The Osstell IDx is a modification of the Osstell ISQ (K082523). The system is designed to measure implant stability in the oral cavity and maxillofacial region. Similar to K082523, the Osstell IDx is a portable, handheld/tabletop instrument that involves the use of the noninvasive technique, Resonance Frequency Analysis. The system involves the use of a Smartpeg (aluminum rod) attached to the implant by means of a screw. The Smartpeg is excited by a magnetic pulse from the measurement probe on the handheld instrument. The resonance frequency, which is the measure of implant stability, is calculated from the response signal. Results are displayed as the Implant Stability Quotient (ISQ). The ISQ is a measurement of the stability of the implant and is derived from the resonance frequency value obtained from the Smartpeg. The Osstell IDx can add important information to the evaluation of implant stability and can be used as part of an overall treatment evaluation program. The final implant treatment decisions are the responsibility of the surgeon.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Osstell IDx, as provided in the document:

1. Table of Acceptance Criteria and Reported Device Performance

Non-clinical evaluation method	Acceptance Criteria	Reported Device Performance
ISQ correlation evaluation	The average difference could be up to +/-5 ISQ.	Approved. The average difference was -1 ISQ and 3.17 ISQ.
Torque correlation evaluation	The average variance due to tightening torque is checked so that it stays within 3 ISQ between 4 and 6 Ncm.	Approved. The highest variance due to tightening torque were measured to 1.33 ISQ. Most of the measured variances were 0 or below 1 ISQ.
Nonclinical Biocompatibility evaluation of the new probe material	Approved Biocompatibility evaluation according to ISO 10993.	Mediprene 500M has passed cytotoxicity test according to ISO 10993-5 and biocompatibility tests according to USP Class VI. Due to very low degree of skin contact and that the ingoing materials are well known. The individual materials have passed the biocompatibility evaluation and the combination into a steam autoclavable product is judged not to change the risk spectrum. Based on the low degree and duration of skin contact, the biocompatibility tests performed is the biocompatibility evaluation approved for the IDx Probe.

2. Sample Size for the Test Set and Data Provenance

The document does not explicitly state the sample size used for the test set for the ISQ correlation and torque correlation evaluations. It refers to two different evaluations being performed, but details on the number of individual tests or cases are not provided.

Data provenance (e.g., country of origin, retrospective or prospective) is also not specified.

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

The document does not mention the use of experts to establish ground truth for the non-clinical evaluations. These tests appear to be technical performance comparisons against defined metrics rather than assessments requiring expert interpretation.

4. Adjudication Method for the Test Set

Not applicable as expert adjudication was not mentioned for these non-clinical evaluations.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was mentioned. The device, Osstell IDx, is a measurement instrument for implant stability, not an AI diagnostic tool requiring human reader comparison.

6. Standalone (Algorithm Only) Performance Study

The studies described are standalone performance tests of the device itself (ISQ and torque correlation, and biocompatibility), comparing it to its predicate device (Osstell ISQ) or established standards. There is no mention of an "algorithm only" study, as the device's function is centered on physical measurement and conversion to an ISQ value.

7. Type of Ground Truth Used

For the ISQ correlation evaluation and Torque correlation evaluation, the "ground truth" implicitly refers to the performance of the predicate device (Osstell ISQ) and the established acceptance criteria (tolerance ranges for ISQ differences and torque variances). Essentially, the new device's measurements are compared to those of a known, previously cleared device or expected physical behavior.

For the Biocompatibility evaluation, the ground truth is established by adherence to recognized international standards: ISO 10993-5 (cytotoxicity) and USP Class VI (biocompatibility).

8. Sample Size for the Training Set

Not applicable. This is a medical device for measuring implant stability, not a machine learning or AI-based device that typically requires a training set. The descriptions of the tests are for verification and validation of the device's physical and functional performance.

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

Not applicable, as no training set is mentioned or implied for this type of device and evaluation.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus with three intertwined snakes and a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

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

February 19, 2015

Osstell AB Ms. Karin Breding QA & RA Manager Stampgatan 14 411 01 Goteborg SWEDEN

Re: K142358 Trade/Device Name: Osstell IDx Regulation Number: 21 CFR 872.4200 Regulation Name: Dental handpiece and accessories Regulatory Class: Class I Product Code: EKX Dated: January 29, 2015 Received: February 2, 2015

Dear Ms. Breding:

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 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 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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Section 5: Indications for Use Statement

510(k) Number (if known): K142358

Device Name: Osstell IDx

Indications For Use: The Osstell IDx is indicated for use in measuring the stability of implants in the oral cavity and maxillofacial region.

AND/OR

Over-The-Counter Use Use

(Part 21 CFR 801 Subpart D) Subpart C)

Prescription Use __ X

(21 CFR 807

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

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Section 6: 510(k) Summary

Applicant/ Manufacturer: Karin Breding Osstell AB Stampgatan 14 411 01 Göteborg Sweden Ph: +46 31 340 82 54 Fax: +46 31 413 115 Email: karin.breding@osstell.com

Establishment Registration Number: 3004070020

Date submitted:	2014-08-22
Proprietary Name:	Osstell IDx
Common Name:	Dental implant stability analyzer
Classification Status:	Class I
Product Codes:	EKX - handpiece, direct drive, ac-powered
Predicate Device:	Osstell ISQ (K082523)
Regulation Number:	21 CFR 872.4200
Regulation Name:	Dental handpiece and accessories

Device Description:

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Indication for Use:

The Osstell IDx is indicated for use in measuring the stability of implants in the oral cavity and maxillofacial region.

Summary of Technological Characteristics:

The modifications to the Osstell ISQ since its previous clearance in K082523 include the following changes:

. Replacing the existing display with a touch screen
New material is added .
. Updated user interface
Cloud connection .

These differences do not affect the safety or performance of the device and do not change the intended use of the Osstell IDx. These changes were implemented to improve the customer need, which is done with an improved user interface. The new material in the probe improves the grip ability. The cloud connection automatically enables the user to install the latest firmware updates.

Summary of Nonclinical Testing:

Based on the Risk Analysis, the verification and validation tests that were performed and the acceptance criteria applied for each were found to pass. The Osstell IDx was subjected to the same preclinical requirements and testing as the predicate device. Performance testing was conducted to confirm compliance to the design specifications; all functions were verified to operate as designed.

A Nouclinical evaluation has been performed where the Osstell IDx has been compared to the predicate device Osstell ISQ. Two different evaluations have been performed.

Test Method: 30229-07 SmartPeg development verification tests Osstell Instrument nr 024 IDx instrument. SW version p2f. Hardware version Circuit board: C

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Non-clinical evaluation method	Acceptance Criteria	Results
ISQ correlation evaluation	The average differencecould be up to +/-5 ISQ.	Approved.The averagedifference was -1ISQ and 3,17 ISQ
Torque correlation evaluation.	The average variance dueto tightening torque ischecked so that it stayswithin 3 ISQ between 4and 6 Ncm.	Approved.The highestvariance due totightening torquewere measured to1,33 ISQ.Most of themeasuredvariances were 0or below 1 ISQ:
Nonclinical Biocopmatibility evaluationof the new probe material.	ApprovedBiocopmatibilityevaluation according toISO 10993.	Mediprene 500Mhas passedcytotoxicity testaccording to ISO10993-5 andbiocompatibilitytests according toUSP Class VI.Due to very lowdegree of skincontact and thatthe ingoingmaterials are wellknown. Theindividualmaterials havepassed thebiocompatibilityevaluation and thecombination intoa steamautoclavable

	product is judged
	not to change the
	risk spectrum
	Based on the low
	degree and
	duration of skin
	contact, the
	biocompatibility
	tests performed is
	the
	biocompatibility
	evaluation
	approved for the
	IDx Probe.

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Clinical Studies:

Clinical data was not required to support the changes to the Osstell IDx.

Substantial Equivalence Discussion:

The changes to the display, user interface, electronics and material of the Osstell IDx do not change the intended use nor do they affect the safety and effectiveness as compared to the Osstell ISQ previously cleared in K082523.

	Osstell IDx	Predicate Device: Osstell ISQ K082523
Device name	Osstell IDx	Osstell® ISQ
Company name	Osstell AB	Osstell AB (formerly IntegrationDiagnostics)
ProductCode/Class	EKX/Class I	Same
RegulationNumber	872.4200	Same
Classificationname	Handpiece, Direct Drive, AC-Powered	Same
Intended Use	Dental implant stability analyzer	Same
Indication for use	The Osstell IDx is indicated for use inmeasuring the stability of implants in theoral cavity and maxillofacial region.	The Osstell IDx is indicated for use inmeasuring the stability of implants in theoral cavity and craniofacial region.
Description	Portable, handheld/tabletop, orfreestanding instrument indicated for usein measuring the stability of implants in	Portable, handheld, or freestandinginstrument indicated for use in measuringthe stability of implants in the oral cavity
	Osstell IDx	Predicate Device: Osstell ISQ K082523
	the oral cavity and maxillofacial region.	and craniofacial region.
Operation ofSystem	The Osstell IDx measures the frequencyresponse from Smartpeg that is directlyattached to the implant or abutment.The system includes the followingcomponents: Instrument,Smartpeg/Measurement Probe,	The Osstell ISQ measures the frequencyresponse from Smartpeg that is directlyattached to the implant or abutment. Thesystem includes the following components:Instrument, Smartpeg/Measurement Probe,and PC Data Manager Software
	The technique involves a SmartPeg (10mm x 3 mm) that is attached to theimplant or abutment. The SmartPeg isexcited over a range of frequencies (1kHz to 10 kHz) and the resonancefrequency is measured with the OsstellIDx instrument and software. Theresonance frequency is determined bythe stiffness of the implant system. TheOsstell IDx presents the resonancefrequency as an Implant StabilityQuotient (ISQ) value (scaled 0-100).The ISQ value is proportional to thestability of the implant.	The technique involves a SmartPeg (10 mmx 3 mm) that is attached to the implant orabutment. The SmartPeg is excited over arange of frequencies (1 kHz to 10 kHz) andthe resonance frequency is measured withOsstell ISQ instrument and software. Theresonance frequency is determined by thestiffness of the implant system. The OsstellISQ presents the resonance frequency as anImplant Stability Quotient (ISQ) value(scaled 0-100). The ISQ value isproportional to the stability of the implant.(In general, a rise in ISQ values from onemeasurement time to the next indicates a
	(In general, a rise in ISQ values from onemeasurement time to the next indicates aprogression towards stability and alower ISQ value may indicate a loss instability and perhaps, implant failure.)	progression towards stability and a lowerISQ value may indicate a loss in stabilityand perhaps, implant failure.)
SystemComponents-	Instrument	Instrument
	The Instrument is a portable ,handheld/tabletop instrument with atouch display. The unit operates from arechargeable power source offering 1hour of continuous use between charges.The operator instructions enablespatients recording and monitoringimplant progress.The size of the touch screen is 154 x 94mm.Firmware can be updated either throughUSB connector or cloud connection.	The Instrument is a compact unit with built-in graphical display. The unit operates froma rechargeable power source offering over 6hours of continuous use between charges.The size of the LCD display is 69 *37 mmThe instrument can be connected to a PCvia the USB cable and the measurementdata can be transferred to the optional ISQData Manager Software.
	Measurement Probe	Measurement Probe
	The Measurement Probe is connected tothe instrument via the probe cable and isheld close to the Smartpeg. Themeasurement probe sends the excitationsignal to the coils in the probe, and alsodetects the response signal from thedetection coil in the probe. Themicrocontroller in the instrumentcalculates the frequency of the response	The Measurement Probe is connected to theinstrument via the probe cable and is heldclose to the Smartpeg. The measurementprobe sends the excitation signal to the coilin the probe, and also detects the responsesignal from the second coil in the probe.The microcontroller in the instrumentcalculates the frequency of the responsesignal.
	Osstell 1Dx	Predicate Device: Osstell ISQ K082523
	signal, and presents it on the display as a	number, the Implant Stability Index (ISQ).
	number, the Implant Stability Index(ISQ).	The measurement probe has fixed cable.
	The measurement probe has fixed cable.
	Smartpeg	Smartpeg
	The stability of the implant is reflected	Same
	by the resonance frequency of a"Smartpeg" attached to the implant. TheSmartpeg is a small aluminum rod,approximately 3 mm in diameter and 10mm long, with a magnet permanentlyattached to its top. The Smartpeg isscrewed onto the implant. TheSmartpeg magnet is excited by a smallmagnetic pulse generated by a coil in themeasurement probe. The Smartpegvibrates freely at its resonance frequencyfor some milliseconds. Since the magnetattached to its top is vibrating togetherwith the Smartpeg, the vibration (the"ringing") can be picked up by a secondcoil in the measurement probe.

	PC Data Manager SoftwareThe system has no PC Data Manager	PC Data Manager Software
	Software.	The Osstell ISQ Data Manager is aWindows 2000/NT/XP/Vista basedsoftware enabling storage, viewing andprinting of patient data.
		The Software is an optional accessory to theOsstell ISQ and is not integral to thefunctioning of the device.
		Patients may be tracked and implantprogress monitored after transfer of datafrom the instrument to a PC. The data istransferred from the instrument to a PC. Thedata is transferred directly from the OsstellISQ instrument to a PC via the USB cable.
Power, Weight	Rated Power: 12VA	Rated Power: 5VA Instrument
and Size	Instrument Size: 210 mm X 165 mm X	Size: 190 x 120 x 45 mm
	55 mm	Instrument Weight: 0.4 kg
	Instrument Weight: 0.750kg	Accuracy: ±2 ISQ units
	Accuracy: ±2ISQ units
Instrumentmaterials	ABS Plastic	Same
Probe materials	Probe: Thermoplastic elastomer,	Probe: PPSU , stainless steel
	medical grade USP class VI	Cable: silicone
	Osstell IDx	Predicate Device: Osstell ISQ K082523
	Cable: SiliconeCable connector: Naturalpolyestersulfone	Cable connector: Natural polyestersulfone
Device Display	Touch display - 155 x 94 mm	LCD - 64x 32-mm
Software Testingand Validation	Software verification and validationperformed.	Same
Mechanical/Electrical safety/Standards	The Osstell IDx was designed andconstructed with applicable standards	Same
Sterilecomponents/methods	Probe with cable /autoclaveSmartPeg /single patient use	Same
Contraindication	None	None
Location of Use	Dental practice or operating room.	Same
User	Professional clinicians	Same

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Conclusion:

Based on the results of the tests performed in the nonclinical testing and biocompatibility performed, the product is approved for its intended use in terms of Non clinical evaluation.

The modified Osstell IDx has the following similarities to the Osstell ISQ previously cleared in K082523:

has the same indications for use, .
uses the same operating principle, .
. has no change in single use components

Therefore the modification to the Osstell IDx 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.