Tigran™ PeriBrush™ is a debridement instrument for titanium dental implants subjected to peri-implantitis. It is indicated for the open debridement of titanium Implant surfaces in bone defects caused by peri-implantitis.

Device Description

The Tigran™ PeriBrush™ is made of pure titanium (brush part) and nitinol (stem part). It is intended to use for mechanical debridement of surgically exposed dental titanium implant surfaces to remove plaque and calculus due to peri-implantitis. The product has a connector that fits into the head (chuck) of a dental handpiece accepting instruments complying with ISO 1797-1. The instrument is delivered sterile. The Tigran™ PeriBrush™ is for single use only.

AI/ML Overview

Here's an analysis of the acceptance criteria and supporting study for the Tigran™ PeriBrush™ based on the provided document:

This device (Tigran™ PeriBrush™) is a Class II medical device that appears to have gone through the 510(k) premarket notification pathway, which means it demonstrated substantial equivalence to a previously legally marketed device (the predicate device). In this regulatory pathway, the primary "acceptance criteria" is typically showing that the new device is as safe and effective as the predicate device, often through comparisons of technological characteristics and performance testing. A formal prospective clinical trial with specific performance metrics and acceptance thresholds (e.g., sensitivity, specificity for diagnostic devices) is usually not required for 510(k) substantial equivalence.

Based on the provided text, the "study" demonstrating the device meets acceptance criteria is primarily a comparative study against a predicate device and pre-clinical performance testing.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied for 510(k))	Reported Device Performance
Intended Use Equivalence: Same intended use as predicate device.	Tigran™ PeriBrush™ has the same intended use as the predicate device (Straumann® TiBrush, K111724): "mechanical debridement of dental titanium implant surfaces to remove plaque and calculus due to peri-implantitis."
Technological Characteristics Equivalence: Similar materials, design principles, and operating mechanisms to predicate.	Materials: Made of pure titanium (brush part) and nitinol (stem part). (Implicitly considered equivalent to predicate). Mechanism: Removes contaminants from the surface of implants using a rotating brush with stiff titanium bristles and a flexible stem. (Implicitly considered equivalent to predicate).
Safety: Biocompatibility validation, sterilization validation.	Biocompatibility: Conducted in accordance with ISO 10993-5; all materials met relevant standards. Sterilization: Validation conducted in accordance with ISO 11137.
Performance/Effectiveness: Ability to perform mechanical surface debridement as intended.	Mechanical Tests & Simulated Clinical Performance Tests: Allows for mechanical surface debridement. The preclinical tests support that the device, when used as intended, is substantially equivalent. "Clinical evaluation showed that the brush is substantially equivalent."
Conclusion: Functions as intended and is substantially equivalent to the predicate.	"The results from the testing conducted demonstrated that the Tigran™ PeriBrush™ functions as intended and is substantially equivalent."

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

Sample Size: The document does not specify a numerical sample size for "mechanical tests and simulated clinical performance tests" or the "clinical evaluation." It generally refers to "preclinical tests" and "clinical evaluation" without quantifying participants or samples.
Data Provenance: Not explicitly stated, but given Tigran Technologies AB is located in Sweden, it is likely some, if not all, of the data originated from (or was supervised by) European entities. The terms "retrospective" or "prospective" are not used in the document for any studies. The "clinical evaluation" may imply prospective data collection, but this is not confirmed.

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

This information is not provided in the document. For a 510(k) substantial equivalence submission, particularly for a mechanical debridement tool, the concept of "ground truth" derived from expert consensus (as one might see for AI diagnostic tools) is generally not applicable in the same way. The "ground truth" for this device is its physical ability to debride surfaces, which is assessed through mechanical and simulated tests and, possibly, observational clinical evaluation.

4. Adjudication Method for the Test Set

This information is not provided and is generally not relevant for this type of device and regulatory pathway. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical trials or studies where multiple readers assess outputs (like images) and resolve discrepancies, which does not appear to be the nature of the evaluation performed here.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, an MRMC comparative effectiveness study was not done. This type of study focuses on the performance of human readers/interpreters, often with and without AI assistance, and is not applicable to a mechanical debridement tool like the Tigran™ PeriBrush™.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone (algorithm-only) study was not done. This concept is relevant for software algorithms or AI tools, not for a physical mechanical device like the Tigran™ PeriBrush™. The device itself is the instrument, and its performance is evaluated in its intended use, typically by a human operator.

7. The Type of Ground Truth Used

For the performance testing:
- Mechanical performance: Likely based on objective measurements (e.g., surface cleanliness, material removal efficiency) established by engineering standards or internal validation protocols.
- Biocompatibility: Based on established ISO 10993-5 standards for material safety.
- Sterilization: Based on established ISO 11137 standards for sterility assurance.
- Clinical evaluation: The "ground truth" here would be the observed effectiveness of the debridement procedure, potentially compared to the predicate device, as assessed by clinicians or through patient outcomes (though specific metrics are not detailed). It emphasizes the device's ability to clean implant surfaces "to remove plaque and calculus due to peri-implantitis."

8. The Sample Size for the Training Set

No training set is mentioned or applicable. This device is a physical, mechanical instrument, not an AI/ML algorithm that requires a "training set" to learn.

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

Not applicable. As stated above, there is no training set for this type of device.

Summary

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Tigran™ PeriBrush™

2012

510(k) SUMMARY

1. SUBMITTER INFORMATION

Name:	Tigran Technologies AB
Address:	Medeon Science ParkSE-205 12 MalmöSweden
Telephone:	+46 40 6939270
Facsimile:	+46 40 650 1666
Contact Person:	Ulf Lundgren, Quality Assurance and Regulatory Manager
Date:	12th of September 2012

2. DEVICE IDENTIFICATION

Trade Name: Tigran™ PeriBrush™ PeriBrush™ Common Name: Classification Name: Scaler, Rotary

3. DEVICE CLASSIFICATION

Device Code:	Rotary Scaler, ELB
Predicate Device	Straumann® TiBrush, K111724

4. DEVICE DESCRIPTION

The instrument is delivered sterile. The Tigran™ PeriBrush™ is for single use only.

5. INTENDED USE

Tigran™ PeriBrush™ is intended for:

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6. SUBSTANTIAL EQUIVALENCE

In summary, Tigran™ PeriBrush™, is substantially equivalent to the cited predicate device, Straumann® TiBrush, K111724.

They have the same intended use designed for mechanical debridement of dental titanium implant surfaces to remove plaque and calculus due to peri-implantitis.

. Straumann® TiBrush, K111724

7. TECHNOLOGICAL CHARACTERISTICS

Tigran™ PeriBrush™, is substantially equivalent to the cited predicate device. Following bone loss caused by peri-implantitis, parts of the implant surface becomes exposed to the oral microflora. Before steps towards regenerating the lost bone and reosseointegration of the implant can be taken, the exposed implant surface must be clean from any contamination that could hamper the treatment outcome. This means that the granulation tissue, calculus and/or other macrostructures like excess cementum must be removed.

The device removes contaminants from the surface of the implants. The rotating Tigran™ PeriBrush™ with stiff titanium bristles and flexible stem.

8. PERFORMANCE TESTING

Mechanical tests and simulated clinical performance tests allows for mechanical surface debridement. It is reasonable to state and conclude that the preclinical tests support that Tigran™ Peribrush™, when used as intended under normal conditions, is substantially . equivalent.

Biocompatibility testing was conducted in accordance with ISO 10993-5, and all materials tested met the relevant standards.

Sterilization validation was conducted in accordance with ISO 11137.

Clinical evaluation showed that the brush is substantially equivalent.

9. CONCLUSION

The results from the testing conducted demonstrated that the Tigran™ PeriBrush™ functions as intended and is substantially equivalent.

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

Tigran Technologies AB
Mr. Ulf Lundgren
Quality Assurance and Regulatory Manager
Medeon Science Park
SE-205 12 Malmö, Sweden

SEP 17 2012

Re: K121114

Trade/Device Name: TigranTM PeriBrushTM Regulation Number: 21 CFR 872.4840 Regulation Name: Rotary Scaler Regulatory Class: II Product Code: ELB Dated: August 21, 2012 Received: August 24, 2012

Dear Mr. Lundgren:

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. e 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- Mr. Lundgren

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 go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

W for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE

510(k) Number: _______________________________________________________________________________________________________________________________________________________________

Device Name: Tigran™ PeriBrush™

Indications for Use:

Prescription Use	X	And/Or	Over-The-Counter Use
(Part 21 CFR 801 Subpart D)			(21 CFR 807 Subpart C)

(Division Sign-Off)

Division of Anesthesiology, General Hospital

Infection Control, Dental Devices

510(k) Number: K122114

2012-03 Concurrence of CDRH, Office of Device Evaluation (ODE) 4-2

Regulation Number and Section

§ 872.4840 Rotary scaler.

(a)
Identification. A rotary scaler is an abrasive device intended to be attached to a powered handpiece to remove calculus deposits from teeth during dental cleaning and periodontal (gum) therapy.(b)
Classification. Class II.