It is used to get an exact negative copy of the patient's dental situation and can be used for optical scanning in dental scanners designed for scanning impression material.

Device Description

Flexitime Monophase Pro Scan is an addition-cross-linking polyvinyl siloxane impression material. Flexitime Monophase Pro Scan is delivered in 380 ml cartridges and is part of the Flexitime Dynamix System. Flexitime Monophase Pro Scan is characterized by the addition of a scannable dye (for scannability). Flexitime Monophase Pro Scan was developed to complement flexitime Monophase regarding scannability and shore hardness, thus improving the impression taking especially for dental implants. Additionally the hydrophilic characteristics for optimal impression taking in the wet surroundings combined with good mechanical properties should be ensured. The mouth retention time for the product is 2.5 minutes.

Flexitime Monophase Pro Scan is for use in the Dynamix automatic dispensing and mixing svstem.

AI/ML Overview

The provided text is a 510(k) summary for a dental impression material, Flexitime Monophase Pro Scan. It focuses on establishing substantial equivalence to existing predicate devices based on physical properties, biocompatibility, and intended use.

Based on the provided document, the requested information for an acceptance criteria and study proving device performance is largely not applicable or not explicitly detailed in the context of a typical AI/medical device performance study.

This document is a regulatory submission for a dental impression material, not an AI or imaging device that would typically have performance metrics like sensitivity, specificity, or reader studies. The "study" mentioned here refers to non-clinical testing to ensure the material meets ISO standards and is biocompatible.

However, I can extract and structure the available information as best as possible to answer your questions where applicable, and note where information is missing or irrelevant to this type of device.

Acceptance Criteria and Device Performance for Flexitime Monophase Pro Scan

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Physical Properties	Compliance with ISO 4823 for addition-cross-linking polyvinyl siloxane impression materials.	"The physical properties of Flexitime Monophase Pro Scan... are in compliance with ISO 4823."
Biocompatibility	Verification in accordance with international standards (implied ISO 10993). Evaluation report should document positive benefit/risk relation.	"The biological compatibility of Flexitime Monophase Pro Scan was verified in accordance with the international standards." "A biocompatibility evaluation has been performed by a toxicologist for Flexitime Monophase Pro Scan and it was confirmed that the product meets the requirements of ISO 10993 Standard..." "a positive benefit versus risk ratio can be stated by the experts for Flexitime Monophase Pro Scan..."
Scannability	Prepared without requiring additional surface treatment for optical scanner in dental scanners designed for scanning impression materials (compared to predicate devices).	"Flexitime Monophase Pro Scan... are prepared without requiring additional surface treatment for optical scanner in dental scanners designed for scanning impression materials." (Compared to predicate "Flexitime Fast and Scan (K102770)"). "Flexitime Monophase Pro Scan is scannable without prior preparation as is required with the predicate device Flexitime Fast and Scan."
Risk Analysis	Safety for intended use is substantially equivalent to predicate devices, considering indications, warnings, and contraindications.	"The risk analysis was carried out for Flexitime Monophase Pro Scan and it is concluded that the safety of the Flexitime Monophase Pro Scan device for the intended use is substantially equivalent to the predicate devices."
Mouth Retention Time	Specific mouth retention time.	"The mouth retention time for the product is 2.5 minutes."
Shore Hardness	Complement Flexitime Monophase regarding shore hardness.	(Implicitly met by "Flexitime Monophase Pro Scan was developed to complement flexitime Monophase regarding scannability and shore hardness...") No specific numerical value provided, but the statement implies it meets the design goal.
Hydrophilic Characteristics	Ensure optimal impression taking in wet surroundings.	(Implicitly met by "...Additionally the hydrophilic characteristics for optimal impression taking in the wet surroundings combined with good mechanical properties should be ensured.") No specific metric provided, but the statement implies it meets the design goal.
Mechanical Properties	Good mechanical properties.	(Implicitly met by "...combined with good mechanical properties should be ensured.") No specific metric provided, but the statement implies it meets the design goal.

Regarding the other questions, they are largely not applicable to this type of regulatory submission for a dental impression material. This document is a 510(k) summary focused on demonstrating substantial equivalence to existing predicate devices, rather than a de novo clinical trial for a novel AI or diagnostic device.

Here's an assessment for each point:

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not Applicable in the typical sense. The "testing" referred to here are non-clinical lab tests for physical properties (ISO 4823 compliance) and biocompatibility (ISO 10993). The document does not specify sample sizes for these lab tests or their data provenance (e.g., country of origin, retrospective/prospective).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not Applicable. "Ground truth" in the context of diagnostic accuracy studies (e.g., for AI) is not relevant here. For biocompatibility, an unnamed "toxicologist" performed an evaluation, and "experts" were mentioned in concluding a positive benefit vs. risk ratio, but their number and specific qualifications are not detailed beyond "toxicologist."
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. This is specific to human reader studies or expert consensus for ground truth establishment, which is not described here.
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:
- Not Applicable. This is a dental impression material, not an AI-assisted diagnostic device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a dental impression material, not an algorithm.
The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- Not Applicable in the typical diagnostic sense. The "ground truth" for this device's performance would be compliance with ISO standards for physical properties and biocompatibility as determined by laboratory testing. For "scannability," the ground truth is simply whether it can be scanned without special preparation.
The sample size for the training set:
- Not Applicable. This is not an AI model, so there is no training set.
How the ground truth for the training set was established:
- Not Applicable. No training set exists for this type of device.

Summary

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ATTACHMENT 3

JUL 1 3 2012

510(k) Summary

Revised 2/20/12

510(k) summary of salety and effectiveness information for Flexitime Monophase Pro Scan

1. Submitter Information

Company Name:	Heraeus Kulzer, LLC
Company Address:	300 Heraeus Kulzer, LLCSouth Bend, IN
Company Phone:	(574) 299-5400
Contact Person:	Chris Holden

Date Summary prepared: November 2, 2011(Revised February 20, 2012)

2. Legally Market Devices to which Substantial Equivalence is claimed:

Heraeus Kulzer, GmBH - Flexitime Fast & Scan K102770 Heraeus Kulzer, GmBH - Flexitime Monophase K000629

3. Device Identification

Trade /Proprietary Name: Common Name: Classification: FDA Code:

Flextime Monophase Pro Scan Impression Material (21 CFR 872.3660) Class II Dental ELW

4. Device Description

Flexitime Monophase Pro Scan is for use in the Dynamix automatic dispensing and mixing svstem.

Intended Use

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Flexitime Monophase Pro Scan is used, to get an exact negative copy of the patient's dental situation andigan be used for optical scanning in dental scanners designed for scanning impression materials.

6. Technological Characteristics

The physical properties of Flexitime Monophase Pro Scan like Flexitime Fast and Scan (K102770) and Flexitime Monophase (K000629) are in compliance with ISO 4823.

Both Flexitime Monophase Pro Scan and Flexitime Fast and Scan (K102770) are prepared without requiring additional surface treatment for optical scanner in dental scanners designed for scanning impression materials.

7. Nonclinical Testing

The biological compatibility of Flexitime Monophase Pro Scan was verified in accordance with the international standards.

The biocompatibility of Flexitime Monophase Pro Scan in the aforementioned indication was documented in a biocompatibility evaluation report and the benefit/risk relation has been judged as positive.

Considering the evaluated scientific data and technical results for Flexitime Monophase Pro Scan it is concluded that the products can be expected to exhibit the claimed technical performance and that potential undesirable clinical effects and risks seem well controlled and accepted, when weighed against their benefit to dentistry. Therefore, a positive benefit versus risk ratio can be stated by the experts for Flexitime Monophase Pro Scan, provided that the products applied in accordance with its intended use as outlined in the manufacturer's instructions for use.

8. Summary of Conclusion

Flexitime Monophase Pro Scan is substantially equivalent to Flexitime Fast & Scan and Flexitime Monophase. All of the products are indicated for taking impression materials of suited techniques. In addition, Flexitime Monophase Pro Scan is scannable without prior preparation as is required with the predicate device Flexitline Fast and Scan.

A biocompatibility evaluation has been performed by a toxicologist for Flexitime Monophase Pro Scan and it was confirmed that the product meets the requirements of ISO 10993 Standard and it is concluded that the safety of Flexitime Monophase Pro Scan is equivalent to that of the predicate devices.

The risk analysis was carried out for Flexitime Monophase Pro Scan and it is concluded that the safety of the Flexitime Monophase Pro Scan device for the intended use is substantially equivalent to the predicate devices. Flexitime Monophase Pro Scan and the predicate devices both have the same indications for use, warnings and contraindications. When used in accordance with the instructions for use, by qualified personnel, Flexitime Monophase Pro Scan is substantially equivalent to the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.

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

Ms. Jamie L. Mearna Ouality Assurance & Regulatory Affairs Heraeus Kulzer, LLC 300 Heraeus Way South Bend, Indiana 46614

JUL 13 2012

Re: K113574

Trade/Device Name: Flexitime Monophase Pro Scan Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: II Product Code: ELW Dated: May 31, 2012 Received: July 11, 2012

Dear Ms. Mearna:

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. Mearna

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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

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

KII 3574 510(k) Number (if known):

Device Name: Flexitime Monophase Pro Scan

Indications for use:

It is used to get an exact negative copy of the patient's dental situation and can be used for optical scanning in dental scanners designed for scanning impression material.

Prescription Use 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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Russ

Page 1 of of ー

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

510(k) Number: TC113374

Regulation Number and Section

§ 872.3660 Impression material.

(a)
Identification. Impression material is a device composed of materials such as alginate or polysulfide intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.(b)
Classification. Class II (Special Controls).