS	TruAbutment DS (K170259)
Indications for Use	The TruAbutment DS is a patient-specific CAD/CAM abutment, directly connected to endosseous dental implants and is intended for use as an aid in prosthetic rehabilitation.	The TruAbutment DS is a patient-specific CAD/CAM abutment, directly connected to endosseous dental implants and is intended for use as an aid in prosthetic rehabilitation.
	It is compatible with the following systems:Astra Tech OsseoSpeed™ EV 3.0, 3.6, 4.2, 4.8, 5.4 mm Nobel Active™ Internal Connection Implant 3.5, 4.3, 5.0, 5.5 mm Straumann® Bone Level Implants 3.3, 4.1, 4.8 mm	It is compatible with the following systems: Zimmer SV/TSV 3.7, 4.1, 4.7, 6.0 mm
	All digitally designed abutments and/or coping for use with the TruAbutment DS abutments are intended to be sent to a TruAbutment-validated milling center for manufacture.	All digitally designed abutments and/or coping for use with the TruAbutment DS abutments are intended to be sent to a TruAbutment-validated milling center for manufacture.
Connection	Internal Connections	Internal Hex
Sterility	Packaged Non-sterile	Packaged Non-sterile
Material	Ti-6Al-4V ELI	Ti-6Al-4V ELI
Abutment Angle	0~25°	0~25°
Dimensions	Astra Tech OsseoSpeed™ EV 3.0. 3.6, 4.2, 4.8, 5.4 mmNobel Active™ 3.5, 4.3, 5.0, 5.5 mmStraumann® Bone Level 3.3, 4.1, 4.8 mm	Zimmer SV/TSV 3.7, 4.1, 4.7, 6.0 mm
Abutment Seat	Sits on Taper	Sits on Taper
Anatomical Site	Oral Cavity	Oral Cavity
Construction	Machined	Machined
Type of Retention	Screw-retained to the implant. The prosthesis can be cement-retained to the abutment.	Screw-retained to the implant. The prosthesis can be cement-retained to the abutment.
Principle Operation	The proposed device is manufactured components utilized for digital prosthetic solutions as an aid in prosthetic restoration. The abutments are fixed to the underlying implant with an abutment screw, upon which a CAD/CAM designed restoration may be processed to complete a dental prosthesis.	The proposed device is manufactured components utilized for digital prosthetic solutions as an aid in prosthetic restoration. The abutments are fixed to the underlying implant with an abutment screw, upon which a CAD/CAM designed restoration may be processed to complete a dental prosthesis.

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Attributes	Reference Device #1	Reference Device #2	Reference Device #3	EQUIVALENCE DISCUSSION
Trade Name	Astra Tech OsseoSpeed™ EV (K121810)	NobelProceraTi Abutment (K091756)	Straumann®CARES® TitaniumAbutment (K052272, K072151, K081005)
Indicationsfor Use	OsseoSpeed™ Angled Abutment EV isintended to be used in conjunction with AstraTech Implant System EV in fully edentulous orpartially edentulous maxillary and/ormandibular arches to provide support forbridges or overdentures.The Atlantis™ Abutment is intended for usewith an endosseous implant to support aprosthetic device in a partially or completelyedentulous patient. It is intended for use tosupport single and multiple tooth prostheses, inthe mandible or maxilla. The prosthesis can becemented, screw retained or friction fit to theabutment. The abutment screw is intended tosecure the abutment to the endosseous implant.The Atlantis™ Crown Abutment in Zirconia isintended for use with an endosseous implant tofunction as a substructure that also serves as thefinal restoration, in partially or completelyedentulous patients. The prosthesis is screwretained. The abutment screw is intended tosecure the crown abutment to the endosseousimplant.	The NobelProcera TiAbutments arepremanufacturedprosthetic componentsdirectly connected toendosseous dentalimplants and are intendedfor use as an aid inprosthetic rehabilitation.	Abutments are placedinto the dental implantsto provide support forprosthetic restorationsuch as crowns orbridges. The NCCARES TitaniumAbutment is indicatedfor cementedrestoration. Theabutment can be usedin single toothreplacements andmultiple toothrestorations.	EquivalentThe basic indication of providing support forprostheses is identical. The subject devices arecompatible with the same CAD/CAM Systemas the primary predicate device.
Connection	Internal Spline	Internal Hex	Internal Cross Fit®	Equivalent
Sterility	Packaged Non-sterile	Packaged Non-sterile	Packaged Non-sterile	Equivalent
Material	Ti-6Al-4V ELI	Ti-6Al-4V ELI or Titanium	Commercially pure	Equivalent
Abutment	20 and 30	UNK	0~30	Equivalent
Dimensions	Astra Tech OsseoSpeed™ EV 3.0. 3.6, 4.2, 4.8,5.4 mm	Nobel Active™ 3.5, 4.3,5.0, 5.5 mm	Straumann® BoneLevel 3.3, 4.1, 4.8 mm	EquivalentThe dimensions vary by implant system but thesubject device and the primary predicate aremanufactured from the same company whichfollowed the identical procedure of reverse-engineering the reference predicates thatrepresents each of the three systems subjectdevice is claiming compatibility with.
Abutment	Sits on Taper	Sits on Taper	Sits on Taper	Equivalent
Anatomical	Oral Cavity	Oral Cavity	Oral Cavity	Equivalent
Construction	Machined	Machined	Machined	Equivalent
Type ofRetention	Screw-retained to the implant. The prosthesis canbe cement-retained to the abutment.	Screw-retained to theimplant. The prosthesis canbe cement-retained to the	Screw-retained to theimplant. The prosthesiscan be cement-retained	EquivalentIdentical.

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K172304

TruAbutment DS incorporates the same material, indication, design, abutment seat, screw seat, anatomical site, connection, type of retention and technological characteristics as the predicate device.

The Indications for Use of the subject and predicate devices are identical other than the compatible implant bodies. This difference is mirigated by fatigue testing, reverse engineering, dimensional analysis, and identification of reference predicate for compatible implant bodies. Both the predicate and subject devices are intended into patient specific abutments using CAD/CAM technology under the manufacturing control of the sponsor.

Any differences in technology characteristics are accompanied by information that device is substantially equivalent as the predicate and do not raise different questions of safety and effectiveness than the predicate.

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Non-clinical Testing

The subject device was tested to evaluate its substantial equivalence according to the following standards.

. Fatigue Test according to ISO 14801:2007
Below tests were performed for predicate device, K152559 and leveraged for the subject device:
End User Steam Sterilization Test according to ISO 17665-1:2006, 17665-2:2009 and ● ANSI/AAMI ST79:2010.
Biocompatibility tests according to ISO 10993-1:2009, ISO 10993-5:2009, and ISO 10993-● 10:2010.

Biocompatibility and sterilization validation test data was used to evaluate the proposed device's substantial equivalence compared to the predicate device which is owned by the applicant. The results of the above tests have met the criteria of the standard, and demonstrated the substantial equivalence with the predicate device.

Non-clinical testing was conducted in accordance with FDA Guidance "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments", and it consisted of testing finished assembled implant/abutment systems of the worst-case scenario, (smallest diameter with maximum angulation) through fatigue testing.

Dimensional analysis and reverse engineering (OEM implant bodies. OEM abutments, OEM fixation screws) of the implant-to-abutment connection platform were performed, including an assessment of maximum and minimum dimensions of critical design aspects, tolerances, and crosssectional images of the submission device and compatible implant body as well as the OEM implant abutment and implant body. The testing demonstrated implant to abutment compatibility and has established substantial equivalency of the proposed device with predicate devices. Clinical testing was not necessary to establish substantial equivalency of the device.

Conclusion

The TruAbutment DS constitutes a substantially equivalent medical device, meeting all the declared requirements of its intended use. This system has the same intended use and fundamental scientific technology as its predicate device. Therefore, TruAbutment DS and its predicate are substantially equivalent.

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.)