The MEGA ISQ is an new generation of the Osstell ISQ, (K082523) the system is designed to measure dental implant stability in the oral cavity and maxillofacial region. Similar to K082523, the MEGA ISQ is a portable, handheld 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 dental 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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "MEGA ISQ" device, which is an updated version of the "Osstell ISQ" predicate device (K082523). The submission focuses on demonstrating substantial equivalence to the predicate, rather than proving novel performance.

Here's an analysis of the acceptance criteria and study information provided:

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

The submission does not present a formal table of acceptance criteria with corresponding performance metrics in the typical sense of a clinical study. Instead, the acceptance criteria are based on demonstrating equivalence to the predicate device through several nonclinical tests.

Acceptance Criteria Category	Specific Acceptance Criteria (Implied)	Reported Device Performance
Safety and Performance Equivalence	The device does not introduce new safety concerns or degrade performance compared to the predicate device.	"These minor differences do not affect the safety or performance of the device and do not change the intended use of the MEGA ISQ."
Electromagnetic Compatibility (EMC)	Conformance to EN IEC 60601-1-2 (Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic compatibility - Requirements and tests).	"The proposed device passed all applicable test per IEC 60601-1-2..."
Comparative Performance (Display)	Performance of the new LED display is equivalent to the predicate's display.	"...comparative testing of the new LED display... demonstrated equivalent performance to the declared predicate."
Comparative Performance (USB Interface)	Performance of the USB interface (now in a dock station) is equivalent to the predicate's USB interface.	"...performance of the USB interface... demonstrated equivalent performance to the declared predicate."
Material Biocompatibility	New materials used for the instrument and docking station are biocompatible and do not pose new risks.	"Material biocompatibility" (listed as a test) and "...biocompatibility of the new material demonstrated equivalent performance to the declared predicate."
Sterilization Parameters	Updated steam sterilization parameters conform to ANSI/AAMI/ST79:2010/A2:2011.	"Updated steam sterilization parameters in accordance with ANSI/AAMI/ST79:2010/A2:2011" (listed as a test). The text implies compliance.

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

The document does not describe a clinical test set with human subjects. The testing described is primarily non-clinical, focused on demonstrating engineering and material equivalence. Therefore, there is no sample size for a "test set" in a clinical sense, nor a provenance (country of origin or retrospective/prospective) for such data. The comparative performance testing was likely conducted in a lab setting.

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

This information is not applicable as there was no clinical test set requiring expert ground truth establishment. The "ground truth" for the non-clinical tests would be defined by engineering standards and predicate device specifications.

4. Adjudication method for the test set

Not applicable, as there was no clinical test set requiring adjudication.

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

An MRMC study was not done. The device is a direct measurement instrument (dental implant stability analyzer), not an AI-assisted diagnostic tool that would involve human readers.

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

This concept is not directly applicable to the MEGA ISQ as it's a measurement device, not an algorithm-based diagnostic tool. However, the core functionality of the device (Resonance Frequency Analysis) operates autonomously to generate an ISQ value. The "standalone" performance is implicitly covered by the "Comparative performance testing to predicate" and conformance to EMC standards. The device's mechanism for calculating ISQ is independent of human interpretation during the measurement process.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the non-clinical and comparative performance testing, the ground truth was based on:

Engineering Standards: For EMC testing (EN IEC 60601-1-2).
Predicate Device Specifications/Performance: For comparative performance of the display, USB interface, and material characteristics. The performance of the predicate device (Osstell ISQ, K082523) served as the benchmark.
Industry Standards: For sterilization parameters (ANSI/AAMI/ST79:2010/A2:2011).

8. The sample size for the training set

This is not applicable. The MEGA ISQ is a hardware device for physical measurement and does not involve machine learning or a "training set" in the context of AI.

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

Not applicable, as there is no training set for a machine learning algorithm.

Summary

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Applicant/

Section 6: 510(k) Summary

APR 0 9 2014

Manufacturer:	Osstell AB
	Stampgatan 14
	411 01 Göteborg
	Sweden
Establishment Registration Number: 3004070020
US Contact:	Cherita James
	M Squared Associates, Inc.
	901 King Street, Suite101
	Alexandria, VA 22314
	Ph: 703-562-9800 Ext 257
	Fax: 703-562-9797
	E-mail: CJames@MSquaredAssociates.com
Date prepared:	2014-04-07
Proprietary Name:	MEGA ISQ
Common Name:	Dental implant stability analyzer
Classification Status:	Class I
Product Codes:	EKX - handpiece, direct drive, ac-powered
Predicate Device:	Osstell ISQ (K082523)

Karin Breding

Device Description:

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Indication for Use:

The MEGA ISO 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 LED display .
. Removing the RAM memory
Removing the real time clock .
Move the USB interface to a dock station .
A new material is added to the instrument and docking station to improve grip ability .

These minor differences do not affect the safety or performance of the device and do not change the intended use of the MEGA ISQ. These changes were implemented to address the needs of the customer for a basic device which offers the same Resonance Frequency Analysis technology, but does not offer the capability of data storage. The relocation of the USB interface allows a reduce size, as well as allowing for a slightly larger display.

Summary of Nonclinical Testing:

Based on the Risk Analysis, the verification and validation tests that were performed and the acceptance criteria applied included:

. Conformance to EN IEC 60601-1-2
. Comparative performance testing to predicate
Material biocompatibility .
. Updated steam sterilization parameters in accordance with

ANSI/AAMI/ST79:2010/A2:2011

The proposed device passed all applicable test per IEC 60601-1-2, comparative testing of the new LED display, performance of the USB interface, and performance and biocompatibility of the new material demonstrated equivalent performance to the declared predicate.

Clinical Studies:

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

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Substantial Equivalence Discussion:

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

has the same indicated use, .
. uses the same operating principle,
incorporates the same basic device design and physical properties, .
has no change in autoclave or single use components, or device software .

The modified MEGA ISQ has the following differences to the Osstell ISQ previously cleared in K082523:

. Replaces the existing display with a LED display
. Removes the RAM memory
. Removes the real time clock
. Moves the USB interface to a dock station
A new material is added to the instrument and docking station to improve grip ability .

	MEGA ISQ	Predicate Device: Osstell ISQK082523
Indication for use	The MEGA ISQ is indicated for use in measuringthe stability of implants in the oral cavity andmaxillofacial region.	No change in Indication for Use
Operation ofSystem	The MEGA ISQ measures the frequency responsefrom Smartpeg that is directly attached to theimplant or abutment. The system includes thefollowing components: Instrument,Smartpeg/Measurement Probe, and PC DataManager Software.The technique involves a smartPeg (10 mm x 3mm) that is attached to the implant or abutment.The SmartPeg is excited over a range offrequencies (1 kHz to 10 kHz) and the resonancefrequency is measured with the MEGA ISQinstrument and software. The resonancefrequency is determined by the stiffness of theimplant system. The MEGA ISQ presents theresonance frequency as an Implant StabilityQuotient (ISQ) value (scaled 0-100). The ISQvalue is proportional to the stability of the implant.	No change in operation of system
SystemComponents-	Instrument	Instrument
	The Instrument is a portable , handheld instrument	The Instrument is a compact unit
		Predicate Device: Osstell I:K082523
	with a built-in LED display. The unit operatesfrom a rechargeable power source offering over1.5 hours of continuous use between charges. TheMeasurement Probe, connected to the instrument,is held close to the Smartpeg. The measurementprobe sends the excitation signal to the coil in theprobe, and also detects the response signal fromthe second coil in the probe. The microcontrollerin the instrument calculates the frequency of theresponse signal, and presents it on the display as anumber, the Implant Stability Index (ISQ).The instrument can be connected to a PC via theUSB cable and firmware can be updated.Smartpeg/Measurement Probe	with built-in graphical display.The unit operates from arechargeable power sourceoffering over 6 hours ofcontinuous use between charges.The Measurement Probe,connected to the instrument, isheld close to the Smartpeg. Themeasurement probe sends theexcitation signal to the coil in theprobe, and also detects theresponse signal from the secondcoil in the probe. Themicrocontroller in the instrumentcalculates the frequency of theresponse signal, and presents it on
	The stability of the implant is reflected by theresonance frequency of a "Smartpeg" attached tothe implant. The Smartpeg is a small aluminumrod, approximately 3 mm in diameter and 10 mmlong, with a magnet permanently attached to itstop. The Smartpeg is screwed onto the implant.The Smartpeg magnet is excited by a smallmagnetic pulse generated by a coil in themeasurement probe. The Smartpeg vibrates freelyat its resonance frequency for some milliseconds.Since the magnet attached to its top is vibratingtogether with the Smartpeg, the vibration (the"ringing") can be picked up by a second coil in themeasurement probe.	the display as a number, theImplant Stability Index (ISQ).Four hundred measurements maybe stored in the instrument.The instrument can be connectedto a PC via the USB cable andthe measurement data can betransferred to the optional ISQData Manager Software.Smartpeg/Measurement ProbeNo change to Smartpeg orMeasurement probe
	PC Data Manager SoftwareData transfer is not an option for the MEGA ISQ.	PC Data Manager SoftwareThe Osstell ISQ Data Manager isa Windows 2000/NT/XP/Vistabased software enabling storage,viewing and printing of patientdata.The Software is an optionalaccessory to the Osstell ISQ andis not integral to the functioning
Instrument andDocking Stationmaterials	ABS Plastic and Dryflex TPE	of the device.ABS PlasticLCD - 64mm x 32mm
Device Display	LED -58mm x 37mm

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Conclusion:

The change to display, RAM memory, Clock ,USB interface, and additional device material of the MEGA ISQ do not change the intended use nor do they affect the safety and effectiveness as compared to the Osstell ISQ previously cleared in K082523. Therefore the MEGA ISQ can be found substantially equivalent to the Osstell ISQ cleared in K082523.

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

April 9, 2014

Osstell AB C/O Ms. Cherita James Regulatory Consultant M Squared Associates, Incorporated 901 King Street, Suite 101 Alexandria, VA 22314

DEPARTMENT OF HEALTH & HUMAN SERVICES

Re: K132401

Trade/Device Name: MEGA ISQ Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EKX Dated: March 14, 2014 Received: March 18, 2014

Dear Ms. James:

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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Page 2 - Ms. James

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safetv/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

Sincerely vours.

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Image /page/6/Picture/7 description: The image shows a logo or stamp with the text "Tejashri Purohit-Sheth, M.D." and "Clinical Deputy Director". Below that is the word "DAGRID". The image also contains some decorative elements, including a stylized design on the left and a triangular shape on the right. The word "FOR" is at the bottom right.

Erin 1. Keith, M.S. 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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Section 5: Indications for Use Statement

510(k) Number (if known): _K132401

MEGA ISQ Device Name:

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

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

AND/OR ·

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Page 1 of __ 1_

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.