The S-mini active Fixture is indicated for use in the treatment of missing maxillary lateral incisors or the mandibular central and lateral incisors to serve as temporary support prosthetic devices during the healing phase of permanent endosseous dental implant, such as artificial teeth, in order to restore chewing function in partially edentulous patients.

Device Description

S-mini active Fixture is one body type mini implant which will be placed in the alveolar bone to replace the function of the missing tooth. It is made of Ti-6Al-4V ELI based on ASTM F136. The surface treatment of device is SLA (Sandblasted with Large-grit and Acid-etching). It is only part to be implanted into bone, and to provide connection of prosthetic devices or other components of a dental implant set with human body (mandibular or maxillary bone). The feature of S-mini active fixture is one body implant which has thread body design include cutting edge for self-tapping. The fixtures' diameters and lengths are available as: Ø 2.5 mm (D) X 8.5/10.0/ 11.5/13.0/15.0mm (L), Ø 3.0 mm (D) X 7.0/8.5/10.0/ 11.5/13.0/15.0mm (L), Ø 3.5 mm (D) X 7.0/8.5/10.0/ 11.5/13.0/15.0mm (L). Tolerance of dimension shall be within ± 1% range. S-mini active Fixture is provided sterilized.

AI/ML Overview

The provided text is a 510(k) summary for the "S-mini active Fixture," an endosseous dental implant. This document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device.

Crucially, this document does not describe a study that proves the device meets specific acceptance criteria based on performance metrics like sensitivity, specificity, or human reader improvement with AI assistance. This is because the device in question is a dental implant, a physical medical device, not a software or AI-based diagnostic tool.

Therefore, many of the requested points in your prompt are not applicable to the information contained within this document. The "acceptance criteria" here refers to demonstrating substantial equivalence to a predicate device based on material, design, sterilization, and non-clinical bench testing.

Here's how the provided information relates to your request, with an emphasis on what's not applicable:

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

The acceptance criteria for a 510(k) for a physical device like a dental implant are primarily centered around demonstrating "substantial equivalence" to a predicate device, as opposed to performance metrics like sensitivity or specificity for a diagnostic algorithm.

The document states:

"The results of the above tests have met the criteria of the standards and demonstrated the substantial equivalence with the predicate device."
"Performance testing has been finished to ensure the devices comply with the applicable International and US FDA Guidance."

Acceptance Criteria (Implicit from Non-Clinical Testing):
The device must meet the criteria of the following standards and tests, demonstrating bio-compatibility, structural integrity, and durability:

Test / Standard	Acceptance Criteria (Implied: Met Standard)	Reported Device Performance (Implied: Passed)
Biocompatibility testing (ISO 10993 series)	Requirements for biocompatibility (e.g., non-cytotoxic, non-irritating, non-sensitizing, non-hemolytic, non-genotoxic, non-toxic)	"demonstrates that the subject device is biocompatible and substantial equivalence with the predicate device"
Bench testing (visual, dimension, compressive, fatigue, adaptation accuracy, torque)	Specific engineering tolerances and performance thresholds for each test (e.g., dimensions within ±1% range, specific load-bearing capabilities, resistance to fatigue)	"The results of the above tests have met the criteria of the standards"
Fatigue Testing (ISO 14801:2007)	Withstand specified cycles/loads under worst-case scenario without failure	"performed... under the worst-case scenario" and implied successful completion ("met the criteria")
Bacterial Endotoxin Test (ANSI/AAMI ST72:2011, USP)	Endotoxin levels below specified limits to ensure sterility and prevent pyrogenic reactions	"met the criteria of the standards"
Sterilization Validation	Ensured sterility with a specified Sterility Assurance Level (SAL) per relevant standards.	"demonstrates the sterilization... safety of the subject device"
Shelf Life Testing	Maintained integrity and sterility over the declared shelf life (5 years).	"demonstrates the... packing validation safety of the subject device"
SLA Surface Assessment (SEM, Chem Analysis)	Surface characteristics (morphology, chemical composition) comparable to predicate or established standards.	"exactly same for the subject device" as reference predicate (K120503)

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

Sample Size: Not explicitly stated in terms of patient data. The "test set" here refers to the number of physical devices tested in the non-clinical bench studies (e.g., how many implants were used for fatigue testing), which is not specified.
Data Provenance: The tests are non-clinical, meaning they are laboratory/bench tests, not studies on human patients. The manufacture is located in South Korea.

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

Not Applicable. This document describes a physical medical device (dental implant), not an AI or diagnostic software. Therefore, there is no "ground truth" in the diagnostic sense, nor experts interpreting images or data for a test set. The "truth" is established through engineering and biological testing against predefined standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not Applicable. See point 3.

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 a physical device, not an AI-assisted diagnostic tool.

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

Not Applicable. This is a physical device.

7. The type of ground truth used:

Not Applicable in the context of diagnostic AI. For this physical device, "ground truth" is defined by established engineering standards (e.g., ISO, ASTM, ANSI, USP) and the physical properties and performance characteristics demonstrated by the predicate devices. For instance, the "ground truth" for biocompatibility is defined by meeting the criteria of the ISO 10993 series.

8. The sample size for the training set:

Not Applicable. There is no "training set" as this is not a machine learning model.

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

Not Applicable. There is no "training set" and thus no "ground truth" establishment process for one.

Summary

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July 24, 2018

Neobiotech Co., Ltd. % April Lee Consultant Withus Group Inc 106 Superior Irvine, California 92620

Re: K181178

Trade/Device Name: S-mini active Fixture Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE Dated: April 26, 2018 Received: May 2, 2018

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.

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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 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,

Andrew I. Steen -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

Expiration Date: 06/30/2020 See PRA Statement below.

Form Approved: OMB No. 0910-0120

510(k) Number (if known) K181178

Device Name S-mini active Fixture

Indications for Use (Describe)

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.

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510(k) Summary

Submitter

Neobiotech Co., Ltd. Young-Ku, Heo #312-1, 36, Digital-ro 27 gil Guro-gu, Seoul 08381 South Korea Email: kylee@neobiotech.com Tel. +82-2-582-2885 Fax. +82-2-582-2883

Device Information

Trade Name: S-mini active Fixture
Common Name: Endosseous Dental Implant
Classification Name: Implant, Endosseous, Root-Form
. Primary Product Code: DZE
Panel: Dental
Regulation Number: 21 CFR 872.3640
Device Class: Class II
Date Prepared: 07/23/2018

Predicate Devices:

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

Primary Predicate

. K112540, S-Mini Implant system manufactured by Neobiotech Co., Ltd.
Reference Predicates
K122171, MS SA Implant System by OSSTEM Implant Co.,Ltd. .
K120503, CMI IMPLANT IS II ACTIVE by Neobiotech Co., Ltd. ●

Indication for Use:

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

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Device Description

S-mini active Fixture is one body type mini implant which will be placed in the alveolar bone to replace the function of the missing tooth. It is made of Ti-6Al-4V ELI based on ASTM F136.

The surface treatment of device is SLA (Sandblasted with Large-grit and Acid-etching).

It is only part to be implanted into bone, and to provide connection of prosthetic devices or other components of a dental implant set with human body (mandibular or maxillary bone).

The feature of S-mini active fixture is one body implant which has thread body design include cutting edge for self-tapping.

The fixtures' diameters and lengths are available as:

Ø 2.5 mm (D) X 8.5/10.0/ 11.5/13.0/15.0mm (L) .
Ø 3.0 mm (D) X 7.0/8.5/10.0/ 11.5/13.0/15.0mm (L)
. Ø 3.5 mm (D) X 7.0/8.5/10.0/ 11.5/13.0/15.0mm (L)

Tolerance of dimension shall be within ± 1% range. S-mini active Fixture is provided sterilized.

Materials:

The fixture is fabricated from Ti-6A1-4V ELI of ASTM F136.

Summary of Technological Characteristics

1) S-mini active Fixture

	Subject Device	Primary Predicate	Reference Predicate
Company	Neobiotech Co., Ltd	Neobiotech Co., Ltd	OSSTEM Implant Co.,Ltd.
Device Name	S-mini active Fixture	S-Mini Implant system	MS SA Implant System
510(k) Number	K181178	K112540	K122171
DeviceClassificationName	Implant, Endosseous,Root-Form	Implant, Endosseous,Root-Form	Endosseous, Dental Implant
Product Code	DZE	DZE	DZE
Regulation	872.3640	872.3640	872.3640
Intended Use	The S-mini active Fixture isindicated for use in thetreatment of missing maxillarylateral incisors or themandibular central and lateralincisors to serve as temporarysupport prosthetic devicesduring the healing phase ofpermanent endosseous dentalimplant, such as artificialteeth, in order to restorechewing function in partiallyedentulous patients.	The S-Mini Implant Systemdivided into two types:Cemented Type-The Cement type is indicatedfor use in the treatment ofmissing maxillary lateralincisors or the mandibularcentral and lateral incisors toserve as temporary supportprosthetic devices during thehealing phase of permanentendosseous dental implant, suchas artificial teeth, in order to	The MS SA Implant(NarrowRidge) is intended to use inthe treatment of missingmandibular central andlateral incisors to supportprosthetic device, such asartificial teeth, in order torestore chewing function inpartially edentulous patients.The MS SA Implant(NarrowRidge) is intended for singleuse only. It is intended fordelayed loading

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		restore chewing function in partially edentulous patients.- Ball TypeThe Ball type is designed for use in dental implant surgery.Ball type is intended for use in partially or fully edentulous mandibles and maxillae, in support of overdentures. Ball type implants are for temporary use, only.
Material	Ti-6Al-4V ELI of ASTM F136	Pure Titanium of ASTM F67	Ti-6Al-4V ELI of ASTM F136
Design	Image: dental implant	Image: dental implant	Image: dental implant
Diameters (Ø)	2.5/3.0/3.5	2.0/2.5/3.0/3.5	2.5/2.9
Lengths (mm)	7.0/8.5/10.0/11.5/13.0/15.0	7.0/8.5/10.0/11.5/13.0/15.0	8.5/10.0/11.5/13.0
SurfaceTreatment	SLA	RBM	SLA
Sterilization	Gamma Sterilization	Gamma Sterilization	Gamma Sterilization
Principle ofOperation	This product is a root-type fixture which is inserted in the alveolar bone. It replaces the functions of the missing teeth as a dental implant fixture.	This product is a root-type fixture which is inserted in the alveolar bone. It replaces the functions of the missing teeth as a dental implant fixture.	This product is a root-type fixture which is inserted in the alveolar bone. It replaces the functions of the missing teeth as a dental implant fixture.
Shelf Life	5 Years	5 Years	5 Years

Similarities:

The S-mini active Fixture has same device characteristics with the Primary predicate devices, S-Mini Implant System (K112540) such as diameters, Length, intended use, general shape (Design), structure, fundamental technologies and applied production method are similar.

The subject device has been supposed to performance and product validations prior to release. Performance testing has been finished to ensure the devices comply with the applicable International and US FDA Guidance.

Differences:

The differences between the subject device and the primary predicate device are indications for use, surface treatment and dimensions. The indications for use of the subject and predicates are different because of the removal of ball abutments in the subject device.

The surface treatment method of the subject fixture is SLA (Sandblasted with Large-grit and Acidetching) and the surface treatment method of the primary Predicate device is RBM (Resorbable Blasting Media) To support this discrepancy, K122171 was selected as reference predicate for the fixtures and biocompatibility testing was performed on the subject device. The dimension is slightly different from the predicate devices. However, this dimensional difference doesn't affect device safety and effectiveness.

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Non-clinical testing data:

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

Biocompatibility testing according to ISO 10993-1:2009, ISO 10993-3:2014, ISO 10993-● 5:2009, ISO 10993-6:2007, ISO 10993-10:2010 and ISO 10993-11:2006 on fixtures
. Bench testing such as visual test, dimension test, compressive loads, fatigue, adaptation accuracy, and torque tests
Fatigue Testing according to ISO 14801:2007 under the worst-case scenario
. Bacterial Endotoxin Test Report according to ANSI/AAMI ST72:2011, USP <161>, and USP <85>

The results of the above tests have met the criteria of the standards and demonstrated the substantial equivalence with the predicate device.

Biocompatibility Test was conducted for the subject devices and it demonstrates that the subject device is biocompatible and substantial equivalence with the predicate device, K112540.

Fatigue evaluation was performed with the angled abutment of the predicate device under the worstcase scenario in accordance with ISO 14801 and "Guidance for Industry and Staff - Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments".

The SLA surface assessment such as SEM and Chem Analysis was provided in our reference predicate device, K120503 and it is exactly same for the subject device.

Sterilization Validation and Shelf Life testing performed on device with the same raw material, surface treatment method, cleaning condition and packing methods as the the subject device and it demonstrates the sterilization and packing validation safety of the subject device.

The non-clinical testing results demonstrate that the subject device is substantially equivalent to the predicate device.

Conclusion

S-mini active Fixture 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 devices. Therefore, S-mini active Fixture and its predicates are substantially equivalent.

Regulation Number and Section

§ 872.3640 Endosseous dental implant.

(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. 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.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.