PECD-01 and PECD Quick-01 are polyether tray impression materials of medium-bodied consistency. They are designed to be used in 3M ESPE's mixing, dosing and dispensing device, Garant™.

AI/ML Overview

The provided text is a 510(k) summary for a dental impression material (PECD-01 and PECD Quick-01). As such, it focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and study results in the manner typically found for a diagnostic device.

Therefore, many of the requested details about acceptance criteria, study methodologies, and performance metrics (especially those related to clinical accuracy, human reader performance, or ground truth derivation from pathology/outcomes data) are not present in this document. The safety and effectiveness are primarily established through biocompatibility testing and by demonstrating that the new device has the same fundamental scientific technology and intended use as the predicates, and that performance data are comparable.

Here's a breakdown of the information that can be extracted or inferred based on the provided text, and where information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present specific numerical acceptance criteria or detailed performance metrics. The primary "acceptance criteria" presented is substantial equivalence to the predicate devices based on chemistry, performance data, and indications for use.

Acceptance Criteria Category	Specific Criteria (from document)	Reported Device Performance (from document)	Notes from provided text
Safety	Biocompatibility	"The results show that PECD-01 and PECD Quick-01 are safe devices."	This is a qualitative statement of safety based on biocompatibility testing. No specific numerical thresholds are provided.
Effectiveness/Performance	Comparable to predicate devices (Impregum™ Penta™ M Monosoft, Poly Q Penta M, Ramitec Penta)	"The comparison for chemistry, performance data and indications for use shows that PECD-01 and PECD Quick-01 are substantially equivalent to the predicate devices."	The core claim is substantial equivalence. The document states "performance data" was compared but does not specify what this data was (e.g., tear strength, dimensional stability, working time, etc.) nor does it provide quantitative results or acceptance thresholds for these.
Chemical Composition	Modified but fundamental character unchanged from predicate (Impregum™ Penta™ M Monosoft)	"The modification is in chemical composition but, however, the fundamental character of the chemistry of Impregum Penta M Monosoft was not changed."	This emphasizes that despite chemical modification, the core nature remains the same, contributing to the claim of substantial equivalence.
Intended Use	Same as predicate devices	"PECD-01 and PECD Quick-01 have the same fundamental scientific technology and the same intended use as Impregum Penta M Monosoft."	The device is intended for "Impressions for inlay, onlay, crown, and bridge restorations, Functional impressions, Fixation impressions, Implant impressions." This matches the predicate's intended use.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not specified. The document refers to "biocompatibility testing" and "performance data" without detailing the number of samples or tests conducted.
Data Provenance: Not explicitly stated. The submitting company is 3M ESPE AG, based in Germany. It is reasonable to infer the testing was likely conducted in Germany or a location affiliated with the manufacturer, but this is not explicitly mentioned. No information on retrospective or prospective studies.

3. 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 / Not specified. This type of study (e.g., involving expert consensus for ground truth) is typically associated with diagnostic devices, not material science evaluations of dental impression materials for 510(k) submission where "substantial equivalence" is the primary goal.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable / Not specified. Adjudication methods are relevant for studies involving human interpretation or subjective assessments, which are not detailed for this material science submission.

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

No. This is not a diagnostic device or an AI-assisted tool. Therefore, an MRMC comparative effectiveness study is not relevant and was not performed.

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

No. This is a material, not an algorithm.

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

For biocompatibility testing, the "ground truth" would be established by standardized toxicological and biological tests according to relevant ISO standards (e.g., ISO 10993 series), comparing results against established safety limits or predicate device performance. For "performance data" (e.g., physical properties), the ground truth would be established by standard test methods (e.g., ISO 4823 for dental elastomeric impression materials) measuring specific properties and comparing them to predicate devices or industry standards. The document does not specify these standards or the exact "ground truth" used beyond stating "biocompatibility testing" and "performance data" were conducted.

8. The sample size for the training set

Not applicable / Not specified. This is not a machine learning or AI device that requires training data.

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

Not applicable / Not specified. This is not a machine learning or AI device.

Summary

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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

MAR 2 6 2008

Submitter

Company:	3M ESPE AG
Street:	ESPE Platz
ZIP-Code, City:	D-82229 Seefeld
Federal State:	Bavaria
Country:	Germany
Establishment Registration Number	9611385
Official Correspondent:	Dr. Andreas Petermann,Manager Regulatory Affairs
Phone:	011-49-8152-700 1395
Fax:	011-49-8152-700 1869
E-mail:	Andreas.Petermann@mmm.com
Date:	February 18, 2008
Name of Devices
Proprietary Name:	PECD-01PECD Quick-01
Classification Name:	Impression material
Common Name:	Dental impression material
Predicate Devices
Impregum™ Penta™ M Monosoft by 3M ESPE	K994192

Poly Q Penta M by 3M ESPE. ..........................................................................................................................K032001 Ramitec Penta by 3M ESPE .....................................................................................................................................................

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Description for the Premarket Notification

PECD-01 and PECD Quick-01 are classified as Impression material (21 C.F.R. § 872,3660) because the products are devices intended to reproduce the structure of a patient's teeth.

3M ESPE is submitting this 510(k) premarket notification for modifications to its polyether based impression material Impregurn Penta M Monosoft. The modification is in chemical composition but, however, the fundamental character of the chemistry of Impregum Penta M Monosoft was not changed. Like Impregum Penta M Monosoft, PECD-01 and PECD Quick-01 are polyether tray impression materials of medium-bodied consistency. While Impregum Penta M Monosoft is intended to be used in 3M ESPE's automatic mixing, dosing and dispensing device Pentamix, PECD-01 and PECD Quick-01 are designed to be used in 3M ESPE's mixing, dosing and dispensing device, Garant™.

PECD-01 and PECD Quick-01 have the same fundamental scientific technology and the same intended use as Impregum Penta M Monosoft.

To provide evidence for safety biocompatibility testing was carried out. The results show that PECD-01 and PECD Quick-01 are safe devices.

The comparison for chemistry, performance data and indications for use shows that PECD-01 and PECD Quick-01 are substantially equivalent to the predicate devices.

In summary, it can be concluded that safety and effectiveness requirements for PFCD-01 and PECD Quick-01 are completely met.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white and appears to be a simple, clean design.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Dr. Desi W. Soegiarto Regulatory Affairs Specialist 3M ESPE AG Dental Products ESPE Platz Seefeld. Bavaria, GERMANY D-82229

MAR 2 6 2008

Re: K080514

Trade/Device Name: PECD-01, PECD Quick-01 Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: II Product Code: ELW Dated: February 18, 2008 Received: February 25, 2008

Dear Dr. Soegiarto:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 - Dr. Soegiarto

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 begin 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) 276-0115. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Smith K. Michie Davis

Chiu Lin, Ph.D. 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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K 080514

Indications for Use

510(k) Number (if known):

Device Name:

Indications For Use:

PECD-01, PECD Quick-01

Impressions for inlay, onlay, crown, and bridge

restorations

Functional impressions

Fixation impressions

Implant impressions

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Albut Betz aos for Dr. Runner

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

Page 1 of __

510(k) Number: K080514

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).