(284 days)
Thermeo powder / Thermeo liquid is a heat cured, moldable, acrylic compound system for use in the fabrication of dental appliances such as mouthguards, bruxism and TMJ splint appliances, and bite splints.
The Thermeo blank is a disc intended for the fabrication of dental appliances such as mouthguards, buxism and TMJ splint appliances, and bite splints using CAD/CAM milling machines.
The Thermeo powder/Thermeo liquid is a two-compound mixable device, containing a powder component and a liquid component. The device is heat cured for the fabrication of dental appliances.
The Thermeo blanks are pre-made by pro3dure using the two-part mixable device. The Thermeo blank is intended to be used in conjunction with CAD/CAM milling technology systems.
The provided document is an FDA 510(k) Premarket Notification for a dental device, the "Thermeo System." It is a regulatory submission for establishing substantial equivalence to existing devices, not a study reporting on the performance of an AI/ML diagnostic system.
The request asks for information typically found in clinical validation studies for AI/ML-driven medical devices, such as:
- Acceptance criteria and device performance table.
- Sample size and data provenance for test sets.
- Number and qualifications of experts for ground truth.
- Adjudication method.
- MRMC study details and effect size.
- Standalone algorithm performance.
- Type of ground truth used.
- Training set sample size.
- Ground truth establishment for training set.
This document, however, describes a physical dental material system (Thermeo powder/liquid and Thermeo blank for dental appliances) and its substantial equivalence to predicate devices based on material properties, manufacturing processes, and safety (biocompatibility, shelf life), not on the diagnostic performance of an algorithm.
Therefore, most of the information requested, which pertains to the validation of an AI/ML diagnostic algorithm, cannot be extracted from this document, as it is not relevant to the Thermeo System's 510(k) submission.
Here's what can be gathered, addressing the relevant parts of your request within the context of this device:
1. A table of acceptance criteria and the reported device performance:
The document indicates that performance testing was conducted according to ISO 20795-2 for the "Thermeo System." This standard covers dental base polymers. The specific mechanical properties measured were:
- Flexural modulus
- Flexural Strength
- Tensile Strength
- Elongation at Break
However, the document does not provide a table with specific acceptance criteria values (e.g., minimum flexural strength) nor the numerical results (reported device performance) for these tests. It only states that testing was "performed in accordance with" the standard. For a 510(k), demonstrating compliance with a recognized standard often suffices without explicitly listing all raw data in the summary.
2. Sample sized used for the test set and the data provenance:
- Sample Size: Not specified in the provided text.
- Data Provenance: The device manufacturer, Pro3dure Medical GmbH, is located in Germany. Testing would likely be conducted at their facilities or a contracted lab. The document does not specify if the testing was retrospective or prospective in terms of data collection for this type of material performance test.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This is a physical material compliance test, not a diagnostic algorithm requiring expert ground truth for images. Performance is measured using standardized mechanical and chemical testing methods.
4. Adjudication method for the test set:
- Not Applicable. See point 3.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No. This is not an AI/ML diagnostic device, so an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical material, not an algorithm.
7. The type of ground truth used:
- For the performance testing (flexural modulus, strength, etc.), the "ground truth" is established by physical measurement results obtained through standardized testing protocols (ISO 20795-2).
- For biocompatibility, the "ground truth" is established by biocompatibility testing in accordance with ISO 10993-1, which assesses biological responses.
- For shelf-life, the "ground truth" is established by accelerated aging and real-time stability testing per ASTM F1980-16.
8. The sample size for the training set:
- Not Applicable. There is no "training set" as this is not a machine learning device.
9. How the ground truth for the training set was established:
- Not Applicable. See point 8.
In summary, the provided document is a regulatory submission for a physical dental product, and the requested performance evaluation criteria are primarily applicable to AI/ML diagnostic software, which is not the subject of this 510(k).
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 8, 2022
Pro3dure Medical GmbH Frank Gischer Technical Director Am Burgberg 13 Iserlohn, 58642 DEU GERMANY
Re: K212017
Trade/Device Name: Thermeo System Regulatory Class: Unclassified Product Code: MQC Dated: February 28, 2022 Received: March 10, 2022
Dear Frank Gischer:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmp/pmn.cfm identifies combination product submissions. 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.
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
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https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K212017
Device Name Thermeo System
Indications for Use (Describe)
Thermeo powder / Thermeo liquid is a heat cured, moldable, acrylic compound system for use in the fabrication of dental appliances such as mouthguards, bruxism and TMJ splint appliances, and bite splints.
The Thermeo blank is a disc intended for the fabrication of dental appliances such as mouthguards, buxism and TMJ splint appliances, and bite splints using CAD/CAM milling machines.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| > Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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5. 510(k) Summary
| 510(k) Number: | K212017 |
|---|---|
| Device Trade Name: | Thermeo System |
| Manufacturer: | Pro3dure Medical GmbHAm Burgberg 1358642 IserlohnGermany |
| Contact: | Mr. Frank GischerPhone: +49 (0)2374 920050-14Fax: +49 (0)2374 920050-50Frank.gischer@pro3dure.com |
| Prepared by: | Ms. Patricia KontoudisConsultant, Regulatory Affairs 804Umbra St.Baltimore, MD, 21224Phone: (443)722-0126pkontoudis@gmail.com |
| Date Prepared: | April 1, 2022 |
| Classification: | Unclassified |
| Product Codes: | MQC |
| Primary Predicate Device: | Astron Dental Clearsplint ES (K111828) |
| Additional Predicate Device: | New Stetic S.A. Portux CAD/CAM Disc (K192153) |
| Reference Device: | Pro3dure GR-17 Resin System (K201827)Pro3dure GR Splint Resin System (K211415). |
| Indications for Use: | Thermeo powder / Thermeo liquid is a heat cured,moldable, acrylic compound system for use in thefabrication of dental appliances such as mouthguards,nightguards, bruxism and TMJ splint appliances, and bitesplints.The Thermeo blank is a disc intended for the fabrication of dentalappliances such as mouthguards, nightguards, bruxism andTMJ splint appliances, and bite splints using CAD/CAMmilling machines. |
| Device Description: | The Thermeo powder/Thermeo liquid is a two-compoundmixable device, containing a powder component and a liquidcomponent. The device is heat cured for the fabrication of dentalappliances. |
| The Thermeo blanks are pre-made by pro3dure using thetwo-part mixable device. The Thermeo blank is intended to beused in conjunction with CAD/CAM milling technologysystems. | |
| Performance Testing: | Performance testing for the Thermeo System was performedin accordance with ISO 20795-2 including Flexuralmodulus, Flexural Strength, Tensile Strength, and Elongation atBreak. |
| Biocompatibility: | Biocompatibility testing was conducted in accordance withISO 10993-1. |
| Shelf-Life: | The shelf life of the Thermeo System is 2 years. Testingwas performed in accordance with ASTM F1980-16. |
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| Subject Device | Predicate Device | Additional Predicate Device | |
|---|---|---|---|
| Device | Thermeo System | Clearsplint ES(K111828) | Portux CAD/CAMDisc (K192153) |
| Manufacturer | Pro3dure Medical GmbH | ASTRON DENTALCORPORATION | New Stetic S.A. |
| Indications for use | Thermeo powder /Thermeo liquid is a heatcured, moldable, acryliccompound system for usein the fabrication of dentalappliances such asmouthguards, nightguards,bruxism and TMJ splintappliances, and bite splints.The Thermeo blank is adisc intended for thefabrication of dentalappliances such asmouthguards, nightguards,bruxism and TMJ splintappliances, and bite splintsusing CAD/CAM millingmachines. | Clearsplint ES is a heatcured, moldable, acryliccompound for use in thefabrication of dentalappliances and dentalprostheses devicesincluding TMJ splintappliances, night guards,bruxism appliances andother devices as prescribed. | For the fabrication ofcrowns, bridges andstructures for implantsupported provisionalremovable denture andappliance prosthetics.- Provisional anterior andposterior crowns & bridges- Implant and abutmentsupported prosthetics.- Partial, complete andhybrid denture prosthetics(base and teeth) -Removable appliances(splint) |
| Comparison: The indications for the subject and the predicate devices include removable dentalappliances. | |||
| Chemical Description | Methyl methacrylate-,BPA- and silicone-freematerial | Methyl methacrylate-,BPA- and silicone-freematerial | Polymethylmethacrylate |
| Comparison: The subject and the predicate devices have similar chemical characterization. | |||
| ManufacturingTechnology | Thermeo powder /Thermeo liquid: Heat curedThermeo blank:CAD/CAM millingtechnology systems. | Clearsplint ES:Heat cured | CAD/CAM millingtechnology systems. |
| Comparison: The subject and the predicate devices fabricate the final product by the sameprocesses. | |||
| Product State | Powder Liquid SystemBlank | Powder Liquid System | Blank |
| Comparison: The subject and the predicate devices are provided in the same physical states. | |||
| Performance Testing | ISO 20795-2 | ISO 20795-2 | ISO 20795 |
| Comparison: The subject and the predicate devices comply with the same performance standards. | |||
| Biocompatibility | ISO 10993 | ISO 10993 | ISO 10993 |
| Comparison: The subject and the predicate devices comply with the same biocompatibility standards. |
Comparison to Predicate:
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Conclusion:
The Thermeo System is substantially equivalent in indications, technical characteristics, function, material. Performance, biocompatibility, and shelf life to the predicate device.
N/A