The Tellos ISQ Buddy measurement system consists of: Tellos ISQ Buddy Instrument (Hand-held instrument), ISQ Peg Driver (Driver to attach the ISQ peg to the implant), Tellos ISQ Buddy Charger (100-240 VAC to 5VDC charger for the instrument batteries), and ISQ Peg (Measurement pin to attach to the implant. Different pins are available to fit different implant types.). The instrument is a hand-held, battery-driven device for measuring the relative stability of a dental implant. A small pin "ISQ peg" is attached to the dental implant by a screw-connection, with the Peg Driver. The pin has a small magnet incorporated into its top. The instrument is held towards the ISQ 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 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 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

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Functional Equivalence:
Produces same ISQ values as predicate device with artificial frequency signal (1,000 to 10,200 Hz).	* Deviation: 0 ISQ (exactly the same)
Accepted deviation: +/- 1 ISQ throughout the scale 1-100 ISQ.	* Deviation: 0 ISQ (exactly the same)
Produces same ISQ values as predicate device when measuring on an Osstell SmartPeg attached to an implant embedded in artificial bone.	* Deviation: 0 ISQ (exactly the same)
Accepted deviation: +/- 1 ISQ (for stability varied from 3 to 85 ISQ).	* Deviation: 0 ISQ (exactly the same)
Safety and Compliance:
Compliance with EMC standard IEC 60601-1-2.	* Compliance: Found to comply.
Software validation according to FDA guidance for Software Contained in a Medical Device.	* Compliance: Validated.
Sterilization validation according to ISO 17665-1 and ISO 17665-2.	* Compliance: Validated.
Biocompatibility standard ISO 10993-1.	* Compliance: Complies (indirectly stated by using USP VI materials and successful assessment).

Study Details

Sample size used for the test set and the data provenance:
- Test Set 1 (Artificial Frequency Signal): The frequency signal was varied from 1,000 to 10,200 Hz with a resolution of 100 Hz. This implies 93 distinct frequency points were tested ( (10200-1000)/100 + 1 ).
- Test Set 2 (Artificial Bone Model): The stability was varied from 3 to 85 ISQ. The exact number of discrete stability points tested is not specified, but it covers a significant range.
- Data Provenance: The data comes from laboratory testing conducted by the device manufacturer (Tellos Medical AB). It is not patient or human subject data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable directly. The ground truth for the functional performance tests was established by comparison against a known, controlled input (artificial frequency signal) and against the predicate device (Osstell ISQ) in a controlled laboratory setting. Expert consensus was not used to establish the "ground truth" for the ISQ values themselves in these specific tests.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- None. Adjudication methods are typically used for subjective assessments or when discrepancies arise between human readers/interpreters. In this case, the measurements are objective device outputs compared against objective criteria and the predicate device's output.
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 a dental implant stability analyzer, not an AI-assisted diagnostic imaging device that involves human readers interpreting cases. Therefore, an MRMC study is not relevant to this device.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, for the device's core functionality. The performance testing described (comparison with artificial signals and artificial bone models) represents a standalone assessment of the device's ability to measure ISQ values accurately. The device outputs the ISQ value directly, without an "algorithm only" component separate from the integrated hardware and software. It does not involve human interpretation as part of its primary function.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Controlled, known inputs and predicate device output. For the artificial frequency signal test, the ground truth was the known input frequency. For the artificial bone model, the ground truth was essentially the output of the predicate device and the varied stability in the controlled setting.
The sample size for the training set:
- Not applicable / Not explicitly mentioned. This device does not appear to use machine learning or AI that requires a "training set" in the conventional sense. Its functionality is based on established physical principles (resonance frequency measurement) and signal processing, calibrated and validated against known standards and a predicate device.
How the ground truth for the training set was established:
- Not applicable. See point 7.

Summary

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

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a symbol. The symbol is a stylized representation of three human profiles facing right, with flowing lines suggesting movement or connection. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

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

January 7, 2016

Tellos Medical AB Mr. Anders Petersson CEO Nedergardsgatan 5 Goteborg, 41654 SWEDEN

Re: K143445

Trade/Device Name: Tellos ISQ Buddy Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EKX Dated: November 30, 2015 Received: December 2, 2015

Dear Mr. Petersson:

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}------------------------------------------------

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 devicerelated 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 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}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K143445

Device Name

Tellos ISO Buddy

Indications for Use (Describe)

Tellos ISO Buddy is indicated for use in measuring the stability of dental implants in the maxillofacial region.

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 Druq 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."

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

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

1. 510(k) Summary

1.1 Submitter

Tellos Medical AB Nedergårdsgatan 5 416 54 Göteborg Sweden Ph: +46 709 741269 Email: info@tellosmedical.com Contact person: Anders Petersson This Summary is made on January 2, 2016

1.2 Device name

Proprietary name:	Tellos ISQ Buddy
Common name:	Dental implant stability analyzer
Accessories name:	ISQ Peg
Regulation Number	872.4200
Classification Product Code	EKX

1.3 Identification of Predicate Device

The predicate device trade name:	Osstell ISQ
Accessories name:	SmartPeg

Predicate Device 510(k) information:
Device Classification Name	Handpiece, Direct Drive, AC-Powered
510(k) Number	K082523
Device Name	OSSTELL ISQ IMPLANT STABILITY METER
Regulation Number	872.4200
Classification Product Code	EKX

1.4 Device description

1.4.1 Description

The Tellos ISQ Buddy measurement system consists of:

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

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

Image /page/4/Picture/2 description: The image shows a digital thermometer with the words "Tellos Medical" printed on the side. The thermometer is white and has a small digital display that reads "82". The thermometer has a probe at the end that is used to take a temperature reading. The background is a solid gray color.

Tellos ISQ Buddy Instrument

Image /page/4/Picture/4 description: The image shows a cylindrical object with a ribbed pattern on the top half and a smooth surface on the bottom half. The object is light gray and appears to be made of a solid material. The ribbed pattern consists of vertical grooves that run along the circumference of the cylinder. The object is standing upright on a gray surface.

Image /page/4/Picture/5 description: The image shows a dental implant. The implant is made of metal and has a cylindrical shape. The top of the implant has a few grooves, and the bottom has screw threads. The implant is set against a gray background.

ISQ Peg Driver

ISQ Peg

Image /page/4/Picture/8 description: The image shows a collection of black power adapters with different plug types. There are four different plug types visible in the image. The adapters are arranged in a way that highlights the variety of plug configurations. The adapters appear to be interchangeable, allowing the user to use the same power supply in different countries.

Tellos ISQ Buddy Charger

1.4.2 Basic principle and functionality

The Tellos ISQ Buddy instrument is a hand-held, battery-driven device for measuring the relative stability of a dental implant.

A small pin "ISQ peg" is attached to the dental implant by a screw-connection, with the Peg Driver. The pin has a small magnet incorporated into its top. The instrument is held towards the ISQ 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.

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

Image /page/5/Picture/2 description: In the image, there is a gray background with two gray objects. The object on the right is a cylinder with a rounded end and a black ring around the base. The object on the left is a smaller cylinder with a screw thread at the bottom and a notched top.

Instrument tip held towards an ISQ Peg

1.4.3 Technical details

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 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 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.

1.4.4 Materials used

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

1.5 Indications for Use

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

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

1.6 Comparison and differences to the Predicate Device

The instrument functions the same way as the predicate device regarding the measurement principle and technology used. The differences are in the handling; Tellos ISQ Buddy is a hand-held instrument while the predicate device consists of two parts; the instrument and the measurement probe.

Tellos ISQ Buddy has no memory to store the measurement values; the predicate device has a memory that stores the measurements. The predicate device also has an inbuilt clock timer, and a computer connection for transferring measurement values. Tellos ISQ Buddy 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.

	510(k) submission	Predicate Device
Device name	Tellos ISQ Buddy	Osstell ISQ
Company name	Tellos Medical AB	Osstell AB
Product Code/Class	EKX / Class I	EKX / Class I
Regulation number	872.4200	872.4200
Indications for use	The device is indicated for use inmeasuring the stability of implants inthe oral cavity and the maxillofacialregion.The differences in Indications for useare based on clarification of the use ofthe device with dental implants and theanatomical region appropriate fordental implants. This clarification iswithin the indications for use of theprimary predicate and does not changethe intended use of the device.	The device is indicated for use inmeasuring the stability of implants inthe oral cavity and craniofacial region.
Target population	Same as predicate device	Patients with one or more dentalimplants
Anatomical site	Same as predicate device	Oral cavity or craniofacial region
Usage location	Same as predicate device	Dentists office or hospital
Energy used/delivered	Same as predicate device	No energy is intended to be delivered.A small amount of energy could reachthe dental implant from the self-vibrating measurement pin.
Technology	Same as predicate device	A microcontroller sends electric pulsesto a coil in the instrument tip. As aconsequence, magnetic pulses areemitted that affect the pin connectedto the implant. The pin then starts tovibrate with its resonance frequency.Vibration creates an alternatingmagnetic field which is being picked upby another coil in the instrument tip.The electrical signal from the receivingcoil is analyzed and the frequency isdetermined. The Frequency ispresented on the display as an "ISQ-value"
Measurement output	Same as predicate device	Osstell ISQ presents the resonancefrequency of the ISQ peg as an ISQnumber, 1-100. The ISQ number is
		calculated from the resonance
		frequency.
Operation	The operating key is pushed and the	Any key is pushed and the
	instrument is held towards the	measurement probe is held towards
	attached ISQ peg. The instrument then	the attached SmartPeg. The instrument
	presents the ISQ value.	then presents the ISQ value.
System components	Tellos ISQ Buddy instrument, ISQ Peg,	Osstell ISQ instrument, measurement
	ISQ Peg Driver and instrument charger.	probe, SmartPeg and instrument
		charger.
Power, weight & size	3VA, 0.1 Kg, 200 x 30 mm	8 VA, 0.4 Kg, 195 x 20 x 45 mm
Materials used	Instrument; PC/ABS and PEEK.	Instrument: Not available
	Gasket and operating key: Silicone	Measurement probe: Not available
	ISQ Peg Driver: Stainless steel	SmartPeg driver: Not Available
	ISQ Peg: Titanium	SmartPeg: Aluminum
Instrument memory	Tellos ISQ Buddy has no data memory.	Osstell ISQ has a memory for storing
	The instrument displays the	measurement values.
	measurement value after the
	measurement. The memory is not a
	necessary feature and the absence of a
	memory decreases the risk of mixing up
	values between different implants
	during a patient session.
Instrument setup-menu	No setup-menu is needed for Tellos ISQ	Instrument has a setup-menu for
	Buddy. The instrument has one	various instrument parameters such as
	operating key and no parameters to	display contrast and computer
	change.	connection.
Data transfer	Since Tellos ISQ Buddy has no memory,	Osstell ISQ has a cable attachment to a
	there are no data to transfer. This is not	PC computer, for transferring data.
	a necessary feature, and the absence of
	a data transfer function decreases the
	risk of mixing up values between
	different implants during a patient
	session.
Clock Timer	Since Tellos ISQ Buddy has no memory,	Osstell ISQ has a built-in clock timer.
	there is no need for a clock timer.
Number of operating keys	Tellos ISQ Buddy has one operating key,	Osstell ISQ has 5 operating keys, for
	used for turning on and off the	working the setup-menu and for
	instrument. Since the instrument has	navigating the instrument memory.
	no memory or setup-menu, not more
	than one key is needed. With one key,
	the instrument is more intuitive and
	easier to use, which leaves less room
	for user errors compared to the
	predicate device.
Display	Tellos ISQ Buddy has two LED-displays;	Osstell ISQ has one LCD display on the
	one on each side of the instrument for	instrument.
	easy reading.
Measurement pins	Tellos ISQ Buddy uses the Osstell	Osstell ISQ uses disposable aluminum
	SmartPegs, or corresponding Tellos	pins, "SmartPegs".
	pins, "ISQ Pegs" from titanium.
Electrical safety	Same as predicate device	Osstell ISQ is designed to the standard
		IEC 60601-1 Medical Electrical
		Fauinment

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

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

1.7 Performance testing

The Tellos ISQ Buddy 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 predicate device does the same, with the same technological principle. The technical differences concerning the measurements are the electronics and the software since other circuits are used. To make sure the instrument present the same values as the predicate device, a comparison was made with an artificial frequency signal which was varied from 1,000 to 10,200 Hz with a resolution of 100 Hz. The accepted deviation was +/-1 ISQ throughout the scale 1-100 ISQ.

A comparison was also made by measuring on an Osstell SmartPeg attached to an implant embedded in artificial bone. The stability of the implant could be altered by compressing the bone with a varying force. The stability was here varied from 3 to 85 ISQ and the acceptance criteria were +/- 1 ISQ.

Both tests produced ISQ values that were exactly the same (deviation 0 ISQ) for both instruments.

The Tellos Buddy 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

1.8 Test conclusions

The conclusion from the tests is that Tellos ISQ Buddy produces the same output data as the predicate device in the same measurement situation.

1.9 Substantial Equivalence Conclusion

The purpose of using the instrument is to measure the ISQ-value (the relative stability) of the implant. Tellos ISQ Buddy has the same indications for use, measurement output and technology as the predicate device. The differences in the memory, clock, display and materials used do not change the intended use nor do they affect the safety and effectiveness as compared to the predicate device cleared in K082523.

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

Therefore, the Tellos ISQ Buddy can be found substantially equivalent to the Osstell ISQ cleared in K082523.

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.