PalaXpress ultra was developed as an auto-polymerizing denture and differs from the substantially equivalent device Palapress vario in the increased fracture resistance compared with that material. The product was developed as an autopolymerizing universal denture base material.

The product consists of powder in various shades (pink veined, link live, pink opaque, R50 veined, clear, light pink, light reddish pink, shade 200, dark pink) and liquid. 80 ml or 500 ml of liquid is supplied in brown glass bottles in an outer cardboard box, the 100 g or 1000 g powder is supplied in square HD-PE bottles in a outer cardboard box. 12000 g are available upon request.

To make sure denture, powder and liquid are mixed, in a ratio of 30 g : 15 ml (2:1) for the injection procedure, and in a ratio of 10 g powder : 7 ml liquid for the pouring procedure, Polymerization time in the pressure vessel is 30 min, at a water temperature 55°C and a pressure of 2 bar.

The material has a shelf life of 42 months and complies with the requirements of ISO 20795-1:2008 for denture base polymers.

AI/ML Overview

Please note: The provided text describes the PalaXpress ultra, a denture base material. The concept of "acceptance criteria" and related study details you've requested (sample sizes, expert consensus, MRMC studies, standalone performance, training sets) are typically associated with the evaluation of artificial intelligence (AI) or diagnostic devices. This document does not describe such a device or AI-related study.

However, I will extract the closest analogous information available in the document to address your request as best as possible, focusing on the material's compliance with established standards and its claimed performance.

Here's the information based on the provided text, adapted to your request where applicable, and highlighting where the requested information is not available due to the nature of the device:

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

Acceptance Criteria (Standard / Property)	Reported Device Performance
Material Properties (ISO 20795-1:2008 for denture base polymers)
Fracture Resistance	Increased fracture resistance compared to substantially equivalent device Palapress vario.
All other properties	Complies with and exceeds the requirements of ISO 20795-1:2008.
Shelf Life	42 months
Biocompatibility (ISO 10993-1)
Cytotoxicity	Met requirements
Sensitization	Met requirements
Irritation / Intracutaneous Reactivity	Met requirements
Subacute / Subchronic Toxicity	Met requirements
Genotoxicity	Met requirements
Clinical Performance (MEDDEV 2.7.1)	Exhibited expected performance and clinical effectiveness without undesirable effects when used as instructed.
Benefit/Risk Ratio	Judged as positive.
Compliance with MDD 93/42/EEC and National European Medical Device Legislation	Meets all relevant requirements.

Explanation:
The "acceptance criteria" here are drawn from the relevant international standards (ISO 20795-1 for material properties, ISO 10993-1 for biocompatibility) and regulatory guidelines (MEDDEV 2.7.1 for clinical evaluation, Medical Device Directive 93/42/EEC). The "reported device performance" reflects whether the device met or exceeded these standards as stated in the submission.

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

Sample size for test set: Not explicitly stated. The document refers to "test results" and "evaluated data" but does not provide specific sample sizes for property testing or biocompatibility assessments.
Data provenance: The standard compliance tests (ISO 20795-1, ISO 10993-1) and clinical evaluation (MEDDEV 2.7.1) were conducted as part of the manufacturer's regulatory assessment for European medical device legislation. The submission is from Heraeus Kulzer, GmbH (Germany) and submitted to the US FDA. The studies were likely performed in Europe. The data is retrospective in the sense that it was generated for internal regulatory purposes before submission.

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/available for this type of device. The "ground truth" for a material like PalaXpress ultra is established by adherence to specified physical, chemical, and biological properties as defined by international standards (e.g., ISO) and regulatory requirements, not by expert consensus on interpretations of images or clinical outcomes in the way an AI diagnostic device would be.

4. Adjudication method for the test set

This information is not applicable/available for this type of device. Adjudication methods (like 2+1 or 3+1) are common in clinical trials or studies involving expert assessment of ambiguous cases for diagnostic tools. For a material properties and biocompatibility study, the "adjudication" is typically the successful completion and approval of tests according to established protocols and standards.

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

This information is not applicable/available. An MRMC study is relevant for diagnostic devices (especially those involving image interpretation) to compare the performance of human readers, with and without AI assistance. PalaXpress ultra is a denture base material, not an AI-powered diagnostic tool.

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

This information is not applicable/available. This question is relevant for AI algorithms. PalaXpress ultra is a physical material, not an algorithm.

7. The type of ground truth used

The "ground truth" for PalaXpress ultra is based on:

Standard Specifications: Compliance with material properties defined by ISO 20795-1:2008 for denture base polymers.
Biocompatibility Standards: Adherence to biological safety requirements specified by ISO 10993-1.
Clinical Evaluation: Assessment against the expected clinical performance and safety benchmarks outlined in MEDDEV 2.7.1.

8. The sample size for the training set

This information is not applicable/available. There is no "training set" in the context of developing a physical dental material like PalaXpress ultra, unlike machine learning models. The development process involves iterative formulation and testing, but not a formally defined "training set" for an algorithm.

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

This information is not applicable/available as there is no "training set" for this product as described in machine learning contexts. The "ground truth" for the development and validation of the material's properties was established through adherence to the aforementioned ISO standards and regulatory guidelines during the material formulation and testing phases.

Summary

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K110037

APR 2 9 2011

510(k) Summary of Safety and Effectiveness of PalaXpress ultra

(1) Submitter's name

Heraeus Kulzer, LLC (for Heraeus Kulzer, GmbH) 300 Heraeus Way South Bend, Indiana 46614

Contact person: Cheryl V. Zimmerman + 574 299-5444 Phone:

Date summary was prepared: 2011-03-11

(2) Name of Device

Trade name - PalaXpress ultra Classification name - Denture relining, repairing, or rebasing resin (872.376) Class - II

(3) Substantial equivalence

PalaXpress ultra, liquid and powders, is substantially equivalent with Palapress vario, liquid and powders, 510(k) No. K902115 Main component of both liquids is methyl methacrylate and dimethacrylates, of the powders polymethyl methacrylate

(4) Description of the device

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The material has a shelf life of 42 months and complies with the requirements of ISO 20795-1:2008 for denture base polymers.

(5) Intended use

PalaXpress ultra is a denture base material to be used with injection or pouring techniques for fixed and removable dentures:

Injection technique: Full maxillary and mandibular prostheses Implant overdenture Pour technique: Implant overdenture Partial dentures, multiple or single saddles Marginal contour and reshaping Repair and additions Relines Dental splints

(6) Summaries and Conclusion

(a) Technological Characteristics
PalaXpress ultra was developed as an auto-polymerizing resin with increased fracture resistance. In all other properties it is compared with the essentially equivalent auto-polymerizing denture base resin Palapress vario. The attained increase fracture resistance has no influence during the fabrication of the denture, but will, in the final dental prosthesis, benefit the patient in so far as it will not break as easily as a denture fabricated from a conventional autopolymerizing denture base material.

(b) Nonclinical tests and clinical tests/evaluations

(1) Nonclinical tests: In accordance with the Medical Device Directive 93/42/EEC and National European medical device legislation, any medical device, must be evaluated by the legal medical device manufacturer regarding its clinical performance and safety. This includes an evaluation of biocompatibility in accordance with ISO 10993-1. As PalaXpress ultra is exclusively used for the fabrication, completion, repair or relining of denture bases as well as implantsupported prostheses and dental splints, it can be concluded that there is only contact with the mucosa. The duration of contact of PalaXpress ultra is > 30 days. According to this classification, (DIN EN ISO 10993-1, Table 1) the following tests must be considered:
Cytotoxicity, Sensitization, Irritation / intracutaneous reactivity, Subacute / Subchronic toxicity, Genotoxicity. On the basis of the test results, the biocompatibility of PalaXpress ultra in the aforementioned indication was documented in a biocompatibility evaluation report and the benefit / riskrelation has been judged as positive.

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Heraeus

(2) Clinical evaluation
In accordance with the Medical Device Directive 93/24/EEC and National European medical device evaluation, any medical device is requested to be evaluated by the legal medical device manufacturer regarding its clinical performance and safety. This includes a clinical evaluation in accordance with MEDDEV 2.7.1, which is intended to critically evaluate the clinical benefits of the medical device in comparison to its potential risks. Therefore, a clinical evaluation is part of the compulsory risk management process according to ISO 14971, and critical findings must further be considered in the current risk management process of the medical device manufacturer responsible for the evaluated device.

On this background, the clinical evaluation was performed in order to comply with the current European medical device legislation, in particular with MEDDEV 2.7.1. This critical evaluation followed the procedures outlined in the corresponding clinical evaluation plan.

PalaXpress ultra is classified according to annex IX of council directive 93/42/EEC as a class lla medical device.

PalaXpress ultra represents as well-known type of acrylic denture base material which has proven to exhibit the expected performance and clinical effectiveness. There is no hint for undesirable effect and potential risks when PalaXpress ultra is applied according to the instructions for use. Considering the evaluated data and technical results for PalaXpress ultra it is concluded that the product will exhibit that claimed clinical and technical performance and that potential undesirable clinical effects and risks seem well controlled and acceptable when weighed against their benefits in dentistry. Therefore, the benefits versus risks ratio was stated to be positive for PalaXpress ultra, provided that the product is applied in accordance with its intended use according to the manufacturer's information for use. Nevertheless, a risk for irritation or sensitization in susceptible patients or users due to the contact with PalaXpress ultra cannot be excluded.

The clinical report was carried out in accordance with MEDDEV 2.7.1 and followed the provisions of the corresponding clinical evaluation plan.

(c) Conclusion

The risk potential of the denture base resin PalaXpress ultra was proven. All properties of the product were verified successfully.

The biological compatibility of the denture base resin was investigated to evaluate the toxicological risk. A biological evaluation report has confirmed that the product PalaXpress ultra meets the requirements of ISO 10993 standard. The results were discussed in the biological evaluation report and the benefit / risk relation has been judge as positive.

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The physical properties of PalaXpress ultra were determined in accordance with ISO 20795-1 for denture base polymers. All properties comply with and exceed the requirements of the standard. This is stated in section (4),

Based on the results of the clinical evaluation report it is concluded that the product can be expected to exhibit the claimed technical performance and that potential undesirable clinical effects and risks seem well controlled and acceptable when weighed against their benefits in dentistry. The risk analysis according to ISO 14971 was carried out for PalaXpress ultra and showed that the application of the product according to the manufacturer's instruction for use can be considered as safe.

PalaXpress ultra meets all relevant requirements for denture base resins in accordance with the Medical Device Directive 93/42/EEC and National European medical device legislation. Based on the actual facts PalaXpress ultra is considered to be effective and safe when used in accordance with the manufacturer's instructions for use.

Wehrheim, April 29, 2011

Dr. K. Ruppert

A. Keishold

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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is an abstract image of an eagle.

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

Ms. Cheryl Zimmerman Director, Quality Assurance & Regulatory Affairs Heraeus Kulzer, LLC 300 Heraeus Way South Bend, Indiana 46614

APR 2 9 2011

Re: K110037

Trade/Device Name: PalaXpress Ultra Regulation Number: 21 CFR 872.3760 Regulation Name: Denture Relining, Repairing or Rebasing Resin Regulatory Class: II Product Code: EBI Dated: April 1, 2011 Received: April 6, 2011

Dear Ms. Zimmerman:

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 mendments, 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 the I cuclar F ood, Drug, and Cosmono, therefore, market the device, subject to the general approvisions 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 (1 vir 1), it may of basyone adde of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Eederal Register.

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Page 2- Ms. Zimmerman

Please be advised that FDA's issuance of a substantial equivalence determination does not Frease be auvised that I DT 3 losaaliso on that your device complies with other requirements Incall that IDA has made a deceminary and regulations administered by other Federal agencies. of the Act of ally I edelar statules and regirements, including, but not limited to: registration Tourinust comply with an the Hot reveal 801); medical device reporting and namig (21 OF R F & F & F & F & F & C S (21 CFR 803); good manufacturing of (reporting of medical as not for the quality systems (QS) regulation (21 CFR Parl 820); practice requirements as occreent in the 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), 11 you desire specific au fida gov/AboutFDA/CentersOffices/CDRH/CDRHOffices prease go to intp. for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to Compilance: "Theo, preace in to are 807.97). For questions regarding the reporting of promation nothlead.org ( 1 CFR Part 803), please go to http://www.fda.goy/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 I ou nikel 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,

h 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 (if known): /( / 0 0 3 7

Device Name:

Indications for use:

Universal high fracture resistant denture base material. Used with injection or pouring techniques for fixed or removable dentures.

Injection procedure:

Full maxillary and mandibular prostheses
Implant over denture
Pouring procedure:
Implant over denture
Partial dentures. Multiple or single saddles
Marginal contour and reshaping
Repairs and additions
Relines
Dental splints

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

Over-The-Counter Use(21 CFR 807 Subpart C)
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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)
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Tusar Kumpa

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

Page 1 of _1

510(k) Number: K110037

Regulation Number and Section

§ 872.3760 Denture relining, repairing, or rebasing resin.

(a)
Identification. A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.(b)
Classification. Class II.