The Osstell® ISQ Implant Stability Meter is an updated version of the Osstell Mentor (K033689). The system is designed to measure dental implant stability in the oral cavity and craniofacial region. Similar to K033689, the Osstell 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 unfortunately does not contain detailed information about acceptance criteria or a specific study proving the device meets these criteria in the way typically expected for a detailed scientific or regulatory report.

The document is a 510(k) Premarket Application for the Osstell® ISQ Implant Stability Meter, indicating it's an updated version of a previously cleared device (Osstell Mentor). The primary focus of this document is to demonstrate "Substantial Equivalence" to the predicate device, not to present a comprehensive de novo study validating new performance criteria or clinical efficacy.

However, I can extract the available information and structure it as requested, acknowledging the limitations of the provided text.

Here's an analysis based on the given text:

Description of the Device and its Purpose:

The Osstell® ISQ Implant Stability Meter is a portable, handheld instrument designed to measure dental implant stability using Resonance Frequency Analysis (RFA). It uses a SmartPeg attached to the dental implant which is excited by a magnetic pulse. The resonance frequency, an indicator of implant stability, is calculated and displayed as an Implant Stability Quotient (ISQ). The device is indicated for use in measuring the stability of implants in the oral cavity and craniofacial region, adding information to implant stability evaluation.

Reason for 510(k) Application:

The modifications from the predicate device (Osstell Mentor) include changes to circuit boards, integration of a docking station, and software. The application states these do "not affect the safety or performance of the device and do not change the intended use."

Acceptance Criteria and Study Details (Based on available information):

Due to the nature of a 510(k) for a modified device seeking substantial equivalence, specific "acceptance criteria" and detailed "device performance" in terms of clinical outcomes or comparative efficacy found in a de novo study are not explicitly stated in the provided text. Instead, the focus is on demonstrating that the modifications do not negatively impact safety or performance compared to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied/Stated Goal)	Reported Device Performance (as stated in the document)
Maintain the safety and performance of the predicate device (Osstell Mentor K033689).	"The modifications... do not affect the safety or performance of the device and do not change the intended use of the Osstell ISQ." "Performance testing was conducted to confirm compliance to design specifications; all functions were verified to operate as designed." "The Osstell ISQ was subject to the same preclinical requirements as the predicate device."
Compliance with design specifications of the modified components (circuit boards, software).	"Performance testing was conducted to confirm compliance to design specifications; all functions were verified to operate as designed." (No specific numerical performance metrics are provided in this summary.)
Continued equivalence to the predicate device.	"The change to the circuit boards, integration of the docking station, and the software of the Osstell ISQ do not change the intended use nor do they affect the safety and effectiveness as compared to the Osstell Mentor previously cleared in K033689." "The modified Osstell ISQ has the following similarities to the Osstell Mentor previously cleared in K033689: same indicated use, same operating principle, same basic device design and physical properties, same materials."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not explicitly stated. The document refers to "verification and validation tests" and "Performance testing" but does not provide numbers for test sets used.
Data Provenance: Not explicitly stated. Given that this is a 510(k) for a device from a Swedish company (Osstell AB, Goteborg, Sweden) and the "Summary of Nonclinical Testing" mentions testing for compliance to design specifications, it's highly likely that this testing was internal, conducted by the manufacturer, and likely occurred at their facilities or approved contract labs. The document does not indicate prospective clinical trials or retrospective studies from specific countries for this specific submission's performance validation.

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

This information is not provided in the text. Since this is a submission focused on technical modifications and substantial equivalence validation (primarily non-clinical performance testing), there is no mention of expert-established ground truth for a clinical test set in the provided summary.

4. Adjudication Method for the Test Set

This information is not provided in the text. Adjudication methods are typically relevant for clinical studies involving multiple reviewers, which is not described here.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study is not mentioned or described in the provided text. The document focuses on the device itself and its technical modifications, not on comparing human reader performance with and without AI assistance (as the device is a measurement tool, not an AI diagnostic aid).

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

The device itself, the Osstell ISQ, is a standalone measurement instrument. Its "performance testing" described in the summary would be standalone, verifying its ability to accurately measure resonance frequency and calculate ISQ values as designed. However, the text does not detail the methodology or specific results of such standalone testing beyond stating that "Performance testing was conducted to confirm compliance to design specifications; all functions were verified to operate as designed."

7. The type of Ground Truth Used

For the non-clinical performance testing mentioned, the "ground truth" would generally be the engineering specifications and expected outputs of the device's components and software. This would involve calibrated test equipment and established reference standards to verify that the device accurately measures resonance frequency and computes the ISQ within acceptable tolerances.
For the broader claim of "safety and effectiveness" remaining equivalent to the predicate, the "ground truth" is established by the prior clearance of the Osstell Mentor (K033689), implying its established clinical utility and safety for measuring implant stability. This submission leverages that established utility rather than generating new clinical ground truth.

8. The Sample Size for the Training Set

This information is not provided. As the device is a measurement instrument based on physical principles (Resonance Frequency Analysis) and signal processing, it is not described as utilizing a "training set" in the context of machine learning algorithms. The software changes are mentioned, but not in a way that suggests a trainable algorithm requiring a data-based training set.

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

As a "training set" is not indicated to be part of the device's development or validation, this question is not applicable based on the provided text.

Summary

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

510(k) Premarket Application

Image /page/0/Picture/2 description: The image shows the text "Section 6: 510(k) Summary" along with the number K082523 written above it. The text is written in a clear, sans-serif font and is positioned at the bottom of the image. The number is handwritten in cursive and underlined.

SEP 2 6 2008

Applicant/Manufacturer:	Satu KomulainenOsstell ABGamlestadsvagen 3 B415 02 GoteborgSweden
Establishment Registration:	3004070020
US Contact:	Cherita JamesM Squared Associates, Inc.901 King Street, Suite 200Alexandria, VA 22314Ph: 703-562-9800 Ext 257Fax: 703-562-9797E-mail: CJames@MSquaredAssociates.com
Date submitted:	September 2, 2008
Proprietary Name:	Osstell® ISQ Implant Stability Meter
Common Name:	Dental implant stability analyzer
Classification Status:	Class I
Product Codes:	EKX - handpiece, direct drive, ac-powered
Predicate Device:	Osstell Mentor Resonance Frequency Analyzer (K033689)

Device Description:

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

2 4 3

510(k) Premarket Application

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.

Indication for Use:

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

Summary of Technological Characteristics:

The modifications to the Osstell Mentor since its previous clearance in K033689 include change to the circuit boards, integration of the docking station, and the software. These minor differences do not affect the safety or performance of the device and do not change the intended use of the Osstell ISQ.

Summary of Nonclinical Testing:

Based on the Risk Analysis, the verification and validation tests that were performed and the acceptance criteria applied for each are listed in Section 10. The Osstell ISQ was subject to the same preclinical requirements as the predicate device. Performance testing was conducted to confirm compliance to design specifications; all functions were verified to operate as designed.

Substantial Equivalence Discussion:

The change to the circuit boards, integration of the docking station, and the software of the Osstell ISQ do not change the intended use nor do they affect the safety and effectiveness as compared to the Osstell Mentor previously cleared in K033689.

Conclusion:

The modified Osstell ISQ has the following similarities to the Osstell Mentor previously cleared in K033689:

has the same indicated use, .
uses the same operating principle, .

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

3583

incorporates the same basic device design and physical properties, .
incorporates the same materials. .

Therefore the modification to the Osstell ISQ can be found substantially equivalent to the Osstell Mentor cleared in K033689.

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

Public Health Service

Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with a serpent coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The caduceus is depicted in black, and the text is also in black against a white background. The overall design is simple and professional, reflecting the organization's role in public health and human services.

FEB 17 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Osstell AB c/o Ms. Cherita James Regulatory Consultant M Squared Associates, Incorporated 901 King Street, Suite 200 Alexandria, Virginia 22314

Re: K082523

Trade/Device Name: Osstell® ISQ Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EKX Dated: September 2, 2008 Received: September 2, 2008

Dear Ms. James:

This letter corrects our substantially equivalent letter of September 2, 2008

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 (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.

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.

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

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); 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.

This letter will allow you to continue marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-3773 http://www.fda.gov/cdrh/ organiz.html#OCfor OC organization structure). Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Syrite Y. Michie Durs

Ginette Y. Michaud, M.D. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

/ 08/

510(k) Premarket Application

2523 Section 5: Indications for Use Statement

510(k) Number (if known): __

Device Name: Osstell® ISQ

Indications For Use: Osstell® ISQ Implant Stability Meter is indicated for use in measuring the stability of implants in the oral cavity and craniofacial region.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) . . . . .. 1

Concurrence of CDRH, Office of Device Evaluation (ODE)

Syra Punna

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K082523

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

Osstell September 2, 2008

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.