(164 days)
Ceramill A-Splint is indicated for the fabrication of removable bite splints.
Ceramill A-Splint are ready to use, polymethyl methacrylate (PMMA) based computer-aided design/computer-aided manufacturing (CAD-CAM) blanks, for milling splints. Ceramill A-Splint is available as a disk (round form) or as an arch-form (or "U"-shape).
This document, concerning the Ceramill A-Splint, primarily details a substantial equivalence determination by the FDA for a medical device and does not describe the acceptance criteria and a study proving a device meets them in the context of an AI/algorithmic device. There is no mention of AI, machine learning, or software performance in this document.
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving device performance using AI or algorithmic methods from the provided text.
The closest information available that might relate to "acceptance criteria" for this device, which is a physical material for dental applications, are the bench performance testing results compared against the ISO 20795-2:2013 standard.
Here's a breakdown of what can be extracted, interpreting "acceptance criteria" as the performance requirements from the referenced international standard for the physical materials:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Attribute | Acceptance Criteria (from ISO 20795-2:2013) | Ceramill A-Splint Performance | Predicate Device (M-PM-Disc) Performance | Comparison to Predicate / Acceptance |
|---|---|---|---|---|
| Residual Monomer | < 1% (implied by predicate) | < 1% | < 1% | Same; meets ISO 20795-2:2013 (<5) |
| 3-Point Bending Strength | ≥ 50 MPa | > 100 MPa | 91.5 MPa - 96.6 MPa | Similar; meets ISO 20795-2:2013 (≥50) |
| Water Solubility | ≤ 5 µg/mm³ | < 0.7 µg/mm³ | 0.2 µg/mm³ | Similar; meets ISO 20795-2:2013 (≤5) |
| Water Absorption | ≤ 32 µg/mm³ | < 25 µg/mm³ | 26.5 µg/mm³ | Similar; meets ISO 20795-2:2013 (≤32) |
| Flexural Modulus | ≥ 1500 MPa | ≥ 2000 MPa | Unknown | Meets ISO 20795-2:2013 (≥1500) |
| Fracture Toughness (Kmax) | ≥ 1.1 MPa m½ | ≥ 1.1 MPa m½ | Unknown | Meets ISO 20795-2:2013 (≥1.1) |
| Fracture Toughness (Wf) | ≥ 250 J/m² | ≥ 250 J/m² | Unknown | Meets ISO 20795-2:2013 (≥250) |
| Polishability | Meets standard requirements | Passed testing | Not explicitly stated | Passed |
| Porosity | Meets standard requirements | Passed testing | Not explicitly stated | Passed |
| Biocompatibility (Cytotoxicity) | No cytotoxic effects expected | No cytotoxic effects observed | Not explicitly stated | Passed (based on ISO 10993-1) |
Regarding the other requested information (which are typically relevant for AI/algorithmic device studies):
- Sample size used for the test set and the data provenance: Not applicable. This is not an AI/algorithmic device, but a physical material. The "test set" here refers to samples of the material itself for physical and chemical property testing. No specific sample sizes for these bench tests are provided in the summary.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for material properties is established through standardized laboratory testing methods, not expert consensus in the way clinical AI ground truth is established.
- Adjudication method for the test set: Not applicable.
- 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 not an AI device.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an algorithmic device.
- The type of ground truth used: For the physical material properties, the "ground truth" is derived from established, standardized laboratory measurement techniques (e.g., ISO 20795-2:2013 for dental polymers, ISO 10993-1 for biocompatibility).
- The sample size for the training set: Not applicable. This is not an AI/algorithmic device, so there is no "training set."
- How the ground truth for the training set was established: Not applicable.
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December 20, 2019
Amann Girrbach AG % Rachel Paul Senior Consultant QA & RA Emergo Europe Consulting Prinsessegracht 20 The Hague, 2514AP N1
Re: K191836
Trade/Device Name: Ceramill A-Splint Regulatory Class: Unclassified Product Code: MQC Dated: October 28, 2019 Received: October 31, 2019
Dear Rachel Paul:
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/cfpmn/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
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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 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 mediation-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,
for Srinivas "Nandu" Nandkumar, Ph.D. Director DHT1B: Division of Dental 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) K191836
Device Name
Ceramill A-Splint
Indications for Use (Describe)
Ceramill A-Splint is indicated for the fabrication of removable bite splints.
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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510(k) K191836 Summary
Ceramill A-Splint
1. Submission Sponsor
Amann Girrbach AG
Herrschaftswiesen 1
6842 Koblach
AUSTRIA
Contact: Debora Engel
Title: Regulatory Affairs Manager
Email: Debora.engel@amanngirrbach.com
Office number: + 49 (7231) 957-260
2. Submission Correspondent
Emergo Europe Consulting
Prinsessegracht 20
The Hague, 2514 AP
THE NETHERLANDS
Office Phone: +31 (0) 70 345 8570 / Direct: +31 (0) 70 850 8249
Contact: Rachel Paul
Title: Senior Consultant, QA & RA
Email: LST.AUS.ProjectManagement@ul.com
Cell Phone : 00 6 89 83 16 09
- Date Prepared
28 October 2019
-
- Device Identification
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Trade/Proprietary Name: Ceramill A-Splint Common/Usual Name: Occlusal splints Classification Name: Mouthguard, Prescription N/A - Unclassified Regulation Number: Product Code: MQC Device Class: N/A - Unclassified Classification Panel: Dental
5. Legally Marketed Predicate Device
K134015, M-PM-Disc (Clear), Merz Dental GmbH
6. Indication for Use Statement
Ceramill A-Splint is indicated for the fabrication of removable bite splints.
7. Device Description
Ceramill A-Splint are ready to use, polymethyl methacrylate (PMMA) based computer-aided design/computer-aided manufacturing (CAD-CAM) blanks, for milling splints. Ceramill A-Splint is available as a disk (round form) or as an arch-form (or "U"-shape).
8. Comparison of Technology
The following table compares the Ceramill A-Splint to the predicate device with respect to indications for use, principles of operation, technological characteristics, and performance testing. The comparison of the devices provides more detailed information regarding the basis for the determination of substantial equivalence. There are no differences in technology.
| Attribute | Ceramill A-Splint | M-PM-Disc | Comparison |
|---|---|---|---|
| Manufacturer | Amann Girrbach AG | Merz Dental GmbH | N/A |
| 510(k) Number | To be determined (TBD) | K134015 | N/A |
| Product Code | MQC | MQC | Same |
| RegulationReference | Unclassified | Unclassified | Same |
| Indications for Use | Ceramill A-Splint isindicated for the | The Merz Dental GmbHM-PM-Disc (Clear) isindicated for the | Similar; both devices areindicated for theproduction of removable |
| Attribute | Ceramill A-Splint | M-PM-Disc | Comparison |
| fabrication of removablebite splints. | fabrication of removablebite splints such asmouthguards andnightguards. | bite splints. Theindications for use ofCeramill A-Splint fallwithin the intended use ofunclassified mouthguarddevices. Both devices arefor prescription only. | |
| Material | SolidPolymethylmethacrylate(PMMA)No pigments | SolidPolymethylmethacrylate(PMMA)No pigments | Same |
| Residual monomer | Less than 1% residualmonomer | Less than 1% residualmonomer | Same; both devices meetrequirements from ISO20795-2:2013 (<5). |
| Shape, sizes | Available in round andarch shapes respectivelyof 98 and 71 mm withthree (3) different height(14, 16, 20 mm). | Available only in roundshape from 90 x 15 to114.8 x 25 mm. | Similar; the arch shapedoes not introduce anyadditional safety orefficacy concerns.Dimensions are in thesame range. |
| 3-point bendingstrength | >100 MPa | 91.5 MPa - 96.6 MPa | Similar; the specificationsare in the same range.This minor variance doesnot introduce additionalsafety or efficacyconcerns. Both devicesmeet requirements fromISO 20795-2:20131 (≥50). |
| Water solubility | <0.7 µg/mm3 | 0.2 µg/mm³ | Similar; the specificationsare in the same range.This minor variance doesnot introduce additionalsafety or efficacyconcerns. |
| Attribute | Ceramill A-Splint | M-PM-Disc | Comparison |
| Both devices meetrequirements from ISO20795-2:2013 (≤5). | |||
| Water absorption | <25 µg/mm3 | 26.5 µg/mm³ | Similar; the specificationsare in the same range.This minor variance doesnot introduce additionalsafety or efficacyconcerns.Both devices meetrequirements from ISO20795-2:2013 (≤32). |
| Flexural modulus | ≥ 2000 MPa | Unknown | The submission devicemeet requirements fromISO 20795-2:2013 (≥1500). |
| Fracture toughness(maximum stressintensity (Kmax) andtotal fracture work(Wf)) | Kmax≥ 1.1 MPa m1/2Wf ≥ 250 J/m² | Unknown | The submission devicemeet requirements fromISO 20795-2:2013 (Kmax ≥1.1 and Wf≥ 250). |
| Sterile | Delivered and use non-sterile | Delivered and use non-sterile | Same |
| Single-Use | Yes | Yes | Same |
| Complies with ISO10993-1 | Yes | Yes | Same |
Table 5A - Comparison of Technology
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¹ ISO 20795-2 :2013 Dentistry – Base polymers : Part 2 : Orthodontic base polymers (FDA Recognition Number: 4-233).
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9. Non-Clinical Performance Data
To demonstrate safety and effectiveness of Ceramill A-Splint and to show substantial equivalence to the predicate device, Amann Girrbach AG completed the following non-clinical tests.
The Ceramill A-Splint passed the testing in accordance with internal requirements, national standards, and international standards shown below:
- . Biocompatibility assessment was conducted according to ISO 10993-1. Considering the chemically defined composition, the existing dental history with PMMA polymers and the inert material properties substantiated by highly sensitive chemical analysis, it was determined that no other
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biocompatibility testing than cytotoxicity testing was required. No cytotoxic effects were observed in presence of the test material extracts.
- . Bench performance testing conducted in conformity with ISO 20795-2:2013 met all of the requirements set forth in the standard for residual monomer testing, 3-point bending strength, water solubility, water absorption, flexural modulus, fracture toughness, polishability, and porosity.
- Wearing testing based on an adapted Ivoclar method in a chewing simulator – the wearing period has been determined to be of a maximum of three years.
- . Shelf Life Testing – it was demonstrated that key characteristics do not degrade after four years of storage.
10. Conclusion
Based on similarities in intended use, indications for use statements, technology, and non-clinical performance testing, Amann Girrbach believes that Ceramill A-Splint is substantially equivalent to the predicate device (K134015).
N/A