NP-Cast Abutment System is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.

Device Description

NP-Cast Abutment System is used for prosthetic restoration. It is used for cases with path and aesthetic and spatial constraints. After customization, be sure to use only dental nonprecious metal (Co-Cr-Mo alloy) for casting to make the prosthesis When cast a prosthesis with NP-Cast Abutment System, Post height above the transmucosal collar of NP-Cast Abutment System has to be taller than 4mm and Maxmimum angulation has to be less than 30°. The NP-Cast Abutment System consists of Abutment and Abutment Screws.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device (NP-Cast Abutment System), not a study report detailing performance against acceptance criteria for an AI/ML diagnostic or predictive device. Therefore, much of the requested information (e.g., sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types) is not applicable or available in this document.

However, I can extract information related to the device's non-clinical testing which serves as the "study" for this type of device and the "acceptance criteria" through comparison with predicate devices.

1. Acceptance Criteria and Reported Device Performance

For this type of device (a dental abutment), "acceptance criteria" are primarily established by demonstrating substantial equivalence to legally marketed predicate devices and meeting relevant performance standards, particularly mechanical safety. The document focuses on showing that the NP-Cast Abutment System is equivalent in material, indication for use, design, and technological characteristics to its predicates.

Acceptance Criteria Category	Specific Acceptance Criteria (Inferred)	Reported Device Performance
Substantial Equivalence	The device should be similar to predicates in intended use, technology, claims, material composition, and performance characteristics.	The NP-Cast Abutment System is "substantially equivalent in design, function and intended use" to the SimpleLine II Abutment System (K112045) and two OSSTEM Prosthetic Systems (K110308, K081575). The materials (Co-Cr-Mo Alloy) and intended use are identical or highly similar to predicates.
Biocompatibility	The device's materials must be biocompatible for their intended use within the human body.	"Safety tests including biocompatibility have been performed to ensure the devices comply with the applicable international and US regulations." (Specific results not detailed, but conformance is stated).
Mechanical Fatigue Strength	The device must withstand expected physiological loading conditions without fracture or failure, as evaluated by relevant testing standards (e.g., "Guidance for industry and FDA staff Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Abutment"). Specific acceptance limits would be defined by the standard and comparison to predicate performance for "worst-case scenario." Post height above transmucosal collar > 4mm and maximum angulation < 30 degrees for custom casting.	"Fatigue testing was conducted according to the 'Guidance for industry and FDA staff Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Abutment' with the worst case scenario of the NP-Cast Abutment System." (Specific results not detailed, but testing was performed to the standard). Additional performance constraints are provided for custom casting: Post height above transmucosal collar > 4mm and maximum angulation < 30 degrees.
Design Specifications	Must meet defined dimensional and functional parameters for prosthetic restoration.	The system includes various models with specified connections (Mini Hex, Mini Non Hex, Standard Hex, Standard Non Hex, Mini Octa, Mini Non Octa, Standard Octa, Standard Non Octa) and diameters (Ø4.0mm, Ø4.5mm, Ø5.05mm, Ø6.3mm). This demonstrates adherence to design parameters.

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

Sample Size: Not applicable in the context of a clinical test set. For non-clinical (fatigue) testing, the sample size would typically be specified by the relevant ASTM or ISO standard used, but it is not explicitly reported in this document.
Data Provenance: Not applicable for clinical data. For manufacturing and testing, the company's address is listed as Busan, Republic of Korea.

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

Not applicable as this involves non-clinical (mechanical and biocompatibility) testing, not diagnostic performance assessed against a ground truth established by experts. The "ground truth" for mechanical testing is compliance with a recognized standard.

4. Adjudication Method for the Test Set

Not applicable.

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 MRMC clinical study was performed or submitted. The document explicitly states: "No clinical studies are submitted." This device also does not involve AI.

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

Not applicable. This is a physical dental device, not an algorithm.

7. The type of ground truth used

For biocompatibility: Adherence to international and US regulations/standards for material safety.
For mechanical fatigue: Compliance with the "Guidance for industry and FDA staff Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Abutment" and related ASTM/ISO standards. The "ground truth" is passing the specified mechanical performance thresholds.

8. The Sample Size for the Training Set

Not applicable. There is no training set for an AI/ML algorithm.

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

Not applicable. There is no training set for an AI/ML algorithm.

Summary

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K121843

OSSTEM
IMPLANT
OSST

507-8 Geoje

SSTEM Implant Co., Ltd 07-8 Geoje3-Dong Yeonje-Gu Busan, 611-804 Republic of Korea

1: +82 51 850-2500 Fax: +82 51 850-4341 www.osstem.com

DEC 1 1 2012

510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.

Date: May 30, 2012

Company and Correspondent making the submission:

Submitter's Name :
Address :
Contact :
Phone:
Correspondent's Name:
Address:
Contact:
Phone:
1. Device :

Trade or (Proprietary) Name : Common or usual name :

Classification Name :

OSSTEM Implant Co., Ltd. #507-8 Geoje3-Dong Yeonje-Gu Busan, 611-804, Republic of Korea Mr. Hee Kwon Son +82 51 850 2575

HIOSSEN Inc. 85 Ben Fairless Dr. Fairless Hills, PA 19030 Patrick Lim 888 678 0001

NP-Cast Abutment System Dental Device Endosseous dental implant abutment 21CFR872.3630 Class II NHA

1. Predicate Device :
  SimpleLine II Abutment System, Dentium Co., Ltd., K112045 Prosthetic System, OSSTEM Implant Co., Ltd., K110308 HU.HS.HG Prosthetic System, OSSTEM Implant Co., Ltd., K081575

4. Description :

Maxmimum angulation has to be less than 30°

QS-QI-505-3(Rev.0)

Letter(8.5 X 11in)

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1. The NP-Cast Abutment System consists of Abutment and Abutment Screws. And Abutment in the NP-Cast Abutment System is distinguished such as below

Model Name	Product name	Connection	Diameter
NP-CastAbutmentSystem	NP Cast Abutment	Mini	Hex,	Ø4.0mm
			Non Hex	Ø 4.0mm
		Standard	Hex,	Ø 4.5mm
			Non Hex	Ø 4.5mm
	HS NP Cast Abutment	Mini	Octa,	Ø 5.05mm
			Non Octa	Ø 6.3mm
		Standard	Octa,	Ø 5.05mm
			Non Octa	Ø 6.3mm

1. The NP-Cast Abutment System is similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics.
1. The NP-Cast Abutment System is substantially equivalent in design, function and intended use to The SimpleLine II Abutment System(K112045) of Dentium Co., Ltd. and Prosthetic System (K110308) of OSSTEM Implant Co., Ltd., HU.HS.HG Prosthetic System (K081575) of OSSTEM Implant Co., Ltd.

- Substantial Equivalence Matrix

	NP-Cast Abutment	SimpleLine II Abutment System	Prosthetic System
Manufacturer	Osstem Implant Co., Ltd	Dentium Co., Ltd.	Osstem Implant Co., Ltd
510(k)Number	New	K112045	K110308
Intended use	NP-Cast AbutmentSystem is intended foruse with a dental implantto provide support forprosthetic restorationssuch as crowns, bridges,or overdentures.	Intended for use as anaid in prostheticrehabilitation.	Prosthetic System isintended for use with adental implant to providesupport for prostheticrestorations such ascrowns, bridges, oroverdentures.
Material	Co-Cr-Mo Alloy	Co-Cr-Mo Alloy	Gold Alloy

5. Indication for use :

The NP-Cast Abutment System is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.

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1. Review :
  The NP-Cast Abutment System has similar material, indication for use, design and technological characteristics as the predicate device.
1. Summary of nonclinical testing
  Safety tests including biocompatibility have been performed to ensure the devices comply with the applicable international and US regulations.

Fatigue testing was conducted according to the "Guidance for industry and FDA staff Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Abutment" with the worst case scenario of the NP-Cast Abutment System

1. Summary of clinical testing No clinical studies are submitted
1. Conclusions

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, and based on the information provided in this premarket notification Osstem Implant Co., Ltd. concludes that the NP-Cast Abutment System is substantially equivalent to the predicate devices as described herein.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular pattern around the symbol. The caduceus is black, and the text is also black.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

December 11, 2012

OSSTEM Implant Company, Limited C/O Mr. Patrick Lim Manager HiOSSEN Incorporated 85 Ben Fairless Drive FAIRLESS HILLS PA 19030

Re: K121843

Trade/Device Name: NP-Cast Abutment System Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: November 28, 2012 Received: December 5, 2012

Dear Mr. Lim:

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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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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Kwame O. Ulmer

Anthony D. Watson, B.S., M.S., M.B.A. 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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OSSTEM Implant Co., Ltd.

#507-8 Geoje3-Dong Yeonje-Gu Busan, 611-804 Republic of Ko Tel: +82 51 850-2500 Fax: +82 51 850-4341 www.osstem.co

Indications for Use

510(k) Number K_121843

Device Name : NP-Cast Abutment System

Indication for use : NP-Cast Abutment System is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.

Prescription Use X (Per 21CFR801 Subpart D) OR Over-The-Counter Use (Per 21CFR807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

2012.12.11 Susan Runner DDS, MA 15:23:21 -05'00'

(Division Sign-Off) (Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number:

QS-QI-505-2(Rev.0)

Letter(8.5 X 1 in)

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.)