Digitek Titanium Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation. They are compatible with the ASTRA TECH Implant System OsseoSpeed™ 3.5mm, 4.0mm, 4.5mm, 5.0mm implants.

Device Description

Digitek Titanium Abutments are endosseous implant abutments which are placed into a corresponding dental implant to provide support for a prosthetic restoration. These abutments are made of titanium grade Ti-6AI-4V ELI (meets ASTM Standard F136). The abutment is mounted into the implant with a screw. These abutments are compatible with the ASTRA TECH Implant System OsseoSpeed™ implants.

Digitek Titanium Abutments are provided straight only and are not intended to be modified to provide an angle correction.

Digitek Titanium Abutments are manufactured in two models "3.5" and "4.0". And a hexagonal prism at the base of the Digitek Titanium Abutments acts as an anti-rotation feature.

Digitek titanium Abutments are supplied in a non-sterile state and should be sterilized prior to installation.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device, specifically a "Digitek Titanium Abutment." This type of document is focused on demonstrating substantial equivalence to a previously approved predicate device, rather than proving a device meets specific performance criteria through clinical or analytical studies in the same way an AI/software device would.

Therefore, many of the requested categories for acceptance criteria and study data are not applicable to this document. The document describes engineering and bench testing rather than performance outcomes with humans where experts establish ground truth.

Here's an analysis of what can be extracted or inferred from the provided text regarding acceptance criteria and testing:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in a numerical or categorical format for performance outcomes. Instead, it demonstrates equivalence to predicate devices and describes adherence to relevant standards and guidance.

Acceptance Criteria (Inferred from testing)	Reported Device Performance
Mechanical Strength: Withstand dynamic fatigue for endosseous dental implants	Passed fatigue testing according to ISO 14801:2007 (Dentistry -- Implants -- Dynamic fatigue test for endosseous dental implants)
Biocompatibility: Non-toxic	Passed cytotoxicity testing according to ISO 10993-5
Sterilization Efficacy: Sterilization method validated	Sterilization method validated according to ANSI/AAMI ST79
Design Equivalence:	Reverse engineering analysis performed on OEM abutments to obtain design data, indicating design similarity to existing devices.
Compatibility:	Compatible with ASTRA TECH Implant System OsseoSpeed™ 3.5mm-5.0mm implants.
Material: Ti-6Al-4V ELI	Made of Ti-6Al-4V ELI (meets ASTM Standard F136)

2. Sample size used for the test set and the data provenance

Fatigue Testing (ISO 14801:2007): The exact sample size is not specified, but it would typically involve a statistically relevant number of abutment-implant assemblies. Data provenance is implied to be laboratory testing conducted by or for Digitek Dental Solutions Limited.
Cytotoxicity Testing (ISO 10993-5): The exact sample size is not specified but would involve a sufficient number of samples of the "final finished sterilized Digitek Titanium Abutment" to assess biological response. Data provenance is implied to be laboratory testing.
Sterilization Validation (ANSI/AAMI ST79): Sample size would be determined by the standard for validating sterilization processes (e.g., bioburden testing, sterility assurance level verification). Data provenance is implied to be laboratory testing.
Reverse Engineering Analysis: The document mentions "OEM abutments" but doesn't specify the number or provenance beyond being used as a basis for design.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This device is a mechanical component, and its "ground truth" is established through engineering specifications, material properties, and adherence to performance standards, rather than expert interpretation of complex data (like medical images in AI).

4. Adjudication method for the test set

Not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in human-in-the-loop studies, particularly when there is inter-reader variability. This is a physical device testing scenario using standardized methods.

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 is not an AI/software device that would involve human readers or AI assistance.

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

Not applicable. This is not a standalone algorithm.

7. The type of ground truth used

The "ground truth" for this medical device is the adherence to established engineering standards (e.g., ISO 14801:2007 for fatigue, ISO 10993-5 for biocompatibility), material specifications (Ti-6Al-4V ELI), and design equivalence to predicate devices as determined by mechanical and material properties.

8. The sample size for the training set

Not applicable. There is no "training set" as this is a physical medical device, not a machine learning model. The closest analogy would be the data from "OEM abutments" used for reverse engineering and design, but this isn't a training set in the AI sense.

9. How the ground truth for the training set was established

Not applicable.

Summary

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

July 31, 2015

Digitek Dental Solutions Limited Mr. Alwin Ngai Director Units B-C Flat D. 6/F, Dragon Ind. Bldg., 93 King Lam St., Cheung Sha Wan, Kowloon, Hong Kong

Re: K141970

Trade/Device Name: Digitek Titanium Abutment Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: June 19, 2015 Received: July 02, 2015

Dear Mr. Ngai,

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.

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Page 2 - Mr. Alwin Ngai

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 (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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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

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Indications for Use

510(k) Number (if known) K141970

Device Name Digitek Titanium Abutment

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

ال Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Section 5: 510(k) Summary

1. Submitter Information

Company Name:	Digitek Dental Solutions Limited
Company Address:	Units B-C, Flat D, 6/F, Dragon Ind. Bldg., 93
	King Lam St., Cheung Sha Wan, Kowloon,
	Hong Kong
Company Phone:	(852) 2742 3210
Company Fax:	(852) 3590 8715
Contact Person:	Alwin Ngai
Date Prepared:	July 29, 2015

2. Device Identification

Device Model Name:	Digitek Titanium Abutment
Classification Name:	Endosseous Dental Implant Abutment
Regulation Number:	872.3630
Product Code:	NHA
Class	II
Panel	Dental

3. Predicated Devices

Primary	Predicate	Inclusive® Titanium Abutment for - Astra OsseoSpeed™
Device		Implants, K100993

Reference predicate GC AADVA TI ABUTMENTS – BO AC SV BH, K103234 Device

4. Device Description

Digitek Titanium Abutments are provided straight only and are not intended to be modified to provide an angle correction.

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Digitek Titanium Abutments are manufactured in two models "3.5" and "4.0". And a hexagonal prism at the base of the Digitek Titanium Abutments acts as an anti-rotation feature.

Digitek titanium Abutments are supplied in a non-sterile state and should be sterilized prior to installation.

5. Indication for Use

6. Substantial Equivalence

The proposed Digitek Titanium Abutments are substantially equivalent to the Inclusive® Titanium Abutments for - Astra OsseoSpeed™ Implants, and the GC AADVA TI ABUTMENTS - BO AC SV BH. These abutments are substantially equivalent in indications for use, material of body and screw, design and sterility status.

Elements ofComparison	Subject Device	Primary PredicateDevice	Reference PredicateDevice
Name	Digitek TitaniumAbutments	Inclusive® TitaniumAbutments for - AstraOsseoSpeed™Implants	GC AADVA TIABUTMENTS - BOAC SV BH
510(k)Number	Applying	K100993	K103234
Indicationsfor Use	Digitek TitaniumAbutments arepremanufacturedprostheticcomponents directlyconnected toendosseous dentalimplants and areintended for use as anaid in prostheticrehabilitation. Theyare compatible withthe ASTRA TECHImplant System	Inclusive® TitaniumAbutments for - AstraOsseoSpeed™Implants arepremanufacturedprosthetic componentsdirectly connected toendosseous dentalimplants and areintended for use as anaid in prostheticrehabilitation. They arecompatible with theAstra Tech	"GC AADVA TIABUTMENTS - BOAC SV BH" are dentalimplant abutments foruse with partially orfully edentulouspatients to restorechewing function byattachment to a dentalimplant fixture placedin the maxilla ormandible. Eachabutment isaccompanied by a

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	OsseoSpeed™3.5mm, 4.0mm,4.5mm, 5.0mmimplants.	OsseoSpeed™ 3.0, 3.5,4.0, 4.5, 5.0 implants.	screw in order toengage correspondingdental implant fixture.
Material ofBody andScrew	Ti-6Al-4V ELI	Ti-6Al-4V ELI	Ti-6Al-4V
Design	Abutment (main body)assembly withabutment screw.Abutment connectionto implant is aninternal hexagon	Implant/Abutmentassembly withabutment screw.Abutment connection toimplant is an internalhexagon	Allows the prosthesisto be retained to theabutment; abutmentscrew is intended tosecure the abutmentto the endosseousdental implant
AbutmentPlatformDiameters(mm)	3.5, 4.0, 4.5, 5.0mm	3.0, 3.5, 4.0, 4.5,5.0mm	Max. 6.0mmMin. 2.5mm
SterilityStatus	Supplied in non-sterilestate	Supplied in non-sterilestate	Supplied in non-sterilestate

7. Performance Testing

Fatigue testing was performed according to ISO 14801:2007, Dentistry --Implants -- Dynamic fatigue test for endosseous dental implants. Testing was performed on Digitek Titanium Abutment with the implants that they are intended to fit.

Final finished sterilized Digitek Titanium Abutment has been tested for cytotoxicity according to ISO 10993-5.

Sterilization method has been validated according to ANSI/AAMI ST79.

Reverse engineering analysis was performed on OEM abutments to obtain data used in the design the Digitek Titanium Abutment.

The Digitek Titanium Abutment conforms to the FDA Guidance Document for Endosseous Dental Implants and Abutments.

8. Conclusion

There are no known technological differences between Digitek Titanium

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Abutments and those of the predicate devices. Thus, Digitek Titanium Abutments is substantially equivalent to the predicate 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.)