IS3 measurement system consists of: IS3 Instrument Hand-held instrument, Multi Peg Driver Driver to attach the ISQ peg to the implant, IS3 Charger 100-240 VAC to 5VDC charger for the instrument batteries, Multi Peg Measurement pin to attach to the implant. Different pins are available to fit different implant types.

The IS3 instrument is a hand-held, battery-driven device for measuring the relative stability of a dental implant. A small pin "Multi peg" is attached to the dental implant by a screw-connection, with the Multi Peg Driver. The pin has a small magnet incorporated into its top. The instrument is held towards the Multi Peg, and sends short magnetic pulses that bring the pin into vibration. After a pulse has been sent, the instrument measures the vibration by sampling the signal from the alternating magnetic field that follows from the vibrating pin. The frequency of the signal is determined by the instrument and is presented as an "ISQvalue", 1 to 100, where a higher number means higher stability. The measurement takes about 1 second.

The instrument consists of a microcontroller and circuits to send the magnetic pulses, to receive the measurement signal, and to present the measurement value. A circuit for battery-charging is also included. Two 2-digit LED displays, one on each side of the instrument, show the measurement value and also communicate possible error codes and software id number at start-up. One operating key is used to turn the instrument on and off. The electronics are contained in a plastic body, which is sealed except for the back of the instrument which has a charging connector. The plastic body is made from PC/ABS plastic except for the tip, which is made from PEEK. No part of the instrument is intended to contact the patient; however, there can be unintentional contact with the tip of the instrument. The instrument is battery-driven and contains re-chargeable NiMh-batteries. The batteries can be charged during use, but it should not be attached while measuring due to the risk of power line interference making it impossible to measure. For safety, a charger complying with IEC 60601-1 is used.The charger connector is of a type that does not allow other chargers to be connected, thereby eliminating the risk of the wrong charger being used.

AI/ML Overview

The provided document for the HIOSSEN IS3 device (K180527) does not contain detailed acceptance criteria and a study that proves the device meets these criteria in the typical format of a clinical or performance study for AI/ML-enabled devices.

This FDA 510(k) submission primarily focuses on establishing substantial equivalence to a predicate device (Tellos ISQ Buddy, K143445), not on providing performance metrics against specific, quantitative acceptance criteria for diagnostically or prognostically critical AI/ML-driven tasks. The IS3 device is described as measuring the resonance frequency of an implant pin to determine an "ISQ-value" for implant stability, which is a direct measurement based on a physical principle. It does not appear to involve AI/ML for image analysis, diagnosis, or prediction, which typically require detailed performance studies.

Therefore, many of the requested categories for acceptance criteria and study details cannot be directly extracted from this document, as they are not applicable to the type of device and submission presented.

However, I can provide information based on the document's content regarding the device's technical performance and comparison to predicate devices, which serves as its "proof" of meeting requirements for substantial equivalence.

Here's a breakdown of the available information:

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

The document does not explicitly state quantitative "acceptance criteria" in the format of specific thresholds for metrics like sensitivity, specificity, AUC, or accuracy, as would be common for AI/ML-powered diagnostic devices. Instead, the "performance" is demonstrated by its functional equivalence and compliance with relevant standards, and it measures an ISQ value from 1-100.

Acceptance Criteria (Implied by Substantial Equivalence and Standards Compliance)	Reported Device Performance (from document)
Functional Equivalence to Predicate Device	IS3 (Subject Device):
Measures stability of dental implants in the oral cavity and maxillofacial region	Indicated for use in measuring the stability of dental implants in the oral cavity and the maxillofacial region.
Operates on the same technological principle (resonance frequency measurement)	The IS3 instrument is a hand-held, battery-driven device for measuring the relative stability of a dental implant. A small pin "Multi peg" is attached to the dental implant by a screw-connection... The instrument is held towards the Multi Peg, and sends short magnetic pulses that bring the pin into vibration. After a pulse has been sent, the instrument measures the vibration by sampling the signal from the alternating magnetic field that follows from the vibrating pin. The frequency of the signal is determined by the instrument and is presented as an "ISQvalue", 1 to 100, where a higher number means higher stability. (Page 4) The instrument functions the same way as the predicate device regarding the measurement principle and technology used. (Page 5) The IS3 instrument brings a pin attached to a dental implant into vibration and then measures the resonance frequency of the vibrating pin. The resonance frequency is then presented as an "ISQ-value" 1-100. The primary predicate device does the same technological principle and the electronic, software since same circuits are used. (Page 7)
Presents measurement output as an ISQ number (1-100)	It presents the resonance frequency of the ISQ peg as an ISQ number, 1-100. (Page 5)
Safety and Performance Standards Compliance	IS3 (Subject Device) was found to comply with the following:
EMC compatibility	EMC standard IEC 60601-1-2 (Page 7)
Software validation	Software validation according to FDA guidance for Software Contained in a Medical Device (Page 7)
Sterilization validation (for components like Multi Peg)	Sterilization validation according to ISO 17665-1 and ISO 17665-2 (Page 7) - Note: The Multi Peg is a measurement pin to attach to the implant, implying it contacts the patient and would require sterilization or being disposable.
Biocompatibility (for patient-contact materials)	Biocompatibility standard ISO 10993-1 (Page 7) - Note: Instrument tip is PEEK (USP VI), Instrument seal and key are Silicone (USP VI), Multi Peg is Titanium grade 5. While the instrument is not intended for patient contact, potential unintentional contact is noted, and the Multi Peg directly contacts the patient's implant. The biocompatibility standard is relevant for these materials.
Electrical safety	Designed to the standard IEC 60601-1 Medical Electrical Equipment (Page 6)

2. Sample sized used for the test set and the data provenance
The document does not describe a "test set" in the context of a dataset for validating AI/ML performance. The "testing" mentioned refers to compliance with engineering standards (EMC, software validation, sterilization, biocompatibility, electrical safety) for the device itself, rather than testing its diagnostic accuracy on a clinical dataset. Thus, there is no sample size for a test set of clinical data from this document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as no clinical test set requiring expert-established ground truth for AI/ML performance is described.

4. Adjudication method (e.g. 2+1, 3+1, none) 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
Not applicable. The IS3 is a direct measurement device, not an AI assistance tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device functions as a standalone instrument for measuring ISQ value. Its performance is inherent in its design and compliance with technical standards, as outlined above. It's not an "algorithm only" in the sense of AI/ML, but a physical measurement system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the fundamental measurement principle, the "ground truth" is the physical resonance frequency of the attached pin, which the instrument is designed to accurately measure and convert to an ISQ value. Beyond this, the device's "performance" is assessed by its ability to meet engineering and safety standards, rather than by comparison to clinical ground truth for a diagnostic task.

8. The sample size for the training set
Not applicable, as this is not an AI/ML device requiring a training set.

9. How the ground truth for the training set was established
Not applicable.

Summary

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

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym followed by the full name of the agency, "U.S. Food & Drug Administration," on the right. The FDA part of the logo is in blue, with the acronym in a solid blue square and the agency's name in a lighter shade of blue.

Hiossen, Inc. David Kim RA Manager 85 Ben Fairless Dr. Fairless Hills, Pennsylvania 19030 May 16, 2018

Re: K180527

Trade/Device Name: IS3 Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece And Accessories Regulatory Class: Class I Product Code: EKX Dated: February 28, 2018 Received: February 28, 2018

Dear David Kim:

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.

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 (OS) regulation (21 CFR Part 820);

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

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

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

Indications for Use

510(k) Number (if known) K180527

Device Name IS3

Indications for Use (Describe)

IS3 is indicated for use in measuring the stability of dental implants in the oral cavity and the maxillofacial region.

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

X 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}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for HIOSSEN. The logo is in two colors, red and gray. The letters "HI" are in red, and the rest of the word "OSSEN" is in gray. There is a red swoosh above the "O" in "OSSEN".

85 Ben Fairless Dr. Fairless Hills, PA 19030 Tel : 1-888-678-0001 / Fax : 1-267-759-7004 www.hiossen.com

510(k) Summarv

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

Date : Feb 26, 2018

1. Company and Correspondent making the submission

1) Submitter's Name :	HIOSSEN, Inc.
2) Address :	85 Ben Fairless Dr. Fairless Hills, PA 19030 USA
3) Telephone No.	888 678 0001
4) Contact :	Mr. David Kim

2. Device

Trade or (Proprietary) Name :	IS3
Common or usual name :	Dental implant stability analyzer
Accessories name :	Mult-Peg
Regulation number :	872.4200
Classification code :	EKX
Device class :	Class I

3. Predicate Device

Primary Predicate Device : Tellos ISQ Buddy ( K143445 ) Reference Predicate Device : Osstell ISQ ( K082523 )

4. Device Description :

4.1. Description : IS3 measurement system consists of:
IS3 Instrument Hand-held instrument

	Multi Peg Driver	Driver to attach the ISQ peg to the implant
	IS3 Charger	100-240 VAC to 5VDC charger for the instrument batteries
	Multi Peg	Measurement pin to attach to the implant. Different pins are available to fit different implant types.

SECTION 008

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

Image /page/4/Picture/0 description: The image shows the logo for Hiossen Implant. The logo is composed of the word "Hiossen" in a stylized font. The "Hi" portion of the word is in red, while the "ossen" portion is in gray. The "H" in "Hi" is connected to a curved line above the "i", adding a unique design element to the logo.

85 Ben Fairless Dr. Fairless Hills. PA 19030 Tel : 1-888-678-0001 / Fax : 1-267-759-7004 www.hiossen.com

4.2. Basic principle and functionality

4.3. Technical detail

4.4. Material used

Instrument body: PC/ABS Instrument tip: PEEK (USP VI) Instrument seal : Silicone (USP VI) Instrument key : Silicone (USP VI) Multi Peg Driver: Stainless steel, ASTM F899 Multi Peg: Titanium grade 5, ASTM F136

5. Indication for Use

IS3 is indicated for use in measuring the stability of dental implants in the oral cavity and the maxillofacial region.

6. Comparison and differences to the Predicate Device

The instrument functions the same way as the predicate device regarding the measurement principle and technology used. There is no difference in between the subject device and primary predicate device. The differences with reference device are in the IS3(subject device) and Tellos(primary predicate device) are hand-held instruments while the Osstell ISO(reference

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

Image /page/5/Picture/0 description: The image shows the logo for Hiossen Implant. The logo is composed of the word "Hiossen" in a stylized font. The "H" and "I" are in red, with a red swoosh above the "H". The rest of the word, "ossen", is in gray.

SECTION 008

85 Ben Fairless Dr. Fairless Hills, PA 19030 Tel : 1-888-678-0001 / Fax : 1-267-759-7004 www.hiossen.com

predicate device) consists of two parts; the instrument and the measurement probe. The IS3(subject device) and Tellos(primary predicate device) have no memory to store the measurement values; the reference predicate device has a memory that stores the measurements and also has an inbuilt clock timer, and a computer connection for transferring measurement values. IS3 and Primary predicate device has no timer or computer connection. The lack of these features (memory, timer, data transfer) is not considered to be an inconvenience for the user. Instead, it decreases the risk of mixing up values with each other.

	Proposed device	PrimaryPredicate devices	ReferencePredicate device
	IS3	Tellos ISQ Buddy(K143445)	Osstell ISQ(K082523)
Manufacturer	HIOSSEN, INC.	Tellos Medical AB	Osstell AB
Product Code/Class	EKX / Class I	EKX / Class I	EKX / Class I
RegulationNumber	872.4200	872.4200	872.4200
Indicationfor Use	Same as primarypredicate device.	The device is indicated for use inmeasuring the stability ofimplants in the oral cavity andthe maxillofacial region.	The device is indicated for use inmeasuring the stability ofimplants in the oral cavity andcraniofacial region.
TargetPopulation	Same as primarypredicate device.	Patients with one or moredental implants	Patients with one or moredental implants
Anatomicalsite	Same as primarypredicate device.	Oral cavity orcraniofacial region	Oral cavity orcraniofacial region
Usagelocation	Same as primarypredicate device.	Dentists office or hospital	Dentists office or hospital
Energyused/delivered	Same as primarypredicate device.	No energy is intended to bedelivered. A small amount ofenergy could reach the dentalimplant from the self-vibratingmeasurement pin.	No energy is intended to bedelivered. A small amount ofenergy could reach the dentalimplant from the self-vibratingmeasurement pin.
Technology	Same as primarypredicate device.	A microcontroller sends electricpulses to a coil in the instrumenttip. As a consequence, magneticpulses are emitted that affect thepin connected to the implant.The pin then starts to vibratewith its resonance frequency.Vibration creates an alternating	A microcontroller sends electricpulses to a coil in the instrumenttip. As a consequence, magneticpulses are emitted that affect thepin connected to the implant.The pin then starts to vibratewith its resonance frequency.Vibration creates an alternating
		magnetic field which is being	magnetic field which is being
		picked up by another coil in the	picked up by another coil in the
		instrument tip. The electrical	instrument tip. The electrical
		signal from the receiving coil is	signal from the receiving coil is
		analyzed and the frequency is	analyzed and the frequency is
		determined. The Frequency is	determined. The Frequency is
		presented on the display as an	presented on the display as an
		"ISQvalue"	"ISQvalue"
Measurementoutput	Same as primarypredicate device.	It presents the resonancefrequency of the ISQ peg as anISQ number, 1-100. The ISQnumber is calculated from theresonance frequency.	It presents the resonancefrequency of the ISQ peg as anISQ number, 1-100. The ISQnumber is calculated from theresonance frequency.
		The operating key is pushed andthe instrument is held towardsthe attached ISQ peg. Theinstrument then presents the ISQvalue.	Any key is pushed and themeasurement probe is heldtowards the attached SmartPeg.The instrument then presents theISQ value.
Operation	Same as primarypredicate device.
Systemcomponents	Same as primarypredicate device.	Tellos ISQ Buddy instrument,ISQ Peg, ISQ Peg Driver andinstrument charger.	Osstell ISQ instrument,measurement probe, SmartPegand instrument charger.
Power, weight& size	Same as primarypredicate device.	3VA, 0.1 Kg, 200 x 30 mm	8 VA, 0.4 Kg, 195 x 20 x 45 mm
Materialsused	Same as primarypredicate device.	Instrument; PC/ABS and PEEK.Gasket and operating key:SiliconeISQ Peg Driver: Stainless steelISQ Peg: Titanium	Instrument: Not availableMeasurement probe: NotavailableSmartPeg driver: Not AvailableSmartPeg: Aluminum
Instrumentmemory	Same as primarypredicate device.	Tellos ISQ Buddy has no datamemory.The instrument displaysthe measurement value after themeasurement. The memory isnot a necessary feature and theabsence of a memory decreasesthe risk of mixing up valuesbetween different implantsduring a patient session.	Osstell ISQ has a memory forstoring measurement values.
Instrumentsetup-menu	Same as primarypredicate device.	No setup-menu is needed forTellos ISQ Buddy. Theinstrument has one operating keyand no parameters to change.	Instrument has a setup-menu forvarious instrument parameterssuch as display contrast andcomputer connection.
Data transfer	Same as primarypredicate device	Since Tellos ISQ Buddy has nomemory, there are no data totransfer. This is not a necessaryfeature, and the absence of	Osstell ISQ has a cableattachment to a PC computer,for transferring data.
Clock Timer	Same as primarypredicate device	the risk of mixing up valuesbetween different implantsduring a patient session.Since Tellos ISQ Buddy has nomemory, there is no need for aclock timer.	Osstell ISQ has a built-in clocktimer.
Number ofoperatingkeys	Same as primarypredicate device	Tellos ISQ Buddy has oneoperating key, used for turningon and off the instrument. Sincethe instrument has no memory orsetup-menu, not more than onekey is needed. With one key,theinstrument is more intuitive andeasier to use, which leaves lessroom for user errors compared tothe predicate device.	Osstell ISQ has 5 operating keys,for working the setup-menu andfor navigating the instrumentmemory.
Display	Same as primarypredicate device	Tellos ISQ Buddy has two LED-displays; one on each side of theinstrument for easy reading.	Osstell ISQ has one LCD displayon the instrument.
Measurementpins	Same as primarypredicate device	Tellos ISQ Buddy uses theOsstell SmartPegs, orcorresponding Tellos pins, “ISQPegs” from titanium.	Osstell ISQ uses disposablealuminum pins, “SmartPegs”.
Electricalsafety	Same as primarypredicate device	It is designed to the standardIEC 60601-1 Medical Electrical	Osstell ISQ is designed to thestandard IEC 60601-1 Medical

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

Image /page/6/Picture/0 description: The image shows the logo for Hiossen Implant. The logo features the word "Hiossen" in a stylized font. The "H" and "I" are in red, while the rest of the word is in gray. There is a red swoosh above the "H" and "I".

Hiossen Inc.

85 Ben Fairless Dr. Fairless Hills, PA 19030 Tel : 1-888-678-0001 / Fax : 1-267-759-7004 www.hiossen.com

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

Image /page/7/Picture/0 description: The image shows the Hiossen logo. The "HI" part of the logo is in red, while the "OSSEN" part is in gray. There is a red swoosh above the "HI" part of the logo.

Hiossen Inc.

85 Ben Fairless Dr. Fairless Hills, PA 19030 Tel : 1-888-678-0001 / Fax : 1-267-759-7004 www.hiossen.com

7. Performance testing

The IS3 instrument brings a pin attached to a dental implant into vibration and then measures the resonance frequency of the vibrating pin. The resonance frequency is then presented as an "ISQ-value" 1-100. The primary predicate device does the same technological principle and the electronic, software since same circuits are used.

Equipment

The IS3 instrument has been tested according to, and found to comply with the following:

· EMC standard IEC 60601-1-2
· Software validation according to FDA guidance for Software Contained in a Medical Device
· Sterilization validation according to ISO 17665-1 and ISO 17665-2
· Biocompatibility standard ISO 10993-1

SECTION 008

Electrical Equipment

{8}------------------------------------------------

Image /page/8/Picture/0 description: The image shows the Hiossen logo. The "HI" is in red, and the "OSSEN" is in gray. The "H" is capitalized, and the "I" is lowercase. The "OSSEN" is all capitalized. There is a red swoosh above the "HI".

SECTION 008

85 Ben Fairless Dr. Fairless Hills, PA 19030 Tel : 1-888-678-0001 / Fax : 1-267-759-7004 www.hiossen.com

8. Substantial Equivalence Conclusion

The purpose of using the instrument is to measure the ISQ value (the relative stability) of the implant. The IS3 has the same indication for use, measurement output and technology as the primary predicate device.

The device description, software validation, performing testing, sterilization and biocompatibility assessment demonstrate the substantial equivalence of the submission device to the identified primary predicate device.

Therefore, the IS3 can be found substantially equivalent to the Tellos ISQ Buddy.

Regulation Number and Section

§ 872.4200 Dental handpiece and accessories.

(a)
Identification. A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.(b)
Classification. Class I.