The TruAbutment DS is a patient-specific CAD/CAM custom abutment, directly connected to endosseous dental implants and is intended for use as an aid in prosthetic rehabilitation. It is compatible with all diameters of the Osstem TS Fixture System which consists of Mini (2.08mm) and Regular (2.48mm) interface sizes.

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 custom abutments which are placed into the dental implant to provide support for a prosthetic restoration. The subject abutments are indicated for screwretained restorations. The custom abutment and abutment screw are made of Titamium grade Ti-6A1-4V ELI (meets ASTM Standard F-I 36) for Osstem TS Fixture System (K121995) which consists of both Mini and Regular interface sizes. Each custom 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. The design and manufacturing of the custom abutments take into consideration the shape of final prosthesis based on the patient's intra-oral indications using CAD/CAM system during the manufacturing. 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.

AI/ML Overview

Here's a summary of the acceptance criteria and study information for the TruAbutment DS, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria in terms of performance metrics (like accuracy, sensitivity, specificity, etc.) for the device itself. Instead, the "acceptance criteria" are implied by meeting various regulatory and engineering standards. The reported device performance is therefore described in terms of compliance with these standards and demonstrated substantial equivalence to a predicate device.

Acceptance Criteria (Implied)	Reported Device Performance
Compliance with ISO 17665-1:2006, 17665-2:2009, ANSI/AAMI ST79:2010 (End User Steam Sterilization)	Met the standard. Device is packaged non-sterile and intended for end-user sterilization.
Compliance with ISO 10993-1:2009, ISO 10993-5:2009, ISO 10993-10:2010 (Biocompatibility)	Met the standard.
Compliance with ISO 14801:2007 (Fatigue Test)	Met the standard. Testing included finished assembled implant/abutment systems of the worst-case scenario (smallest diameter with maximum angulation). Demonstrated implant to abutment compatibility.
Substantial Equivalence to Predicate Device	Demonstrated with predicate device (ET SmartFit Abutment K123627) in terms of material (Ti-6A1-4V ELI), similar indications for use, dimension, design, abutment seat, screw seat, anatomical site, connection (internal hex), and type of retention (screw-retained). Differences in manufacturing process and maximum abutment angulation (25° vs 30° for predicate) were deemed not to raise new questions of safety or effectiveness.
Compliance with FDA Guidance "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments"	Non-clinical testing was conducted in accordance with this guidance.
Dimensional Compatibility	Dimensional analysis and reverse engineering of the implant-to-abutment connection platform, including assessment of maximum/minimum dimensions, tolerances, and cross-sectional images, demonstrated compatibility.

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

Sample Size for Test Set: The document describes non-clinical testing for mechanical and material properties. For the Fatigue Test (ISO 14801:2007), it states "testing finished assembled implant/abutment systems of the worst case scenario, (smallest diameter with maximum angulation)." While the exact number of samples tested isn't specified, this indicates a specific test configuration rather than a large statistical sample of diverse cases. The other tests (sterilization, biocompatibility) typically involve multiple samples to demonstrate compliance, but specific numbers are not provided.
Data Provenance: Not applicable in the context of clinical data for a medical device. This is a technical performance study, not a study involving patient data.

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

Not applicable. The ground truth for this device (an implant abutment) is based on engineering standards, material specifications, and physical measurements, rather than expert consensus on medical imaging or clinical diagnoses.

4. Adjudication Method for the Test Set

Not applicable. This is not a study requiring human adjudication of results in the way a diagnostic imaging study would. The "adjudication" is essentially the determination of whether the device met the specified engineering and material performance 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

No. This is not an AI-based device or a diagnostic tool that would involve human readers. It is a custom dental implant abutment.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

No. This device is a physical medical device (an abutment), not an algorithm or software. It is designed using CAD/CAM, but the "performance" discussed is related to its physical properties and mechanical compatibility.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance evaluation is primarily:

Engineering Standards: Compliance with international standards such as ISO 14801 (Fatigue), ISO 10993 series (Biocompatibility), and ISO 17665 series/ANSI/AAMI ST79 (Sterilization).
Material Specifications: Adherence to ASTM Standard F-I 36 for Ti-6A1-4V ELI titanium.
Dimensional Specifications: Measured dimensions and tolerances to ensure compatibility with the Osstem TS Fixture System.
Predicate Device Performance: The established safety and effectiveness of the legally marketed predicate device (ET SmartFit Abutment K123627) serves as a benchmark for demonstrating substantial equivalence.

8. The Sample Size for the Training Set

Not applicable. The device is not an AI algorithm that requires a training set of data. Its design and manufacturing process utilize CAD/CAM, but the "training set" concept doesn't apply to the device's physical evaluation.

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

Not applicable, as there is no "training set." The CAD/CAM system used for design would operate based on established anatomical parameters, prosthetic requirements, and material properties, rather than being "trained" on a dataset in the AI sense.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

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

May 20, 2016

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

Re: K152559

Trade/Device Name: TruAbutment DS Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: April 15, 2016 Received: April 20, 2016

Dear Ms. 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.

{1}------------------------------------------------

Page 2 - Ms. April Lee

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 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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K152559

Device Name TruAbutment DS

Indications for Use (Describe)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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 complete 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:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510(k) Summary

Submitter

TruAbutment Inc. Brandon Kim 300 S. Harbord Blvd #520 Anaheim, CA 92805 USA Email: Brandon.kim@truabutment.com Phone: 1-714-956-1488

Official Correspondent

WithUS Group Inc April Lee 2531 Pepperdale Drive, Rowland Heights, CA 9174 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: 5/18/2016 ●

General Description

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

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 custom abutments are available in internal hex connection, and are compatible with the Osstem TS Fixture System implant bodies. The Osstem TS Fixture System consists of two interface hex

{4}------------------------------------------------

Implant System	Implant Diameter (mm)	Platform Connection Size(mm)	Type of Implant-Abutment Connection
Osstem TSFixture System	3.5	2.08 (Mini)	Internal Hex
	4.0		Internal Hex
	4.5		Internal Hex
	5.0	2.48 (Regular)	Internal Hex
Osstem TSFixture System(Ultra Wide)	6.0		Internal Hex
	7.0		Internal Hex

sizes which are 2.08mm (Mini) and 2.48mm (Regular). The available range of diameters is summarized below:

Indication for Use

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.

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.

Non-clinical Testing

. 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.
. Fatigue Test according to ISO 14801:2007

{5}------------------------------------------------

Non-clinical test data was used to evaluate the proposed device's substantial equivalence compared to the predicate device. The result of the above tests have met 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 of the implant-to-abutment connection platform were performed, including an assessment of maximum and minimum dimensions of critical design aspects, tolerances, and cross-sectional 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.

Predicate Devices:

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

. ET SmartFit Abutment K123627

Comparison between Predicate and Proposed Device

Attributes	Proposed Device	Predicate Device
	TruAbutment DS	ET SmartFit Abutment (K123627)
Indications for Use	The TruAbutment DS is a patient-specific CAD/CAM custom abutment,directly connected to endosseous dentalimplants and is intended for use as anaid in prosthetic rehabilitation. It iscompatible with all diameters of theOsstem TS Fixture System whichconsists of Mini (2.08mm) and Regular(2.48mm) interface sizes.All digitally designed abutments and/orcoping for use with the TruAbutmentDS abutments are intended to be sent toa TruAbutment-validated milling centerfor manufacture.	ET SmartFit Abutment is intended for usewith a dental implant to provide supportfor prosthetic restorations such as crowns,bridges, or overdentures.
Dimensions	Interface Hex Size:Mini (2.08 mm) and Regular (2.48mm)	Interface Hex Size:Mini (2.08 mm) and Regular (2.48 mm)
Connection	Internal Hex	Internal Hex
Sterility	Packaged Non-sterile	Packaged Non-sterile
Material	Ti-6AI-4V ELI	Ti-6AI-4V ELI
Picture of Abutment	(Milled from rods)	(Milled from puck)
	Mini	Mini
	Image: Regular abutment	Image: Regular abutment
	Image: Regular abutment	Image: Regular abutment
Picture of Screw	Image: Mini screw	Image: Mini screw
	Image: Regular screw	Image: Regular screw
	Image: Regular screw	Image: Regular screw
Abutment Angle °	0~25	0~30
Abutment Seat	Sits on Taper	Sits on Taper
Screw Seat	Sits on Taper	Sits on Taper
Anatomical Site	Oral Cavity	Oral Cavity
Construction	Machined	Machined
Type of Retention	Screw-retained to the implant. Theprosthesis can be cement-retained tothe abutment.	Screw-retained to the implant. Theprosthesis can be cement-retained to theabutment.

{6}------------------------------------------------

Substantial Equivalence Discussion

TruAbutment DS incorporates the same material, similar indications for use, dimension, 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 feature different language or wording. However, both the subject and predicate device share intended use, namely to serve as an aid in prosthetic reconstructions, such as crowns, bridges or overdentures. Also both the predicate and subject devices are intended to be milled into patient specific abutments using CAD/CAM technology under the manufacturing control of the sponsor.

{7}------------------------------------------------

The only other difference between the subject device and primary predicate is the manufacturing process and the maximum angulation of the abutment design. While the industry standard for CAD/CAM abutment is usually 30°, TruAbutment placed limitation on the abutment design at 25°in order to limit instances of having to re-design extraordinarily long abutments where the head protrudes from of the 14 mm () titanium rods. Other than this difference, there aren't any further variations between the two devices which would anyway impede the substantially equivalent decision.

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

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.)